Showing papers in "Pilot and Feasibility Studies in 2015"

Pilot and feasibility studies come of age

Abstract: This editorial introduces the new, online, open-access journal Pilot and Feasibility Studies. The journal considers manuscripts on any aspect of the design and analysis of pilot and feasibility studies, as well as protocols for pilot and feasibility studies, and discussions and reviews of methodological issues around the planning and reporting of such studies. These studies are generally carried out in preparation for future large-scale definitive randomised controlled trials or observational studies and address key issues of uncertainty. Objectives for conducting pilot and feasibility studies therefore differ from those of the future large-scale study and should be clearly expressed. The journal provides a dedicated place for publication of this important work as well as a forum for discussion of methodological issues that will lead to increased scientific rigour in this area.

Maximising the impact of qualitative research in feasibility studies for randomised controlled trials: guidance for researchers

Abstract: Feasibility studies are increasingly undertaken in preparation for randomised controlled trials in order to explore uncertainties and enable trialists to optimise the intervention or the conduct of the trial. Qualitative research can be used to examine and address key uncertainties prior to a full trial. We present guidance that researchers, research funders and reviewers may wish to consider when assessing or undertaking qualitative research within feasibility studies for randomised controlled trials. The guidance consists of 16 items within five domains: research questions, data collection, analysis, teamwork and reporting. Appropriate and well conducted qualitative research can make an important contribution to feasibility studies for randomised controlled trials. This guidance may help researchers to consider the full range of contributions that qualitative research can make in relation to their particular trial. The guidance may also help researchers and others to reflect on the utility of such qualitative research in practice, so that trial teams can decide when and how best to use these approaches in future studies.

The person-based approach to enhancing the acceptability and feasibility of interventions

Abstract: Background: This paper provides three illustrations of how the “person-based approach” can be used to assess and enhance the acceptability and feasibility of an intervention during the early stages of development and evaluation. The person-based approach involves using mixed methods research to systematically investigate the beliefs, attitudes, needs and situation of the people who will be using the intervention. The in-depth understanding of users’ perspectives derived from this research then enables intervention developers to design or modify the intervention to make it more relevant, persuasive, accessible and engaging. Methods: The first illustration describes how relevant beliefs and attitudes of people with asthma were identified from the existing qualitative and quantitative literature and then used to create guiding principles to inform the design of a web-based intervention to improve quality of life. The second illustration describes how qualitative “think-aloud” interviews and patient and public involvement (PPI) input are used to improve the acceptability of a booklet for people with asthma. In the third illustration, iterative think-aloud methods are used to create a more accurate and accessible activity planner for people with diabetes. Results: In the first illustration of the person-based approach, we present the guiding principles we developed to summarise key design issues/objectives and key intervention features to address them. The second illustration provides evidence from interviews that positive, non-medical messages and images were preferred in booklet materials for people with asthma. The third illustration demonstrates that people with diabetes found it difficult to complete an online activity planner accurately, resulting in incorrect personalised advice being given prior to appropriate modification of the planner. Conclusions: The person-based approach to intervention development can complement theory- and evidence-based development and participant input into intervention design, offering a systematic process for systematically investigating and incorporating the views of a wide range of users.

A new era for intervention development studies

Abstract: This editorial introduces a new special series on intervention development in the on-line open access journal Pilot and Feasibility Studies. An intervention development study reports the rationale, decision-making processes, methods and findings which occur between the idea or inception of an intervention until it is ready for formal feasibility, pilot or efficacy testing prior to a full trial or evaluation. This editorial begins to explore some of the challenges associated with this early research stage. It commences a debate about how to produce novel interventions which are fit for purpose and which solve important health and social care problems. By transparently reporting more intervention development studies, scientific rigour will be improved and everyone can learn from the experiences of others.

"Not just another walking program": Everyday Activity Supports You (EASY) model—a randomized pilot study for a parallel randomized controlled trial

Abstract: Maintaining physical activity is an important goal with positive health benefits, yet many people spend most of their day sitting. Our Everyday Activity Supports You (EASY) model aims to encourage movement through daily activities and utilitarian walking. The primary objective of this phase was to test study feasibility (recruitment and retention rates) for the EASY model. This 6-month study took place in Vancouver, Canada, from May to December 2013, with data analyses in February 2014. Participants were healthy, inactive, community-dwelling women aged 55–70 years. We recruited through advertisements in local community newspapers and randomized participants using a remote web service. The model included the following: group-based education and social support, individualized physical activity prescription (called Activity 4-1-1), and use of a Fitbit activity monitor. The control group received health-related information only. The main outcome measures were descriptions of study feasibility (recruitment and retention rates). We also collected information on activity patterns (ActiGraph GT3X+ accelerometers) and health-related outcomes such as body composition (height and weight using standard techniques), blood pressure (automatic blood pressure monitor), and psychosocial variables (questionnaires). We advertised in local community newspapers to recruit participants. Over 3 weeks, 82 participants telephoned; following screening, 68% (56/82) met the inclusion criteria and 45% (25/56) were randomized by remote web-based allocation. This included 13 participants in the intervention group and 12 participants in the control group (education). At 6 months, 12/13 (92%) intervention and 8/12 (67%) control participants completed the final assessment. Controlling for baseline values, the intervention group had an average of 2,080 [95% confidence intervals (CIs) 704, 4,918] more steps/day at 6 months compared with the control group. There was an average between group difference in weight loss of −4.3 [95% CI −6.22, −2.40] kg and reduction in diastolic blood pressure of −8.54 [95% CI −16.89, −0.198] mmHg, in favor of EASY. The EASY pilot study was feasible to deliver; there was an increase in physical activity and reduction in weight and blood pressure for intervention participants at 6 months. ClinicalTrials.gov identifier: NCT01842061

Feasibility of titrating PEEP to minimum elastance for mechanically ventilated patients

Abstract: Selecting positive end-expiratory pressure (PEEP) during mechanical ventilation is important, as it can influence disease progression and outcome of acute respiratory distress syndrome (ARDS) patients. However, there are no well-established methods for optimizing PEEP selection due to the heterogeneity of ARDS. This research investigates the viability of titrating PEEP to minimum elastance for mechanically ventilated ARDS patients. Ten mechanically ventilated ARDS patients from the Christchurch Hospital Intensive Care Unit were included in this study. Each patient underwent a stepwise PEEP recruitment manoeuvre. Airway pressure and flow data were recorded using a pneumotachometer. Patient-specific respiratory elastance (E rs ) and dynamic functional residual capacity (dFRC) at each PEEP level were calculated and compared. Optimal PEEP for each patient was identified by finding the minima of the PEEP-E rs profile. Median E rs and dFRC over all patients and PEEP values were 32.2 cmH2O/l [interquartile range (IQR) 25.0–45.9] and 0.42 l [IQR 0.11–0.87]. These wide ranges reflect patient heterogeneity and variable response to PEEP. The level of PEEP associated with minimum E rs corresponds to a high change of functional residual capacity, representing the balance between recruitment and minimizing the risk of overdistension. Monitoring patient-specific E rs can provide clinical insight to patient-specific condition and response to PEEP settings. The level of PEEP associated with minimum-E rs can be identified for each patient using a stepwise PEEP recruitment manoeuvre. This ‘minimum elastance PEEP’ may represent a patient-specific optimal setting during mechanical ventilation. Australian New Zealand Clinical Trials Registry: ACTRN12611001179921 .

