Pilot and Feasibility Studies最新文献

{"title":"Virtual Intervention for Vertebral frActures (VIVA): protocol for a feasibility study of a multicentre randomized controlled trial.","authors":"Ada Sevinc, Alexandra Papaioannou, Suzanne N Morin, Jennifer A Watt, Raheem B Kherani, Sheila Brien, Larry Funnell, Lehana Thabane, Lauren A Beaupre, Jenna C Gibbs, Heather Keller, Caitlin McArthur, Matteo Ponzano, Sonia Singh, Sharon Straus, Jenny Thain, Zachary J Weston, Timothy H Wideman, Christopher D Witiw, Lora Giangregorio","doi":"10.1186/s40814-025-01665-x","DOIUrl":"https://doi.org/10.1186/s40814-025-01665-x","url":null,"abstract":"<p><strong>Background: </strong>Vertebral fractures due to osteoporosis cause significant pain and disability. There is guidance available on the management of osteoporotic vertebral fractures, informed by systematic reviews and a consensus process. However, few studies examine whether implementing pragmatic and patient-oriented rehabilitation interventions can improve outcomes for individuals with a vertebral fracture.</p><p><strong>Methods: </strong>The purpose of the study is to investigate the feasibility of a multicentre randomized controlled trial of an 8-week virtual rehabilitation intervention for people with an osteoporotic vertebral fracture in Ontario, British Columbia, and Quebec. The design is a multicentre randomized controlled trial with two parallel groups randomized in a 1:1 ratio, stratified by centre to immediate or delayed (10 weeks after randomization) receipt of the Virtual Intervention for Vertebral frActures (VIVA). Four centres will each recruit eight individuals (total n = 32) over the age of 50 who have had at least one vertebral fracture in the past 2 years confirmed by a radiology report. VIVA involves once weekly virtual rehabilitation sessions delivered over 8 weeks by an exercise professional, covering four areas: pain management, safe movement, exercise, and nutrition. Exercise professional provides resources and prescribes exercise therapy for participants to implement outside of the scheduled sessions. The primary feasibility outcomes are recruitment, retention, and adherence, and criteria for success are as follows: (a) recruiting eight people per site in 5 months, (b) 80% of participants completing the trial, and (c) 75% adherence to the virtual rehabilitation sessions. The secondary outcomes include costs relative to benefit, effects on health-related outcomes (e.g. 30-s chair stand, Brief Pain Inventory, Quality of Life Questionnaire of the European Foundation for Osteoporosis-41, SCREEN-14), and outcomes related to implementation (e.g. participant and provider experience using semi-structured interviews, fidelity, number of screened and enrolled participants by referral source, fracture verification process). Descriptive analyses (e.g. mean, count, percentage) will be performed for primary feasibility outcomes and secondary outcomes.</p><p><strong>Discussion: </strong>The results will establish the feasibility of a future trial investigating the effectiveness of the VIVA intervention in people with an osteoporotic vertebral fracture.</p><p><strong>Trial registration: </strong>The trial was registered in ClinicalTrials.gov on October 21, 2024 (NCT06650410), https://clinicaltrials.gov/study/NCT06650410 .</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"94"},"PeriodicalIF":1.5,"publicationDate":"2025-07-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144567698","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Applying a co-designed medication plan for safer medication treatment in older persons: a feasibility study.","authors":"Malin Holmqvist, Axel Ros, Johan Thor, Linda Johansson","doi":"10.1186/s40814-025-01661-1","DOIUrl":"10.1186/s40814-025-01661-1","url":null,"abstract":"<p><strong>Background: </strong>To promote patient safety, international guidelines highlight the importance of a joint plan for continued treatment in older persons. Accordingly, in a co-design initiative involving older persons and healthcare professionals, a medication plan was developed. This study aimed to assess the feasibility of applying the medication plan for older persons in primary care. The objectives were to examine the feasibility of the medication plan in clinical practice and to examine the feasibility of methods that could be used to study a broader implementation.</p><p><strong>Methods: </strong>A prospective study design, using both qualitative and quantitative methods, was employed. During appointments at primary care centres, physicians (n = 6), persons aged 75 or older (n = 21), and, when applicable, their next of kin (n = 2) collaboratively agreed on a medication plan, which was documented in the electronic health record. Over a 3-month follow-up period, data regarding the feasibility of the medication plan (usability and fidelity) and the feasibility of the research methods (recruitment and retention rates, data collection, and outcome measures) were collected.