Pilot and Feasibility Studies最新文献

{"title":"Recruitment for a digitally based follow-up program for people with chronic obstructive pulmonary disease: a pilot cluster randomized controlled trial.","authors":"Haakon Kristian Kvidaland, Marjolein Memelink Iversen, Bente Frisk, David A Richards, Kirsten Lomborg, Christine Råheim Borge, Beate-Christin Hope Kolltveit","doi":"10.1186/s40814-026-01832-8","DOIUrl":"10.1186/s40814-026-01832-8","url":null,"abstract":"<p><strong>Background: </strong>Recruiting participants for clinical trials in primary care settings remains challenging, not least for interventions targeting individuals with chronic obstructive pulmonary disease (COPD). Clinical outcomes and the effects of interventions receive considerable attention compared to factors influencing recruitment success. Identifying and addressing possible barriers and facilitators is essential for optimizing recruitment strategies and ensuring the feasibility of trials.</p><p><strong>Aim: </strong>This study aimed to assess uncertainties regarding recruitment for a digitally based Guided Self-Determination (GSD) follow-up program for people with COPD, prior to a fully powered cluster randomized controlled trial (cRCT), and to explore characteristics of primary care practices and patients willing to be included in the study.</p><p><strong>Methods: </strong>The intervention was a 9-month digitally based follow-up program performed with the GSD counseling method, conducted by nurses in primary care practices. Eligible primary care practices were invited to participate, and participants were recruited through their respective practices. The primary feasibility outcome was recruitment, assessed at both the practice (cluster) and patient (participants) level. Eligible participants were people between 35 and 80 years diagnosed with COPD. Baseline characteristics included demographic data, COPD Assessment Test, Dyspnea-12, WHO-5 Well-being Index, and Health Education Impact Questionnaire domains. Progression criteria Go, Amend, and Stop were applied to assess feasibility.</p><p><strong>Results: </strong>Recruitment occurred from May to December 2024. Of 16 eligible practices, 12 (75%) responded, of which ten (83%) agreed to participate, corresponding to 63% of the eligible practices. A total of 64 participants with COPD were recruited, 28 in the intervention and 36 in the control clusters. The overall median recruitment rate was 6.5 participants per cluster, 7 in the intervention clusters and 6 in the control clusters. One of three progression criteria, cluster recruitment, met the target Go, while cluster sizes and participant recruitment met the amended criteria.</p><p><strong>Conclusion: </strong>Recruitment was deemed feasible. However, successful cluster-level recruitment does not necessarily ensure effective patient enrollment, highlighting the necessity for amendments before a fully powered cRCT. Future research should integrate qualitative data obtained from patients and primary care practitioners to enhance the understanding of recruitment strategies.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov (NCT06401512). Registered 23 April 2024, https://clinicaltrials.gov/study/NCT06401512 .</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-05-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13326346/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147864012","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":"Implementation of a Mental Health Literacy e-Curriculum (MHLeC) in Malawi Universities: a feasibility cluster randomised trial protocol.","authors":"Gloria Chirwa, Beatrice Chitalah, Joel Nyali, Christopher Newby, Michael Udedi, Richard Hooper, Sandra Jumbe","doi":"10.1186/s40814-026-01831-9","DOIUrl":"10.1186/s40814-026-01831-9","url":null,"abstract":"<p><strong>Background: </strong>Mental health literacy (MHL) in Malawi is low. Mental illness is often attributed to substance abuse or spirit possession, resulting in stigma, maltreatment, and discrimination towards people with mental health problems. Inadequacies in Malawi's mental health services and workforce increase limited treatment access, knowledge, and negative attitudes, causing an epidemic of substance use and suicides. MHL is foundational for mental health promotion, prevention of mental illness, and stigma reduction. Educational settings are ideal for implementing mental health promotion activities. We want to deliver a MHL e-curriculum (MHLeC) to first-year university students in Malawi to improve their MHL. The project aims to assess the feasibility of implementing MHLeC in four Malawian universities within a cluster randomised trial.</p><p><strong>Methods: </strong>In this pragmatic, cluster randomised feasibility trial, we will approach four to eight public and private tertiary institutions about study participation. Clusters will be participating universities allocated to the mandatory MHLeC or the voluntary MHLeC group using stratified randomisation on a 1:1 ratio. University type (e.g. public or private) will be used as the stratification factor for randomisation, with two levels ensuring two universities per stratum. This approach is appropriate for the four-cluster design. Specific feasibility objectives include (1) estimating likely participation rates of universities and students, (2) establishing potential attendance/retention rates during MHLeC delivery, (3) assessing acceptability of the MHLeC through qualitative feedback after intervention delivery, (4) assessing appropriateness of chosen questionnaires for measuring student outcomes. Data will be analysed descriptively. Outcomes from data collected will inform the feasibility of a future main trial including main trial design and recruitment strategies, sample size and power calculations for a full-scale cluster randomised trial.