搜索结果：Pilot and feasibility studies

People leaving prison face significant barriers to reintegration, often resulting in homelessness, which exacerbates health issues and increases recidivism. Critical time interventions aim to support vulnerable individuals during significant life transitions by providing time-limited, emotional and practical support. While effective in other contexts, the impact of housing-led critical time interventions for people leaving prison in the United Kingdom remains unclear. The PHaCT study was a pilot randomised controlled trial of a housing-led critical time intervention for people leaving prison at risk of homelessness. This study aimed to determine whether a full-scale randomised controlled trial of the critical time intervention model in prison leavers at risk of homelessness was feasible. The pilot was a parallel two-arm, individual-level randomised controlled trial of a pre-existing critical time intervention intervention with an integrated process evaluation and embedded exploratory health economic evaluation. Recruitment occurred in fours male prisons across England and Wales with participants followed up in the communities. Prisons were randomised by site to either receive the critical time intervention or receive usual support, and participants were recruited within 12 weeks of their release. The locations were predetermined by where the intervention was already being delivered by the intervention provider (critical time intervention teams). Critical time intervention included pre-engagement, transition to community, try-out and transfer of care phases, each lasting 3 months. Data collection methods included baseline surveys, follow-up assessments at 3, 6 and 9 months, qualitative interviews, and session observations. Routine data linkage was explored separately to assess feasibility. Progression criteria included recruitment, retention, process evaluation and fidelity. Thirty-four male participants (mean age 38 years) were recruited, with 19 assigned to the intervention and 15 to control. The study achieved a high recruitment rate of 92%, but retention was a significant challenge, with only 18% of participants retained at 9 months follow-up. The process evaluation found critical time intervention was acceptable to staff and participants, but ethical concerns around randomisation and informed consent were raised. Fidelity to the critical time intervention model was generally high, though contextual instability in housing and criminal justice systems posed challenges. Data collection methods for health economics and data linkage were feasible and acceptable. The approval to access prisons was lengthy and support provided by Clinical Research Networks was delayed. Contextual instability within the housing and criminal justice systems, including a lack of social housing, high recall rates, the removal of the requirement to have a probation officer and the emergency early release of people in prison, further complicated the trial. Ethical concerns around randomisation and informed consent affected trial acceptability. The trial methodology faced significant challenges. Low retention rates, ethical concerns by intervention delivery staff around randomisation and contextual instability suggest that a full-scale randomised controlled trial is not feasible. The findings highlight the need for systemic changes within the research support provided to prison-based studies, housing and criminal justice systems to support research in prisons and interventions for people leaving prison. Decision-makers should prioritise policies that increase the availability of affordable housing and provide post-release support. Future research should explore alternative study designs and more intensive recruitment and retention strategies. This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme as award number NIHR134281. People leaving prison often struggle when returning to the community, leading to homelessness, worse health and higher chances of committing more crimes. Critical time intervention is a structured support model delivered by trained caseworkers to help during this transition. Critical time intervention includes four phases, pre-engagement, transition to community, try-out and transfer of care, each lasting 3 months. Caseworkers support individuals to secure housing, access services and build life skills. From October 2023 to August 2024, 34 men leaving three prisons in England and Wales were recruited for a pilot study. Participants were randomly assigned to either receive critical time intervention or usual support. The study aimed to test whether a full-scale research project could be done to evaluate critical time intervention. We assessed recruitment (did people take part), retention (could we stay in touch), fidelity (was critical time intervention delivered as planned) and acceptability (were the study and intervention acceptable to participants and staff). Data were collected through surveys at baseline and at 3, 6 and 9 months, interviews and session observations. Most people agreed to take part, but it was difficult to maintain contact over time. Critical time intervention was well received by staff and participants, but the research process faced challenges. These included high rates of return to prison, limited housing options, reduced probation contact and emergency early releases. Critical time intervention was valued by those who delivered and received it, but conducting a larger study to evaluate its effects would be difficult. Maintaining contact with participants was challenging, and wider issues in housing and criminal justice systems suggest a full-scale trial may not be feasible. Future work should focus on improving support for prison leavers and adapting research methods to better suit this population.

Hypertension is the leading global risk factor for mortality, causing over 10 million deaths annually. In sub-Saharan Africa, hypertension prevalence is high, particularly in rural areas, where it is less likely to be diagnosed, treated or controlled effectively. This results in a high burden of complications, including heart failure, stroke and kidney disease. Community-centred approaches using community health workers (CHWs), risk-based approaches and simplified treatment regimens have shown promise in improving hypertension management. However, there is limited evidence on the effectiveness of such approaches in rural sub-Saharan Africa.The primary aim of this study is to assess the feasibility of a community-centred intervention for hypertension management in rural Kenya and The Gambia. The objectives are to evaluate the intervention's adoption, fidelity, reach and dose; understand the mechanisms of action and contextual factors affecting its implementation; assess acceptability from the perspectives of patients, healthcare providers and policymakers; estimate the costs associated with the intervention; and evaluate study procedures to inform the design of a future full-scale trial. We will conduct a mixed-methods, non-randomised, single-arm feasibility study, designed in accordance with the Consolidated Standards of Reporting Trials (CONSORT) framework and checklist for feasibility and pilot studies, including best practice guidance for non-randomised feasibility studies. The study will be conducted in two rural sites: Kilifi, Kenya and Kiang West, The Gambia. The intervention was codesigned with stakeholders and includes community-based hypertension screening by CHWs, risk stratification and hypertension-mediated organ damage assessment at primary healthcare facilities, followed by treatment initiation using single-pill combination (SPC) antihypertensive therapy for eligible individuals. Training will be provided to all healthcare providers involved in the study. We will screen 500 participants aged 30-80 years at their residence (250 from each country), and we expect that about 45% will be referred for additional assessments and of these 25% (or 10% of the total sample) will be prescribed treatment with SPC. Data collection to evaluate the intervention and its implementation will involve quantitative measures of feasibility and clinical outcomes; observations to assess fidelity and costing measures; and qualitative interviews and focus group discussions with patients, healthcare providers and policymakers to understand the acceptability and contextual influences on intervention implementation. Ethics approval was obtained from the Kenyan National Committee for Science, Technology and Innovation (ref: 415561), the Gambia Government/Medical Research Council Joint Ethics Committee (ref: 31372) and the London School of Hygiene and Tropical Medicine Ethics Committee (ref: 31372). Study findings will be disseminated through peer-reviewed publications, conferences, policy briefs, community engagement forums and accessible summaries shared via the Improving Hypertension Control in Rural sub-Saharan Africa and partner newsletters. This study is registered with the ISRCTN- The UK's Clinical Study Registry (ISRCTN81228019), and Pan African Clinical Trials Registry (PACTR202504839027548).

