Pilot and Feasibility Studies最新文献

Background: In the original BETTER (Building on Existing Tools to Improve Chronic Disease Prevention and Screening in Primary Care) intervention, a "Prevention Practitioner" meets with a participant aged 40-65 years to improve their uptake of prevention activities (e.g. cancer screening, physical activity). The BETTER intervention was found to be effective in a randomised control trial. We adapted BETTER to focus on a younger age group (adults aged 18-39 years) living with low income, a group known to have a higher prevalence of preventable cancers and chronic diseases than their higher-income peers. Here, we describe the development, piloting, and qualitative evaluation of the acceptability of the adapted BETTER intervention ("BETTER Life") to inform future large-scale implementation research.

Methods: To support adaptation of BETTER, we interviewed community residents from low-income areas in Durham Region, Ontario, Canada and healthcare program service providers across Canada who had knowledge about preventive care. We developed an adapted intervention, BETTER Life, and piloted it at the Durham Community Health Centre to understand acceptability and appropriateness. Pilot participants were contacted a minimum of 2 weeks afterward to complete a semi-structured interview and share their experiences with the intervention and preventive care.

Results: We conducted 22 adaptation interviews with 10 community residents and 12 healthcare service providers, 6 interviews with pilot participants (of 8), and a focus group with the two Prevention Practitioners. We found that participants felt that poverty contributes to poor health, including mental health; health education and interventions are often missing, unknown, or difficult to access in low-income communities; and that social networks are important for health. As a direct response to these issues, BETTER Life was seen as a unique, comprehensive program in the community that helps people set goals and reinforce healthy behaviours. However, many different strategies may be required to encourage engagement in the BETTER Life program.

Conclusions: We developed BETTER Life by adapting the original BETTER to focus on adults aged 18-39 years living with low income, piloted it, and evaluated its acceptability and appropriateness. Although BETTER Life was seen as an important program, recruitment for the larger-scale study will be challenging as young adults struggle with competing life priorities and the social determinants of health.

Background: Ageing is associated with a loss of fluid intelligence and motor functions which hamper independence and quality of life. Training in a musical instrument can improve fluid intelligence and executive function (EF) in older non-musicians but the neural correlates underpinning the benefits remain elusive. The primary aims of this study are to: i) test the acceptability of Piano Instruction for Adult Novices as Online Cognitive Intervention (PIANO-Cog), a novel bespoke 8-week self-guided piano training programme for adults over the age of 50 years; and ii) to test the feasibility (in terms of recruitment, retention and adherence) of a large scale RCT comparing PIANO-Cog to a passive control. Secondary aims of this study are: i) to investigate the effects of online piano training on fluid abilities, EF and motor function; ii) to investigate training-induced microstructural brain changes using ultra-strong gradient (300mT/m) magnetic resonance imaging (MRI) and iii) to investigate how the latter may be linked to cognitive improvements post-training.

Method: A two-armed unblinded RCT will be conducted on 50 healthy non-musician adults over the age of 50. Participants will be randomised to a piano training (PT) or passive control group for 8 weeks, stratified for age and sex. PT participants will receive a training manual and 20-min video tutorials each week, and will practice 30 min, 5 days per week. Control participants will receive no intervention for the 8-week period. Cognitive testing and MRI of the brain will take place before and after the intervention.

Discussion: The primary aim of the trial is to determine the acceptability of PIANO-Cog as an online cognitive intervention for adults over 50 who are non-musicians, and the feasibility of conducting a large-scale RCT in terms of recruitment, retention and adherence. Self-guided music training programmes could provide a cost-effective method of maintaining or improving cognitive and motor functions that individuals can implement in their own homes. Secondary aims are regarding the investigation of positive transfer of piano training to EF and fluid abilities in ageing, and to provide evidence for the relationship between training-induced cognitive enhancements and underlying white and grey matter microstructural changes.

Trial registration: ISRCTN11023869 (retrospectively registered).

Protocol version: 20/10/2025 version 1.5.

Background: Muscle-strengthening activity (MSA) is beneficial for school-aged children, but most school-based MSA interventions have been delivered by external specialists or research staff, limiting scalability. We aimed to assess the feasibility of a teacher-delivered MSA intervention for children in advance of a future efficacy trial.

Methods: We conducted a single-group feasibility trial with two Stage 2 (i.e. grade 3-4) classes from one primary school in New South Wales, Australia. The 6-week Muscle Movers intervention included (i) enhanced PE lessons focused on foundational MSA skills (1 × 45 min/week), (ii) classroom energiser breaks (2 × 5 min/week), and (iii) active homework tasks (1 × 10 min/week). We assessed acceptability, implementation, adaptation, and practicality using survey and interview methods. We also assessed pre-post change in children's perceived strength, upper-body muscular endurance, and lower-body muscular power. Data were analysed in SPSS (V.25) using descriptive statistics and paired-samples t-tests, with Cohen's d as a measure of effect size.

