scholarly journals Youth social behaviour and network therapy (Y-SBNT): adaptation of a family and social network intervention for young people who misuse alcohol and drugs – a randomised controlled feasibility trial

2017 ◽  
Vol 21 (15) ◽  
pp. 1-260 ◽  
Author(s):  
Judith Watson ◽  
Paul Toner ◽  
Ed Day ◽  
Donna Back ◽  
Louca-Mai Brady ◽  
...  
Keyword(s):  
Young People ◽  
Social Behaviour ◽  
Substance Misuse ◽  
Health Technology ◽  
Research Process ◽  
Feasibility Trial ◽  
Network Therapy ◽  
Randomised Controlled ◽  
To Receive

BackgroundFamily interventions appear to be effective at treating young people’s substance misuse. However, implementation of family approaches in UK services is low. This study aimed to demonstrate the feasibility of recruiting young people to an intervention based on an adaptation of adult social behaviour and network therapy. It also sought to involve young people with experience of using substance misuse services in the research process.ObjectivesTo demonstrate the feasibility of recruiting young people to family and social network therapy and to explore ways in which young people with experience of using substance misuse services could be involved in a study of this nature.DesignA pragmatic, two-armed, randomised controlled open feasibility trial.SettingTwo UK-based treatment services for young people with substance use problems, with recruitment taking place from May to November 2014.ParticipantsYoung people aged 12–18 years, newly referred and accepted for structured interventions for drug and/or alcohol problems.InterventionsA remote, web-based computer randomisation system allocated young people to adapted youth social behaviour and network therapy (Y-SBNT) or treatment as usual (TAU). Y-SBNT participants were intended to receive up to six 50-minute sessions over a maximum of 12 weeks. TAU participants continued to receive usual care delivered by their service.Main outcome measuresFeasibility was measured by recruitment rates, retention in treatment and follow-up completion rates. The main clinical outcome was the proportion of days on which the main problem substance was used in the preceding 90-day period as captured by the Timeline Follow-Back interview at 3 and 12 months.ResultsIn total, 53 young people were randomised (Y-SBNT,n = 26; TAU,n = 27) against a target of 60 (88.3%). Forty-two young people attended at least one treatment session [Y-SBNT 22/26 (84.6%); TAU 20/27 (74.1%)]; follow-up rates were 77.4% at month 3 and 73.6% at month 12. Data for nine young people were missing at both months 3 and 12, so the main clinical outcome analysis was based on 24 young people (92.3%) in the Y-SBNT group and 20 young people (74.1%) in the TAU group. At month 12, the average proportion of days that the main problem substance was used in the preceding 90 days was higher in the Y-SBNT group than in the TAU group (0.54 vs. 0.41; adjusted mean difference 0.13, 95% confidence interval –0.12 to 0.39;p = 0.30). No adverse events were reported. Seventeen young people with experience of substance misuse services were actively involved throughout the study. They informed key elements of the intervention and research process, ensuring that the intervention was acceptable and relevant to our target groups; contributing to the design of key trial documents, ideas for a new model of public involvement and this report. Two parents were also involved.ConclusionsThe adapted intervention could be delivered in young people’s services, and qualitative interviews found that Y-SBNT was acceptable to young people, family members and staff. Engagement of family and network members proved difficult within the intervention and research aspects. The study proved the feasibility of this work in routine services but outcome measurement based on narrow substance use variables may be limited and may fail to capture other important changes in wider areas of functioning for young people. Validation of the EuroQol-5 Dimensions for young people aged 12–18 years should be considered and flexible models for involvement of young people in research are required to achieve inclusive representation throughout all aspects of the research process. Although recommendation of a full trial of the Y-SBNT intervention compared with TAU is not supported, this study can inform future intervention development and UK research within routine addiction services.Trial registrationCurrent Controlled Trials ISRCTN93446265.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 21, No. 15. See the NIHR Journals Library website for further project information.

scholarly journals Opportunities and challenges of delivering digital clinical trials: lessons learned from a randomised controlled trial of an online behavioural intervention for children and young people

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Charlotte L. Hall ◽  
Charlotte Sanderson ◽  
Beverly J. Brown ◽  
Per Andrén ◽  
Sophie Bennett ◽  
...  
Keyword(s):  
Mental Health ◽  
Clinical Trials ◽  
Young People ◽  
Healthcare Delivery ◽  
Health Technology ◽  
Lessons Learned ◽  
Behavioural Intervention ◽  
Link Type ◽  
Randomised Controlled

