Pilot and Feasibility Studies最新文献

{"title":"Feasibility of the Promoting Pupils' Physical Literacy (3PL) intervention: Does it work? Will it work?","authors":"Thea Toft Amholt, Mette Kurtzhals, Paulina Melby, Mads Bølling, Olivia Mandal Møller, Mathilde Kragh Lise, Anna Stage, Wesley O'Brien, Sarahjane Belton, Peter Elsborg, Glen Nielsen, Peter Bentsen","doi":"10.1186/s40814-026-01806-w","DOIUrl":"10.1186/s40814-026-01806-w","url":null,"abstract":"<p><strong>Background: </strong>The rise in physical inactivity among children poses serious health risks impacting physical, mental, and social well-being. Physical literacy (PL) has been identified as an effective approach to encourage long-term physical engagement. Schools and communities, particularly through physical education (PE) programs, play a critical role in promoting PL. However, while there are several PL-focused PE interventions worldwide, no such programs have been specifically tailored to Nordic contexts, making feasibility testing essential for effective implementation. This study investigated the feasibility of a Danish adaptation of an Irish PL program, Y-PATH.</p><p><strong>Methods: </strong>The adapted program, the Promoting Pupils' Physical Literacy (3PL) intervention, provided PE teachers with resources, courses, and a website to enhance motivational climates in PE and promote PL among 4th and 5th grade pupils. The study was conducted in accordance with Medical Research Council guidelines and Bowen et al.'s (2009) framework. Feasibility indicators including acceptability, demand, implementation, practicality, adaptation, and integration were investigated using a weekly questionnaire for PE teachers, interviews (n = four teachers and 20 pupils), observations, and field notes. The quantitative data were analyzed descriptively, while the qualitative data were analyzed using thematic analyses.</p><p><strong>Results: </strong>3PL was found to be feasible and acceptable among pupils and teachers (e.g., materials were used in 71% of lessons). While the materials supported implementation for teachers, workload adjustments are needed. Teachers adapted lessons effectively, balancing an inclusive and motivating learning environment. Despite minor challenges, 3PL fostered engagement among pupils and teachers with potential for expansion.</p><p><strong>Conclusion: </strong>3PL represents a feasible and promising approach to promote PL in a Danish school setting. Feasibility testing demonstrated the potential for scaling 3PL, while recognizing that large-scale trials are needed to validate its broader impact.</p><p><strong>Trial registration: </strong>A protocol for adaptation of 3PL was published in Open Science Framework, registered in December 2022 (1). The 3PL study was preregistered at ClinicalTrials.gov (ID NCT05822024), April 2023, version 1 ( https://classic.</p><p><strong>Clinicaltrials: </strong>gov/ct2/show/NCT05822024 ), before enrolment. A study protocol was written before intervention start (August 2023) and hereafter officially published in January 2024 (2).</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-03-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13151210/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147575101","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Optimization of care and recovery in older colorectal cancer surgery patients: a hybrid effectiveness-implementation pilot study protocol.","authors":"Ferhat Yildiz, Stephen J Bartels, Christy Cauley, Matthew Vrees, Benjamin F Crabtree, Edward R Marcantonio, Christine S Ritchie, John O Hwabejire, Rocco Ricciardi, Stacie G Deiner, Sevdenur Cizginer","doi":"10.1186/s40814-026-01796-9","DOIUrl":"10.1186/s40814-026-01796-9","url":null,"abstract":"<p><strong>Background: </strong>The exponential rise in colorectal cancer surgeries among older adults combined with 30-day readmission rates as high as 25% highlights the crucial need to optimize post-discharge care. While geriatrics surgery programs such as the Optimization of Senior Care and Recovery (OSCAR) model improve outcomes, they do not address the post-discharge transition. This study will address this gap by systematically integrating the OSCAR program with an evidence-based Care Transitions Intervention (CTI), using implementation science frameworks to guide adaptation. The resulting integrated model, OSCAR-S, will be evaluated in a pilot feasibility hybrid type 1 implementation-effectiveness trial.</p><p><strong>Methods: </strong>This three-phase project will apply implementation science frameworks to adapt and test an integrated care transition model (OSCAR-S) for older colorectal surgery patients. The first phase involves qualitative interviews with stakeholders to inform the adaptation of the combined model (OSCAR-S), guided by the ADAPT, Consolidated Framework for Implementation Research (CFIR), and FRAME frameworks. Subsequently, we will determine an optimal implementation strategy, guided by the Expert Recommendations for Implementing Change (ERIC). The final phase will include a pilot feasibility type I implementation-effectiveness trial. Guided by the RE-AIM framework and through a mixed methods approach, we will collect quantitative data from electronic medical records and qualitative data from post-implementation interviews to evaluate reach, effectiveness, adoption, implementation, and maintenance.