</p><p><strong>Results: </strong>Usability assessed by the System Usability Scale scored a median of 51.3 out of 100 for physicians. The participants' experiences of the medication plan's usability addressed functionalities, individualisation for relevance, resources, and a de-prioritised medication plan. Fidelity was assessed based on 8 out of 15 older persons reporting that they had received a medication plan, and 59% of all prescribed medications had documented goals and/or comments. The recruitment rate was 75% for physicians and 70% for older persons. There were no changes in polypharmacy and no contact with healthcare due to suspected adverse drug events. The participants' perceptions of the medication plan's ability to promote patient safety addressed awareness and information, challenges beyond the medication plan, and patient involvement.</p><p><strong>Conclusions: </strong>The implementation of the co-designed medication plan encountered challenges related to usability and fidelity, requiring collaborative refinements of the prototype. Additional difficulties arose from using a low-fidelity prototype in clinical practice. Our results emphasise the strength of combining qualitative and quantitative methods to capture participants' perspectives on the medication plan's ability to promote patient safety. Before conducting a larger study, the evaluation methods require further refinement.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06016140 (retrospectively registered).</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"92"},"PeriodicalIF":1.5,"publicationDate":"2025-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12224353/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144560804","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":"Open label placebo to treat fatigue in people with multiple sclerosis: feasibility and preliminary effects.","authors":"Navneet Kaur Baidwan, Tracy Tracy, Chia-Ying Chiu, Tanjila Nawshin, Teri Hoenemeyer, Emily Riser, Robert Motl, Kevin Fontaine, Tapan Mehta","doi":"10.1186/s40814-025-01674-w","DOIUrl":"10.1186/s40814-025-01674-w","url":null,"abstract":"<p><strong>Background: </strong>Fatigue is highly prevalent in adults with multiple sclerosis (MS) and current treatments offer limited benefit. It has been speculated that placebos only have an effect when they are administered with deception and concealment, which is unethical in clinical practice. Recent studies suggest that ethically informed, open-label placebos (OLP) can produce symptomatic benefits. As such, we primarily sought to investigate the feasibility and secondarily assess the preliminary effects of OLP to treat MS fatigue.</p><p><strong>Methods: </strong>Feasibility outcomes including accrual, retention, and OLP adherence estimates were assessed in this 21-day assessor blinded, RCT. We compared results of assignment to three conditions: (1) OLP with a positive expectancy for beneficial effects along with the prescription to take 2 placebo pills twice a day (OLP), (2) positive expectancy (EXP) for beneficial placebo effects, or (3) a usual care only (UCO). We considered the study to be feasible if progression criteria, including the enrollment target of 48 participants, retention target of > 80% participants, and OLP adherence target of > 90%, were met. As secondary analyses, we provide descriptive statistics and crude linear mixed models (LMM) based estimates to assess the change in fatigue (assessed via Fatigue Severity Scale (FSS) and Modified Fatigue Impact Scale (MFIS)) at days 21, 28, and 35 versus baseline with corresponding 95%, 85%, and 75% confidence intervals.</p><p><strong>Results: </strong>One-hundred and eight adults with MS were screened of which 48 were randomized (16 per group). Retention rate was 98% with one participant being lost to follow-up. Placebo adherence was over 90%. At day 21, 7 of 9 (78%) randomized to OLP considered prescribing placebos to treat fatigue as \"moderately-to-completely\" acceptable. Next, the LMM based change in FSS mean score at day 21 with respect to baseline in the OLP and EXP group versus UCO group was about 0.6 units lower (95% CI: - 1.206, - 0.003; - 1.301, - 0.065, respectively).</p><p><strong>Conclusions: </strong>OLP was deemed feasible and acceptable by most participants and there was mild evidence that, compared to UCO, it may reduce fatigue severity in adults with MS. Larger trials of OLP are required to determine whether OLP might be a viable treatment for MS fatigue.</p><p><strong>Trial registration number: </strong>NCT04002102 ( https://clinicaltrials.gov/show/NCT04002102 , 2019); registered 30 September 2019.