Mobile apps and wearable devices may help to facilitate early detection of mental health conditions by providing objective, real-time data to supplement other forms of feedback and diagnoses. Few studies have investigated the acceptability and feasibility of using a mobile app to track survey- and wearable-based data in mental health research in Sub-Saharan Africa. This pilot study evaluated the feasibility and acceptability of using a mobile app and wearables to capture mental health-based survey data and passively sensed data among Kenyan health care workers. A mixed methods study was conducted among health care workers employed at 4 hospitals in Nairobi, Kenya, over 30 days. A mobile app was used to collect and integrate active (baseline questionnaire and daily mood) and passive (wearable) data. The baseline questionnaire gathered information on sociodemographics, work environment, and mental health assessments on depression, anxiety, personality, early family environment, posttraumatic stress disorder, and substance use. A wearable device was used to gather data on steps, heart rate, and sleep. Qualitative interviews were conducted post trial to gain in-depth insights into participants' experiences during the study. Fifty-one participants enrolled in the pilot study. They were primarily nurses (47%) and female (70%), with a median (IQR) age of 32 (29-36) years. Attrition over 30 days was low, with only one participant dropping out due to device malfunction, which was a broken screen. Completeness of the baseline survey was high, with participants completing 96.1% of the questions. Further, 58% of the daily mood ratings were completed over the 30 days. For the wearable measures, participants submitted steps, heart rate, and sleep data on 93%, 73%, and 51% of study days, respectively. The proportion of days the wearable was worn for over 10 hours was 63%. Interviews revealed 2 primary themes. The first was intrinsic and extrinsic motivation; participants indicated that they liked having their health metrics tracked and receiving congratulatory messages from the app, encouraging increased step counts. The second theme was technical and usability challenges; 48% (10/21) of the participants reported discomfort wearing the watch while sleeping and challenges with synchronization of data due to the nonautomated nature of the process. Participants suggested additional prompts to remind them to complete the daily mood question. This pilot study demonstrates the feasibility of deploying mental health surveys, collecting data through wearable devices, and integrating such data within a single mobile platform under real-world infrastructure constraints. Health care workers in Kenya were willing to provide sensitive information through mental health assessments using a mobile app. To improve adherence, future studies should consider addressing some contextual factors such as daily prompts, enhanced data synchronization methods, and comfort concerns to improve adherence, especially during sleep.

Health interventions should be designed to be appropriate for scaling from the outset, but the extent to which factors that are important for scalability are reported on in pilot randomised trials is unclear. This review assesses the extent to which pilot randomised trials report on 15 domains of intervention scalability. Methodological review. Four journals were searched: BMJ Open, BMC Pilot and Feasibility Studies, BMC Trials and PLoS One for articles published between January 2023 and October 2024. We included pilot randomised trials of health interventions. Data relevant to 15 scalability domains, derived from the Intervention Scalability Assessment Tool and wider implementation science literature, were extracted. Data were double-extracted for 20% of the included studies. Two authors scored all studies from 0 to 3 (0=Not at all; 1=Small extent; 2=Moderate extent; 3=Large extent) on the extent to which each of the 15 scalability domains was reported. For each scalability domain, we calculated the mean score and the frequency of each categorical score across the included studies. Titles and abstracts screening (521 publications) resulted in 132 full-text publications for review. Of the 104 eligible studies, a random sample of 50 studies were selected for detailed review. Through snowballing, an additional 49 associated publications were identified (eg, protocols), resulting in 99 publications across 50 studies. Most studies reported the Problem (30/50, 60%; mean=2.4 ± 0.8) and the Intervention (37/50, 74%; mean=2.7 ± 0.4) to a large extent (ie, scored 3), with the Delivery Setting and Workforce domain most often receiving a score of 2 (28/50, 56%; mean=2.2 ± 0.7). For eight of the scalability domains, the majority of studies scored 0. The extent of scalability domain reporting in pilot trials of health interventions is limited. Explicit consideration of scalability in pilot trials could improve the design of fully powered randomised controlled trials and enhance the potential for effective interventions to be translated into practice. Future research should consider if and how to incorporate scalability considerations into pilot trials, and whether pilot trial and intervention reporting guidelines should be expanded to include scalability considerations.

