Pilot and Feasibility Studies最新文献

Background: Body dissatisfaction is a growing concern among adolescent females, particularly those living in rural communities where access to supportive mental and physical health resources is limited. High levels of social media use and low engagement in structured physical activity are linked to negative body image, elevated anxiety, and reduced overall well-being in this population. The Hoosier Sport Re-Social intervention was developed to address these challenges by integrating sport participation, social media literacy, and mental skills training in a community-based program designed for adolescent girls.

Methods: This study follows the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) guidelines and is structured around three aims. First, we will conduct a cross-sectional study with adolescent girls in grades 6 through 9 to examine the relationship between body satisfaction, physical activity levels, and social media use. Second, we will develop the Hoosier Sport Re-Social intervention using a co-design process that actively involves adolescents, parents, and school staff to ensure relevance and feasibility. Finally, we will conduct a mixed-methods pilot study in two rural middle and high schools to assess feasibility and acceptability. The intervention will be implemented within physical education and health classes over a 6-week period. Primary outcomes will include feasibility indicators such as recruitment, retention, fidelity, and participant engagement. Secondary outcomes will include measures of body satisfaction and social media literacy, while exploratory outcomes will examine changes in psychosocial factors and physical literacy.

Discussion: This study will provide important insights into the acceptability and practicality of delivering a biopsychosocial, school-based intervention targeting body dissatisfaction among rural adolescent girls. Findings will inform future efforts to scale the program and evaluate its effectiveness in improving mental, physical, and cognitive health outcomes.

Trial registration: This trial was prospectively registered with ClinicalTrials.gov (NCT06556719).

Background: Growing evidence suggests that mental health issues heavily impact Muslims, the largest, fastest growing minority religious group in the UK. High prevalence of anxiety and depression has been reported in young women aged 18 to 30 largely from Bangladeshi and Pakistani Muslim communities in Britain. Evidence suggests that incorporating religious and culturally adapted interventions may improve their effectiveness for Muslim populations, but their feasibility for young women in UK contexts is uncertain. This study aims to test whether a randomised controlled trial (RCT) of a faith-based intervention for young Muslim women living with depression is feasible.

Methods: This study is a two-arm cluster randomised controlled feasibility trial with embedded process evaluation. Participants will be young Muslim women aged 18 to 24 years experiencing mild to moderate low mood or depression in Birmingham and London. The intervention will be delivered by trained therapists, supported by mental health support workers, once a week for 6 weeks. The two arms will be the IM-Adapted faith-based intervention and the standard NHS psychoeducation support group control with a proposed sample size of 30 per arm. Outcomes are referral, recruitment and retention rates, session attendance, adherence and acceptability of intervention, data collection, and adverse events, measured at baseline, 3 and 6 months.

Discussion: The findings will provide early indication as to whether tailored mental health interventions may increase accessibility and effectiveness of support in underserved communities, addressing barriers linked to social and cultural factors. This will guide health services on the incorporation of cultural and religious adaptations in their programmes to better engage minority groups and improve mental health outcomes.

Trial registration: ISRCTN, https://www.isrctn.com/ISRCTN17842222 , registered 17th April 2024.

Background: Mindfulness-based interventions, such as mindfulness-based stress reduction (MBSR), are efficacious mind-body treatments for chronic pain, though their modest effect sizes suggest room for improvement. Notably, recent studies indicate that mindfulness meditation does not engage the endogenous opioid system, which plays an important role in analgesia. Therefore, exploring the combination of a mindfulness-based intervention with a non-opioid treatment that activates this system is warranted. Open-label placebo (OLP), a placebo that is given to a participant without deception, has shown significant promise as a safe and potentially effective analgesic, with studies indicating its effects are mediated by the release of endogenous opioids. This study aims to evaluate the feasibility and acceptability of combining MBSR and OLP treatment compared to each intervention alone for chronic pain in a three-arm randomized controlled trial (RCT).