</p><p><strong>Discussion: </strong>This study will offer insights into the adaptation, implementation, and assessment of an integrated care transition model (OSCAR-S) for older adults undergoing major colorectal surgery. The model integrates core components of two evidence-based interventions: OSCAR (geriatrics surgery co-management) and CTI (Care Transitions Intervention) programs. A novel aspect of this work is the application of multiple implementation science frameworks to guide this process. The findings will inform future strategies to optimize care transitions and postoperative outcomes, demonstrating how the implementation science approach can enhance the effectiveness and scalability of integrated care models.</p><p><strong>Trial registration: </strong>This trial was registered at ClinicalTrials.gov ( NCT06752031 ). Registered December 30, 2024.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-03-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13130537/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147494083","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Mindful self-compassion to reduce stigma among individuals diagnosed with lung cancer (MSC-LC): a pilot study protocol for a parallel-group, randomized controlled trial.","authors":"Timothy J Williamson, Whitney M Brymwitt, Jamie S Ostroff, Lisa Carter-Bawa, Christopher K Germer, Steven D Hickman, Jun J Mao, Heidi A Hamann, Kristen E Riley, Jamie L Studts, McKenzie T Reese","doi":"10.1186/s40814-026-01808-8","DOIUrl":"10.1186/s40814-026-01808-8","url":null,"abstract":"<p><strong>Background: </strong>Lung cancer stigma (i.e., perceived and internalized negative appraisal and devaluation associated with lung cancer) is a clinically significant psychosocial concern among individuals diagnosed with lung cancer. Stigma has been linked to increased psychological distress, higher depressive symptoms, anxiety, lower quality of life, and reduced engagement in care. However, few patient-centered interventions address lung cancer stigma. Mindful Self-Compassion (MSC) is a promising approach that promotes emotional resilience and reduces psychological distress. However, MSC has not been tailored for the needs of people with lung cancer. To address this gap, we developed Mindful Self-Compassion for Lung Cancer (MSC-LC)-a disease-specific adaptation designed to reduce stigma by cultivating self-compassion. This study aims to assess the feasibility, acceptability, and preliminary efficacy of MSC-LC among individuals with lung cancer who report elevated stigma.</p><p><strong>Methods: </strong>Theoretically grounded in the Conceptual Model of Lung Cancer Stigma, the Health Stigma and Discrimination Framework, and the CDC Map of Adaptation, this pilot trial uses a parallel-group randomized controlled design (1:1 allocation) comparing MSC-LC to an enhanced standard-of-care waitlist control group (CTL). We aim to enroll 60 adults diagnosed with lung cancer (n=30 per condition) who exceed a validated cutoff for elevated stigma on the Lung Cancer Stigma Inventory. MSC-LC includes weekly 90-min virtual group sessions co-facilitated by trained interventionists and home practice assignments between sessions. Feasibility and treatment fidelity (primary outcomes) will be assessed using quantitative benchmarks (e.g., recruitment, retention, session attendance, interventionist adherence). Acceptability will be evaluated through qualitative interviews. Secondary outcomes including stigma, self-compassion, depressive symptoms, anxiety, and spiritual well-being will be collected at baseline, mid-intervention, post-intervention, and longer-term follow-up. Quantitative and qualitative data will be integrated at the interpretation phase to examine signals of change and inform refinement and implementation.</p><p><strong>Discussion: </strong>This study will address the gap of patient-centered interventions that target the reduction of lung cancer stigma. Findings will inform the rigorous evaluation of the efficacy of MSC-LC to reduce stigma among individuals with lung cancer.</p><p><strong>Trial registration: </strong>The protocol for this study has been registered on ClinicalTrials.gov (ID: NCT06191939). First posted December 20, 2023, last update posted July 17, 2025. https://clinicaltrials.gov/study/NCT06191939 .</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-03-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13126763/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147491419","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Swallow Strength and Skill Training with biofeedback In acute Post stroke dysphagia (ssSIP): a protocol for a multi-centre feasibility trial.","authors":"Jacqueline K Benfield, Kirsten Woods, Lisa Woodhouse, Cristina Roadevin, Marilyn James, Philip M Bath, Timothy J England, Kate Radford, Catriona Steele","doi":"10.1186/s40814-026-01803-z","DOIUrl":"10.1186/s40814-026-01803-z","url":null,"abstract":"<p><strong>Background: </strong>Post stroke dysphagia is common and has negative consequences on health and wellbeing. Collectively, behavioural interventions including swallow strength and skill training with biofeedback improve dysphagia, but little is known about which interventions are most effective and at what dose. Early intensive intervention may be most beneficial for motor recovery, but it is unclear whether dysphagia therapy such as this is feasible to deliver in the inpatient acute stage.