Reducing dementia risk by targeting modifiable risk factors in mid-life:: Study protocol for the Innovative Midlife Intervention for Dementia Deterrence (In-MINDD) randomised controlled feasibility trial

Abstract: Dementia prevalence is increasing as populations live longer, with no cure and the costs of caring exceeding many other conditions. There is increasing evidence for modifiable risk factors which, if addressed in mid-life, can reduce the risk of developing dementia in later life. These include physical inactivity, low cognitive activity, mid-life obesity, high blood pressure, and high cholesterol. This study aims to assess the acceptability and feasibility and impact of giving those in mid-life, aged between 40 and 60 years, an individualised dementia risk modification score and profile and access to personalised on-line health information and goal setting in order to support the behaviour change required to reduce such dementia risk. A secondary aim is to understand participants’ and practitioners’ views of dementia prevention and explore the acceptability and integration of the Innovative Midlife Intervention for Dementia Deterrence (In-MINDD) intervention into daily life and routine practice. In-MINDD is a multi-centre, primary care-based, single-blinded randomised controlled feasibility trial currently being conducted in four European countries (France, Ireland, the Netherlands and the UK). Participants are being recruited from participating general practices. Inclusion criteria will include age between 40 and 60 years; at least one modifiable risk factor for dementia risk (including diabetes, hypertension, obesity, renal dysfunction, current smoker, raised cholesterol, coronary heart disease, current or previous history of depression, self-reported sedentary lifestyle, and self-reported low cognitive activity) access to the Internet. Primary outcome measure will be a change in dementia risk modification score over the timescale of the trial (6 months). A qualitative process evaluation will interview a sample of participants and practitioners about their views on the acceptability and feasibility of the trial and the links between modifiable risk factors and dementia prevention. This work will be underpinned by Normalisation Process Theory. This study will explore the feasibility and acceptability of a risk profiler and on-line support environment to help individuals in mid-life assess their risk of developing dementia in later life and to take steps to alleviate that risk by tackling health-related behaviour change. Testing the intervention in a robust and theoretically informed manner will inform the development of a future, full-scale randomised controlled trial. ISRCTN Registry: ISRCTN 98553005 (DOI: 10.1186/ISRCTN98553005 ).

Journeying through Dementia, a community-based self-management intervention for people aged 65 years and over : a feasibility study to inform a future trial

Abstract: A study to determine the feasibility of conducting a future population-based trial into a self-management intervention for community-living adults with early stage dementia included evaluation of intervention content and modes of delivery, staffing requirements, recruitment methods and the utility and usability of patient reported outcomes. Participants identified through memory clinics in one city took part in an intervention called ‘Journeying through Dementia’. The 12-week programme incorporating four individual sessions with one of the facilitators encourages participants to engage in discussion and activities related to health and well-being positioning them as the expert enabling long-term behavioural change. Participants (n = 10) and their nominated carers (n = 7) were all asked to complete selected outcomes at baseline, 8 weeks (participants only) and post intervention and invited to comment on their usability. All participants and carers were qualitatively interviewed before intervention delivery about their expectations and participants; nominated carers and facilitators were all interviewed after cessation about their experiences. The manualised intervention and modes of delivery proved acceptable to participants and carers. Reported benefits included increased confidence and self-efficacy, engagement in new or lapsed activities and re-engagement in fun and friendships. People with dementia and carers were able to self-complete all outcome measures, but time required to complete the measures is a key factor. Strategies for recruitment need to include direct contact within 24–48 h post invitation to the study. Analysis of data on the primary outcome did not reveal any trends. Facilitators found the training and support to be appropriate and helpful. The tailored intervention reportedly met the needs of all participants. The study confirmed the need for careful identification and application of patient-reported outcome measures. Outcomes to measure some dimensions of reported benefit are not available. Current Controlled Trials ISRCTN67209155 .

Rhythmic cued motor imagery and walking in people with multiple sclerosis: a randomised controlled feasibility study

Abstract: Novel physiotherapy approaches such as motor imagery and rhythmic auditory stimulation have been shown to improve walking in people with multiple sclerosis (MS). Rhythmic cued motor imagery was used in this study, whose objectives were to evaluate the feasibility of a larger randomised controlled trial (RCT) in people with MS and to obtain information on walking. Thirty adult people with MS who scored 1.5–4.5 on the Expanded Disability Status Scale were recruited at the MS Clinic Innsbruck, Austria. Participants were randomly allocated to one of three groups, all receiving usual care: 17 min of motor imagery, six times per week, for 4 weeks, with music (A) or metronome cues (B) and (C) controls. Primary outcomes were recruitment rates, retention, compliance, adverse events and fatigue (Modified Fatigue Impact Scale). Secondary outcomes were walking speed (Timed 25-Foot Walk) and walking distance (6-Minute Walk Test). We achieved our recruitment target by recruiting 12 participants per month, a mean eligibility rate of 40.1 % (95 % confidence interval (CI) 35.8, 44.6 %) out of 2500 MS Centre patients, mean consent rate of 15.9 % (95 % CI 11.3, 21.7 %) plus 54.5 % (95 % CI 47.4, 61.4 %) of eligible patients who expressed their interest to participate. Retention of 100 %, no adverse events, good compliance, high acceptability of the interventions and no worsening of fatigue confirmed feasibility. The mean improvement in walking speed in both groups A and B was −0.9 s (95 % CI −1.3, −0.5), and mean worsening in group C was 0.4 s (95 % CI −0.3, 1.1). The mean improvement in walking distance in group A was 68.1 m (95 % CI 51.4, 84.7) and in group B 92.9 m (95 % CI 55.2, 130.5), and mean worsening in group C was −9.4 m (95 % CI −35.6, 16.9). Results from our study showed that a full-scale RCT is feasible to investigate the effects of rhythmic cued motor imagery on walking in people with MS, with no changes to the interventions and assessments. Based on the walking improvements, a total sample size of 138 participants was calculated. Stratified blocked randomisation, allocation concealment and blinding will be used in the main study. ISRCTN: ISRCTN67054113