Methods: This study will include an 8-week exposure to one of three treatments for individuals with chronic pain: MBSR-only, OLP-only, or a combined MBSR + OLP intervention. Participants will attend four in-person sessions (baseline assessment, randomization session, mid-treatment assessment, and posttreatment assessment), followed by an online assessment at a 3-month follow-up. MBSR sessions will be conducted live via Zoom. Participants in OLP groups will take placebo pills twice daily, with adherence monitored using an electronic pill bottle cap and urine riboflavin tracer testing. Daily diary assessments will be completed over 7-day periods at baseline, mid-treatment, post-treatment, and 3-month follow-up.

Discussion: Findings from this single-site feasibility RCT will help refine and optimize study protocols needed for a future, fully powered multi-site efficacy trial.

Trial registration: NCT06720909 . Registered 12/06/2024.

Background: Iron deficiency is prevalent among female athletes, often leading to fatigue, impaired recovery, and decreased performance. Conventional oral iron supplements are associated with poor absorption and negative gastrointestinal side effects, resulting in low adherence. This feasibility trial investigated the tolerability and gastrointestinal effects of an iron-yeast complex (FeSC) supplement in physically active females to assess its potential for further study.

Methods: This single-arm, mixed-methods feasibility trial recruited 14 active females (18-25 years) who consumed FeSC-fortified cookies (40 mg elemental iron) every other day for 14 days. Gastrointestinal symptoms, stress, and recovery were assessed through daily and weekly questionnaires (daily questionnaires: Gastrointestinal Symptoms Questionnaire and Short Recovery and Stress Scale; weekly questionnaires: Patient-Reported Outcomes Measurement Information System (PROMIS) Gastrointestinal Symptom Scale; RESTQ Basic-24). Qualitative data on supplement acceptability were collected post-intervention. Feasibility was evaluated based on recruitment, retention, adherence, and safety criteria.

Results: Out of 52 participants who completed our screening questionnaire, 14 (age = 22 SD 2 years; weekly physical activity = 420 SD 140 min/week) met all criteria and completed the intervention. All feasibility criteria were met, including 100% retention, adherence, and questionnaire completion rates. Participants reported good supplement tolerability, with only a few cases of mild, transient gastrointestinal symptoms. A reduction in constipation symptoms compared to baseline and a reduction in diarrhea symptoms on days cookies were consumed compared to days they were not were observed. No serious adverse events occurred. While some participants noted a metallic aftertaste, 57% indicated that they would prefer the supplement in cookie form over traditional iron pills if given the choice.

Conclusions: This study demonstrates the feasibility and tolerability of FeSC supplementation in active females, with potential gastrointestinal benefits. Findings support progression to a larger trial assessing FeSC's impact on iron status and long-term adherence.

Trial registration: ClinicalTrials.gov NCT06285851. Registered on January 30, 2024.

Introduction: Distress is experienced by more than 30% of patients during palliative withdrawal of mechanical ventilation at the end of life in the intensive care unit. There is a lack of high-quality evidence for specific approaches to risk factor identification and management of distress during this process. Structured "time-outs" and checklist interventions improve surgical outcomes and have been widely adopted in procedural care, but they have not been tested for use at end-of-life in intensive care unit settings.

Methods: We describe the development and planned testing of a novel time-out checklist intervention, the Comfort Measures Only Time Out (CMOT) in a non-randomized single arm pilot study. Intervention development was guided by published literature and a structured inter-professional advisory panel. The intervention will be tested by clinical teams caring for 46 patients undergoing palliative withdrawal of mechanical ventilation. Nurses, physicians, advanced practice providers, and respiratory therapists will convene within an hour before withdrawal of mechanical ventilation to complete the checklist. Implementation outcomes, including feasibility, will be measured by a 12-question survey and by clinician protocol adherence. Effect size calculations will determine power for future randomized controlled trials testing efficacy of the CMOT in reducing patient distress.

Discussion: This protocol will pilot test the feasibility of the CMOT, a structured time-out and checklist intervention, for WMV in the ICU. The study will inform potential changes to the protocol and intervention for a future randomized control trial. The CMOT is grounded in a quality and safety framework already adopted in procedural and critical care settings. Given high rates of distress, the CMOT will fill an identified gap in evidence surrounding the process of WMV.