Abstract Background Despite being the gold standard of research to determine effectiveness, randomised controlled trials (RCTs) often struggle with participant recruitment, engagement and retention. These issues may be exacerbated when recruiting vulnerable populations, such as participants with mental health issues. We aimed to update understanding of the scope of these problems in trials of health technology and identify possible solutions through reflecting on experiences from an exemplar trial (Online Remote Behavioural Intervention for Tics; ORBIT). Method We extracted anonymised data on recruitment, retention and requests for more funding and time from trials funded by the largest funder of health technology trials in the UK (the National Institute of Health Research Health Technology Assessment) between 2010 and 2020, and compared these with data from a recent, successful trial (ORBIT). ORBIT aimed to assess the clinical- and cost-effectiveness of blended online and human behavioural therapy for tics in young people. Many of the trial procedures, including recruitment, the intervention and data collection, were undertaken online. Results Data were extracted on 51 trials conducted between 2010 and 2020. Sixty per cent of trials failed to reach their original recruitment target and only 44% achieved their follow-up in the specified time frame. In contrast, ORBIT recruited to target and achieved 90% follow-up. We posit that these achievements are related to (a) judicious use of digital technology for trial procedures and (b) adequate numbers of highly trained and motivated trial staff. We provide details of both these to help other research teams plan and cost for successful trials. Conclusion An approach combining human and online methods may be advantageous in facilitating trial delivery, particularly in paediatric mental health services. Given the importance of successful clinical trials in advancing healthcare delivery and the waste of human and economic resources associated with unsuccessfully delivered trials, it is imperative that trials are appropriately costed and future research focusses on improving trial design and delivery. Trial registration The ORBIT trial is registered with ISRTCN (ISRCTN70758207) Registered on March 20, 2018. and ClinicalTrials.gov (NCT03483493). Registered on March 30, 2018.

scholarly journals 71 Ultrasound directed reduction of Colles’ type distal radial fractures in ED (UDiReCT): a feasibility randomized controlled trial

2020 ◽  
Vol 37 (12) ◽  
pp. 835.3-836
Author(s):  
Hamza Malik ◽  
Andrew Appelboam ◽  
Gordon Taylor ◽  
Daryl Wood ◽  
Karen Knapp
Keyword(s):  
Data Collection ◽  
Controlled Trial ◽  
Wrist Fracture ◽  
Recruitment Rate ◽  
Feasibility Trial ◽  
Point Of Care Ultrasound ◽  
Distal Radial Fractures ◽  
Definitive Trial ◽  
Randomised Controlled

Aims/Objectives/BackgroundWrist fractures are among the commonest injuries seen in the emergency department (ED). Around 25% of these injuries have Colles’ type fracture displacement and undergo manipulation in the ED. In the UK, these manipulations are typically done ‘blind’ without real time imaging and recent observational studies show that over 40% of the injuries go on to require surgical fixation (due to inadequate initial reduction or re-displacement). Point of care ultrasound has been used to guide and improve wrist fracture reductions but it’s effect on subsequent outcome is not established. We set up and ran the UK’s first randomised controlled feasibility trial comparing standard and ultrasound guided ED wrist fracture manipulations to test a definitive trial protocol, data collection and estimate recruitment rate towards a future definitive trial.Methods/DesignWe conducted a 1:1, single blind, parallel group, randomised controlled feasibility trial in two UK hospitals. Adults with Colles’ type distal radial fractures requiring manipulation in the ED were recruited by supervising emergency physicians supported by network research nurses. Participants were randomised to ultrasound directed fracture manipulation (intervention) or standard care with sham ultrasound (controls). The trial was run through Exeter Clinical Trials Unit and consent, randomisation and data collection conducted electronically in REDCap cloud. All participants were followed up at 6 weeks to record any surgical intervention and also underwent baseline and 3 month quality of life (EQ-5D-5L) and wrist function (Patient Rated Wrist Evaluation (PRWE) assessments.Results/ConclusionsWe recruited 47 patients in total, with 23 randomised to the interventional arm and 24 randomised to the control arm. We were able to follow up 100% of the patients for the 6 week follow up. Data analysis and results will be presented at the time of the conference.

scholarly journals Treating sleep problems in young people at ultra-high-risk of psychosis: study protocol for a single-blind parallel group randomised controlled feasibility trial (SleepWell)