Exploring the Determinants of Suicidal Behavior: Conventional and Emergent Risk (DISCOVER): a feasibility study

Abstract: Suicidal behavior is a growing public health concern resulting in morbidity and premature death. Although certain factors such as age, sex, and psychiatric disorders have been consistently reported to be associated with suicidal behavior, other factors including biological markers, diet, and physical activity may also influence suicidal behavior. The purpose of this pilot study was to evaluate the feasibility of conducting a full-scale study to identify the conventional and novel risk factors of suicidal behavior in individuals who made a recent suicide attempt. This pilot study was a case-control study of participants with recent (within 1 month of admission) suicide attempts admitted to hospital and compared to two control groups: 1) psychiatric inpatient participants without a history of suicide attempts and 2) community-based controls. We collected information on demographic variables, circumstances of suicide attempts (for cases), medical and psychiatric diagnoses, behavioral patterns, physical measurements, and social factors. Blood and urine samples were also collected for biological markers. Feasibility outcomes are as follows: 1) 50 % of all eligible cases will consent to participate, 2) 50 cases and 100 controls per year can be recruited, and 3) at least 80 % of the participants will provide blood samples for DNA and biological markers. We recruited 179 participants in total; 51 cases, 57 psychiatric controls without suicide attempt, and 71 non-psychiatric controls in Hamilton, Ontario. Recruitment rate was 70 % (213/304), and we obtained urine and blood specimens from 90 % (191/213) of participants. Questionnaire completion rates were high, and data quality was very good with few data-related queries to resolve. We learned that cases tended to be hospitalized for long periods of time and the suicide attempt occurred more than a month ago in many of the cases; therefore, we expanded our inclusion criterion related to timing of suicide attempt to 3 months instead of 1 month. The study procedures needed certain modifications including extending the time between suicide attempt and date of recruitment, and more detailed questionnaires related to diet were necessary while other questionnaires such as social support needed to be shortened. Overall, this study showed that it is feasible to conduct a larger-scale study.

Probiotics: Prevention of Severe Pneumonia and Endotracheal Colonization Trial—PROSPECT: protocol for a feasibility randomized pilot trial

Abstract: Probiotics are defined as live microorganisms that may confer health benefits when ingested. Meta-analysis of probiotic trials suggests a 25 % lower ventilator-associated pneumonia (VAP) and 18 % lower infection rates overall when administered to patients in the intensive care unit (ICU). However, prior trials are small, largely single center, and at high risk of bias. Before a large rigorous trial is launched, testing whether probiotics confer benefit, harm, or have no impact, a pilot trial is needed. The aim of the PROSPECT Pilot Trial is to determine the feasibility of performing a larger trial in mechanically ventilated critically ill patients investigating Lactobacillus rhamnosus GG. A priori, we determined that the feasibility of the larger trial would be based on timely recruitment, high protocol adherence, minimal contamination, and an acceptable VAP rate. Patients ≥18 years old in the ICU who are anticipated to receive mechanical ventilation for ≥72 hours will be included. Patients are excluded if they are at increased risk of probiotic-associated infection, have strict enteral medication contraindications, are pregnant, previously enrolled in a related trial, or are receiving palliative care. Following informed consent, patients are randomized in variable unspecified block sizes in a fixed 1:1 ratio, stratified by ICU, and medical, surgical, or trauma admitting diagnosis. Patients receive 1 × 1010 colony forming units of L. rhamnosus GG (Culturelle, Locin Industries Ltd) or an identical placebo suspended in tap water administered twice daily via nasogastric tube in the ICU. Clinical and research staff, patients, and families are blinded. The primary outcomes for this pilot trial are the following: (1) recruitment success, (2) ≥90 % protocol adherence, (3) ≤5 % contamination, and (4) ~10 % VAP rate. Additional clinical outcomes are VAP, other infections, diarrhea (total, antibiotic associated, and Clostridium difficile), ICU and hospital length of stay, and mortality. The morbidity, mortality, and cost of VAP underscore the need for cost-effective prophylactic interventions. The PROSPECT Pilot Trial is the initial step toward rigorously evaluating whether probiotics decrease nosocomial infections, have no effect, or actually cause infections in critically ill patients. ClinicalTrials.gov. NCT01782755

The effect of glass shape on alcohol consumption in a naturalistic setting: a feasibility study

Abstract: Background: Alcohol-related harms are a major public health concern, and population-level interventions are needed to reduce excessive alcohol consumption. Glass shape is an easily modifiable target for public health intervention. Laboratory findings show beer is consumed slower from a straight glass compared to a curved glass, but these findings have not been replicated in a naturalistic setting. The purpose of this study is to investigate the feasibility of conducting a randomised controlled trial investigating the effect of glass shape on alcohol consumption in public houses. Methods: Straight and curved half-pint and pint glasses were delivered to three public houses over two weekends. Glass type was counterbalanced over the two weekends and between the public houses. Monetary takings were recorded as an indirect measure of consumption. Results: Replacing stocks of glassware in public houses was feasible and can be enacted in a short space of time. One landlord found the study too disruptive, possibly due to a laborious exchange of glassware and complaints about the new glassware from some customers. One public house’s dishwasher could not accommodate the supplied curved full-pint glasses. Obtaining monetary takings from public house staff was a feasible and efficient way of measuring consumption, although reporting absolute amounts may be commercially sensitive. Monetary takings were reduced by 24 % (95 % confidence interval 77 % reduction to 29 % increase) when straight glasses were used compared to curved glasses. Conclusions: This study shows that it is feasible to carry out a trial investigating glass shape in a naturalistic environment, although a number of challenges were encountered. Brewery owners and landlords are willing to engage with public health research in settings where alcohol is consumed, such as public houses. Good communication with stakeholders was vital to acquire good data, and highlighting the potential commercial benefits of participating was vital to the study’s success. A full scale evaluation of the effects of glass shape on alcohol consumption could inform local and national policy.

