Pilot and Feasibility Studies最新文献

Background: Incontinence-associated dermatitis (IAD) is prevalent in long-term care (LTC) facilities and homecare settings amongst adults who are incontinent of urine and/or faeces. Strategies to protect skin integrity are needed. This study aimed to co-design and test the feasibility of a training manual and care guidance (IAD-Manual) to prevent and treat IAD in LTC facilities and homecare settings.

Methods: This was a three-phase study: (1) developing the intervention, (2) designing the empirical study (a cluster RCT with an embedded process evaluation) to assess its effectiveness (not reported here) and (3) a 3-month feasibility study. The feasibility study recruited three LTC facilities and two homecare providers, randomising them (each as a cluster) to intervention or control. Process evaluation interviews with two care recipients, 11 family carers and 13 care staff implementing the IAD-Manual and their managers were conducted. Observations of 22 episodes of care assessed fidelity to the intervention. Qualitative data were analysed using thematic analysis. Summary feasibility outcome measures using means or proportions together with 95% confidence intervals were reported.

Results: Five sites were recruited from 49 approached. All randomised sites were retained. Seventy-six (16% [95% CI: 13-20%]) of the 477 participants approached were randomised, of which 58 (76% [95% CI: 65-85%]) completed the study. Candidate IAD outcomes had complete or almost-complete 3-month outcome data in those participants remaining, whereas other outcome measures had contrastingly poor data completeness largely due to participant cognitive impairment. Process evaluation showed few potential participants had the capacity to consent, and gaining consultee approval was challenging. Care staff at study sites liked the IAD-Manual, describing it as 'helpful'. Twenty-eight people accessed the IAD-Manual online, and 15 care staff downloaded a certificate of completion of training. Intervention fidelity was not always observed.

Conclusions: It was feasible to develop the IAD-Manual. The RCT as designed was not feasible in its original form, with specific challenges regarding site and participant recruitment, governance and intervention fidelity.

Trial registration: This trial was prospectively registered on 07/02/2020 (intervention development) ISRCTN26169429 and 28/02/2024 (feasibility study) ISRCTN70866724.

Background: The increasing prevalence of atrial fibrillation (AF) poses a global healthcare challenge, necessitating effective management strategies. AF is associated with reduced health-related quality of life (HRQoL), higher mental distress, and frequent hospital readmissions. Interventions like patient education and physical exercise have shown promise in reducing these burdens, yet their integration into primary care in a complex intervention set-up lacks thorough qualification and evidence.

Aim: This study aimed to investigate the feasibility of delivering a comprehensive prevention and rehabilitation intervention for individuals with AF in a primary Healthcare Center. Secondary objectives explored participant experiences and acceptability, needs and preferences, and changes in HRQoL, anxiety, and depression as well as feasibility of collecting patient-reported outcome measures (PROMs).

Trial design: A single-arm, intervention, feasibility study was conducted.

Methods: The primary feasibility outcomes were to investigate acceptability among participants and impact on the key outcomes HRQoL, anxiety and depression. Participants were consecutively recruited from a university hospital outpatient AF-clinic and referred to a primary Healthcare Center. The complex intervention included patient education, physical exercise, Medicinal yoga, psychosocial support and risk factor management. Quantitative data were collected using PROMs for HRQoL, anxiety and depression, while qualitative data were obtained through focus group interviews and field notes. Data analysis involved descriptive statistics and thematic analysis in a mixed-methods evaluation.

Results: Of the 50 participants enrolled, 43 (86%) completed the intervention. The complex intervention was feasible in a primary Healthcare Center with high acceptability. HRQoL improved from baseline to end-intervention and maintained at two-month follow-up, and symptoms of anxiety and depression decreased. Qualitative findings highlighted the importance of support from healthcare professionals and peers, alongside increased knowledge and tools to manage AF symptoms.

Harms: No adverse events were reported.

Conclusions: The study demonstrated the feasibility of a complex prevention and rehabilitation intervention for individuals with AF in a primary care setting and valuable insights were gained into the potential effectiveness and acceptability of the intervention. These findings underscore the importance of implementing comprehensive AF management programs and warrant further evaluation through large-scale randomized controlled trials.

Trial registration: ClinicalTrials Identifier: NCT06337045.