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"93"},"PeriodicalIF":1.5,"publicationDate":"2025-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12226847/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144560805","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":"Study protocol for a feasibility evaluation of Charge Up!: an adaptation of Critical Time Intervention for young adults moving from homelessness to housing.","authors":"Sarah C Narendorf, Michelle R Munson, Umaira Khan, Marcus Brown, Gregory Gomez, Diane Santa Maria, Todd Gilmer, Maurice N Gattis, Prince Hayward, Daniel Herman","doi":"10.1186/s40814-025-01677-7","DOIUrl":"10.1186/s40814-025-01677-7","url":null,"abstract":"<p><strong>Background: </strong>Young adults experiencing homelessness (YAEH) have high rates of mental health challenges, yet low rates of mental health service utilization. The transition from homelessness to housing is a key time for intervention to connect YAEH with mental health treatment and provide support to improve both mental health and housing stability. Charge Up! is a 6-month, phased support intervention that utilizes a team-based approach to connect young adults to community and mental health support. It is an adaptation of Critical Time Intervention that integrates components of Cornerstone, a mental health support intervention designed for young adults.</p><p><strong>Methods: </strong>This pilot study uses a phased open trial that begins with a feasibility trial to refine the adapted Charge Up! intervention (n = 8), then further tests feasibility, acceptability, and preliminary signal of impact in a small, randomized pilot trial (n = 52). Participants are young adults moving into a transitional housing to rapid rehousing program (TH/RRH) in Houston, Texas. Quantitative interviews are conducted at baseline, 3 months, 6 months, and 12 months. Qualitative interviews are also conducted at 6 months. Exploratory analyses will examine the feasibility of implementing Charge Up!, the performance of measures, and whether Charge Up! is changing the hypothesized targets. Qualitative analysis from interviews will examine demand for the intervention, acceptability of the intervention, and integration of the intervention within the housing system context.</p><p><strong>Discussion: </strong>The aim of this study is to pilot test Charge Up!, an adapted version of Critical Time Intervention designed to provide targeted support for mental health at the point of transition from homelessness to housing. The Charge Up! intervention was co-developed with young adults and providers, and this phased open trial will help to refine and provide preliminary evidence of the feasibility and acceptability of the intervention. The program is provided in conjunction with a widely used housing model, RRH, and has the potential for scalability as an adjunctive intervention to support youth transitioning into RRH across the United States.</p><p><strong>Trial registration: </strong>This study was registered on ClinicalTrials.gov on October 20, 2023 (Identifier: NCT06102850), as Protocol ID R34MH129542-01A1, University of Houston, Title: Adaptation of Critical Time Intervention for Young Adults with MH Challenges (CTI-YAMH).</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"91"},"PeriodicalIF":1.5,"publicationDate":"2025-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12220015/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144554190","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":"Surgical wounds healing by Secondary Intention-2 Trial: outcomes and learning from the internal pilot phase and main trial.","authors":"Catherine Arundel, Sabeen Zahra, Ian Chetter","doi":"10.1186/s40814-025-01658-w","DOIUrl":"10.1186/s40814-025-01658-w","url":null,"abstract":"<p><strong>Background: </strong>Randomised controlled trials are the most rigorous way of investigating the effectiveness of intervention(s) in healthcare settings. During their conduct, trials often run into challenges which if not overcome can lead to significant research waste. Inclusion of a pilot phase provides a way to evaluate elements such as recruitment rate, site set-up and participant follow-up and to address any difficulties early in the trial. The number of trials including a pilot phase is increasing; however, findings are rarely shared in detail, meaning relevant information and learning may not benefit the wider research community. We aimed to report the learning from the SWHSI-2 internal pilot phase, to inform internal pilot trial design and conduct and to also share the subsequent learnings from the main trial phase.</p><p><strong>Methods: </strong>The design and outcomes of the 6-month internal pilot phase were embedded within the surgical wounds healing by secondary intention trial. The internal pilot phase assessed site set-up, participant randomisation, intervention delivery and follow-up rates using a pre-specified grading. Details of the impact of the pilot phase on, and subsequent changes to, the main trial phase are also presented. We highlighted the challenges faced during the study and detail strategies that were included to minimise or mitigate these.</p><p><strong>Results: </strong>The trial achieved satisfactory site set-up and intervention delivery levels; however, recruitment and follow-up rates were lower than anticipated. Approval was received from the funder to proceed to the main trial. Following the pilot phase, and continually during the main trial phase, processes and documentation were reviewed, revised and evaluated to mitigate challenges observed in relation to site engagement, participant recruitment and outcome data collection.