Fracture in the Elderly Multidisciplinary Rehabilitation (FEMuR): study protocol for a phase II randomised feasibility study of a multidisciplinary rehabilitation package following hip fracture [ISRCTN22464643]

Abstract: Proximal femoral fracture is a common, major health problem in old age resulting in loss of functional independence and a high-cost burden on society, with estimated health and social care costs of £2.3 billion per year in the UK. Rehabilitation has the potential to maximise functional recovery and maintain independent living, but evidence of effectiveness is lacking. Usual rehabilitation care is delivered by a multi-disciplinary team in the hospital and in the community. An ‘enhanced rehabilitation’ intervention has been developed consisting of a workbook, goal-setting diary and extra therapy sessions, designed to improve self-efficacy and increase the amount and quality of the practice of physical exercise and activities of daily living. This paper describes the design of a phase II study comprising an anonymous cohort of all proximal femoral fracture patients admitted to the three acute hospitals in Betsi Cadwaladr University Health Board over a 6-month period with a randomised feasibility study comparing the enhanced rehabilitation intervention with usual care. These will assess the feasibility of a future definitive randomised controlled trial and concurrent economic evaluation in terms of recruitment, retention, outcome measure completion, compliance with the intervention and fidelity of delivery, health service use data, willingness to be randomised and effect size for a future sample size calculation. Focus groups will provide qualitative data to contribute to the assessment of the acceptability of the intervention amongst patients, carers and rehabilitation professionals and the feasibility of delivering the planned intervention. The primary outcome measure is function assessed by the Barthel Index. Secondary outcomes measure the ability to perform activities of daily living, anxiety and depression, potential mediators of outcomes such as hip pain, self-efficacy and fear of falling, health utility, health service use, objectively assessed physical function and adverse events. Participants’ preference for rehabilitation services will be assessed in a discrete choice experiment. Phase II studies are an opportunity to not only assess the feasibility of trial methods but also to compare different methods of outcome measurement and novel methods of obtaining health service use data from routinely collected patient information. Current Controlled Trials ISRCTN22464643 , UKCRN16677.

Experiences of recruiting to a pilot trial of Cardiac Rehabilitation In patients with Bowel cancer (CRIB) with an embedded process evaluation: lessons learned to improve recruitment

Abstract: Background: Recruitment to randomised controlled trials (RCTs) is a perennial problem. Calls have been made for trialists to make recruitment performance publicly available. This article presents our experience of recruiting to a pilot RCT of cardiac rehabilitation for patients with bowel cancer with an embedded process evaluation. Methods: Recruitment took place at three UK hospitals. Recruitment figures were based on the following: i) estimated number of patient admissions, ii) number of patients likely to meet inclusion criteria from clinician input and iii) recruitment rates in previous studies. The following recruitment procedure was used: 1. Nurse assessed patients for eligibility. 2. Patients signed a screening form indicating interest in and agreement to be approached by a researcher about the study. 3. An appointment was made at which the patient signed a consent form and was randomised to the intervention or control group. Information about all patients considered for the study and subsequently included or excluded at each stage of the recruitment process and reasons given were recorded. Results: There were variations in the time taken to award Research Management approval to run the study at the three sites (45–359 days). Sixty-two percent of the original recruitment estimate was reached. The main reason for under-recruitment was due to over-estimation of the number of patient admissions; other reasons were i) not assessing all patients for eligibility, ii) not completing a screening form for eligible patients and iii) patients who signed a screening form being lost to the study before consenting and randomisation. Conclusions: Pilot trials should not simply aim to improve recruitment estimates but should also identify factors likely to influence recruitment performance in a future trial and inform the development of that trial’s recruitment strategies. Pilot trials are a crucial part of RCT design. Nevertheless, pilot trials are likely to be small scale, involving only a small number of sites, and contextual differences between sites are likely to impact recruitment performance in any future trial. This means that ongoing monitoring and evaluation in trials are likely to be required.

Lumbar transversus abdominis plane block: the role of local anesthetic volume and concentration-a pilot, prospective, randomized, controlled trial.

Abstract: The lumbar transversus abdominis plane (TAP) block has become an optional part of multimodal analgesia following several abdominal surgeries. There remains a lack of consensus regarding the extent of dermatomal blockade following lumber TAP block, as well as the optimal local anesthetic volumes and concentrations. The objectives of this pilot trial were to assess the feasibility of conducting a similar full-scale trial and gather information on relevant clinical outcomes, namely whether greater local anesthetic volumes would lead to more cephalad dermatomal blockade. The study was a prospective, double-blinded pilot randomized controlled trial (RCT) with three arms, each representing different local anesthetic volumes: 20 ml 0.5% ropivacaine, 30 ml 0.33% ropivacaine, and 40 ml 0.25% ropivacaine. We planned to recruit 30 females undergoing total abdominal hysterectomy for non-malignant pathology, who would then receive bilateral ultrasound-guided midaxillary TAP blocks at the completion of surgery. Randomized patients would be followed for 48 h post-block and would receive multimodal analgesia. The primary outcomes were measurements of patient recruitment and safety, to inform the feasibility of a larger trial. The main secondary outcome was the clinically pertinent endpoint of dermatomal blockade, which was assessed by loss of sensation to ice and pinprick. Our target sample size was reached in 8 months, and the recruitment rate was 52% (31/60). A total of 58 TAP blocks were performed among 29 patients. All but one of the patients who received interventions were successfully followed and assessed up to 48 h. No patient safety-related adverse events were reported during the study period. The mean highest dermatome blocked in each group at any time point was T8. The 20 ml 0.5% ropivacaine group achieved a T9–L1 block that lasted for 48 h. The 30 ml 0.33% ropivacaine group had a sensory block from T9–L1 that regressed to T10–T12 between 24 and 48 h. The 40 ml 0.25% ropivacaine group reported an initial sensory block from T9–T12 that regressed by 24 h to include only the T12 dermatome. This pilot study demonstrated that the study design is feasible and safe to be carried to a full-scale RCT. The preliminary clinical findings showed that increasing the volume, while maintaining a constant dose, of local anesthetic does not appear to extend the height of dermatomal blockade following midaxillary TAP block. This finding needs to be confirmed in future studies. ClinicalTrials.gov registration is: NCT01307215 .

Facilitating return to work through early specialist health-based interventions (FRESH): protocol for a feasibility randomised controlled trial.

Abstract: Over one million people sustain traumatic brain injury each year in the UK and more than 10 % of these are moderate or severe injuries, resulting in cognitive and psychological problems that affect the ability to work. Returning to work is a primary rehabilitation goal but fewer than half of traumatic brain injury survivors achieve this. Work is a recognised health service outcome, yet UK service provision varies widely and there is little robust evidence to inform rehabilitation practice. A single-centre cohort comparison suggested better work outcomes may be achieved through early occupational therapy targeted at job retention. This study aims to determine whether this intervention can be delivered in three new trauma centres and to conduct a feasibility, randomised controlled trial to determine whether its effects and cost effectiveness can be measured to inform a definitive trial. Mixed methods study, including feasibility randomised controlled trial, embedded qualitative studies and feasibility economic evaluation will recruit 102 people with traumatic brain injury and their nominated carers from three English UK National Health Service (NHS) trauma centres. Participants will be randomised to receive either usual NHS rehabilitation or usual rehabilitation plus early specialist traumatic brain injury vocational rehabilitation delivered by an occupational therapist. The primary objective is to assess the feasibility of conducting a definitive trial; secondary objectives include measurement of protocol integrity (inclusion/exclusion criteria, intervention adherence, reasons for non-adherence) recruitment rate, the proportion of eligible patients recruited, reasons for non-recruitment, spectrum of TBI severity, proportion of and reasons for loss to follow-up, completeness of data collection, gains in face-to-face Vs postal data collection and the most appropriate methods of measuring primary outcomes (return to work, retention) to determine the sample size for a larger trial. To our knowledge, this is the first feasibility randomised controlled trial of a vocational rehabilitation health intervention specific to traumatic brain injury. The results will inform the design of a definitive trial. The trial is registered ISRCTN Number 38581822 .

