Pilot and Feasibility Studies最新文献

{"title":"Feasibility randomised controlled trial of a brief psychological intervention for adolescents with borderline personality disorder symptoms delivered with schools and colleges.","authors":"Jon Wilson, Brioney Gee, Nicola Martin, Sarah Maxwell, Jamie Murdoch, Tim Clarke, Allan Clark, David Turner, Thando Katangwe-Chigamba, Peter B Jones, Peter Fonagy","doi":"10.1186/s40814-025-01679-5","DOIUrl":"10.1186/s40814-025-01679-5","url":null,"abstract":"<p><strong>Background: </strong>There is an urgent need for accessible interventions to facilitate early intervention for young people with borderline personality disorder (BPD) symptoms. Existing evidence-based interventions for adolescent BPD are highly resource-intensive, and few young people with BPD symptoms have access to timely treatment. We adapted a brief psychological treatment for adolescent BPD symptoms previously provided within secondary mental health services for delivery within schools and colleges. This study aimed to assess the feasibility of evaluating the effectiveness and cost-effectiveness of this intervention (BEST (brief education support treatment)) in a future randomised controlled trial (RCT).</p><p><strong>Methods: </strong>The feasibility RCT involved 12 schools and colleges. Eligible participants were aged 13-18 years and self-reported BPD symptoms above a clinical threshold and a history of repeated self-harm. Over 9 months, 32 participants were randomised to receive either the BEST intervention plus treatment as usual (TAU) or TAU alone. Participants were assessed at baseline and 12 and 24 weeks. A mixed-methods process evaluation was conducted.</p><p><strong>Results: </strong>Recruitment was slower than anticipated, but participant retention was high (89.5% at 12 weeks and 73.7% at 24 weeks). Performance of all outcome measures was satisfactory. Fidelity of intervention delivery was high (93.5% adherent), and we did not identify any evidence of contamination of the control arm. The intervention was perceived by staff and young people as beneficial to participants, practitioners and the wider school/college and therefore highly acceptable.</p><p><strong>Limitations: </strong>The study was disrupted by the closure of schools and colleges in response to the COVID-19 pandemic. This reduced the window for participant recruitment and limited data collection.</p><p><strong>Conclusions: </strong>The intervention was delivered successfully within schools and colleges and was acceptable to staff and young people. The findings provide support for continuing this programme of research and should inform the design of a future evaluation of intervention outcomes.</p><p><strong>Trial registration number: </strong>ISRCTN16862589.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"102"},"PeriodicalIF":1.5,"publicationDate":"2025-07-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12275424/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144668126","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":"Feasibility of a dietary life skills course aimed at fostering cooking skills and a healthy diet among university students.","authors":"Ida Ulrikke Valand, Tormod Bjørkkjær, Charlotte Kiland, Elisabet R Hillesund, Frøydis N Vik, Nina C Øverby","doi":"10.1186/s40814-025-01680-y","DOIUrl":"10.1186/s40814-025-01680-y","url":null,"abstract":"<p><strong>Background: </strong>The transition from living at home to independent university life has been associated with deteriorated health outcomes, and many university students lack cooking skills. Life skills education promotes skills essential to mastering everyday challenges such as planning and preparing healthy meals. We developed a dietary life skills course to foster cooking skills and a healthy diet among university students. This paper describes the feasibility testing of this Skills for Life course.</p><p><strong>Methods: </strong>Skills for Life was feasibility tested as a pre-post intervention without a control group. The course comprised 10 weekly, practical lessons at a university teaching kitchen. Topics included among others: nutrition from a life course perspective and why diet matters, how to stock your kitchen, how to make the most of your student loan, and sustainable food and 'food rescuing'. The emphasis was on how to plan and cook easy, cheap, healthy, tasty, and sustainable meals. The students were encouraged to engage with a course-specific website that included short video lectures, relevant literature, learning activities, recipes, and a podcast. An online survey including background information and a validated dietary screener (MyFoodMonth 1.1) was distributed pre- and post-course. Feasibility questionnaires were distributed after each of the 10 lessons and post-course. Progression criteria were set regarding acceptability (mean value ≥ 4 of 5), demand (30 or more sign up; 20 or more participate), implementation (10 lessons delivered), practicality (intervention delivered within normal working hours) and limited efficacy (no significant adverse effects on participants).