Chronic low back pain (CLBP) is a significant public health problem and the leading cause of years lived with disability globally. Evidence suggests that interprofessional rehabilitation programs are effective for people with CLBP in improving health-related quality of life, reducing pain, and improving function and work abilities for people with CLBP. So far, however, little attention has been given to interprofessional rehabilitation programs for people with CLBP in low- and middle-income countries. Hence, this pilot randomized control trial (RCT) aims to evaluate the feasibility of conducting a future fully powered RCT to assess the effectiveness of an interprofessional rehabilitation program compared to the usual care for people with CLBP in Ethiopia. A two-arm parallel pilot RCT, with embedded mixed methods process evaluation, will be employed. A total of 40 patients with CLBP will be randomly assigned to the intervention and control groups at a 1:1 ratio. Participants of the intervention group will receive interprofessional rehabilitation that contains progressive physical activity and exercise, pain education, psychological interventions, and task-oriented and ergonomic interventions components. The comparison group participants will receive usual care for the same 4-week period. The primary outcome will be the feasibility of trial procedures (recruitment rate, retention rate, adherence rate, and acceptability of intervention). Secondary outcomes include the outcomes planned for the full trial, including physical functioning, pain intensity, pain self-efficacy, and health-related quality of life. Results will be analyzed and reported using descriptive statistics. The process evaluation will include a fidelity checklist, adherence measures, and qualitative interviews with 10 patients and all care providers involved to understand their experiences, barriers, and facilitators to implementing the intervention and trial methods with the goal of refining the intervention and trial methods in preparation for the fully powered trial. This pilot RCT will be critical to informing the methods, minimizing uncertainties, and increasing the likelihood of successfully conducting a definitive RCT in the future. In addition, it provides a source of evidence for other initiatives aimed at developing and implementing interprofessional rehabilitation programs in a similar context particularly in low- and middle-income countries. This trial is registered at clinicaltrials.gov (registration number, NCT05866146, date of registration, 19th July 2023).

Poverty is associated with depression and anxiety among adolescents, but evidence of interventions that prevent adolescent depression and anxiety among adolescents living in poverty is weak. Interventions either focus on reducing poverty or addressing depression and anxiety, but an approach that combines both may offer larger benefit. This multi-site parallel pilot cluster randomised controlled trial (cRCT) evaluates the feasibility and acceptability of a selective preventive intervention for depression and anxiety that simultaneously intervenes on both poverty and self-regulation among adolescents living in urban poverty. The study takes place in Bogotá (Colombia), Kathmandu (Nepal) and Cape Town (South Africa). The pilot cRCT has four arms: (i) self-regulation intervention, (ii) economic intervention, (iii) combined (self-regulation + economic) intervention, and (iv) control group (care as usual). Interventions consist of 20 weekly group sessions with adolescents, and 6 monthly group sessions with their caregivers. The self-regulation intervention for adolescents includes psychological activities (mindfulness breathing, problem solving, biofeedback and goal setting) and a physical activity. The economic intervention includes three dimensions (financial training, negotiation training, education information) and a monthly cash transfer. In each site, the aim was to recruit 240 adolescents and their caregivers across eight schools (clusters), with two schools randomised to each arm. Adolescents residing in areas at risk of multidimensional poverty and who had symptoms of depression or anxiety, but who did not meet thresholds indicating depression and anxiety disorders, were considered for enrolment. Recruitment into the study is complete: a total of 628 adolescents and 536 caregivers were enrolled. Participants will be assessed four times: at enrolment, post-intervention and at 12 and 18 months post-enrolment. Primary outcomes include feasibility and acceptability criteria for study and intervention delivery procedures (i.e. randomisation, masking, recruitment, retention, missingness, fidelity, attendance, adverse events) defined as traffic light criteria to assess progression to an adequately powered trial. Secondary outcomes include self-report instruments, physiological measures and neuropsychological tasks. The effectiveness of combining self-regulation and anti-poverty interventions remains untested. This study will establish the feasibility and acceptability of delivering such an intervention, as well as test the trial procedures to inform a future adequately powered trial. ISRCTN 14601588. Retrospectively registered. Date: 19 May 2024.

The first 2000 days can profoundly influence long-term health. Healthy Beginnings for Hunter New England Kids (HB4HNEKids) is an SMS text messaging program delivered alongside routine Child and Family Health Nursing (CFHN) care, which provides families with evidence-based, age- and stage-related preventive health information across the first 2000 days. This pilot study aimed to explore the feasibility, engagement, and acceptability of the HB4HNEKids program. It also aimed to explore the potential effectiveness of the program at 6 and/or 12 months post partum on outcomes including breastfeeding, child diet, child movement, and parental mental well-being. During the pilot phase (October 2021 to July 2024), project records were used to assess the number of families enrolled, number of SMS text messages sent (feasibility), and the number of opt outs (engagement). Repeat cross-sectional surveys were conducted at 5-7 months post partum and again at 12-14 months post partum using validated survey instruments. Using convenience sampling methods, survey participants consisted of birthing parents who had received HB4HNEKids and a concurrent nonrandomized comparison group that did not receive the program. Surveys assessed parental self-reported engagement with the messages, program acceptability, breastfeeding status, child diet, child movement, and parental mental well-being. Mixed linear regression analyses were conducted to calculate mean differences and odds ratios. During the pilot phase, HB4HNEKids was delivered to 6243 families (73.4% of families contacted by CFHN). A total of 383 birthing parents completed the survey at 6 months (99/383, 26% receiving HB4HNEKids), and 283 completed the survey at 12 months (104/283, 37% receiving HB4HNEKids). Of the survey participants who received HB4HNEKids (n=200), between 76% and 83% reported that they always or very often read the SMS text messages, spending on average 5-7 minutes engaged with the content. At both survey time points, more than 90% of participants receiving HB4HNEKids agreed that the program was acceptable. Child daily intake of vegetables was significantly higher in the HB4HNEKids group (adjusted mean difference 0.23, 95% CI 0.07-0.40; P=.006) than in the comparison group at 12 months. Parents receiving HB4HNEKids also reported significantly better mental well-being scores (P=.005). While HB4HNEKids participants reported breastfeeding rates 5 percentage points greater than comparison participants at 6 and 12 months, this result was not statistically significant. There were no statistically significant differences between HB4HNEKids, and comparison participant responses related to child movement behaviors. The HB4HNEKids SMS text messaging program is feasible to deliver at scale alongside routine CFHN care and is highly acceptable and engaging to parents. This pragmatic evaluation of the pilot, embedded into usual care, indicates potential effectiveness of the program for improving child vegetable intakes and parental mental well-being. Further evaluation of this program using robust methodology is needed to determine the effectiveness of this innovative mHealth program across the first 2000 days.