Background: Across the United Kingdom (UK), there are increasing calls for the implementation of multi-agency approaches to addressing violence or criminal exploitation outside the home (i.e. extra-familial harm) that address the needs of the child/young person (and their families) and the neighbourhood context in which harms occur. However, to date, there is very little evidence on what an effective multi-agency approach to supporting children and young people, and their families, looks like, or the services they should provide. This article presents the protocol for a feasibility and pilot study of a specialist multi-agency team embedded in neighbourhoods to support children and young people, and their families, who are at risk of, or experiencing, violence or criminal exploitation outside the home.

Methods: A mixed-methods feasibility and pilot study will examine implementation across five UK sites. Pre- and post-outcome measures will be collected from ~1000 children/young people receiving targeted support (~200 per site). Interviews will be undertaken with children and young people, parents/carers, and stakeholders to examine views and experiences of programme implementation and outcomes/impacts, and as relevant evaluation design and outcome measurements. The extent to which findings from the feasibility and pilot study support progression to a full impact study will be reviewed. If a randomised controlled trial (RCT) is not feasible, we will explore a quasi-experimental (natural experiment) evaluation design, using the 'Target Trial Framework' to make explicit where a future evaluation will align with, and where it deviates, from the ideal target trial (RCT).

Discussion: This study will provide an important and timely contribution to the emerging, but limited, evidence base surrounding the implementation of place-based multi-agency interventions to support children, young people, and their families at risk of extra-familial harm. This work has direct implications for informing UK policy and practice in the wake of the Independent Review of Children's Social Care (2022), which called for a 'whole system reset' including an improved, multi-disciplinary 'revolution in Family Help' to improve outcomes for children and young people, and their families.

Protocol registration: The full study plan is available here: https://youthendowmentfund.org.uk/wp-content/uploads/2024/07/REVIEWED-YEF-AC2-Feasibility-Pilot-Study-Plan-FINAL-July-2024.pdf and via the Open Science Framework: https://osf.io/s9bux/ .

Background: Adolescent and young adult cancer survivors (AYACS), aged 15-39, experience higher rates of depressive symptoms (25%-32%) compared to their non-cancer peers or older cancer survivors. While mobile health applications have shown promise in managing physical symptoms, their efficacy in addressing depression in AYACS remains underexplored. This study aims to evaluate the feasibility and acceptability of study procedures for a full factorial trial that will identify the optimal components of a digital tool (ASCENT) designed to promote self-management of depressive symptoms among AYACS.

Methods: Using a full factorial design, we will randomize 16 AYACS who have completed cancer treatment within the past 5 years to 1 of 16 conditions. The primary outcome for this study is the acceptability of study procedures, evaluated via an investigator-developed acceptability survey. Further, semi-structured exit interviews will be conducted to characterize reasons for aspects of the study with sub-optimal acceptability. Quantitative and qualitative data will also be collected on secondary outcomes including the feasibility of study procedures (as measured by recruitment and retention rates), participant use of and engagement with ASCENT, and participant feedback on ASCENT (e.g., usability, acceptability, and satisfaction).

Discussion: This pilot trial will assess the acceptability and feasibility of study procedures for a full factorial trial that will optimize a digital tool targeting depressive symptom self-management in AYACS. Findings will inform adjustments to enhance the design and implementation of a fully powered trial.

Trial registration: This trial was prospectively registered in ClinicalTrials.gov (NCT06420193) on May 17, 2024, https://clinicaltrials.gov/study/NCT06420193 . All items from the World Health Organization Trial Registration Data Set are listed in the table below.

Background: In the UK, over 980,000 people are living with dementia, and two-thirds of them live in their own homes. Up to 60% of this population is estimated to be at risk of or already experiencing malnutrition, with 45% facing significant weight loss. As dementia progresses, ensuring that people eat and drink well becomes challenging. Many families affected by dementia access home care services, with home care professionals playing a vital role in supporting and enhancing overall quality of life. Training in identifying nutritional problems and supporting family carers to prevent malnutrition is an identified research need; however, research on the contribution of home care professionals in this area is limited. This study aims to assess the feasibility and acceptability of a nutritional intervention for people living with dementia receiving home care from the perspectives of people with dementia, family carers (dyads), and home care professionals (including home care managers).