</p><p><strong>Discussion: </strong>This trial will give us insights on how best to conduct the definitive trial. The intervention can be rolled out nationally within a full-scale trial in Malawi and tested in similar cohorts across Africa if positive results are obtained. More broadly, this research has the potential to significantly increase mental health awareness among young people in Malawi.</p><p><strong>Trial registration: </strong>This study is registered on the Pan African Clinical Trials Registry (PACTR) website https://pactr.samrc.ac.za/ (PACTR202308849574524). Registered 31st August 2023.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-05-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13326328/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147863973","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 an ICU follow-up clinic - qualitative process evaluation alongside a feasibility study.","authors":"Karl Philipp Drewitz, Christine Bernardi, Katharina Pielmeier, Susanne Brandstetter, Magdalena Rohr, Vreni Brunnthaler, Christoph Fisser, Maximilian V Malfertheiner, Christian Apfelbacher","doi":"10.1186/s40814-026-01827-5","DOIUrl":"10.1186/s40814-026-01827-5","url":null,"abstract":"<p><strong>Background: </strong>Previous studies have not demonstrated sufficient effects of intensive care unit (ICU) follow-up clinics on health-related quality of life. This may also be influenced by the design and implementation of these studies. Feasibility and context of such studies have yet to be sufficiently researched. It is therefore crucial to investigate these contextual factors. This study aimed to explore the experiences of patients, relatives, and healthcare professionals with both the randomised controlled trial (RCT) and the ICU follow-up clinic, to assess the feasibility and acceptability of the intervention and the study design from the perspectives of those involved.</p><p><strong>Methods: </strong>This qualitative research was embedded in the process evaluation of a pilot RCT on an ICU follow-up clinic. We conducted 18 semi-structured interviews with former ICU patients, relatives and the clinical study team who participated in the PINA study and used field notes from the clinical study team. Data analysis was carried out using qualitative content analysis.</p><p><strong>Results: </strong>The pilot RCT was well received by potential patients and their relatives, and the motivation to participate was high, as was the motivation of the clinical study team. The main benefits of the ICU follow-up clinic intervention named by participants were being taken seriously and receiving referrals that they would not typically get from a general practitioner. The offer of home visits for patients with long travel distances to the ICU follow-up clinic was highly appreciated.</p><p><strong>Conclusions: </strong>It was feasible to integrate the perspectives of patients, relatives, and healthcare professionals within a pilot RCT on an ICU follow-up clinic. Across all stakeholder groups, the ICU follow-up clinic and the RCT trial design were considered acceptable and valuable, suggesting that such follow-up care meets patient needs and that a large-scale study appears feasible.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov US NLM, NCT04186468, Submission: 02/12/2019, Registration: 04/12/2019, https://clinicaltrials.gov/ct2/show/NCT04186468 .</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-05-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13156872/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147856987","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":"Pilot study protocol to increase resistance to peer pressure in tobacco use among nursing students (T-RESIST).","authors":"Chareni Itzel Vázquez Jiménez, Angelica Susana López Arellano, María Del Carmen Santes Bastián, David Zepeta-Hernandez","doi":"10.1186/s40814-026-01838-2","DOIUrl":"10.1186/s40814-026-01838-2","url":null,"abstract":"<p><strong>Background: </strong>In Mexico, tobacco use represents one of the leading threats to public health, being associated with thousands of preventable deaths and diseases. Social factors, such as peer pressure, play a significant role in the initiation of tobacco use among young people, who seek acceptance and identity. Although intervention studies exist, few address peer pressure comprehensively and from a theoretical framework. Therefore, a psychoeducational intervention is proposed for university students, with the aim of assessing its acceptability and feasibility, as well as exploring changes in self-esteem, emotional dependence, and social skills. Its contribution lies in providing preliminary evidence for future large-scale clinical trials.</p><p><strong>Methods: </strong>The study was designed as a prospective, single-arm pilot. Nursing students from a faculty in Veracruz will participate, with a recruitment target of 30 students aged 18 years or older. The group intervention consists of four 50-min sessions, in addition to pre- and post-test evaluations, addressing peer pressure, self-esteem, social skills, and emotional dependence.</p><p><strong>Discussion: </strong>Tobacco use among young people is a multifactorial problem in which peer pressure constitutes a central factor. The proposed psychoeducational intervention seeks to strengthen resistance, promote self-esteem, enhance social skills, and address emotional dependence. Its implementation entails practical challenges, including student participation, retention, logistical organization, and resource availability. This study will allow for the evaluation of the intervention's acceptability and feasibility, generating preliminary evidence for future trials. The findings will contribute to the design of evidence-based preventive strategies relevant to the university setting and adolescent public health.</p><p><strong>Trial registration: </strong>UMIN000059102.