A single-blind, pilot randomised trial of a weight management intervention for adults with intellectual disabilities and obesity: study protocol

Abstract: The prevalence of obesity in adults with intellectual disabilities has consistently been reported to be higher than the general population. Despite the negative impact of obesity on health, there is little evidence of the effectiveness of weight management interventions for adults with intellectual disabilities and obesity. Preliminary results from a single-stranded feasibility study of a multi-component weight management intervention specifically designed for adults with intellectual disabilities and obesity (TAKE 5) and that satisfied clinical recommendations reported that it was acceptable to adults with intellectual disabilities and their carers. This study aims to determine the feasibility of a full-scale clinical trial of TAKE 5. This study will follow a pilot randomised trial design. Sixty-six obese participants (body mass index (BMI) ≥30 kg/m2) will be randomly allocated to the TAKE 5 multi-component weight management intervention or a health education ‘active’ control intervention (Waist Winners Too (WWToo)). Both interventions will be delivered over a 12-month period. Participants’ anthropometric measures (body weight, BMI, waist circumference, percentage body fat); indicators of activity (levels of physical activity and sedentary behaviour) and well-being will be measured at three time points: baseline, 6 and 12 months. The researcher collecting outcome measures will be blind to study group allocation. The data from this study will generate pilot data on the acceptability of randomisation, attrition rates and the estimates of patient-centred outcomes of TAKE 5, which will help inform future research and the development of a full-scale randomised clinical trial. ISRCTN52903778 .

Measuring the implementation of a group-based Lifestyle-integrated Functional Exercise (Mi-LiFE) intervention delivered in primary care for older adults aged 75 years or older: a pilot feasibility study protocol

Abstract: Declines in function and quality of life, and an increased risk of cardiovascular events, falls, and fractures occur with aging and may be amenable to exercise intervention. Primary care is an ideal setting for identifying older adults in need of exercise intervention. However, a cost-effective, generalizable model of chronic disease management using exercise in a real-world setting remains elusive. Our objective is to measure the feasibility, potential effectiveness, and implementation of an evidence-based Lifestyle-integrated Functional strength and balance Exercise (LiFE) intervention adapted as a group-based format (Mi-LiFE) for primary care to promote increased physical activity levels in older adults aged 75 years or older. We hypothesize that the intervention will be feasible without modification if ≥30 individuals are recruited over 6 months, ≥75 % of our sample is retained, and ≥50 % of our sample complete exercises ≥3 days per week. A pre-post pilot study design will be used to evaluate feasibility, potential effectiveness, and implementation outcomes over a 6-month period in physically inactive older adults ≥75 years recruited from a local family health team practice. The reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) framework will be applied to evaluate the public health effects of the intervention including outcomes both at the individual and organizational levels. A physical therapist will teach participants how to integrate strength and balance activities into their daily lives over one individual and four group-based sessions, and two phone calls. Assessments will be completed at baseline and 6 months. Feasibility outcomes include recruitment over 6 months, retention at follow-up, and adherence measured by activity diaries. Change in patient-centered and implementation outcomes that will be evaluated include physical activity levels using accelerometers and International Physical Activity Questionnaire, physical performance using short physical performance battery, quality of life using EQ5D questionnaire, falls and harms using daily calendar diaries and self-report, fidelity using descriptive feedback, barriers and facilitators to implementation using thematic content analysis, and process outcomes. The feasibility and implementation of the Mi-LiFE intervention in primary care for older adults will be evaluated, as well as the effects of the intervention on secondary outcomes. If the intervention appears feasible, we will use the resultant information to design a larger trial. ClinicalTrials.gov: NCTO2266225

Investigating the collection and assessment of patient-reported outcome data amongst unplanned surgical hospital admissions: a feasibility study

Abstract: Randomised controlled trials (RCTs) in surgery can be challenging to conduct, and trials in the emergency surgical setting when patients have unplanned hospital admissions are particularly difficult. One area of challenge is capturing baseline patient-reported outcome (PRO) data. This study examined the feasibility and optimal methods for the collection of baseline and follow-up PRO data in the setting of unplanned surgical hospital admissions. Clinically stable adult patients with unplanned admissions through the day and night under the care of general surgeons at two acute NHS trusts were approached during working week days and asked to complete validated PRO measures (European Quality of Life-5 Dimension, Short Form-12, and Gastrointestinal Quality of Life Index) on admission and 6 weeks following discharge. Feasibility of PRO data collection was determined by the proportions of admitted patients eligible and recruited and by questionnaire-response rates at baseline and follow up. Reasons for non-recruitment and non-completion of questionnaires were sought and recorded. There were 276 admissions, of whom 235 (85.1 %) were eligible. Reasons for ineligibility were the following: age under 18 years old (n = 5, 1.8 %), non-surgical presenting complaint (n = 6, 2.2 %) and clinical instability (n = 30, 10.9 %). One hundred and sixty-six patients (70.6 %) were recruited (98 female, 59.0 %); median age 53, range 19–100). Common reasons for non-recruitment included patients being discharged home before approached by researchers (n = 29, 12.3 %) or declining participation because they felt unwell (n = 15, 6.4 %). The most common reason for admission to the hospital was abdominal pain (n = 120, 72.3 % recruited patients), of whom 50 (30.1 %) required operative intervention. Baseline PRO data was obtained from 153 patients (93.3 %), and 74 (48.4 %) returned follow-up questionnaires. Collection of baseline PRO data amongst unplanned admissions in general surgery is feasible. Methods for optimising retention and follow up are needed.

A randomised controlled feasibility trial of family and social network intervention for young people who misuse alcohol and drugs: study protocol (Y-SBNT).