Method: This is a mixed-method single-arm feasibility study of a nutrition intervention with embedded process evaluation. Thirty-two participants living with dementia and their carers (dyads) will be recruited from home care organisations providing services for older adults across the South, Midlands, and North of England. The intervention comprises a nutritional awareness training session for home care workers, combined with educational resources for home care professionals, family carers, and friends. It is based on a model of person-centred nutritional care and will be delivered by trained home care professionals in the homes of participating dyads over 4 months. Outcome measures will be collected at baseline and at 4 months. Analyses will be descriptive and centred on the feasibility and acceptability of the interventions and study procedures. Key feasibility outcomes will include the rate of participant recruitment and dropout, and the percentage of home care staff who adhere to the intervention schedule (setting at least four actions in response to using the resources). Quantitative data analysis will primarily involve descriptive statistics. Acceptability of the intervention will be determined through in-depth semi-structured qualitative interviews conducted with a subsample of participants dyads and home care professionals. An embedded process evaluation will assess intervention implementation, capturing barriers and facilitators through participant interviews.

Discussion: Findings from this study will help inform the development and implementation of a future RCT, should this nutrition intervention be feasible.

Trial registration: NCT05866094.

Background: Adolescent tobacco use remains a significant public health concern in low- and middle-income countries (LMICs) such as Bangladesh. To address this issue, an Intervention for Adolescent Tobacco Initiation Prevention (IATIP) has been developed. This study aims to assess the feasibility of implementing the IATIP and to evaluate its potential efficacy in preventing tobacco initiation and promoting adolescent health and well-being.

Methods: This pilot school-based cluster randomised controlled trial will be conducted among adolescents (N ≈ 1280 participants) in school years 8 and 9 attending participating schools (K = 8 schools) in Dhaka, Bangladesh. The intervention consists of three 40-min sessions delivered over three successive days, incorporating knowledge- and skill-based lectures, interactive activities, and materials targeting tobacco prevention and health promotion. The intervention was developed based on evidence from a systematic review, a quantitative survey, qualitative focus groups, and expert consensus. The primary outcome is intervention feasibility, assessed through recruitment and attrition rates, fidelity of delivery, and acceptability. Secondary outcomes include changes in tobacco use intentions, tobacco-related knowledge, attitudes and beliefs, skills development, and measures of health and well-being. Data will be collected through structured questionnaires at baseline and at 1-month follow-up. A post-intervention process evaluation will be conducted with a sub-sample of pupils in the intervention arm and their teachers, using a mixed-methods approach to explore implementation processes, facilitation, participant experiences, and areas for improvement.

Discussion: This pilot trial addresses a critical gap in adolescent tobacco control in LMICs. By combining evidence-based strategies, the IATIP aims to equip adolescents with the knowledge and skills necessary to resist tobacco initiation and to enhance overall health and well-being. Successful implementation of the intervention may contribute to reduced tobacco initiation, lower exposure to second-hand smoke, and improved adolescent health outcomes. Given the scalability of school-based interventions, the findings of this study may inform future large-scale definitive trials and influence national policies and strategies.

Trial registration: ClinicalTrials.gov (NCT06399588).

Background: Thinking about the future in a clear and detailed way is critical to daily life, generating meaning, motivation, and well-being overall. In depression and suicidal ideation (SI), executive functioning deficits can make future-oriented thinking (FT) particularly effortful. Many interventions address the quality of future thinking in depression and SI but are limited by the thoughts that a person can generate on their own. Finding ways to intervene on FT that do not rely fully on the overburdened cognitive processes of a person experiencing depression or SI may improve the efficacy of these interventions. The present pilot RCT investigates the feasibility, acceptability, and proof of concept for a novel virtual-reality (VR)-based intervention on thoughts of the future self (FutureU for Mental Health; FU-MH) to improve a person's ability to think about the future and to reduce symptoms of depression and SI.

Methods: Using a 4-month, randomized, controlled, participant-blind, add-on superiority trial with three parallel groups, we will evaluate the potential of a two-part VR-based intervention on thoughts of the future and the future self to reduce negative affect and depressive symptoms. We aim to recruit 60 participants and randomize them to either a control group, treatment group A, or treatment group B, where treatment groups are exactly the same with the exception of the order of presentation for intervention parts. Feasibility will be measured in terms of enrollment and retention, as well as subjective measures of participant engagement and embodiment in VR. Acceptability will be measured through participant self-report. Proof of concept will be evaluated through the demonstration of the intended effect on targeted cognitive mechanisms, evidence of improvement in clinical outcomes, and evidence of efficacy among those with cognitive processing deficits.

Discussion: This study will provide valuable direction for further iterations of FutureU for Mental Health and a larger scale clinical trial. Implications of hypothesized outcomes include support for a novel intervention on thoughts of the future self in depression and SI, and VR as a novel medium of intervention and prevention in depression and SI.