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e045235
Author(s):  
Felicity Waite ◽  
Thomas Kabir ◽  
Louise Johns ◽  
Jill Mollison ◽  
Apostolos Tsiachristas ◽  
...  
Keyword(s):  
Mental Health ◽  
High Risk ◽  
Young People ◽  
Sleep Problems ◽  
Qualitative Interviews ◽  
Feasibility Trial ◽  
Psychotic Experiences ◽  
Post Intervention ◽  
Ultra High Risk ◽  
Randomised Controlled

BackgroundEffective interventions, targeting key contributory causal factors, are needed to prevent the emergence of severe mental health problems in young people. Insomnia is a common clinical issue that is problematic in its own right but that also leads to the development and persistence of psychotic experiences. The implication is that treating sleep problems may prevent the onset of psychosis. We collected initial case series data with 12 young people at ultra-high-risk of psychosis. Post-intervention, there were improvements in sleep, depression and psychotic experiences. Now we test the feasibility of a randomised controlled trial, with a clinical aim to treat sleep problems and hence reduce depression, psychotic experiences, and prevent transition to psychosis.Methods and analysisA randomised controlled feasibility trial will be conducted. Forty patients aged 14 to 25 years who are at ultra-high-risk of psychosis and have sleep disturbance will be recruited from National Health Service (NHS) mental health services. Participants will be randomised to receive either a novel, targeted, youth-focussed sleep intervention in addition to usual care or usual care alone. Assessor-blinded assessments will be conducted at baseline, 3 months (post-intervention) and 9 months (follow-up). The eight-session psychological intervention will target the key mechanisms which disrupt sleep: circadian rhythm irregularities, low sleep pressure, and hyperarousal. To gain an in-depth understanding of participants’ views on the acceptability of the intervention and study procedures, 16 participants (n=10 intervention, n=6 control) will take part in qualitative interviews. Analyses will focus on feasibility outcomes (recruitment, retention, and treatment uptake rates) and provide initial CI estimates of intervention effects. Thematic analysis of the qualitative interviews will assess the acceptability of the intervention and trial procedures.Ethics and disseminationThe trial has received ethical approval from the NHS Health Research Authority. Findings will be disseminated through peer-reviewed publications, conference presentations, and lay networks.Trial registration numberISRCTN85601537.

scholarly journals Optimising medication management in children and young people with ADHD using a computerised test (QbTest): a feasibility randomised controlled trial

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Laura Williams ◽  
Charlotte L. Hall ◽  
Sue Brown ◽  
Boliang Guo ◽  
Marilyn James ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Young People ◽  
Controlled Trial ◽  
Medication Management ◽  
Control Group ◽  
Global Functioning ◽  
Children And Young People ◽  
Link Type ◽  
Randomised Controlled

Abstract Background Medication for attention deficit hyperactivity disorder (ADHD) should be closely monitored to ensure optimisation. There is growing interest in using computerised assessments of ADHD symptoms to support medication monitoring. The aim of this study was to assess the feasibility and acceptability of a randomised controlled trial (RCT) to evaluate the efficacy of one such computerised assessment, the Quantified Behavior (Qb) Test, as part of medication management for ADHD. Methods This feasibility multi-site RCT conducted in child and adolescent mental health and community paediatric settings recruited participants aged 6–15 years diagnosed with ADHD starting stimulant medication. Participants were randomised into one of two arms: experimental (QbTest protocol) where participants completed a QbTest at baseline and two follow-up QbTests on medication (2–4 weeks and 8–10 weeks later) and control where participants received treatment as usual, including at least two follow-up consultations. Measures of parent, teacher, and clinician-rated symptoms and global functioning were completed at each time point. Clinicians recorded treatment decision-making and health economic measures were obtained. Data were analysed using multi-level modelling and participants (children and parents) and clinicians were interviewed about their experiences, resulting data were thematically analysed. Results Forty-four children and young people were randomised. Completion of study outcome measures by care-givers and teachers ranged from 52 to 78% at baseline to 47–65% at follow-up. Participants reported the questionnaires to be useful to complete. SNAP-IV inattention scores showed greater reduction in the intervention than the control group (− 5.85, 95% CI − 10.33, − 1.36,). Engagement with the intervention ranged from 100% at baseline, to 78% follow-up 1 and 57% follow-up 2. However, only 37% of QbTests were conducted in the correct time period. Interview data highlighted that the objectivity of the QbTest was appreciated by clinicians and parents. Clinicians commented that the additional time and resources required meant that it is not feasible to use QbTest for all cases. Conclusion The trial design and protocol appear to be feasible and acceptable but could be improved by modifying QbTest time periods and the method of data collection. With these changes, the protocol may be appropriate for a full trial. Adding QbTest may improve symptom outcome as measured by SNAP-IV. Trial registration ClinicalTrials.gov, NCT03368573, prospectively registered, 11th December 2017, and ISRCTN, ISRCTN69461593, retrospectively registered, 10th April 2018