Abstract: Background: A growing body of research has identified family interventions to be effective in treating young people’s substance use problems. However, despite this evidence, take-up of family-based approaches in the UK has been low. Key factors for this appear to include the resource-intensive nature of most family interventions which challenges implementation and delivery in many service settings and the cultural adaptation of approaches developed in the USA to a UK setting. This study aims to demonstrate the feasibility of recruiting young people to a specifically developed family- and wider social network-based intervention by testing an adapted version of adult social behaviour and network therapy (SBNT). Methods: A pragmatic, randomised controlled, open feasibility trial delivered in two services for young people in the UK. Potential participants are aged 12–18 years referred for drug or alcohol problems to either service. The main purpose of this study is to demonstrate the feasibility of recruiting young people to a specifically developed family and social network-based intervention. The feasibility and acceptability of this intervention will be measured by recruitment rates, treatment retention, follow-up rates and qualitative interviews. The feasibility of training staff from existing services to deliver this intervention will be explored. Using this opportunity to compare the effectiveness of the intervention against treatment as usual, Timeline Follow-Back interviews will document the proportion of days on which the main problem substance was used in the preceding 90-day period at each assessment point. The economic component will examine the feasibility of conducting a full incremental cost-effectiveness analysis of the two treatments. The study will also explore and develop models of patient and public involvement which support the involvement of young people in a study of this nature. Discussion: An earlier phase of work adapted social behaviour and network therapy (adult approach) to produce a purpose-designed youth version supported by a therapy manual and associated resources. This was achieved by consultation with young people with experience of services and professionals working in services for young people. This feasibility trial alongside ongoing consultations with young people will offer a meaningful understanding of processes of delivery and implementation. (Continued on next page)

Feasibility and preliminary efficacy of a physical activity counseling intervention using Fitbit in people with knee osteoarthritis: the TRACK-OA study protocol

Abstract: Physical activity (PA) reduces pain and improves functioning in people with knee osteoarthritis (OA), but few people with the condition meet recommended PA guidelines. Successful intervention strategies to increase PA include goal setting, action planning, self-monitoring, and follow-up feedback from a healthcare professional. Recently developed consumer wearable activity trackers allow users to set activity goals, self-monitor daily goal-progress, and provide feedback on goal attainment. It is hypothesized that a multi-component physiotherapist-led intervention that includes a short (40-min) education module, guided goal-setting and action planning, the use of a wristband activity tracker, and weekly follow-up phone calls will lead to increased PA outcomes. Thirty-six participants will be recruited from the community for a two-group pilot randomized controlled trial with a stepped-wedge design using an intention-to-treat analysis. Computer-generated block randomization will be performed using varying block sizes and a 1:1 allocation ratio. The 4-week intervention will be delivered immediately (immediate-intervention group) or after a 5-week delay (delayed-intervention group). Outcome measures of pain and disability (Knee Injury and OA Outcome Score), disease self-management ability (Partners in Health Scale), and objective bouted moderate-to-vigorous PA and sedentary time (BodyMedia SenseWear Mini Armband) will be collected at baseline (week 0) and two follow-ups (weeks 5 and 10), for a total study duration of 11 weeks. Feasibility data relating to process, resource, management, and scientific elements of the trial will be collected. Outcome measure and feasibility data will be summarized, and an estimate of intervention efficacy will be obtained by regression model with planned comparisons. The trial began recruiting in February 2015. To date, 34 subjects have been recruited. This study will evaluate the feasibility and preliminary efficacy of a novel intervention to promote PA in people living with knee OA. The results will provide valuable information to inform a larger randomized trial to assess intervention effectiveness. ClinicalTrials.gov Identifier: NCT02313506 (registration date 8 December 2014). First participant randomized 20 February 2015.

Protocol for a pilot randomised controlled trial of an intervention to increase the use of traffic light food labelling in UK shoppers (the FLICC trial)

Abstract: Traffic light labelling of foods—a system that incorporates a colour-coded assessment of the level of total fat, saturated fat, sugar and salt on the front of packaged foods—has been recommended by the UK Government and is currently in use or being phased in by many UK manufacturers and retailers. This paper describes a protocol for a pilot randomised controlled trial of an intervention designed to increase the use of traffic light labelling during real-life food purchase decisions. The objectives of this two-arm randomised controlled pilot trial are to assess recruitment, retention and data completion rates, to generate potential effect size estimates to inform sample size calculations for the main trial and to assess the feasibility of conducting such a trial. Participants will be recruited by email from a loyalty card database of a UK supermarket chain. Eligible participants will be over 18 and regular shoppers who frequently purchase ready meals or pizzas. The intervention is informed by a review of previous interventions encouraging the use of nutrition labelling and the broader behaviour change literature. It is designed to impact on mechanisms affecting belief and behavioural intention formation as well as those associated with planning and goal setting and the adoption and maintenance of the behaviour of interest, namely traffic light label use during purchases of ready meals and pizzas. Data will be collected using electronic sales data via supermarket loyalty cards and web-based questionnaires and will be used to estimate the effect of the intervention on the nutrition profile of purchased ready meals and pizzas and the behavioural mechanisms associated with label use. Data collection will take place over 48 weeks. A process evaluation including semi-structured interviews and web analytics will be conducted to assess feasibility of a full trial. The design of the pilot trial allows for efficient recruitment and data collection. The intervention could be generalised to a wider population if shown to be feasible in the main trial. ISRCTN: ISRCTN19316955

A pragmatic pilot randomized trial to investigate the effectiveness of behavioural activation group therapy in reducing depressive symptoms and improving quality of life in patients with depression: the BRAVE pilot trial protocol

Abstract: Depression is a common disorder with a lifetime prevalence of 16 %. Despite the availability of several treatment options for depression, many patients do not respond to treatment and develop chronic illness associated with several secondary comorbidities. Behavioural activation (BA) is a simple therapy that has the potential for improving symptoms of depression and quality of life in patients with depression. The effectiveness of BA has not, however, been tested in a group format for patients with moderate to severe depression attending a specialized mood disorders tertiary care setting. Group format has the advantage of treating more patients at the same time especially in resource-limited settings. The primary objective of this pilot study is to test the feasibility of a main trial by assessing the recruitment and retention rates, average group size, completion of data and resources needed and receive the participants’ feedback on the intervention. The secondary objective is to explore the change in mood and quality of life measures in adults with depression receiving BA. Using a pragmatic pilot randomized controlled trial design, we will test the feasibility of a large trial to assess the effectiveness of BA added to usual care compared to a depression support group with usual care. Participants will be randomized after obtaining informed written consent to one of two study arms. Face-to-face group therapy will be provided in a hospital setting by trained therapists. Intervention and control groups will be seen twice weekly for 10 weeks and then once weekly for further 8 weeks. Participants will be completing mood symptom scales, quality of life questionnaires and anthropometric measures and provide blood samples for future analysis of biomarkers of response to treatment. During the pilot study we will also solicit participants’ feedback and experience regarding the number, frequency and contents of the sessions as well as to explore participant perceptions of barriers or benefits associated with the BA program. The pilot study will help to inform a larger trial and assist in modifying the intervention based on patients’ feedback. Clinicaltrials.gov Identifier NCT02045771 . Hamilton Integrated Research Ethics Board (HiREB) number: 14–042.