</p><p><strong>Aim: </strong>To understand the feasibility of clinical teams delivering swallow strength and skill training with biofeedback in acute inpatient stroke and explore which dose may result in better outcomes.</p><p><strong>Methods: </strong>One hundred twenty participants from inpatient stroke units 1-8 weeks post stroke in the UK will be recruited in this multi-centre prospective randomised controlled feasibility trial. If eligible, they will be randomised 1:1:1 to either usual care, low-intensity therapy (once daily) or high-intensity therapy (twice daily) groups. In addition to usual care, treatment groups will receive 1 or 2 × 35-min daily sessions of swallow strength and skill training with surface electromyographic biofeedback over 2 weeks. The primary outcome is feasibility measured by recruitment and treatment fidelity. Secondary outcomes will explore treatment effects and dose of the intervention on swallowing, clinical, quality of life and health economic outcomes. Embedded qualitative process evaluation of intervention delivery (fidelity, barriers and enablers), clinical staff training and trial procedures informed by the Conceptual Framework for Intervention Fidelity (CFIF) and Conceptual Framework for Implementation Research (CFIR). Criteria have been outlined for progression to a definitive study.</p><p><strong>Discussion: </strong>This trial will inform the feasibility of a definitive study to determine the effectiveness of optimal dose swallow strength and skill training with surface electromyographic biofeedback on the severity of dysphagia 3 months post stroke. The process evaluation will inform refinements to the intervention, training and trial procedures to ensure effective delivery.</p><p><strong>Trial registration: </strong>Registration Clinical Trials.gov NCT05744245, date of release 20/12/2022.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13169879/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147481154","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effects of a device-measured physical activity intervention on visual outcomes, including contrast sensitivity, and glycaemic control in individuals with abnormal glucose tolerance: a pilot randomised trial post-CarMeR study.","authors":"Ebenezer Oduro Antiri, Thomas Hormenu, Stephen Ocansey, Rudolf Aaron Arthur, Eric Awlime-Ableh, Iddrisu Salifu, Benjamin Nyane, Augustine Mac-Hubert Gabla, Juliet Elikem Paku, Edward Wilson Ansah","doi":"10.1186/s40814-026-01805-x","DOIUrl":"10.1186/s40814-026-01805-x","url":null,"abstract":"<p><strong>Background: </strong>Abnormal glucose tolerance (AGT), a summary term for prediabetes and diabetes, is a significant public health concern in sub-Saharan Africa, where diabetes-related complications like retinopathy are underdiagnosed. Lifestyle interventions, specifically physical activity, offer a cost-effective approach to improve glycaemic and visual outcomes in resource-limited settings. However, feasibility data on the effectiveness of these interventions in low-resource settings are limited. This pilot randomised controlled trial (RCT) assessed the feasibility of a 12-week device-measured physical activity intervention on glycaemic control and visual functioning among individuals newly diagnosed with AGT in Ghana.</p><p><strong>Methods: </strong>Twenty-four participants were randomly assigned to intervention and control groups, with the intervention group receiving a progressive physical activity regimen monitored by smartphone sensors and mobile apps, while the control group received general health education. The primary outcomes were feasibility measures, including recruitment, retention, adherence, and adverse events. Secondary outcomes included clinical measures of visual function (visual acuity, contrast sensitivity, central visual field, and visual disability index) and glycaemic control [glycated haemoglobin (HbA1c), fasting blood sugar (FBS), fasting plasma glucose (FPG), 2-h plasma glucose level (2hPG)].</p><p><strong>Results: </strong>The trial demonstrated good feasibility with 93.3% target sample attainment, 85.7% retention, and no adverse events. Participants in the intervention group achieved an average of 77 min of objectively measured physical activity daily. Regarding secondary clinical outcomes, participants in the intervention group demonstrated a 1.18% reduction in HbA1c (95% CI, -1.65, -0.71) and improvements in contrast sensitivity in the right (Δ = 0.029; 95% CI, -0.11, 0.17) and left (Δ = 0.046; 95% CI, -0.09, 0.19) eyes.</p><p><strong>Conclusion: </strong>This pilot study offers promising evidence for the feasibility of a technology-monitored physical activity intervention in improving glycaemic control and contrast sensitivity among community-dwelling individuals with AGT. Insights from this study will inform future practical and scalable physical activity interventions in resource-limited settings.