scholarly journals Perineural local anaesthetic catheter after major lower limb amputation trial (PLACEMENT): results from a randomised controlled feasibility trial

BMJ Open ◽  
2019 ◽  
Vol 9 (11) ◽  
pp. e029233 ◽  
Author(s):  
David Bosanquet ◽  
Graeme Ambler ◽  
Cherry-Ann Waldron ◽  
Emma Thomas-Jones ◽  
Lucy Brookes-Howell ◽  
...  
Keyword(s):  
Postoperative Pain ◽  
Local Anaesthetic ◽  
Lower Limb ◽  
Rating Scale ◽  
Lower Limb Amputation ◽  
Feasibility Trial ◽  
Limb Amputation ◽  
Effectiveness Trial ◽  
Randomised Controlled

ObjectivesTo determine the feasibility of undertaking a randomised controlled effectiveness trial evaluating the use of a perineural catheter (PNC) after major lower limb amputation with postoperative pain as the primary outcome.DesignRandomised controlled feasibility trial.SettingTwo vascular Centres in South Wales, UK.Participants50 patients scheduled for major lower limb amputation (below or above knee) for complications of peripheral vascular disease.InterventionsThe treatment arm received a PNC placed adjacent to the sciatic or tibial nerve at the time of surgery, with continuous infusion of levobupivacaine hydrochloride 0.125% for up to 5 days. The control arm received neither local anaesthetic nor PNC. Both arms received usual perioperative anaesthesia and postoperative analgesia.Primary and secondary outcome measuresThe primary outcomes were the proportion of eligible patients who were randomised and the proportion of recruited patients who provided primary effectiveness outcome data. Secondary outcomes were: the proportion of recruited patients reaching 2 and 6 month follow-up and supplying pain data; identification of key cost drivers; development of an economic analysis framework for a future effectiveness trial; identification of barriers to recruitment and site set-up; and identification of the best way to measure postoperative pain.ResultsSeventy-six of 103 screened patients were deemed eligible over a 10 month period. Fifty (64.5%) of these patients were randomised, with one excluded in the perioperative period. Forty-five (91.3%) of 49 recruited patients provided enough pain scores on a 4-point verbal rating scale to allow primary effectiveness outcome evaluation. Attrition rates were high; 18 patients supplied data at 6 month follow-up. Costs were dominated by length of hospital stay. Patients and healthcare professionals reported that trial processes were acceptable.ConclusionsRecruitment of patients into a trial comparing PNC use to usual care after major lower limb amputation with postoperative pain measured on a 4-point verbal rating scale is feasible. Evaluation of longer-term symptoms is difficult.Trial registration numberISRCTN: 85 710 690. EudraCT: 2016-003544-37.

scholarly journals Promoting activity, Independence and stability in early dementia (PrAISED): a, multisite, randomised controlled, feasibility trial

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Sarah E. Goldberg ◽  
◽  
Veronika van der Wardt ◽  
Andy Brand ◽  
Clare Burgon ◽  
...  
Keyword(s):  
Adverse Events ◽  
Falls Prevention ◽  
Feasibility Trial ◽  
Moderate Intensity ◽  
Eligibility Criteria ◽  
Intervention Delivery ◽  
Link Type ◽  
Early Dementia ◽  
Randomised Controlled