Nail bed INJury Assessment Pilot (NINJA-P) study: should the nail plate be replaced or discarded after nail bed repair in children? Study protocol for a pilot randomised controlled trial

Abstract: Nail bed injuries account for the majority of paediatric hand trauma cases Despite their frequency, controversy remains regarding their treatment The accepted teaching is to remove the fingernail, repair the underlying nail bed with fine sutures and replace the nail under the nail fold A recent study by Miranda et al (Plast Reconst Surg 129(2):394e-396e, 2012) suggests that replacing the nail is associated with increased complications, in particular post-operative infection Nail bed INJury Assessment Pilot (NINJA-P) is an external pilot study for a large pragmatic, multicentre, randomised, controlled study (NINJA) to assess whether the nail should be replaced or discarded after nail bed repair in children under the age of 16 NINJA-P is a randomised pilot study The participants are patients below 16 years of age who require surgical repair of the nail bed Eligible patients will be randomised to receive one of two possible interventions Group 1 will have the nail replaced after nail bed repair, and group 2 will have the nail discarded The clinical outcome measures include the presence of post-operative complications at 2 weeks and 30 days, the cosmetic appearance of the nail at 4 months and the level of pain experienced by the child at their first dressings change at 2 weeks In order to inform the design of the main NINJA trial, the following feasibility data will also be recorded: the number of potentially eligible children and the proportion which agree to take part in the study, the proportion of children who received the allocated treatment and reasons for any non-compliance and the proportion of participants with a valid response at each follow-up point Neither the patient, family members nor treating physicians will be blinded A replaced nail can take several weeks to fall off once a new nail has grown out The cosmetic appearance of the nail at 4 months will be assessed by a blinded assessor The NINJA-P pilot study will inform the design and execution of the NINJA trial, which will assess whether the nail should be replaced or discarded after nail bed repair in children under 16 It will provide randomised comparative evidence for the treatment of this common injury First participant randomised: 21/04/2015, UKCRN Portfolio ID: 18516, ISRCTN16571591

A pilot cluster randomised controlled trial to investigate the addition of direct access to physiotherapy to usual GP-led primary care for adults with musculoskeletal pain: the STEMS pilot trial protocol (ISRCTN23378642)

Abstract: Musculoskeletal problems are common, accounting for up to 30 % of general practitioner (GP) consultations and are a major cause of chronic disability worldwide. Demand for health care for musculoskeletal conditions is likely to continue to rise given the ageing population and the increasing impact of these common painful conditions. Physiotherapists are well equipped to deliver evidence-based management for these conditions. Direct access allows patients to access physiotherapy without seeing their GP or another referring practitioner first; however, for most patients in the UK, access to National Health Service physiotherapy is controlled through GP referral. The aim of this pilot, pragmatic, cluster trial is to assess the feasibility of a future large trial to compare the clinical and cost-effectiveness of the additional offer of direct access to physiotherapy versus continuing with usual GP-led primary care alone for adults with common musculoskeletal problems. The pilot will focus on process outcomes to assess feasibility, although performance of the likely outcomes of a main trial will also be assessed. This is a two-arm parallel, cluster RCT where GP practices are the units of randomisation (the clusters), yet data are collected from individual patients with musculoskeletal problems (the participants). A direct access service will be set up in the participating physiotherapy service to provide the option of direct access to patients of the intervention arm practices. Inclusion criteria are broad to reflect the ‘real-world’ operation of an NHS physiotherapy direct access service for patients with musculoskeletal pain. Data collection will be through patient self-reported questionnaires at baseline, 2, 6 and 12 months and medical record review. No previous trials have been conducted into direct access to physiotherapy for patients with musculoskeletal problems. The strengths of the STEMS pilot trial are its size, the length of follow-up, and collection of process, clinical and cost outcomes to fully inform a future main trial to meet calls to provide robust trial evidence of the impact on clinical outcomes, work loss and costs to provide clinicians and service funders with the high quality trial data they need to guide decisions on the best models of care. The STEMS pilot trial is registered at Current Controlled Trials: ISRCTN23378642

Exploring the feasibility and synergistic value of the One Health approach in clinical research: protocol for a prospective observational study of diagnostic pathways in human and canine patients with suspected urinary tract infection

Abstract: The One Health approach is emerging in response to the development of bacterial resistance. To the best of our knowledge, the possibility to use this approach in a clinical context has not yet been explored. Thus, in this paper, we report the procedures to implement a prospective observational study of diagnostic pathways in human and canine patients with suspected urinary tract infection as a means to assess the feasibility and synergistic value of setting up One Health clinical research projects and interventions. A prospective observational study will compare different diagnostic pathways (i.e., 16 possible combinations of diagnostic tools) to gold standard in human and veterinary primary care practice in Denmark. Fifty primary care practices and 100 veterinary clinics will each consecutively include 20 human patients or 8–10 dogs, respectively. Data will be collected at practice and patient level comprising (a) information about the organization of the practice and access to different diagnostic tools, (b) information about clinical history, diagnostic path and treatment during the index consultation, (c) information about severity of symptoms during the 7–10 days following inclusion, and (d) urine culture (type of microorganism and susceptibility test). The feasibility and synergistic value of conducting future research, and/or designing common interventions, will be assessed by evaluating the comparability of human primary care and veterinary primary care with respect to study implementation and study results. Results from this study will give an insight into the feasibility and synergistic value of setting-up One Health research projects in a clinical context. This is crucial if we are to embrace the One Health approach, as a legitimate strategy to implement common interventions aimed at influencing the diagnostic process in human and canine patients in order to decrease inappropriate use of antibiotics. The study in humans has been registered in ClinicalTrials.gov NCT02249273 .