Trial registration: Clinical trials.gov ( NCT05861323 ); 16 May 2023.

Background: Excess body weight is associated with higher breast cancer mortality rate. This study assessed the feasibility of a co-designed weight loss intervention (NEWDAY-ABC) versus standard care in early-stage oestrogen receptor-positive, human epidermal growth factor receptor 2-negative breast cancer patients.

Methods: This was a two-arm, parallel group, randomised controlled feasibility study. Twenty-one ER + ve, HER2-ve stages I-III breast cancer patients, within 3 years of completing primary treatment (excluding endocrine therapy), were recruited from two UK National Health Service Breast Care Units and randomised (2:1) to intervention plus standard care or standard care alone. The intervention was co-designed with patients and comprised small group-based Support & Skills workshops delivered remotely via teleconference by trained lifestyle advisors and dieticians. Feasibility outcomes included recruitment rate, data quality, intervention acceptability and adherence. Exploratory clinical outcomes included weight loss, anthropometric measures, dietary change, physical activity and patient-reported outcomes.

Results: Twenty-one women consented to the study, and 1 withdrew prior to randomisation, leaving 13 in the intervention group and 7 standard care controls, with 11 participants being followed up for 6 months. The overall attendance rate for intervention sessions was 79.6% (74/93 sessions completed). Body weight (candidate primary outcome for a fully powered randomised controlled trial) was reduced in the intervention group by 3.3 kg from baseline to 6 months, versus a 1.1 kg loss of body weight in the standard care control group. Furthermore, the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC-QLQ30) breast module symptom scale scores for breast and arm symptoms improved in the intervention arm only, accompanied by positive changes in physical activity and dietary behaviours.

Conclusion: The NEWDAY-ABC intervention is feasible and showed preliminary evidence of efficacy in terms of weight loss and other important health outcomes in women with early-stage breast cancer. The clinical and cost-effectiveness of the intervention versus standard care now needs to be robustly evaluated via an adequately powered clinical trial.

Trial registration number: ISRCTN15088551, registered 3 February 2020.

Background: Antimicrobial resistance is a worldwide problem caused by the inappropriate use of antibiotics. In Australia, antibiotics are frequently prescribed in general practice (primary care) settings for acute respiratory infections (ARIs) despite these infections most commonly being caused by viruses. The Optimal Implementation of Antimicrobial Stewardship in General Practice (OptimasGP) study aims to provide implementation support for effective antimicrobial stewardship (AMS) interventions for ARIs. The current study will examine if a redesigned workflow, and an AMS Toolbox containing AMS resources, is an acceptable way to access AMS interventions and clinical data collected in general practice settings.

Methods: A mixed-methods approach will be applied using a single-arm, pragmatic exploratory study. Data will be collected for a period of 3 months. Data collection from general practice settings in New South Wales, Australia, will involve the participation of 4 to 6 practices, 12 general practitioners (GPs), and 6 to 8 practice staff. We also aim to recruit 50-100 patients to complete surveys and 12 patients to participate in focus group discussions. Participating GPs and practice staff will be provided with an online AMS Toolbox to facilitate access to AMS resources. Two hours of online training and a reminder card will also be provided. The AMS Toolbox will contain AMS resources for shared decision-making, clinical decision support (including point-of-care testing), and delayed antibiotic prescribing in patients with ARIs. The primary outcome of the study will be the acceptability of the AMS Toolbox to GPs, practice staff, and patients. Secondary outcomes will include recruitment and completion rates, qualitative findings from the focus group discussions, resource use and antibiotic prescription rates, patient-reported outcome measures (PROMs), and patient-reported experience measures (PREMS).

Discussion: AMS interventions are needed to help reduce inappropriate antibiotic prescribing for ARIs in general practice settings. The findings of this study will inform a hybrid type 3 implementation trial.

Trial registration: Registered prospectively with the Australian and New Zealand Clinical Trial Registry (ACTRN12624001011572) on 20 August 2024.