Abstract Background We tested the feasibility of delivering and evaluating a complex therapy intervention which aimed to promote activity and independence for people with early dementia (PrAISED). Feasibility questions were on: recruitment, randomisation, intervention delivery, adherence and withdrawals, level of supervision required, adverse events, data collection and sample size assumptions. Methods We conducted a three-arm, multi-site, single-blind, randomised controlled feasibility trial. Eligibility criteria were aged 65 years or older, diagnosed mild dementia or mild cognitive impairment, able to walk without human help, and communicate in English, no co-morbidities that prevented participation in cognitive assessment and capacity to give consent. Participants were recruited from Memory Assessment Service clinics and the ‘Join Dementia Research’ register. Patient participants were randomised 1:1:1 to a high intensity supervision PrAISED intervention, moderate intensity supervision PrAISED intervention or brief falls prevention assessment and advice (control). The PrAISED intervention aimed for participants to complete three hours of PrAISED exercises a week for 12 months. It included individualised activity and exercise plans and supervised exercises with regular re-assessment and progression, and was delivered by occupational therapists, physiotherapists and rehabilitation support workers. Primary efficacy outcome was the Disability Assessment for Dementia (DAD), measured after 12 months. Secondary outcomes included physical activity, quality of life, mood, cognition, strength, balance, rate of falls, frailty and carer strain. Falls and activity were ascertained by monthly diary. Results Between September 2016 and March 2017 we recruited 60 patient participants and 54 carer participants from two sites. Forty-nine patient participants completed a follow-up interview. Feasibility outcomes were mostly satisfactory, including recruitment and retention, intervention delivery and data completeness for most scales used. We could not maintain blinding of researchers at follow-up and experienced difficulties collecting data using some questionnaires and devices. Participants only completed a mean 77 (moderate supervision) and 71 (high supervision) minutes per week of PrAISED exercises over 12 months. We recorded 19 adverse events, none serious and related to the intervention. Conclusion We conclude that with some adjustments to the trial protocol, it is feasible to deliver the PrAISED intervention and conduct a trial. Trial registration ClinicalTrials.gov: NCT02874300 (first posted 22nd August 2016), ISRCTN: 10550694 (date assigned 31st August 2016).

scholarly journals Effects of training community staff in interventions for substance misuse in dual diagnosis patients with psychosis (COMO study)

2007 ◽  
Vol 191 (5) ◽  
pp. 451-452 ◽  
Author(s):  
Sonia Johnson ◽  
Graham Thornicroft ◽  
Sarah Afuwape ◽  
Morven Leese ◽  
Ian R. White ◽  
...  
Keyword(s):  
Dual Diagnosis ◽  
Substance Misuse ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Effectiveness Of Training ◽  
Training Community ◽  
Community Staff ◽  
Randomised Controlled ◽  
Policy Guidance

SummaryA cluster randomised controlled trial was used to investigate the effectiveness of training staff in 13 London community mental health teams (CMHTs) to deliver substance misuse interventions to patients with psychosis and comorbid substance misuse (‘dual diagnosis’). The primary hypotheses, which were that experimental group patients would spend fewer days in hospital over 18 months of follow-up and show reduced alcohol and drug consumption, were not confirmed, although confidence intervals were wide for some outcomes. Current UK policy guidance advocates training CMHT professionals to deliver dual diagnosis interventions, but the effectiveness of this strategy has not so far been demonstrated.

DHA supplementation in infants born preterm and the effect on attention at 18 months’ corrected age: follow-up of a subset of the N3RO randomised controlled trial

2020 ◽  
pp. 1-12 ◽  
Author(s):  
Erandi Hewawasam ◽  
Carmel T. Collins ◽  
Beverly S. Muhlhausler ◽  
Lisa N. Yelland ◽  
Lisa G. Smithers ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
High Dose ◽  
Peak Period ◽  
Soya Oil ◽  
Randomised Controlled ◽  
To Receive ◽  
The Brain

Abstract Infants born preterm miss out on the peak period of in utero DHA accretion to the brain during the last trimester of pregnancy which is hypothesised to contribute to the increased prevalence of neurodevelopmental deficits in this population. This study aimed to determine whether DHA supplementation in infants born preterm improves attention at 18 months’ corrected age. This is a follow-up of a subset of infants who participated in the N3RO randomised controlled trial. Infants were randomised to receive an enteral emulsion of high-dose DHA (60 mg/kg per d) or no DHA (soya oil – control) from within the first days of birth until 36 weeks’ post-menstrual age. The assessment of attention involved three tasks requiring the child to maintain attention on toy/s in either the presence or absence of competition or a distractor. The primary outcome was the child’s latency of distractibility when attention was focused on a toy. The primary outcome was available for seventy-three of the 120 infants that were eligible to participate. There was no evidence of a difference between groups in the latency of distractibility (adjusted mean difference: 0·08 s, 95 % CI –0·81, 0·97; P = 0·86). Enteral DHA supplementation did not result in improved attention in infants born preterm at 18 months’ corrected age.