Everyday listening ability is essential for individual health and well-being. Age-related hearing loss (ARHL) is associated with reduced communication engagement, social isolation, loneliness, cognitive decline, and increased dementia risk. Interventions that simultaneously target auditory processing and cognitive function, particularly within engaging and ecologically valid contexts, may offer greater benefits than unimodal approaches. However, culturally adapted, web-based, gamified auditory-cognitive dual-task training (ACDT) tailored for older adults with ARHL remains underexplored. At the time of this writing, few auditory or auditory-cognitive training programs are available in Chinese languages, creating linguistic and cultural barriers for older adults. This study aimed to (1) assess the feasibility and acceptability of home-based ACDT among older Chinese adults with ARHL and (2) examine its preliminary effects on global cognition, hearing, social engagement, and loneliness. It was hypothesized that the intervention group would demonstrate greater improvements in global cognition, hearing, and social engagement than the control group. Sixty community-dwelling older adults with mild-to-moderate ARHL were randomized 1:1 to either the ACDT group or a waitlist control group in a single-blinded pilot randomized controlled trial. Demographic data and outcome measures were collected at baseline, week 6, and week 12. Postintervention interviews were conducted to assess the feasibility and acceptability of ACDT. A total of 60 participants were randomized (mean age 67.65, SD 4.78 years; 45/60, 75% male). ACDT demonstrated high feasibility and acceptability. The ACDT group showed significant improvements in focused attention (mean change=-0.15; P=.02; d=-0.46) and divided attention (mean change=-0.21; P=.002; d=-0.63). Significant cognitive improvements on the Hong Kong-Montreal Cognitive Assessment were identified in naming (r=0.37; P=.05) and visual cognition (r=0.44; P=.02) in the intervention group, while no significant improvements were found in the control group. Both groups reported significant decreases in emotional hearing handicap, with slightly greater improvement in the intervention group (r=0.39; P=.03) than in the control group (r=0.37; P=.04). Linear mixed model analysis revealed a small to moderate group effect (Cohen d=0.38) for 5-minute delayed recall on the Auditory Verbal Learning Test, with the fixed effects explaining 69% of the variance (marginal R²=0.69). A significant time×group interaction was observed for left-ear thresholds (P=.01). Qualitative analysis identified three key themes: (1) intervention coherence and participants' affective attitude toward ACDT; (2) perceived benefits in cognition, information acquisition, and self-awareness from ACDT; and (3) perceiving ACDT as less burdensome with enhanced self-efficacy. Future iterations should incorporate artificial intelligence-enhanced personalization. Large-scale randomized controlled trials involving diverse samples and active control conditions are needed to confirm sustained effects on auditory and cognitive health, dual-task listening-cognitive abilities, and real-world functioning.

South African women are vulnerable to HIV acquisition during the postpartum period which can result in perinatal transmission via breastfeeding; many male partners do not know their HIV status. Biomedical approaches to preventing HIV for postpartum women include pre-exposure prophylaxis (PrEP) and antiretroviral treatment for male partners with HIV. Gaps in implementation include low uptake of PrEP among postpartum women and infrequent testing of men who may be motivated to test for HIV to protect the health of their infant. We will conduct a randomised pilot trial in KwaZulu-Natal (KZN) Province, South Africa among postpartum women and their male partners. The study will pilot a combination intervention consisting of cognitive behavioural strategies (including communication skills training, motivational interviewing and problem-solving) to promote H IV self-testing (HIVST) for P artners and P rEP uptake for HIV-uninfected P ost p artum Women, the 'H4P' intervention. The study aims to determine the feasibility, acceptability and preliminary effectiveness of the H4P intervention. We will enrol 60 HIV-uninfected women, aged 18 years and older, in their third trimester of pregnancy and reporting a partner whose HIV-serostatus is unknown. Sixty male partners will also be eligible to enrol. Enrolled women will receive three oral HIVST kits to distribute to their male partners and standard of care information on HIVST and PrEP. Women randomised to the intervention arm will receive additional counselling and reproductive health-centred HIVST information for the male partner, including information about why HIV testing is important during their partners' postpartum period. To evaluate feasibility, we will calculate screening-to-enrolment ratios for women and men, the number of women who distribute HIVST kits to their male partners and the number of men who test. Acceptability will be evaluated using the Client Satisfaction Questionnaire and qualitative interviews. Effectiveness will be assessed at 3 months by measuring the proportion of women initiating PrEP via self-report and urine tenofovir measurements or receipt of injectable PrEP and the proportion of men who test positive who link to HIV care. Qualitative interviews will explore perceptions of the intervention. Ethics approval for this study was obtained from the Human Research Ethics Committee at The University of the Witwatersrand, Johannesburg, South Africa (Reference number: 250612) and the Institutional Review Boards at Massachusetts General Brigham (2025P002271, Boston, Massachusetts, USA) and the University of Alabama at Birmingham (300015167, Birmingham, Alabama, USA) in the USA. Site support and approvals were obtained from the health facility and the KwaZulu-Natal Provincial Department of Health. Results will be disseminated through peer-reviewed manuscripts, reports and both local and international presentations. NCT07194902.