Prescribed computer games in addition to occlusion versus standard occlusion treatment for childhood amblyopia: a pilot randomised controlled trial

Abstract: Amblyopia (“lazy eye”) is the commonest vision deficit in children. If not fully corrected by glasses, amblyopia is treated by patching or blurring the better-seeing eye. Compliance with patching is often poor. Computer-based activities are increasingly topical, both as an adjunct to standard treatment and as a platform for novel treatments. Acceptability by families has not been explored, and feasibility of a randomised controlled trial (RCT) using computer games in terms of recruitment and treatment acceptability is uncertain. We carried out a pilot RCT to test whether computer-based activities are acceptable and accessible to families and to test trial methods such as recruitment and retention rates, randomisation, trial-specific data collection tools and analysis. The trial had three arms: standard near activity advice, Eye Five, a package developed for children with amblyopia, and an off-the-shelf handheld games console with pre-installed games. We enrolled 60 children age 3–8 years with moderate or severe amblyopia after completion of optical treatment. This trial was registered as UKCRN-ID 11074. Pre-screening of 3600 medical notes identified 189 potentially eligible children, of whom 60 remained eligible after optical treatment, and were enrolled between April 2012 and March 2013. One participant was randomised twice and withdrawn from the study. Of the 58 remaining, 37 were boys. The mean (SD) age was 4.6 (1.7) years. Thirty-seven had moderate and 21 severe amblyopia. Three participants were withdrawn at week 6, and in total, four were lost to follow-up at week 12. Most children and parents/carers found the study procedures, i.e. occlusion treatment, usage of the allocated near activity and completion of a study diary, easy. The prescribed cumulative dose of near activity was 84 h at 12 weeks. Reported near activity usage numbers were close to prescribed numbers in moderate amblyopes (94 % of prescribed) but markedly less in severe amblyopes (64 %). Reported occlusion usage at 12 weeks was 90 % of prescribed dose for moderate and 33 % for severe amblyopes. Computer-based games and activities appear acceptable to families as part of their child’s amblyopia treatment. Trial methods were appropriate and accepted by families.

NOURISH, Nutritional OUtcomes from a Randomised Investigation of Intradialytic oral nutritional Supplements in patients receiving Haemodialysis: a pilot randomised controlled trial

Abstract: The study was done to assess the feasibility of conducting a trial evaluating the use of an intradialytic oral nutritional supplement (ONS) on nutritional status. The study design is a single centre, parallel group, external pilot randomised controlled trial (RCT). The setting was at a haemodialysis unit in Sheffield, UK. The aim was to recruit 30 trial participants to allow at least 12 evaluable patients per arm, but the actual study sample consisted of 10 adults with a body mass index (BMI) ≤22 kg/m2, receiving thrice weekly haemodialysis. All participants received nutritional advice from a renal dietitian as per usual practice. The intervention included the provision of an intradialytic ONS. Feasibility outcomes included recruitment to time and retention of participants along with palatability of ONS. Secondary outcomes were clinical parameters to obtain variance and estimates of effect size to inform the sample size calculation for a definitive trial. Recruitment was undertaken for a fixed period of 6 weeks. Rates were lower than expected mainly due to ineligibility with only 7% of screened patients (19/265) being eligible and 4% (10/265) of these being recruited. Due to the small proportion of patients eligible for the trial, all haemodialysis patients at the specified unit were assessed for eligibility. Data completion rates were low for session questionnaires (23%). Sample sizes derived from variance in secondary outcome measure of handgrip strength and adjusted for a dropout rate of 20% indicate that 189 patients would be required for a definitive RCT, requiring 19 UK haemodialysis units to participate. A definitive RCT is feasible with some adaptation to exclusion criteria and methodology. The exclusion criteria could be adapted to include an increase in upper limit for BMI. The use of questionnaires at each dialysis session may not be feasible but the inclusion of appetite and supplement consumption data collection at the main assessments would provide similar outcome data. Quality of life assessment using SF-12 would be acceptable. ISRCTN37431579 .

Online intervention, ‘MePlusMe’, supporting mood, wellbeing, study skills, and everyday functioning in students in higher education: a protocol for a feasibility study

Abstract: Background: Psychological and study skill difficulties faced by students in higher education can lead to poor academic performance, sub-optimal mental health, reduced study satisfaction, and drop out from study. At the same time, higher education institutions’ support services are costly, oversubscribed, and struggle to meet demand whilst facing budget reductions. The purpose of the proposed study is to evaluate the acceptability of a new online intervention, MePlusMe, aimed at students in higher education facing mild to moderate psychological and/or study skill difficulties. The study will also assess the feasibility of proposed recruitment and outcome assessment protocols for a future trial of effectiveness. The system supports self-management strategies alongside ongoing monitoring facilitated by a messaging service, as well as featuring a built-in community of student users. It is based on current clinical guidelines for the management of common mental health problems, together with best practice from the educational field. Methods/design: Two hundred and forty two students will be recruited to a within-subjects, repeated measures study conducted over 8 weeks. Self-report measures of depression and anxiety symptoms, mental wellbeing, academic self-efficacy, and everyday functioning will be collected at baseline, and then at 2, 4, and 8 weeks. During this period, students will have access to the intervention system. UK higher education institutions Bournemouth University and University of Warwick will participate in the study. Data on student satisfaction and engagement will also be collected. Study findings will help to determine the most appropriate primary outcome and the required sample size for a future trial. Discussion: This study will evaluate the acceptability of an online intervention system for students facing psychological and/or study skill difficulties and will test recruitment procedures and outcome measures for a future trial of effectiveness. The system is designed to be implemented as a stand-alone service or a service complementary to student support services, which is accessible to the majority of students and effective in improving student experience at higher education institutions.

A cluster randomised feasibility trial evaluating six-month nutritional interventions in the treatment of malnutrition in care home-dwelling adults: recruitment, data collection and protocol.

Abstract: Protein energy malnutrition predisposes individuals to disease, delays recovery from illness and reduces quality of life. Care home residents are especially vulnerable, with an estimated 30%–42% at risk. There is no internationally agreed protocol for the nutritional treatment of malnutrition in the care home setting. Widely used techniques include food-based intervention and/or the use of prescribed oral nutritional supplements, but a trial comparing the efficacy of interventions is necessary. In order to define outcomes and optimise the design for an adequately powered, low risk of bias cluster randomised controlled trial, a feasibility trial with 6-month intervention is being run, to assess protocol procedures, recruitment and retention rates, consent processes and resident and staff acceptability. Trial recruitment began in September 2013 and concluded in December 2013. Six privately run care homes in Solihull, England, were selected to establish feasibility within different care home types. Residents with or at risk of malnutrition with no existing dietetic intervention in place were considered for receipt of the allocated intervention. Randomisation took place at the care home level, using a computer-generated random number list to allocate each home to either a dietetic intervention arm (food-based or prescribed supplements) or the standard care arm, continued for 6 months. Dietetic intervention aimed to increase daily calorie intake by 600 kcal and protein by 20–25 g. The primary outcomes will be trial feasibility and acceptability of trial design and allocated interventions. A range of outcome assessments and data collection tools will be evaluated for feasibility, including change in nutrient intake, anthropometric parameters and patient-centric measures, such as quality of life and self-perceived appetite. The complexities inherent in care home research has resulted in the under representation of this population in research trials. The results of this feasibility trial will be used to inform the development and design of a future cluster randomised controlled trial to compare food-based intervention with prescribed oral nutritional supplements (ONS) in the treatment of malnutrition within the care home population. Current Controlled Trials ISRCTN38047922