</p><p><strong>Conclusion: </strong>Inclusion of an internal pilot enabled early identification of recruitment and retention challenges with a comprehensive suite of interventions subsequently introduced to mitigate these. There was a successful main trial. The findings from this pilot phase add to the evidence base on the design and evaluation of internal pilot phases of a RCT. Future studies including an internal pilot phase should be encouraged to report their experiences for the benefit of others.</p><p><strong>Trial registration: </strong>ISRCTN26277546. Prospectively registered 25 March 2019, https://www.isrctn.com/ISRCTN26277546.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"90"},"PeriodicalIF":1.5,"publicationDate":"2025-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12219939/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144554191","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":"Precision targeting in acupuncture: a pilot and feasibility study protocol of ultrasound-guided approach for non-specific low back pain.","authors":"Zihan Liu, Tianying Chang, Jili Fu, Hui Chi, Xiaodan Wang, Lisha Wang, Wenqi Cui, Yingzi Cui, Zhibin Cong","doi":"10.1186/s40814-025-01673-x","DOIUrl":"10.1186/s40814-025-01673-x","url":null,"abstract":"<p><strong>Introduction: </strong>Non-specific low back pain (NLBP) is increasingly prevalent in the world due to changes in lifestyle and work habits. It is found that the symptom is usually associated with damage in the thoracolumbar fascia (TLF) and its surrounding muscles. This paper introduces a pioneering approach for treating NLBP, using the heterogeneous echo zones on ultrasound images as needling targets, presenting a novel treatment protocol.</p><p><strong>Methods: </strong>An open randomized controlled trial is designed and conducted, in which 48 patients with NLBP will be randomly allocated at a ratio of one to one to an ultrasound-guided acupuncture (UGA) group and a regular acupuncture treatment (RA) group. The trial involves a 3-week treatment along with a follow-up for 3 weeks. Its primary purpose is to evaluate the feasibility and safety of ultrasound-guided acupuncture in the TLF and its adjacent muscles as a treatment method for NLBP. As its secondary objective, the treatment effectiveness will be assessed by observing the changes in the patient's pain level and low back dysfunction before and after treatment. The ultrasound-related parameters and adverse events will also be collected.</p><p><strong>Discussion: </strong>It is a novel therapeutic approach to treat NLBP with ultrasound-guided acupuncture performed in the TLF and its adjacent muscles, which is characterized by integrating acupuncture with ultrasound. This study is a single-site, open, randomized controlled study designed and conducted to evaluate the effectiveness of the method. If this strategy turns out to be safe and feasible, future in-depth and extensive research will be planned.</p><p><strong>Trial registration: </strong>International Traditional Medicine Clinical Trial Registry, ITMCTR2025000046. Registered on January 9, 2025. http://itmctr.ccebtcm.org.cn/.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"89"},"PeriodicalIF":1.5,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12210429/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144541906","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 justification in feasibility studies: moving beyond published guidance.","authors":"Robert Montgomery","doi":"10.1186/s40814-025-01675-9","DOIUrl":"10.1186/s40814-025-01675-9","url":null,"abstract":"<p><p>Pilot and feasibility studies are crucial for determining whether follow-up trials should be conducted. To be effective, these studies need to be properly designed and have large enough samples to make correct decisions about proceeding to a future trial at a high rate. However, there is significantly less clarity about best practices concerning sample size justifications compared to larger randomized controlled trials which are usually justified by power analyses. This has led to many feasibility studies justifying sample sizes based on pragmatic reasons (e.g., the ability to complete) or on published guidance and various rules of thumb. We argue that feasibility studies should be designed for, or at least report relevant operating characteristics, specifically, the probability of determining a future trial will be feasible when it is and the probability of determining a trial will be feasible when it is not and that sample size justifications should be based on these operating characteristics whenever possible. If relevant operating characteristics for a study are not reported, it is difficult to know whether the evidence from these trials can be used to claim a future trial would be feasible. In this paper, we review common methods for determining samples sizes in feasibility studies, report a narrative review of recently published feasibility studies and use two case-studies to highlight core issues we believe exist in the current design and reporting of these studies. Finally, we provide some suggestions that we believe will enhance the sample size justifications and overall effectiveness of these important trials.