Nursing students experience high levels of academic and emotional stress, yet the relationships among self-efficacy, mental health challenges and utilization of institutional support services remain poorly understood in nursing education. In particular, limited empirical work has examined these factors together or assessed the feasibility of studying their associations within nursing student populations. To explore the relationship between self-efficacy, mental health challenges and utilization of student support services as potential factors influencing nursing student success and retention and to assess current utilization of student services and feasibility of continuing or adding services. A cross-sectional, exploratory pilot study. Descriptive and comparative analyses were conducted to examine associations between self-efficacy scores and the use of support services among nursing students to assess current utilization of student services and feasibility of continuing or adding services. Data were collected through a survey distributed to nursing students enrolled in a prelicensure programme at a single academic institution. Tutoring emerged as the most frequently utilized student support service, followed by peer mentoring and counselling. Correlational analyses identified no statistically significant associations between self-efficacy scores and measures of depression, anxiety, or stress in this pilot sample. Findings from this pilot study highlight the feasibility of assessing self-efficacy, mental health and student support service utilization within nursing education settings. Future multi-site studies with larger and more diverse samples are recommended to better characterize these relationships and to inform the development of targeted support strategies, improved outreach efforts and optimized use of student support resources. In this small, underpowered sample, findings suggest that while support services were widely used, their direct association with self-efficacy was limited. These preliminary results highlight the need for further investigation to more fully understand the broader context of nursing student success and retention. This exploratory study contributes preliminary evidence to the limited literature on self-efficacy, support services and nursing student outcomes; however, the small analytic sample limits statistical power and generalizability. Further adequately powered research is needed to inform evidence-based strategies that support student success and retention in nursing education. This study adhered to the STROBE and Equator guidelines for reporting cross-sectional research. No patients or members of the public were involved in the design, conduct, or reporting of this research.

Recent neutral randomized controlled trials have created clinical equipoise around the treatment of obstructive sleep apnea (OSA) for the secondary prevention of cardiovascular disease. These findings are in part limited by poor compliance, lack of treatment optimization and personalization strategies with OSA therapy. This pilot study aims to assess the feasibility and impact of a personalized OSA treatment program on therapy compliance and cardiovascular health in patients with acute coronary syndrome (ACS) diagnosed with OSA. Patients with ACS and OSA (oxygen desaturation index 3% > 10 events/hour) will be recruited and randomized to receive either personalized OSA therapy (PT) or usual care (UC) with six-month follow-up. The PT group will receive standard medical care for ACS plus the choice of continuous positive airway pressure and/or mandibular advancement device therapy for OSA. Treatment optimization strategies including treatment acclimatization, augmented support and patient engagement tools will be implemented. The UC group will receive standard medical care for ACS but no treatment for OSA. The primary outcome is the feasibility of personalized treatment for OSA assessed by study and treatment acceptance, and treatment compliance. Secondary outcomes include treatment effectiveness, cardiovascular health markers and patient reported outcomes across the six-months intervention. This study will provide novel findings on the impact of personalized and optimized OSA therapy on patient compliance, preliminary treatment effectiveness and health outcomes in patients with established cardiovascular disease. Such novel data will inform the design and delivery of future large scale randomized clinical trials to assess cardiovascular disease benefit in patients with OSA. ACTRN 12620000050954. Registered 22 January 2020, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=378536&isReview=true.

Chronic insomnia is a highly prevalent sleep disorder that adversely affects quality of life and mental health. Cognitive behavioral therapy for insomnia (CBT-I) is internationally recommended as the first-line treatment, and digital CBT-I (dCBT-I) has been developed to improve accessibility and scalability. While existing dCBT-I systems effectively support structured behavioral training through standardized protocols, they provide relatively limited support for users' cognitive exploration and meaning-making processes, particularly in helping users reflect on and internalize the rationale behind CBT-I practices in daily life. These limitations may contribute to challenges in sustained engagement and long-term adherence. This study aimed to examine the usability and feasibility of SleepPathfinder, a conversational CBT-I support chatbot that integrates Socratic questioning and a self-decision mechanism to support users' understanding of and engagement with CBT-I practices. SleepPathfinder was designed around a 4-stage conversational flow: education on CBT-I techniques, Socratic cognitive exploration, self-decision, and advice provision. We conducted (1) a single-session pilot usability study (n=45) to assess system stability and user experience and (2) a 5-day condition-based comparative experiment (n=30) consisting of daily sessions, comparing an exploratory dialogue condition with a directive, protocol-guided dialogue condition. Quantitative measures assessed usability, cognitive appraisals related to sleep problems, autonomy-related experiences, and behavioral readiness, while qualitative feedback and conversational log analyses were used to examine interaction patterns and engagement characteristics. In the comparative experiment, the exploratory dialogue condition showed a tendency toward reduced perceived threat and severity appraisal of sleep problems compared with the directive condition, accompanied by moderate effect sizes in cognitive perception measures. Autonomy-related experiences, including perceived choice and engagement, demonstrated suggestive upward trends in the exploratory condition. Behavioral intention changes were comparable across conditions, while overall readiness for change increased across participants. Conversational log analyses indicated that greater depth and volume of user self-narrative were associated with larger shifts in cognitive appraisals, whereas the frequency of chatbot questions alone was not. The pilot usability study indicated generally positive evaluations of system usability and content credibility, while identifying areas for improvement in emotional responsiveness and conversational naturalness. These findings suggest that a Socratic questioning-based and self-decision-based conversational structure is usable and feasible as a supportive interaction layer within dCBT-I systems. Rather than altering the directive behavioral structure of CBT-I, such an approach may complement existing protocols by facilitating cognitive exploration and supporting user-perceived autonomy. This study provides design-oriented evidence to inform the refinement of dialogue-supported digital CBT-I systems aimed at enhancing user engagement with CBT-I practices.