Results: Two female teachers (31 and 59 years) and 30 students (mean [SD] = 9.8 [0.6] years; 40% female) were enrolled. Acceptability was high for teachers (mean [SD] = 5.0 [0.0] out of 5) and students (mean [SD] = 4.1 [1.0] out of 5). Teachers implemented all PE lessons and more than double the intended energiser breaks (mean [SD] = 5.5 [2.1] per week). Conversely, homework task assignment (mean [SD] = 5.0 [1.4]) and completion (mean [SD] = 2.5 [0.7]) were lower than intended. Teachers reported high confidence to deliver the program and viewed it as practical and adaptable. We found a moderate increase in children's push-up performance (mean [95%CI] = 2.2 repetitions [0.7 to 3.8]; d = 0.61), but no meaningful changes in perceived strength (mean [95%CI] = 0.1 units [- 0.1 to 0.4]; d = 0.22) or standing long jump (mean [95%CI] = - 1.4 cm [- 7.4 to 4.7]; d = - 0.09).

Conclusions: Muscle Movers was feasible for classroom teachers to implement in a primary school setting. The observed improvement in students' upper-body muscular endurance should be confirmed using an appropriately powered randomised controlled trial.

Trial registration: Retrospectively registered with the Australian and New Zealand Clinical Trials Registry (ACTRN12625000703404).

Background: Medicines management for people with dementia is a global health priority. Cognitive difficulties, such as memory problems, can impact safe and effective medicines management. With appropriate support, people with mild-moderate dementia can self-manage medicines, with and without family. People with dementia can enhance medicines safety by building resilience into their medicines management system through their ability to respond, learn, monitor and anticipate. Medicines self-management interventions have more often focused on adherence as opposed to other experiences, such as knowledge of medicines, though psychosocial interventions have addressed other components of medicines self-management. Co-design approaches draw on the person's experience. A co-designed resilience-enhancing psychosocial intervention for medicines self-management for community-dwelling people living with dementia and with or without family carers (MAGNET) was developed. This protocol describes a study aiming to assess the feasibility and acceptability of the MAGNET intervention.

Methods: Study objectives are to assess the feasibility and acceptability of implementing the MAGNET intervention in preparation for a randomised controlled trial; to develop materials for estimating the effectiveness and cost-effectiveness of the intervention in a randomised controlled trial, and to assess the feasibility and acceptability of collecting data using these materials. This is a non-randomised feasibility study. Seventy-two people living with dementia and their family carers will be recruited to the study and receive the MAGNET intervention. The intervention involves an 8-week community-based medicines self-management programme involving a 'Managing My Medicines' guide for people living with dementia and carers, and a medicines self-management professional's guide to support implementation by trained professionals. Methods of evaluation include questionnaires and interviews with people living with dementia, family carers and professionals. Intervention delivery will be observed. Quantitative and qualitative data will be completed at baseline, end month 1, end month 2, and post intervention. The evaluation will be underpinned by the Consolidated Framework for Implementation Research (CFIR).

Discussion: This study will indicate whether the MAGNET intervention is feasible and acceptable. If the study findings support feasibility and acceptability, then we will seek further funding for the development and implementation of a randomised controlled trial.

Trial registration: ISRCTN 15712227.

Background: Diabetes mellitus is a surgical risk factor, yet perioperative diabetes management remains debated, with inconsistent guidelines and limited consideration on the implementation of "enhanced recovery after surgery" (ERAS) programs. A detailed prospective observational multicenter study was launched to investigate perioperative risk factors and outcomes in diabetic patients undergoing modern optimized hip and knee arthroplasty within an established ERAS program.

Methods: This study reports on the feasibility of launching prospective detailed observational studies as part of daily clinical practice within a multicenter collaboration, focusing on data completeness and successful recruitment.The feasibility analysis was conducted from October 1, 2022, to January 31, 2024, across eight public arthroplasty centers in Denmark, in diabetic patients undergoing elective primary total hip (THA), total knee (TKA), or unicompartmental knee (UKA) arthroplasty. Prospective data collection included antihyperglycemic medication, preoperative HbA1c, data on perioperative diabetes management, length of stay (LOS), and readmission after surgery.