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"88"},"PeriodicalIF":1.5,"publicationDate":"2025-06-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12186404/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144476351","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":"Mindfulness-Based Stress Reduction adapted to pregnant women with psychosocial vulnerabilities - a randomized feasibility trial in a Danish hospital-based outpatient setting.","authors":"Sine Skovbjerg, Michelle Kolls, Anette Kjærbye-Thygesen, Lone Overby Fjorback","doi":"10.1186/s40814-025-01670-0","DOIUrl":"10.1186/s40814-025-01670-0","url":null,"abstract":"<p><strong>Background: </strong>Supporting prenatal mental health in women with a preconception history of mental disorders or psychosocial vulnerability is important for a positive transition to parenthood. There is a need for more evidence-based and non-pharmacological mental health interventions in antenatal care. The primary objective of this trial was to evaluate the feasibility of prenatal MBSR, which is an adaption of Mindfulness-based stress reduction (MBSR). This to inform a randomized controlled trial.</p><p><strong>Methods/design: </strong>The trial was conducted at an obstetric outpatient clinic at Copenhagen University Hospital, Amager and Hvidovre, Denmark. The outpatient clinic specializes in antenatal care for pregnant women with psychosocial vulnerabilities. Pregnant women were randomly assigned to an intervention group receiving prenatal MBSR or a waitlist control group. The primary outcome was the feasibility of a full-scale randomized controlled trial (RCT). Second, to examine trends in self-reported outcomes, i.e., mental well-being, perceived stress, anxiety, depression, decentering, reflective functioning, mindfulness, and self-compassion.</p><p><strong>Results: </strong>Of 123 eligible women, 73 consented to participate (59.3%). The majority (75.3%) were nulliparous. The mean age was 30.7 (SD 4.7) years, and most participants were employed (74%) and living with a partner (93.1%) at the time of recruitment. The majority of participants had a history of one or more mental disorders. Most frequently depression or an anxiety disorder. For the intervention group (n = 37), 54.1% completed the prenatal MBSR program. The loss to follow-up was 56.8% for the intervention group (n = 21) and 50% for the waitlist control group (n = 18). For the secondary outcomes, all variables except for reflective functioning pointed in the expected direction, e.g., improved mental well-being, reduced mental distress, and more self-compassion.</p><p><strong>Conclusions: </strong>The results from this trial suggest that prenatal MBSR is a feasible intervention for a clinical setting, supporting the conduct of an RCT. Strategies for improving adherence and reducing the extent of missing data would be advisable in a future RCT. Overall, there is a need for more evidence-based and non-pharmacological interventions addressing prenatal mental health. Results from a future RCT could thus be of relevance to antenatal care.</p><p><strong>Trial registration: </strong>NCT04571190, September 30, 2020 (ClinicalTrials.gov).</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"86"},"PeriodicalIF":1.5,"publicationDate":"2025-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12181856/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144340361","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":"Recovery from disability after geriatric-home rehabilitation versus standard of care: protocol for a pilot study in older persons with disability at hospital discharge.","authors":"Bastiaan Van Grootven, Margreet van Dijk, Farah Islam, Birgit Coucke, Steffen Fieuws, Gijs Van Pottelbergh, Johan Flamaing, Nele Van Den Noortgate, Anja Velghe, Anne-Marie De Cock, Sophie Gillain, Joris Meeuwissen, Ivan Bautmans, David Beckwée, Marie de Saint-Hubert, Jannique van Uffelen, Didier Schoevaerdts, Jos Tournoy, Theo van Achterberg","doi":"10.1186/s40814-025-01668-8","DOIUrl":"10.1186/s40814-025-01668-8","url":null,"abstract":"<p><strong>Background: </strong>Currently, there is insufficient evidence supporting geriatric home rehabilitation after hospital discharge. Some studies demonstrate a positive effect, but meta-analytic evidence demonstrates uncertainty on the magnitude of the expected effect. Yet, evidence from other populations indicates that home rehabilitation could also be an effective strategy for older persons. Therefore, we aim to evaluate the effectiveness of geriatric home rehabilitation in older persons discharged from the hospital with disability. Given the potential challenges in recruiting participants delivering the intervention, and executing other study procedures in a multi-centre study, we will first carry out a pilot study.