</p><p><strong>Results: </strong>All progression criteria were met. Sixty-nine students signed up, but the dropout rate was substantial. Twenty-eight students attended at least one lesson, and 14 students attended at least five of the 10 lessons. The overall attendance rate was 49%. The course was well received by the students and was assessed as acceptable. Self-perceived course effects such as a healthier diet, increased knowledge of a healthy diet, and improved cooking skills were reported.</p><p><strong>Conclusions: </strong>The Skills for Life course is feasible in a university setting. Further research should investigate how to increase participation to be able to explore possible changes in diet quality in a larger sample.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"100"},"PeriodicalIF":1.5,"publicationDate":"2025-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12273360/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144659886","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":"Feasibility and acceptability of a contextualized brief psychological intervention for people with bipolar disorder in rural Ethiopia.","authors":"Mekdes Demissie, Charlotte Hanlon, Lauren C Ng, Rosie Mayston, Abebaw Fekadu","doi":"10.1186/s40814-025-01683-9","DOIUrl":"10.1186/s40814-025-01683-9","url":null,"abstract":"<p><strong>Background: </strong>There is a very large unmet need for appropriate psychological interventions for bipolar disorder (BD) for use in low- and middle-income countries. We developed a psychological intervention for BD in a primary health care (PHC) setting in Ethiopia using the Medical Research Council's framework for the Development and Evaluation of Complex Interventions. The aim of this study is to investigate the feasibility, acceptability, and fidelity of this newly developed psychological intervention for BD in a PHC setting in south-central Ethiopia.</p><p><strong>Method: </strong>A total of 12 euthymic people with bipolar disorder and five caregivers participated in five 20-min weekly sessions of the psychological intervention. We conducted a mixed-method evaluation, including in-depth qualitative interviews, fidelity ratings of a random selection of 25% of the audio recorded intervention sessions, and self-reported change in symptom severity. We used thematic analysis for qualitative data and descriptive analysis for quantitative data.</p><p><strong>Results: </strong>Except for one caregiver, all participants completed all five sessions. Intervention providers and recipients expressed satisfaction with the intervention. Intervention providers reported that the intervention can be feasibly delivered in the PHC setting, although 20 min was considered insufficient. While participants acknowledged the importance of involving caregivers in the intervention, they raised privacy concerns. Intervention providers' adherence to the manual was moderate. Preliminary findings indicate a reduction in depressive symptoms post-intervention and improvement in providers' perceived knowledge and skills.</p><p><strong>Conclusions: </strong>This contextually developed psychological intervention for bipolar disorder has promising feasibility, acceptability, and potential utility. Further studies should evaluate time considerations and effectiveness.</p><p><strong>Trial registration: </strong>The trial was registered on 16 August 2024, retrospectively on the Pan African Clinical Trial Registry database [PACTR202408896160144],  https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=31727 .</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"99"},"PeriodicalIF":1.5,"publicationDate":"2025-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12273223/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144659885","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":"Feasibility of a group-based intervention to enhance health-related quality of life and physical activity in children and adolescents with chronic illness: a study protocol.","authors":"Lars Peder Vatshelle Bovim, Elisabeth Ørskov Rotevatn, Haakon Kristian Kvidaland, Bård Bogen, Thomas Halvorsen, Mette Engan","doi":"10.1186/s40814-025-01682-w","DOIUrl":"10.1186/s40814-025-01682-w","url":null,"abstract":"<p><strong>Background: </strong>Chronic or long-term illnesses in early years increase the risk of comorbidities such as mental disorders, social exclusion, and difficulties in forming relationships. In Bergen, Norway, the three-phased intervention Life Coping Program is established. This program is designed to support adolescents with chronic or long-term illnesses through tailored preparation, a hospital-based Life Coping Course, and structured follow-up aimed at empowering them to actively manage their health and adopt a more active lifestyle. This protocol paper describes a feasibility trial of the Life Coping Program, focused on improved health-related quality of life (HRQoL) and levels of physical activity.