Results: The cohort comprised 1007 DM patients (37.6% (n = 379) THA, 44.5% (n = 448) TKA, 17.9% (n = 180) UKA) with a mean age of 70.7 years (SD 8.8), and the median age was 71 (IQR 65-77); 48% were female and 19% were insulin-treated. Data on the type of preoperative antihyperglycemic medications was available in 100% of patients. LOS was registered in 100% of patients, and 90-day follow-up was completed in 99% of patients. Preoperative HbA1c assessment increased from 68% in February 2023 to 96% in January 2024. From March 1st, 2023, data on perioperative diabetes management was available for 98% of all patients, with a total completion variation between 94 and 96% across the included parameters.

Conclusion: The study demonstrates the feasibility of a prospective multicenter setup for detailed data collection on diabetic patients undergoing ERAS hip or knee arthroplasty. The high compliance rates of key metrics (≥ 94%) support that data completeness and quality are sufficient to proceed with the main study to assess the impact of diabetes and its management on outcomes within an ERAS program in 2000 patients, since enrollment exceeded expectations.

Trial registration: ClinicalTrials.gov. NCT05613439. Registered on 9 January 2022, https://clinicaltrials.gov/study/NCT05613439?id=NCT05613439&rank=1.

Background: Problematic benzodiazepine use alongside opioids contributes to drug-related deaths among people who use drugs. Clinical management varies considerably. An intervention to address the root causes of benzodiazepine use with opioids has been developed, which included maintenance prescribing of diazepam with anxiety, sleep, and pain management, harm reduction, and safety conversations. This study tested the feasibility of recruiting and retaining people in the intervention to address 'street' benzodiazepine use. Outcome measures and economic evaluation data collection were piloted to determine the feasibility of a future trial.

Methods: The study tested the intervention in three sites (Grampian, Lothian and Fife) with a target of 15 patients per site. Inclusion criteria were people who were stable on opioid agonist treatment (OAT) with ongoing street benzodiazepine use. The intervention duration was 4-6 months depending on the site. Validated tools were used to monitor outcomes covering: anxiety (GAD-7), depression (PHQ-9), quality of life (EQ-5D-5L), substance use recovery (SURE), and cognitive function (ACE-III). 'Street' drug use was measured through oral fluid tests and self-report. Resource use data were collected from an NHS perspective using a bespoke questionnaire to inform a future economic evaluation.

Results: After revisions to the inclusion criteria, 39 people were recruited (9 women, 30 men), mean age: 42 yrs. Almost all had diagnosed anxiety (n = 38) and depression (n = 39,); sleep problems were common (n = 34), and over half had chronic pain (n = 21). Retention was 77% at final data collection at 4-6 months (n = 30). There were indications of improvement in anxiety, depression, self-reported recovery, and quality of life. Cognitive function was stable. Self-reported 'street' benzodiazepine use reduced from 100% (n = 39) at baseline to 35% at follow-up (n = 10). The economic data indicated good completion of the resource use and quality of life questionnaires, but this was dependent on the participants attending clinic appointments.

Conclusion: Recruitment was feasible, and there were signs of clinical improvements across anxiety, depression, quality of life, and recovery measures. Findings justify a randomised controlled trial of this intervention vs. standard care of a benzodiazepine tapering dose. However, accurate, objective measurement of current 'street' drug use is required.

Trial registration: ISRCTN number: 95130898. Registered 23/10/2023-retrospectively registered; ethical approval: approved 29/10/2021, North of Scotland Ethics Committee, ref: 21/NS/0135.

Background: Telehealth has been proven to be an effective means of delivering psychotherapy, yet there is a lack of evidence in Vietnam where access to psychotherapy is limited. We conducted a study to evaluate the feasibility, acceptability, and preliminary efficacy of Tele-SSM-a mobile health-supported self-management intervention for depression in Vietnam.

Methods: This was a pre-post, mixed-methods study. Adults aged between 18 and 64 years old with symptoms of depression were recruited and participated in 10 individual weekly sessions delivered remotely by mental health para-professionals. Feasibility was assessed by recruitment capacity, retention, and participant compliance; acceptability by participant satisfaction ratings and in-depth interviews; and preliminary efficacy by changes in depression, anxiety, stress, suicidal ideation, self-esteem, and perceived social support scores from baseline to endline.

Results: Seventy-five adults with depression were enrolled and 58 of those completed the intervention. Feasibility was adequate as recruitment, retention, and compliance all exceeded the predefined progression criteria. Recruitment reached 93.75% (progression criterion of ≥70%), retention was 77% (progression criterion of ≥75%), and compliance was high, with 93.1% of participants completing the intervention within the expected number of sessions (progression criterion of ≥80%). The intervention was well-accepted by participants with 96% of participants reporting satisfaction with the materials and coaching sessions. The average number of coaching calls required to deliver 10 sessions was 10.81, suggesting that the intervention may need to be implemented over 11 calls. Additional emphasis should be placed on realistic thinking and non-violent communications skills as participants reported more difficulties with these components. Exploratory pre-post analyses suggested potential improvements across depression, anxiety, stress, suicidal ideation, self-esteem, and perceived social support; however, these findings should be interpreted cautiously given that the study was not powered to assess efficacy.