</p><p><strong>Methods: </strong>The pilot study will commence with an initial start-up phase at two centres: UZ Leuven and CHU UCL Namur, Belgium. Up to three participants per centre will be included to test the procedures and assessments, excluding randomisation and intervention delivery. The study then progresses to the full pilot phase to evaluate and confirm the feasibility of the proposed trial. This pilot study will take place at the same two centres. The pilot study aligns with the design of the envisioned full trial, i.e. a pragmatic, multicentre, individually randomised superiority trial. A 1 to 1 allocation ratio will be used for the pilot. A total of 24 participants from the two centres will be recruited to investigate the pilot study objectives. The pilot endpoints will be used to determine the feasibility of recruitment and study procedures including data collection, assessments and delivery of the intervention (a 6-week program consisting of exercise sessions 3 times per week, 45 min each). The results from the pilot study will be discussed within the pilot study steering group. Progression criteria will be reviewed to determine if the study progresses to a full trial, and which adaptations are needed.</p><p><strong>Discussion: </strong>In case of a successful pilot, the study will progress to a full trial. The ambition of the full trial is to recruit 333 participants across 8 centres in Belgium, and to investigate the effectiveness of home rehabilitation for older persons discharged from the hospital with disability.</p><p><strong>Trial registration: </strong>Clinicaltrials.gov, NCT06404138 on 08 May 2024.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"87"},"PeriodicalIF":1.5,"publicationDate":"2025-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12181865/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144340362","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":"Could a feedback device help manage work-related shoulder disorders?: protocol of a mixed methods pilot study.","authors":"Philippe Meidinger, Quan Nha Hong, Jean Tittley, Alexandre Campeau-Lecours, Jean-Sébastien Roy","doi":"10.1186/s40814-025-01646-0","DOIUrl":"10.1186/s40814-025-01646-0","url":null,"abstract":"<p><strong>Background: </strong>Work-related shoulder disorders (WRSDs) significantly impact workers' health and well-being. Various factors contribute to WRSDs, including work environment, physical workload, psychological stressors, and an aging workforce. Despite numerous interventions proposed to address WRSDs, finding high-quality evidence to support any of them remains challenging. One potential reason is the lack of valid tools to measure physical workload and customize interventions. To address this, we developed a portable feedback system, the ShoulderWatchLoad (SWL), designed to estimate physical work demands on the shoulder. The objectives of this pilot study are (a) to evaluate the feasibility of implementing the SWL in the workplace and conducting a large-scale randomized clinical trial (RCT) by assessing recruitment success, intervention adherence, usability of the technology, and the research team's capacity to refine the SWL and (b) to explore the SWL capacity to reduce disability, pain, work limitations, and physical work demands while increasing pain self-efficacy among workers with WRSDs.</p><p><strong>Methods/design: </strong>A convergent mixed methods pilot study will be conducted. The quantitative component will consist of a two-arm parallel group external pilot RCT involving 42 participants with WRSDs who will be randomized into one of the two study groups. Following baseline evaluation, all participants will attend an education session in the workplace. Following this session, participants of the experimental group will receive a 2-week workplace intervention using feedback from the SWL, while participants in the control group will not receive this intervention. All participants will undergo four evaluations over a 12-week period (baseline, 3rd, 6th, and 12th weeks). The qualitative component will be a interpretative descriptive qualitative study involving three focus groups with 21 participants from the experimental group. An innovative joint display will be used to represent the integration of qualitative and quantitative data, along with progression criteria, to draw meta-inferences about the feasibility of implementing the SWL in the workplace and conducting a full-scale RCT in the future.</p><p><strong>Discussion: </strong>A holistic approach combining qualitative and quantitative elements will enable us to determine the SWL usability and whether the conduct of a full RCT is feasible.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06693479.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"84"},"PeriodicalIF":1.5,"publicationDate":"2025-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12180215/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144336733","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}