</p><p><strong>Trial registration: </strong>Pan African Clinical Trials Registry PACTR202409492459905. Registered on 16th September 2024.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13112855/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147481172","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Suprachoroidal VIsco-bucKlING versus gas tamponade for the treatment of rhegmatogenous retinal detachment (VIKING): study protocol for a multi-centre, randomised, controlled feasibility study.","authors":"Shohista Saidkasimova, Chan Ning Lee, George S P Murphy, Timothy L Jackson","doi":"10.1186/s40814-026-01787-w","DOIUrl":"10.1186/s40814-026-01787-w","url":null,"abstract":"<p><strong>Background: </strong>Rhegmatogenous retinal detachment (RRD) is a potentially blinding condition that affects ~ 1 in 10,000 adults per year. Retinal detachment surgery usually involves internal reapposition of the retina using the injection of a gas tamponade into the vitreous cavity. However, this has downsides including delayed visual recovery, the need to posture postoperatively, limiting fundal view during postoperative monitoring, and the risk of raised intraocular pressure. We examine a novel surgical variation, using a temporary suprachoroidal viscobuckle (SCVB) instead of gas. SCVB involves the controlled injection of high viscosity viscoelastic through an external scleral incision into the suprachoroidal space to create an indent under a causative retinal break. The sodium hyaluronate viscoelastic is resorbed over 2-3 weeks, long enough for intraoperative laser retinopexy to cause chorioretinal adhesion. The primary objective of this study is to establish if it is feasible to recruit, retain, and evaluate patients with RRD into a larger randomised controlled trial of SCVB. Secondary objectives are to make a preliminary assessment of safety and efficacy.</p><p><strong>Methods: </strong>This multicentre, randomised, controlled, two-group, unmasked feasibility trial recruits participants with primary RRD and a break or breaks within 1 clock hour. The CE-marked sodium hyaluronate viscobuckle is created during otherwise standard pars plana vitrectomy RRD surgery. Feasibility outcomes include screen failure rate, rate of recruitment, protocol compliance, and participant retention. The main efficacy outcome is retinal attachment with no intravitreal tamponade present and no subretinal fluid which could spread, without the need for further surgery, at week 12. The key secondary efficacy outcome is Early Treatment of Diabetic Retinopathy Study best-corrected visual acuity at week 24. Safety is recorded through adverse events and serious adverse events.</p><p><strong>Discussion: </strong>SCVB has multiple potential advantages for patients. This study will help determine if a definitive study of SCVB is justified and deliverable and inform its design.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT04557527, registered 09 September 2020.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13188390/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147475004","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Sample size calculations for pilot cluster-randomised controlled trial: a review 2010-2020.","authors":"Rebecca M Simpson, Jen Lewis, Michael J Campbell, Lauren Desoysa, Peter J Dodd, Dan Green, Bright C Offorha, Ines Rombach, Stephen J Walters, Steven Julious","doi":"10.1186/s40814-026-01792-z","DOIUrl":"10.1186/s40814-026-01792-z","url":null,"abstract":"<p><strong>Background: </strong>There is no recommended guidance on appropriate sample sizes for pilot cluster-randomised controlled trials (cRCTs). Pilot trials should not aim to demonstrate efficacy, and achieving power should not be used to justify the sample size. However, the CONSORT extension for pilot trials states that some justification for their sample size should be given. We conducted a review to understand the choices and justifications of pilot cRCT sample sizes and their trends over time, and to explore apparent changes following the publication of CONSORT extensions for cluster trials and for pilot and feasibility trials.</p><p><strong>Methods: </strong>We searched PubMed and Web of Science for pilot cRCTs. The search took place on 01/10/2020 and was restricted to papers published on or after 01/01/2010. Identification of papers was based around a search for the terms 'pilot' or 'feasibility' in the title and abstract/topic. The primary interest in the review was in the planned sample size in terms of clusters per-arm. We also examined participants per-arm and enrolled sample size. Analyses were descriptive or displayed graphically.</p><p><strong>Results: </strong>Our search returned 3090 records. After removing exact duplicates, aggregating records into unique studies and excluding ineligible studies, we identified 170 pilot or feasibility cRCTs. The median sample size was four clusters per arm. Stratification showed this to be fairly consistent, regardless of the justification given, whether a formal analysis was planned, whether the intention was to estimate the Intra-Cluster Correlation, cluster type, general medical area, funding type, and over time.