An estimated 5 to 8 million US children live with a parent who uses cannabis, and most cannabis users report smoking cannabis inside their homes, placing children at risk for cannabis secondhand smoke (cSHS) exposure. Indoor air quality (IAQ) monitoring provides real-time feedback on airborne pollutants and has shown promise in reducing in-home tobacco secondhand smoke exposure, suggesting its potential as an effective harm reduction strategy for cSHS. This pilot study evaluated the feasibility, acceptability, and preliminary effectiveness of using low-cost, off-the-shelf IAQ monitors to increase caregivers' awareness of children's cSHS exposure risk and to change smoking behavior. Secondary aims were to assess participant engagement, perceived usefulness, and household communication regarding in-home cannabis smoking. Between February 2025 and April 2025, 14 adults who smoked cannabis indoors and lived with at least 1 child aged younger than 16 years were recruited primarily via targeted social media advertisements and completed a 3-week trial. Participants received an Awair Element IAQ monitor, printed health education materials, and text messaging prompts for brief surveys. The IAQ monitor continuously measured PM2.5, VOCs, CO₂, temperature, and humidity. Daily surveys captured self-reported PM2.5 readings and recent cannabis use, while baseline and end-of-study assessments evaluated IAQ perceptions, cSHS risk awareness, and in-home smoking behavior. Survey results were summarized via descriptive statistics, and linear mixed-effects models were used to characterize objective IAQ trends. Six additional adult household members provided parallel end-of-study data. Reported engagement was high, with 85% (11/13) of participants indicating that they reviewed the monitor at least daily. The average number of days in the previous week that a caregiver reported a child being home while cannabis was smoked declined from 4.5 (SD 2.2) at the trial start to 2.8 (SD 2.9) at the end (6/13, 46% had a reduction; 1/13, 8% reported an increase). Furthermore, 62% (8/13) of participants reported that they reduced (4/13, 31%) or thought about changing (4/13, 31%) their smoking habits. Around 62% (8/13) of participants agreed or strongly agreed that IAQ monitoring helped drive conversations about changing indoor smoking rules, while 100% (13/13) reported no IAQ-driven disagreements among household residents regarding in-home smoking rules. A linear mixed-effects model did not indicate a consistent trend in PM2.5 levels across participants over time (β=-0.28; SE 1.13; P=.81), but there was heterogeneity in trends, and those with the largest reductions in PM2.5 over the trial had the largest reduction in reported children's cSHS exposure. In-home IAQ monitoring was feasible and perceived as useful among caregivers who smoked cannabis indoors. Real-time IAQ feedback supported risk awareness, promoted family dialogue, and coincided with reductions in in-home smoking around children. These findings suggest that IAQ feedback may represent a scalable tool for reducing children's cSHS exposure and merits further testing in larger, controlled trials.

Hispanic adults with type 1 diabetes (T1D) have suboptimal access to continuous glucose monitoring (CGM). Widening access to and increasing uptake of CGM for Hispanic adults with T1D are warranted. This randomized controlled trial (RCT) will evaluate the feasibility of a federally qualified health center (FQHC) CGM intervention and assess for an intervention signal in patient outcomes. A mixed methods, pragmatic pilot RCT will be used. A total of 30 adult Hispanic patients with T1D will be recruited from 4 FQHC sites allocated to provide the intervention (n=2) or control (n=2) conditions. At intervention sites, participants must be willing to use CGM for 3 months and have a willing adult family member participate in the study. Guided by the socioecological model, our intervention has three levels: (1) individual (culturally sensitive CGM information, motivation, and skills acquisition), (2) family or social networks (integration of the core Hispanic values of familismo and collectivismo to leverage family and peer support for CGM uptake), and (3) health care provider levels with CGM training using Project ECHO (Extension for Community Healthcare Outcomes). Intervention participants (n=15) will receive a culturally sensitive CGM intervention with 4 weekly intervention sessions (coattended by a family member), followed by 7 peer support group sessions over 6 months. Control participants will receive a self-monitoring of blood glucose control condition over a 6-month period. Study feasibility will be assessed in terms of recruitment, enrollment, retention, adherence, study procedures and implementation, and acceptability with mixed methods. We will collect physiological (eg, glycated hemoglobin and CGM metrics) and psychosocial (eg, depression, quality of life, social support, and interpersonal processes of care) outcome data. Feasibility data will be analyzed using content analysis and univariate or bivariate statistics. Linear and generalized linear mixed modeling will assess intervention signals and clinically meaningful differences from baseline to 3 and 6 months. Funding for this project was secured in September 2022. As of May 2024, recruitment commenced following formative qualitative data collection on the social determinants of health and CGM uptake in Hispanic adults with T1D (N=32). Our community advisory board informed protocol modifications by reviewing qualitative findings, collaborating on related intervention refinement, and advising on cultural sensitivity methods. Guided by the socioecological model, our novel FQHC CGM intervention will provide feasibility and outcome data to guide a full-scale RCT. Our intervention model has unique potential to widen CGM access and increase CGM uptake in low-income Hispanic adults with T1D while improving outcomes for this vulnerable population. ClinicalTrials.gov NCT06487962; https://clinicaltrials.gov/study/NCT06487962. PRR1-10.2196/60583.