scholarly journals A self-management programme to reduce falls and improve safe mobility in people with secondary progressive MS: the BRiMS feasibility RCT

2019 ◽  
Vol 23 (27) ◽  
pp. 1-166 ◽  
Author(s):  
Hilary Gunn ◽  
Jackie Andrade ◽  
Lorna Paul ◽  
Linda Miller ◽  
Siobhan Creanor ◽  
...  
Keyword(s):  
Usual Care ◽  
Intervention Group ◽  
Health Technology ◽  
Feasibility Trial ◽  
Completion Rates ◽  
Economic Data ◽  
Definitive Trial ◽  
Secondary Progressive ◽  
Edss Score ◽  
Randomised Controlled

Background Balance, mobility impairments and falls are common problems for people with multiple sclerosis (MS). Our ongoing research has led to the development of Balance Right in MS (BRiMS), a 13-week home- and group-based exercise and education programme intended to improve balance and encourage safer mobility. Objective This feasibility trial aimed to obtain the necessary data and operational experience to finalise the planning of a future definitive multicentre randomised controlled trial. Design Randomised controlled feasibility trial. Participants were block randomised 1 : 1. Researcher-blinded assessments were scheduled at baseline and at 15 and 27 weeks post randomisation. As is appropriate in a feasibility trial, statistical analyses were descriptive rather than involving formal/inferential comparisons. The qualitative elements utilised template analysis as the chosen analytical framework. Setting Four sites across the UK. Participants Eligibility criteria included having a diagnosis of secondary progressive MS, an Expanded Disability Status Scale (EDSS) score of between ≥ 4.0 and ≤ 7.0 points and a self-report of two or more falls in the preceding 6 months. Interventions Intervention – manualised 13-week education and exercise programme (BRiMS) plus usual care. Comparator – usual care alone. Main outcome measures Trial feasibility, proposed outcomes for the definitive trial (including impact of MS, mobility, quality of life and falls), feasibility of the BRiMS programme (via process evaluation) and economic data. Results A total of 56 participants (mean age 59.7 years, standard deviation 9.7 years; 66% female; median EDSS score of 6.0 points, interquartile range 6.0–6.5 points) were recruited in 5 months; 30 were block randomised to the intervention group. The demographic and clinical data were broadly comparable at baseline; however, the intervention group scored worse on the majority of baseline outcome measures. Eleven participants (19.6%) withdrew or were lost to follow-up. Worsening of MS-related symptoms unrelated to the trial was the most common reason (n = 5) for withdrawal. Potential primary and secondary outcomes and economic data had completion rates of > 98% for all those assessed. However, the overall return rate for the patient-reported falls diary was 62%. After adjusting for baseline score, the differences between the groups (intervention compared with usual care) at week 27 for the potential primary outcomes were MS Walking Scale (12-item) version 2 –7.7 [95% confidence interval (CI) –17.2 to 1.8], MS Impact Scale (29-item) version 2 (MSIS-29vs2) physical 0.6 (95% CI –7.8 to 9) and MSIS-29vs2 psychological –0.4 (95% CI –9.9 to 9) (negative score indicates improvement). After the removal of one outlier, a total of 715 falls were self-reported over the 27-week trial period, with substantial variation between individuals (range 0–93 falls). Of these 715 falls, 101 (14%) were reported as injurious. Qualitative feedback indicated that trial processes and participant burden were acceptable, and participants highlighted physical and behavioural changes that they perceived to result from undertaking BRiMS. Engagement varied, influenced by a range of condition- and context-related factors. Suggestions to improve the utility and accessibility of BRiMS were highlighted. Conclusions The results suggest that the trial procedures are feasible and acceptable, and retention, programme engagement and outcome completion rates were sufficient to satisfy the a priori progression criteria. Challenges were experienced in some areas of data collection, such as completion of daily diaries. Future work Further development of BRiMS is required to address logistical issues and enhance user-satisfaction and adherence. Following this, a definitive trial to assess the clinical effectiveness and cost-effectiveness of the BRiMS intervention is warranted. Trial registration Current Controlled Trials ISRCTN13587999. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 27. See the NIHR Journals Library website for further project information.

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