</p><p><strong>Conclusion: </strong>Average sample sizes for cRCTs have remained strikingly constant over the period 2010-2020 and across several key features of studies; they do not appear to be meaningfully impacted by the stated study aims or sample size justifications. This is despite the fact that the reported main aims for pilot cRCTs, and justifications for their sample sizes, do appear to have changed during this time. Given that aims and justifications appear to have changed, but typical sample sizes have not, it is possible that some researchers choose sample size for pilot cRCTs primarily out of convenience or practical reasons, whilst stating other justifications.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-03-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13104208/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147468630","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A municipality implemented behavioural intervention to improve quality of life among older adults: protocol for a mixed-methods pilot case study.","authors":"Kiran M Gerhardsson, Christina Brogårdh, Åsa B Tornberg, Ellen Hellblom, Steven M Schmidt","doi":"10.1186/s40814-026-01795-w","DOIUrl":"10.1186/s40814-026-01795-w","url":null,"abstract":"<p><strong>Background: </strong>Ageing is associated with circadian rhythm sleep disorders, poor sleep at night, less physical activity and more time spent indoors, affecting the wellbeing of older adults. Their sleep and mood could benefit from daytime outdoor physical activity, exposure to daylight, better indoor lighting and sleep routines. However, changes to routines can be challenging depending on individual behavioural conditions (e.g. having the physical and cognitive capacity) and a supportive social and physical environment, such as a walk-friendly environment. To address these challenges, we have developed a complex behavioural intervention, delivered as a web-based course ('Light, activity and sleep in my daily life') that targets light-related behaviour, outdoor walking and sleep behaviour among community-dwelling older adults. The study aims to evaluate the usability, usefulness and acceptance of the intervention, the intervention outcomes and whether changes to routines are sustained. In addition, perceived enablers and inhibitors to daytime outdoor walking will be identified.</p><p><strong>Methods: </strong>We use a case study design and mixed methods because a deeper understanding of the real-world context is critical for a successfully implemented complex behavioural intervention. Eligible intervention participants (target N = 40) are Swedish-speaking adults (≥ 70 years), living in one-person households in apartments in four municipalities. Participants complete questionnaires assessing intervention outcome measures (e.g. quality of life), are interviewed about their daily routines, and wear an accelerometer which tracks activity and rest at the baseline. They then enrol in a 9-week course, including self-studies at home and four physical meetings at the senior citizen meeting point. Baseline measures are repeated directly after the course, at 3 and 10 months. In addition, participants evaluate the intervention's usability and usefulness after the course and are interviewed at three months about perceived enablers and inhibitors to daytime outdoor walking. Staff from the municipality (a potential future service provider) assess their acceptance of the intervention delivery and discuss future implementation in focus groups (N = 4).</p><p><strong>Discussion: </strong>Results will inform a subsequent randomised study including a control group focused on optimising the intervention's content and delivery procedures to enable an intervention better integrated into municipal health promotion services/strategies. An anticipated long-term outcome is continued independence.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT06807060. Registered on 3 February 2025-retrospectively registered.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13063510/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147459251","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The feasibility and acceptability of conducting a randomised controlled trial evaluating a healthcare professional-supported, self-management intervention for people suffering from fatigue after critical illness.","authors":"Yijun Yu, Sophie Eleanor Brown, Akshay Shah, Wladyslawa Czuber-Dochan, Suzanne Bench, Clare Martin, Georgia Cook, David McWilliams, Emma Hedley, Najib Rahman, Rebecca Langley, Louise Stayt","doi":"10.1186/s40814-026-01798-7","DOIUrl":"10.1186/s40814-026-01798-7","url":null,"abstract":"<p><strong>Background: </strong>Fatigue is a common problem that significantly affects intensive care unit (ICU) survivors' physical, psychological, and social functioning. ICU survivors often experience a loss of self-worth and identity, struggle to return to their normal roles, and face ongoing challenges with cognitive and emotional recovery. Despite its profound impact, there are limited rehabilitation interventions targeting this population. This research aims to evaluate the acceptability of implementing the Fatigue After CriTical illness (FACT) self-management intervention into usual care for patients experiencing fatigue after critical illness and the feasibility of the intervention for a future clinical trial.