Anxiety, depression and stress-related conditions are prevalent and growing public health challenges, impacting individuals' quality of life and placing significant strain on healthcare systems globally. These complex conditions rarely respond to a single mode of treatment, underscoring the importance of diverse and complementary approaches. Nature-based health interventions (NBHIs) represent one such perspective, offering novel opportunities to address mental health by engaging with natural environments. While international interest in NBHIs is growing, evidence on how these interventions can be systematically developed and implemented remains limited. The aim of this study protocol is to report the planned Nature Impact Feasibility Study. The Nature Impact Feasibility Study is a one-armed, mixed methods feasibility study aiming to evaluate a complex, group-based NBHI developed using the Medical Research Council framework for complex interventions. The intervention will be conducted across three sites in Denmark: Glostrup outpatient clinic, Kolding and Silkeborg municipality centres. The intervention consists of group-based NBHI programmes delivered weekly over 10 consecutive weeks, facilitated by experienced health professionals. The feasibility evaluation will examine three core domains. These include (1) the implementation process, including fidelity, dose, reach, adaptations and acceptability; (2) mechanisms of change and (3) contextual factors influencing implementation and intervention processes. Data will be collected through participant observations, focus group interviews, registration forms and participant questionnaires assessing mental health outcomes and the participants' relationship to nature. Data will be analysed using a mixed methods convergent design. Quantitative and qualitative data will be analysed separately and then integrated thematically during interpretation. By reporting the study protocol for the Nature Impact Feasibility Study in advance, the project enhances transparency, allows for critical appraisal of the planned design and methods and strengthens the foundation for the subsequent feasibility evaluation and future large-scale trials. The Nature Impact Feasibility Study will provide valuable insight into delivering NBHIs for adults experiencing mild to moderate anxiety, depression and/or stress, while informing intervention refinement, outcome measures and future research aimed at investigating the potential of integrating NBHIs into existing practices for treating anxiety, depression and stress. NCT06981000. Registered on March 13, 2025.

Occupational therapy interventions can improve the ability to perform activities of daily living (ADL) in individuals with chronic conditions. The group-based ADAPT program was developed as an alternative to usual one-to-one occupational therapy (UOT), aiming to enhance ADL ability through structured problem-solving processes and implementation of adaptational strategies. This pilot and feasibility study evaluated the feasibility of delivering ADAPT 3.0 in a municipal setting and informed the design of a future full-scale randomised controlled trial (RCT). A two-armed pilot RCT was conducted in a Danish municipality, comparing outcomes of ADAPT 3.0 to UOT. Eligible clients (≥ 18 years, chronic conditions, decreased ADL ability) were randomised to either intervention or control group. Outcomes included recruitment and retention, trial participation, impact on staff, access to UOT documentation, completion of outcome measures, and fidelity to the ADAPT manual. Descriptive statistics, logbook notes, and predefined progression criteria guided the evaluation. Twelve clients and four ADAPT-trained occupational therapists participated. ADAPT 3.0 was delivered with high fidelity and dose. Most progression criteria were met, including access to UOT documentation and successful delivery of ADAPT 3.0. However, recruitment was slower than anticipated, and clients in the UOT group reported to receive limited trial-related information. Completion rates of follow-up evaluations were acceptable in the ADAPT group but lower in the UOT group. Minor structural and procedural challenges were identified. The study supports the feasibility of delivering ADAPT 3.0 in a municipal setting and progressing to a full-scale RCT. To ensure robust trial conduct, key refinements are needed in recruitment procedures, participant information for the UOT group, and clarity of outcome measures. ClinicalTrials.gov Identifier: NCT05775653.