Conclusions: These results provide promising evidence for the adequate feasibility, acceptability and preliminary efficacy of Tele-SSM on depression. The intervention also has the potential to address anxiety and stress. These preliminary insights can inform the design of a future randomized hybrid effectiveness-implementation study, particularly with regard to recruitment, retention, adherence, and potential outcome trends.

Trial registration: Clinicaltrials.gov, NCT06456775. Registered June 13, 2024 - Retrospectively registered, https://clinicaltrials.gov/study/NCT06456775?cond=depression&intr=Tele-SSM&rank=1.

Background: Depersonalization-derealization disorder (DDD) is characterized by feelings of "unreality" about the self and/or external world. Cognitive Behavioral Therapy adapted for DDD (CBT-f-DDD) has been effective in published clinical audits. This study aimed to provide feasibility and acceptability data.

Methods: An individually randomized design of CBT-f-DDD versus Treatment as Usual (TAU) was carried out with adult DDD participants from NHS Trusts in London. The CBT-f-DDD group received individual sessions over a 6-month period from CBT therapists. Qualitative interviews were conducted with CBT-f-DDD participants and their clinicians. Eight feasibility objectives were evaluated (recruitment, retention, resources, representativeness, acceptability of study design and intervention, preliminary responses to intervention, and health economics).

Results: Thirty participants with DDD were recruited over 13 months. Only 63% completed the final assessment, so retention needs improvement. Resources were acceptable. The sample was comparable to previous studies, although younger, with a shorter duration of DDD and lower mean DDD scores. In a post-study questionnaire, no aspect of the study or treatment was rated unacceptable; however, some areas need improvement. Qualitative interviews with participants and clinicians recorded positive responses to CBT-f-DDD. Those in the CBT arm had a mean decrease of 16.9 points (SD 43.6) on the Cambridge Depersonalization Scale versus a mean decrease of 5.5 points (SD = 25.0) for the TAU arm. Health economics analyses found that CBT-f-DDD saved £153 per person. Participants reported an additional 0.08 Quality-Adjusted Life Years at low cost.

Conclusions: This study suggests that a subsequent RCT for CBT-f-DDD is feasible and represents the first step in the process of establishing evidence-based treatments for DDD. However, refinements to the current design and delivery were indicated for a future fully powered definitive RCT of CBT-f-DDD.

Trial registration: ISRCTN, ISRCTN97686121. Retrospectively registered 5 January 2023: https://doi.org/10.1186/ISRCTN97686121.

Background: Osteoarthritis is one of the most prevalent musculoskeletal disorders. In osteoarthritis patients, physical activity has been shown to be an effective tool to improve quality of life as well as to reduce the pain associated with the disease and the development of additional comorbidities. Yet osteoarthritis patients often do not meet the level of physical activity recommended to stay in good health. The PIANISSIMO study primarily aims to test the adherence of people with hip and knee osteoarthritis to a 6-month intervention for the promotion of physical activity specific to this population using a dedicated mobile app.

Methods: The PIANISSIMO study is a longitudinal, interventional feasibility study conducted through a dedicated mobile app. A total of 151 participants with hip or knee osteoarthritis will be included. The app will collect data and deliver the intervention. Data will be collected through questionnaires (i.e. demographic data, osteoarthritis history, sport history, pain and functional capacities, app evaluation) and from Apple Health/Google Fit apps. The PIANISSIMO study will use a 6-month physical activity intervention based on the Capability, Opportunity, Motivation-Behaviour change theory. Participants will receive a text notification on a daily basis; they will be asked to set their daily steps goal for the next week, and the mobile app will deliver feedback on daily step count and whether the goal of the week has been reached. The primary outcome of this study is the adherence (i.e. connection log and rate of answered questionnaires) to the app-based physical activity intervention. Retention will be calculated as the number of drop-outs over 6 months of follow-up. Moreover, the acceptability of the app and intervention by the study participants will be evaluated through a questionnaire.

Discussion: This mobile app was designed to provide a digital solution for the promotion of physical activity in people with osteoarthritis. If the feasibility of delivering a physical activity intervention through the mobile app is confirmed, the efficiency of the tool in improving the quality of life of people with hip and knee osteoarthritis should then be properly investigated.

Trial registration: Registration number NCT06385028 (https://clinicaltrials.gov/study/NCT06385028) Protocol version 1.2.