</p><p><strong>Methods/design: </strong>This study is based on the British Medical Research Council's (MRC) modified framework for developing and evaluating complex interventions. Feasibility and acceptability of the Life Coping Program will be evaluated in an uncontrolled open-label trial using quantitative measures. Sixty children and adolescents with chronic illness or severe medical conditions will be recruited along with one associated caregiver. Feasibility will be assessed by tracking attendance and participation in the different parts of the intervention. Acceptability of the intervention will be assessed by patient-reported questionnaires. HRQoL and levels of physical activity will be measured using the KidScreen-27 and Actigraph GT3X + monitor, respectively, at baseline and 1 and 6 months post-intervention.</p><p><strong>Discussion: </strong>The study will explore the feasibility of an innovative treatment strategy targeting children and adolescents at risk of poor health-related outcomes across multiple dimensions. The findings will inform the design of a future randomized controlled trial.</p><p><strong>Trial registration: </strong></p><p><strong>Clinicaltrials: </strong>gov, NCT06709248. Registered 15th of November 2024-retrospectively registered, https://clinicaltrials.gov/study/NCT06709248?term=NCT06709248&rank=1.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"101"},"PeriodicalIF":1.5,"publicationDate":"2025-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12273055/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144659887","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 community pharmacy-based program to enhance adherence to adjuvant endocrine therapy among breast cancer survivors (PACHA): protocol for a pilot cluster-randomized controlled trial.","authors":"Julie Lapointe, Laurence Guillaumie, Anne Dionne, Lyne Lalonde, Julie Lemieux, Michel Dorval, Hermann Nabi, Martine Lemay, Line Guénette, Jason Robert Guertin, Benoît Mâsse, Sophie Lauzier","doi":"10.1186/s40814-025-01676-8","DOIUrl":"10.1186/s40814-025-01676-8","url":null,"abstract":"<p><strong>Background: </strong>Adjuvant endocrine therapy (AET) is an oral treatment prescribed for 5 to 10 years to women with hormone-sensitive breast cancer. Despite the benefits of AET for reducing breast cancer recurrence, suboptimal adherence is common. Community pharmacists can play a role in supporting women with this treatment, given their frequent encounters with patients, access to refill information, and expertise in managing side effects. The goal of this pilot study is to assess the acceptability and feasibility of implementation, and preliminary effects of the PACHA program, a community pharmacy-based program designed to support women who are prescribed AET. Another goal is to assess the feasibility of a large-scale randomized controlled trial (RCT).</p><p><strong>Methods: </strong>This is a pilot cluster-RCT using mixed-methods. A cluster consists of a pharmacy, its pharmacists, and its patients with an AET prescription in the last 30 months. Pharmacies will be recruited through targeted advertisement. Participating pharmacies will be randomized 1:1 to two groups (n = 33 pharmacies per group). In the first group (control), pharmacists will provide usual services to women. In the second group (intervention), pharmacists will complete web-based training and perform consultations using a standardized guide based on motivational interviewing principles and evidence-based online strategy sheets to cope with AET side effects. Women in the intervention group will have access to a website featuring video modules on AET, strategies for managing side effects, testimonials from women who have had an AET, and a list of resources. Acceptability and feasibility indicators, as well as psychosocial factors expected to influence AET adherence and treatment experience, will be collected at baseline, during, and at the end of the 6-month follow-up using online questionnaires, study data logs, and pharmacy claim records. Semi-structured interviews will be conducted to explore participants' experiences with the program.</p><p><strong>Discussion: </strong>Results will help to refine the program and, if the results support this, to design a full-scale cluster-RCT to assess the program's effect on 5-year adherence and costs. If effective, this program could fill a gap in breast cancer supportive care and contribute to reducing cancer burden by improving survivorship experience and survival.</p><p><strong>Trial registration: </strong>This trial has been approved by the Research Ethics Board of the CHU de Québec-Université Laval (MP-20-2023-6625) and registered at Clinicaltrials.gov (NCT05887102) on 2023-05-24, https://classic.</p><p><strong>Clinicaltrials: </strong>gov/ct2/show/NCT05887102 , prior to beginning the study. Protocol version 1 is dated as 2022-12-12.