Capecitabine and Oxaliplatin (CAPOX) chemotherapy is a standard treatment for stage 2/3 colorectal cancer but is associated with dose-limiting toxicities. Short-term fasting may protect healthy cells from chemotherapy-related side effects via differential stress resistance. However, it is not known whether it is possible to recruit to a trial of short-term fasting in this population, or whether participants would adhere to the intervention. The aim was to test the feasibility and acceptability of a pre-chemotherapy, 36-h, water-only fast prior to the first three cycles of chemotherapy in people receiving CAPOX chemotherapy for stage 2/3 colorectal cancer. A two-armed randomised controlled feasibility trial with an embedded qualitative interview study conducted in two NHS foundation trust hospital sites in England. Participants were randomly allocated, in a 1:1 ratio using random permuted blocks, by a secure online randomisation system, to either a 36-h fast immediately prior to chemotherapy administration or standard dietary advice. The intervention was delivered during chemotherapy cycles 1-3. Primary outcomes were adherence, recruitment, retention, data completion, and acceptability. Secondary outcomes included chemotherapy side effects, quality of life, metabolic and inflammatory markers, appetite, and sarcopenia. Seventy-nine patients were screened, of whom44 were eligible. Twelve consented and were randomised (intervention: n = 6; control: n = 6). The retention rates for chemotherapy cycles 1, 2, and 3 were 100%, 83%, and 83% for the intervention group and 100%, 100%, and 100% for the control. Five out of six participants adhered to the fast. The trends observed in levels of insulin-like growth factor I (IGF-I) and insulin-like growth factor binding proteins 2 and 3 (IGFBP-2 and IGFBP-3) were consistent with effective fasting. Qualitative findings indicated that fasting was achievable but sometimes perceived as an additional burden alongside chemotherapy. Recruitment challenges were influenced by site-level factors, including competing priorities, COVID-19-related disruptions, and perceptions of the intervention. The SWiFT study was feasible to deliver and adherence to the fast was high. In a future definitive trial, success in recruitment appears to depend more on specific local factors rather than the intervention being unattractive to most potential participants. ISRCTN, ISRCTN17994717, registered 23 October 2018, https://www.isrctn.com/ISRCTN17994717.

Southeast Asian (SEA) children are burdened by high rates of diet-related chronic conditions and diseases. These burdens partly result from socioeconomic disadvantages and refugee migration trajectories. Yet, to our knowledge, no dietary interventions exist for this population. This protocol paper describes the rationale, study design, intervention and study evaluation for the SEA Healthy Habits, Healthy Kids Study. The study enrollment goal was 75 parent-child dyads recruited in Providence, Rhode Island, in the United States. A SEA parent/guardian and one of their 6-to-11-year-old children were randomized to (1) a monthly financial incentive only group; (2) an enhanced financial incentive group that receives additional interventions including family-based group nutrition education, three motivational interviewing (MI) phone calls, and weekly text messages on healthy eating norms and other nutrition topics; or (3) a structurally equivalent attention-matched control group. The primary study goals were to assess feasibility and acceptability, conduct process evaluation to determine implementation fidelity and intervention dose, and determine preliminary efficacy. Feasibility was assessed based on attendance (primary) and secondary measures, recruitment, enrollment, intervention dose, and retention at 6 months. Acceptability was measured using satisfaction questionnaires on study favorability. Preliminary efficacy (i.e., comparing changes in children's diet quality (Healthy Eating Index and dermal carotenoids)) will be determined via longitudinal mixed effects models. Regression models will investigate the relationship between dose, implementation measures and study outcomes. This intervention received Institutional Review Board approval on February 16, 2023. We conducted intervention development from July 2022 to August 2022 with 62 SEA parents and children. For the intervention, we began participant recruitment in April 2023, which concluded January 2025. This study will demonstrate whether a culturally tailored healthy eating intervention for SEA families is feasible and acceptable and whether it leads to changes on key efficacy indicators. The intervention is informed by theories and frameworks relevant for the population and utilizes a family-centered approach. If this innovative pilot intervention achieves the study objectives, then we will refine it and pursue a larger randomized control trial. This study is registered at ClinicalTrials.gov under registration number NCT05817838. The trial was registered on April 17, 2023. The trial registry record is available at https://clinicaltrials.gov/study/NCT05817838.

South Asia has the highest rates of suicide fatalities among women globally. Existing suicide prevention interventions are largely based on Western-informed risk reduction programs and theories. This pilot trial aims to test the acceptability and feasibility of a co-designed suicide prevention program for peri-rural Pakistani women called the Khushal Pur-Umeed Zindagi (KPZ, خوشحال پُرامید زندگی پروگرام), compared to enhanced usual care (EUC). The study seeks to innovate suicide prevention by grounding interventions in decolonized frameworks, leveraging peer mothers, and developing robust health system integration strategies. We will conduct a two-arm, mixed-methods, hybrid type 2, stratified pilot cluster randomized controlled trial in peri-rural areas of the Islamabad Capital Territory (ICT). KPZ is a decolonized, culturally salient brief intervention combining narrative-based safety planning and contact follow-up, delivered by peer mothers over 6 months. EUC entails the WHO Mental Health Gap Action Programme (mhGAP) suicide prevention module, along with referral support delivered through Primary Health Care (PHC) by Medical Officers (n = 2) and Lady Health Worker teams (n = 11). KPZ is integrated into the PHC system and is implemented through close collaboration between peer mothers (delivery agents) and the government-employed LHWs. A cohort of peer mothers (n = 11), identified from the same communities as participants, will be trained and supervised for the study duration. We will enroll 50 women aged 18-45 with a child under 3 years who report suicidal ideation and will conduct follow-ups at 3- and 6-months post-recruitment. Qualitative interviews with trial participants and periodic reflections from peer mothers will be conducted iteratively over 6 months. A mixed-methods approach will be used to assess both clinical and implementation outcomes. Primary clinical outcomes include suicidal ideation severity and suicidal behaviors. Implementation outcomes include feasibility, acceptability, fidelity, appropriateness, and peer mothers' competence. Secondary outcomes assess additional clinical domains (depression, anxiety) and culturally relevant constructs (moral injury, cultural suicide cognitions). This pilot trial will provide evidence on the feasibility and acceptability of integrating a decolonized, peer-delivered suicide prevention program for women into the existing Pakistani health system. The findings have the potential for large-scale public health impact by improving the availability, accessibility, and quality of culturally appropriate suicide prevention interventions in resource-constrained and complex environments. Results will inform a larger definitive trial of a community-initiated suicide prevention program in Pakistan. NCT06208293.