</p><p><strong>Methods: </strong>This is a multicentre, open-label, feasibility randomised controlled trial (RCT) with an embedded qualitative evaluation, conducted across. Seventy participants recruited from three United Kingdom (UK) National Health Service (NHS) Trusts will be randomised either to the FACT self-management intervention following hospital discharge, which focuses on fatigue management, goal setting, and personal action planning, in addition to usual care, or to a control group receiving usual care alone. The intervention will be accessible for six months and will include a 30-min phone or video call with an ICU follow-up healthcare professional (HCP) in the third month. HCPs will attend an online training session and follow a protocol to guide patients in goal setting. Outcome assessments will occur at baseline, three months, and six months post-randomisation to evaluate feasibility and acceptability. Semi-structured interviews with patients and HCPs will explore their experiences and acceptability outcomes at 6 months.</p><p><strong>Discussion: </strong>This study aims to provide insights into the feasibility and acceptability of the FACT intervention, with the goal of improving fatigue management among survivors of critical illness. Preliminary findings will inform the design of a larger-scale RCT to evaluate its effectiveness in enhancing recovery from critical illness in patients who are experiencing fatigue.</p><p><strong>Trial registration: </strong>Study ID: ISRCTN1381359 . Date registered: 01/04/2025.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13101231/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147459263","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Fracture table vs. lateral positioning for intramedullary fixation of femur fractures (The FLiP Trial): the feasibility of a cluster randomized crossover trial.","authors":"Daniel E Axelrod, Sheila Sprague, Ernesto Guerra-Farfan, Yaiza Garcia-Sanchez, Brad Meulenkamp, Melanie Dodd-Moher, Sofia Bzovsky, Christy Shibu, Gina Del Fabbro, Jodi L Gallant, Thomas Mammen, Herman Johal","doi":"10.1186/s40814-026-01789-8","DOIUrl":"10.1186/s40814-026-01789-8","url":null,"abstract":"<p><strong>Background: </strong>Femoral shaft fractures are common severe injuries that carry an elevated risk of operative complications, including femoral malrotation, neurologic, and vascular injuries. There is no definitive research comparing two commonly used surgical tables and patient positions in aiding with both reduction and fixation of femoral shaft fractures. The objective of this pilot trial was to test the feasibility of a cluster randomized crossover trial that assesses the comparative effectiveness of supine positioning on a fracture table versus lateral positioning on a radiolucent table for antegrade intramedullary fixation of femoral shaft fractures.</p><p><strong>Methods: </strong>Three orthopaedic trauma centres participated in this pilot trial. Each clinical site was randomized to a starting position, crossed over to the other treatment after 2 months, and alternated treatments in this fashion for the length of the trial. During the enrolment phase, we assessed compliance, enrolment rates, participant follow-up, and accurate documentation of the primary clinical outcome. The feasibility success criteria were: (1) 90% enrolment of eligible participants during enrolment phases; (2) 90% compliance with the trial interventions as per the cluster randomization crossover scheme; (3) timely collection of primary outcome data (i.e., within 6 weeks of fracture) in 95% of participants, (4) 90% completion of participant follow-up data; and (5) definition of the primary outcome as a categorical variable with an appropriate threshold value. Feasibility outcomes were summarized using descriptive statistics reported as means (standard deviation) or medians (first quartile, third quartile) for continuous variables depending on their distribution and counts (percentage) for categorical variables.</p><p><strong>Results: </strong>All five of the criteria for feasibility were met. Of the 110 eligible patients identified at the three clinical sites, 101 (91.8%) were enroled over a 2.5-year period and 95/101 (94.1%) received the correct cluster-assigned treatment. The primary outcome (malrotation measured on the CT) was accurately documented within 6 weeks of fracture for 98% of participants (99/101) with 93 participants completing the final follow-up (92.0%). Lastly, the trial data informed an appropriate threshold, a malrotation cut off of 15°, for the primary outcome in the definitive trial.</p><p><strong>Conclusions: </strong>These results confirm the feasibility of a definitive trial comparing patient positioning during intramedullary fixation of femoral shaft fractures using a cluster randomized crossover trial design. However, due to funding limitations, a slower than anticipated enrolment, and concerns with surgical equipoise, this trial did not proceed to the definitive phase.</p><p><strong>Trial registration: </strong>ClincialTrials.gov NCT03868280.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13097760/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147444850","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}