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"98"},"PeriodicalIF":1.5,"publicationDate":"2025-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12261619/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144637744","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 study protocol for a randomized controlled feasibility trial of behavioural therapy for interepisode bipolar symptoms (STABILISE).","authors":"Kim Wright, Fiona Warren, Sandra Bucci, Barnaby D Dunn, Steven Jones, Heather O'Mahen, Rod S Taylor, Antonieta Medina-Lara","doi":"10.1186/s40814-025-01678-6","DOIUrl":"10.1186/s40814-025-01678-6","url":null,"abstract":"<p><strong>Background: </strong>In between episodes of (hypo) mania and major depression, people with bipolar disorder can experience ongoing low mood or mood instability, and these may also be present as part of cyclothymic disorder. This is a phase II evaluation of an adapted form of behavioural therapy (STABILISE) for inter-episode bipolar symptoms. The study aims to establish the feasibility and acceptability of the therapy and research procedures, including an economic component, to inform a future definitive trial.</p><p><strong>Methods: </strong>Patients will be randomised 1:1 to either Treatment as Usual (control arm) or Treatment as Usual plus STABILISE intervention (intervention arm). Follow up points will be at 14, 30 and 52 weeks post eligibility confirmation, with 30 weeks as the primary end point. We aim to recruit 60 individuals meeting diagnostic criteria for a Bipolar Spectrum Disorder, and reporting ongoing bipolar symptoms (low mood or mood instability) outside of a manic or severe depressive episode. Feasibility and acceptability will be examined through recruitment and retention rates, completion rates for the candidate primary outcome measures (PHQ9, ALS-SF, QoL.BD and BRQ) and feedback from participants on their experience of study participation and therapy. Proceeding to a definitive trial will be indicated if the following criteria are met: (i) trial participation is deemed, or can be made, sufficiently safe; (ii) recruitment rate indicates that larger-scale recruitment would be feasible (recruitment rate of at least two participants per month within at least one site, with mitigation plan if overall target sample size not met); (iii) for candidate primary outcome measure follow up data is available at 30 weeks from at least 75% of participants, or from between 55 and 74% with clear plan for improvement.</p><p><strong>Discussion: </strong>This study is a randomised, controlled feasibility trial that builds on an initial case series of the STABILISE approach. The findings will be used to establish whether a future, definitive trial is feasible and to refine the research procedures and therapy protocol.</p><p><strong>Trial registration: </strong>ISRCTN18207465. Registered 13th March 2024, https://www.isrctn.com/ISRCTN18207465 .</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"97"},"PeriodicalIF":1.5,"publicationDate":"2025-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12243248/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144609006","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":"Co-designing and evaluating a prenatal yoga intervention for ethnic minority women: a feasibility study.","authors":"Carolina Estevao, Carola Chiarpenello, Winsze Kwok, Hemant Bhargav, Nishitha Jasti, Prabha Chandra, Shivarama Varambally, Carmine Pariante","doi":"10.1186/s40814-025-01667-9","DOIUrl":"10.1186/s40814-025-01667-9","url":null,"abstract":"<p><strong>Background: </strong>Prenatal depression is the greatest risk factor for postnatal depression and subsequently, impaired mother-infant attachment. Prenatal yoga may improve both mental and physical health during pregnancy and support mother-fetal attachment. However, its integration into perinatal care remains limited due to a lack of standardization. This study primarily assessed the feasibility of a prenatal yoga module co-developed by King's College London and the National Institute of Mental Health and Neurosciences (NIMHANS). This study aimed to evaluate the feasibility of the first rigorously designed, scientifically backed prenatal yoga module for mental health and mother-fetal attachment.</p><p><strong>Methods: </strong>We codeveloped the PRENAYOGA intervention through Preliminary Patient and Public Involvement (PPI) and a 3-month collaboration project with NIMHANS. The final yoga module consisted of biweekly 1-h sessions for 8 weeks in South London, with 15 ethnic minority women. Data were collected at baseline, 4 weeks, and 8 weeks. Feasibility outcomes, including intervention acceptability, appropriateness, and attendance, were assessed using validated measures and focus group data. Clinical exploratory outcomes, such as mental health and maternal-fetal attachment, quality of life, social support, and self-efficacy were also evaluated.