Trial registration: This trial was preregistered with OSF Registries prior to the beginning of any data collection on October 9, 2022 (doi: https://osf.io/8c5n6 ).

Background: In India, newly married young women (18-25 years of age) face high rates of unintended pregnancy. Poor sexual and reproductive health knowledge combined with restrictive social norms leads to adverse pregnancy outcomes among young women, while limited female autonomy prevents them from accessing accurate healthcare information and support. We examined the feasibility and acceptability of TARANG, a life skills and reproductive health empowerment intervention developed for and with young newly married women using a community-engaged approach.

Methods: We report the findings from a convergent mixed-methods, single-group cluster pilot study in Rajasthan, India. We recruited 42 newly married women as participants in our study. Of these, 41 participants (retention rate = 97.6%) completed both baseline and endline surveys in July 2023 and January 2024, respectively. The intervention comprised 16 weekly sessions. Attendance was tracked electronically. We assessed three primary outcomes: feasibility (proportion completing ≥ 50% sessions), acceptability (proportion satisfied/somewhat satisfied), and usefulness (proportion finding TARANG useful/somewhat useful). Twelve participants were interviewed to understand intervention acceptance and usefulness, and 6 program staff and moderators were interviewed to understand implementation barriers. We analyzed quantitative data using descriptive statistics and qualitative data using thematic analysis.

Results: Thirty-five participants completed at least one session, with 73.8% attending at least half of the sessions (6 did not attend any sessions). Among those who attended at least one session, 97.1% were satisfied/somewhat satisfied, and 100% found the intervention useful/somewhat useful. Qualitative findings revealed participants' appreciation for open discussions on sensitive topics like family planning. The intervention filled knowledge gaps in family planning methods, fostered social connections through rapport building, enhanced sense of agency, and improved relationships with mothers-in-law and husbands. Implementation barriers included women's workload, cultural norms of extended stays at natal homes, and the need for intense rapport building. These insights informed intervention refinements, including session modifications, increased engagement strategies, and integration of educational videos.

Conclusion: Our pilot study demonstrated high acceptability and feasibility, with multiple benefits for young, newly married women. Our findings informed adaptations to enhance TARANG's delivery and satisfaction. The effectiveness of TARANG will be tested in a larger cluster randomized controlled trial currently underway.

Trial registration: The study is registered at ClinicalTrials.gov (NCT06320964). Registered retrospectively on 13 March 2024, https://clinicaltrials.gov/study/NCT06320964.

Background: Postpartum weight retention and maternal obesity are associated with short- and long-term maternal morbidity and mortality risk. Most weight-loss interventions among postpartum individuals follow evidence-based lifestyle recommendations but have produced only modest effects and have had substantial heterogeneity. We developed a novel internet-assisted weight management intervention for postpartum people that integrates concepts for improving sleep health within a diet and physical activity-focused intervention. We describe the intervention protocol and discuss how the pilot study's findings will inform future development and evaluation.

Methods: We will recruit 40 postpartum individuals with overweight or obesity from Western Pennsylvania to participate in a single-blind, parallel-arm, randomized controlled trial design. Participants will be randomized at a 1:1 ratio to the Sleep GOALS (Goal-focused Online Access to Lifestyle Support) intervention or education control group. The Sleep GOALS intervention includes interactive lessons addressing sleep, diet, physical activity, behavioral self-monitoring tools, and a lifestyle coach to provide accountability, encouragement, and personalized support. The education control group will receive brochures from the American Academy of Sleep Medicine (e.g., sleep hygiene, sleep in women), SNAP education connection (e.g., family-friendly activities, meal planning), and the U.S. Department of Health and Human Services (e.g., physical activity promotion during and after pregnancy). Primary study outcomes include the intervention feasibility (i.e., recruitment, enrollment, attrition rates, intervention engagement) and acceptability (i.e., participant ratings of the intervention delivery, curricula, approach to behavioral self-monitoring, action plans, intervention platform, and coaching). Secondary outcomes include weight loss and retention of pregnancy and postpartum weight gain.

Discussion: Incorporating a holistic approach that addresses sleep health alongside diet and physical activity, the Sleep GOALS intervention aims to not only facilitate weight loss but also enhance overall maternal well-being. Pilot testing will help us identify and refine factors related to the conduct of the planned larger, definitive trial and estimate the change in secondary outcomes.

Trial registration: NCT05942326.