Background: Lumbar spinal stenosis (LSS) affects older people, leading to a decline in functional ability, and its prevalence is projected to rise with the aging population. Effective, affordable, and low-risk interventions are needed to maintain the function and quality of life for LSS patients. This study tested the feasibility of implementing a comprehensive conservative treatment program (Boot Camp Program) for LSS in Danish chiropractic clinics to inform a future randomised clinical trial. The objectives were to assess feasibility in terms of recruitment, adherence, data collection procedures, and completeness of outcomes, and to describe patient characteristics and investigate changes in outcomes over time.

Method: Using a prospective, single-arm, pretest-posttest design, this study sought to recruit 50 patients with LSS from six chiropractors in two primary care chiropractic practices. The program consisted of 12 visits and included patient education, manual therapy, and a progressive home exercise program. The impact of the program was assessed by measuring walking distance using a treadmill test at the 6- and 12-week follow-ups visits and self-reported pain and physical function at 6-, 12-, 20-, and 52-week intervals.

Results: In total, 147 patients were screened for eligibility and 38 (26%) were included. The mean age was 69 years (SD 10, range 47-89) and 61% were women. Thirty-four (90%) completed the 6-week program and 32 (84%) provided follow-up data. Almost 80% completed one daily exercise session 5 to 7 days a week. Overall, data collection procedures were feasible, except for paper patient diaries. Follow-up rates at 12, 20, and 52 weeks were 87%, 82%, and 74% respectively. Participants improved their walking distance on average by 45% and 53% at 6 and 12 weeks, respectively. Clinically relevant improvement was observed in secondary outcomes such as leg pain, back pain, and physical function at all follow-ups.

Conclusions: The Boot Camp Program for LSS was feasible to deliver in Danish chiropractic practice and patients improved on relevant outcomes. However, the recruitment procedure was ineffective. Logistics, awareness, incentives, timeframes, and patient motivation may have influenced enrolment and adherence. Recruitment in multiple settings and patient enrolment incentives will be considered.

Background: Most long-term care (LTC) residents live with dementia and the proportion with more advanced cognitive impairment is increasing. Residents with dementia often have limited functional ability to complete their activities of daily living (ADLs) and are vulnerable to further functional decline. Multicomponent exercise can help prevent functional decline, but residents with dementia are less likely to receive it and have not often been included in previous intervention studies. The Dementia Moves intervention was designed to fill this gap. It is an individually tailored multicomponent group exercise program with an aerobic warm-up and a focus on moderate to high-intensity functional balance and strength training. We will measure the feasibility and effect of the Dementia Moves program on ADLs for LTC residents with moderate to severe dementia (Mini-Mental State Exam of 20 or less). We hypothesize the intervention will be feasible without modification if 16 individuals are recruited over 6 months, 65% of our sample is retained at 6 months and 75% of the completed exercises are performed at a moderate to high intensity.

Methods: A pre-post study will be used to assess feasibility, safety (rates of falls and adverse events extracted from the electronic medical record), and change in ADLs at 3 and 6 months among LTC residents with moderate to severe dementia. There will be no control or comparison group. A physiotherapist, physiotherapy assistant and three volunteers will deliver the group-based exercise program to groups of four residents, three times per week, for 6 months. Assessments will be completed at 3 and 6 months. Feasibility outcomes include (1) recruitment over 6 months; (2) retention at 3- and 6-month follow-up; and adherence via (3) attendance and (4) proxy and self-reported ratings of exercise intensity. We will also assess fidelity of the intervention through program audits, and audio diaries and interviews to identify barriers and facilitators to implementation of the intervention.

Discussion: The feasibility of the Dementia Moves intervention will be evaluated in LTC residents with dementia, and we will examine rates of falls and adverse events and change in ADLs. We will use the collected information to inform a definitive parallel cluster randomized controlled trial.

Trial registration:

Clinicaltrials: gov: NCT06400108, May 3, 2024, Version 1. https://classic.

Clinicaltrials: gov/ct2/show/NCT06400108.