</p><p><strong>Results: </strong>The findings demonstrated the acceptability and appropriateness of the adapted yoga module among participants and stakeholders. Attendance and attrition rates alongside qualitative analyses highlighted both barriers and enablers to sustained engagement. Participants reported enhanced physical and mental health, flexibility, and relief from physical ailments. Insights into session frequency and duration suggested that two 1-h sessions per week for 8 weeks are a viable model, with 80% attending at least once weekly. Yoga teachers highlighted the community-building aspect and adapted sessions to participants' unique needs. Preliminary clinical findings suggested improvements in mental health and maternal-fetal attachment, though these require further investigation.</p><p><strong>Conclusions: </strong>These preliminary results indicate the potential benefit of rigorously developed prenatal yoga for ethnic minority populations. These findings support the need for larger trials to evaluate the module's clinical effectiveness and scalability; such research would contribute to evidence-based prenatal care for underrepresented populations.</p><p><strong>Trial registration: </strong>ClinicalTrial.gov Identifier: NCT05824208.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"96"},"PeriodicalIF":1.5,"publicationDate":"2025-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12232825/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144584481","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":"Piloting a team-based telemedicine care for hypertension focused on Black patients.","authors":"Srista Manandhar, Sunit Chhetri, Danielle Sutton, Animita C Saha, Suneet Kaur, Josh Brown, Jeff Williamson, Kathryn E Callahan, Justin B Moore, Yhenneko J Taylor, Hayden B Bosworth, Yashashwi Pokharel","doi":"10.1186/s40814-025-01656-y","DOIUrl":"10.1186/s40814-025-01656-y","url":null,"abstract":"<p><strong>Background: </strong>Current telemedicine programs to manage hypertension are less effective in Black compared with White patients in the US. Insufficient support for self-care skills and unaddressed social needs may explain the differences. We evaluated feasibility of a team-based telemedicine program using home blood pressure (BP) monitoring (HBPM) guided pharmacotherapy and supporting patients' self-care skills and social needs.</p><p><strong>Methods: </strong>We conducted a single-arm pilot study in two safety-net clinics in North Carolina, enrolling 20 adults with uncontrolled hypertension on stable antihypertensive regimen with smartphone access, and English proficiency. We excluded individuals with conditions impairing home BP monitoring, complex chronic illnesses, or recent acute health events. The 12-week intervention included daily HBPM, HBPM-guided pharmacotherapy, telephone-based self-management support by trained nurses, and social support from community health workers (CHW) and social workers. We evaluated feasibility for recruitment and retention and completion of intervention components, pre-specified as ≥ 70% of expected HBPM (7 times/week/patient) and ≥ 80% self-management calls/patient (8 in clinic 1 and 12 in clinic 2).</p><p><strong>Results: </strong>Among 135 patients approached, 28.9% (n = 39) were eligible. We enrolled 20 patients (17 Black patients, 9 women) and 18 (90%) completed the study. Patients measured their BP an average of 9.4 (SD 8.6) times/week (134.3% of expected) and completed 78.3% of expected calls. We provided social support to 11 patients 19 times including support at home visits by CHWs, mostly for food and medications. There were challenges in supporting other social needs like housing. There was mean (SD) of 1.1 (0.8) medication activation/patient (dose or medication changes), and 8 minor technical issues about HBPM/telemonitoring application use, which were promptly resolved.</p><p><strong>Conclusion: </strong>Our team-based telemedicine hypertension intervention shows feasibility for recruitment, retention, and HBPM, partial feasibility for social support, and almost met feasibility for self-management support. Community informed approaches can further improve program implementation.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov, NCT05424744, Registered 9 June 2022, https://clinicaltrails.gov/study/NCT05424744 .</p><p><strong>Trial funding: </strong>Department of Cardiovascular Medicine, Wake Forest University School of Medicine.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"95"},"PeriodicalIF":1.5,"publicationDate":"2025-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12232565/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144584482","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":"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":"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":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12228205/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144567698","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":"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}