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13321638/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147856933","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 passive digital marker for childhood asthma risk prognosis: a pilot cross-sectional study.","authors":"Arthur H Owora, Bowen Jiang, Yash Shah, Kirsten Kloepfer, Nadia Krupp, Robert Tepper","doi":"10.1186/s40814-026-01837-3","DOIUrl":"10.1186/s40814-026-01837-3","url":null,"abstract":"<p><strong>Background: </strong>Electronic health records (EHR)-based childhood asthma prediction may be a valid, cost-effective, and scalable option for early detection of at-risk children for targeted preventive intervention, but this approach has not been adopted in clinical practice. The purpose of this pilot study was to evaluate the feasibility and acceptability of the Pediatric Asthma Risk Score (PARS) as an EHR-based passive digital marker (PDM) for childhood asthma prognosis in clinical practice.</p><p><strong>Methods: </strong>Feasibility was defined by the level of concordance between the PARS and a clinician's classification of a case study's risk of developing school-age asthma. Acceptability was based on clinicians' intentions to use the PARS and its usability as a PDM for childhood asthma prognosis. Blinded to the PARS risk classification, clinicians were asked to predict the case study's risk of school-age asthma based on their professional judgment as either low or high risk and rate their confidence in their prediction. Unblinded to the PARS risk classification, clinicians rated the acceptability of the PARS as a PDM. Logistic regression models were used to summarize and identify correlates of feasibility and acceptability measures.</p><p><strong>Results: </strong>There was 74% (95% CI: 66-81%) concordance between the PARS and clinician prediction of our case study's risk of developing school-age asthma. Risk discordance (26%) was associated with low confidence in a clinician's professional judgment (adjusted odds ratio [aOR]: 4.78; 95% CI: 1.85, 12.34) and PARS (aOR: 4.48; 95% CI: 1.16, 17.33). Unblinded to the PARS risk classification, more than 80% of clinicians ranked their intentions to use the PARS and its usability as a PDM as 4+ on a 0-6 Likert scale.</p><p><strong>Conclusion: </strong>Our findings demonstrate preliminary feasibility and acceptability of the Pediatric Asthma Risk Score (PARS) as a passive digital marker for childhood asthma risk, supporting further evaluation in prospective real-world studies.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13321505/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147857009","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 preliminary effectiveness of the Individual Placement and Support (IPS) model for people with serious mental illness in Jalisco, Mexico: a pilot study protocol.","authors":"Jesús Alejandro Aldana-López, Ricardo Saracco-Alvarez, Sol Durand-Arias, Jaime Carmona-Huerta, Elsy Cárdenas-García, Juan Carlos Arámbula-Román, Justin Metcalfe, Sarah Swanson, Jennie Keleher, Eveling Charrlot Villafuerte-Jacob, Denisse Flores-Bizarro, Jorge Antonio Blanco-Sierra, Robert E Drake, Ezra Susser, Franco Mascayano","doi":"10.1186/s40814-026-01809-7","DOIUrl":"10.1186/s40814-026-01809-7","url":null,"abstract":"<p><strong>Background: </strong>Severe mental illness (SMI) is associated with substantial barriers to competitive employment, including stigma, cognitive impairments, and limited social support. The Individual Placement and Support (IPS) model is an evidence-based intervention that provides individualized assistance for job search, placement, and retention. Although IPS has shown effectiveness in high-income countries, there is limited evidence regarding its feasibility and preliminary outcomes in low- and middle-income settings, particularly in Latin America.</p><p><strong>Methods: </strong>This pilot randomized controlled trial will assess the feasibility of implementing the IPS model for adults with SMI in Jalisco, Mexico. We will recruit 120 participants who are actively seeking employment and randomly assign them to either the IPS intervention or a control group receiving standard employment services. The intervention includes tailored support from trained IPS Employment Specialists in resume building, interview preparation, job search, and follow-up after job placement. Primary feasibility outcomes include recruitment and retention rates, participant acceptance, implementation fidelity, and identification of contextual barriers and facilitators. Secondary outcomes will explore employment status at 12 months, financial well-being, and health-related outcomes.</p><p><strong>Discussion: </strong>Findings from this pilot study will contribute to addressing the current gap in implementation research on IPS in Latin America. Findings will offer preliminary insights into the feasibility, acceptability, and contextual adaptability of the model in a public mental health setting. These results are expected to guide the refinement of study procedures and support planning for a future definitive trial. Additionally, exploratory data on employment and quality of life outcomes may help identify relevant domains for further investigation.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06019247. Registered on August 31, 2023.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13217790/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147819285","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":"An open-label, clinical feasibility study of the efficacy of Remdesivir for Long-COVID.","authors":"Helen Neilens, Victoria Allgar, Kayle-Anne Sands, Jade Chynoweth, Amber Lord, Paigan J Aspinall, Helen Hambly, Anton Barnett, Lindsay Skipper, Tom Bewick, Ian Maidment, Hairil Abdul Razak, Ruth Ashton, David Strain, Karen Knapp, Mark A Faghy","doi":"10.1186/s40814-026-01823-9","DOIUrl":"10.1186/s40814-026-01823-9","url":null,"abstract":"<p><strong>Background: </strong>Long COVID (LC) affects around two million people in the UK and over 65 million people globally. Antiviral medications have shown positive effects in reducing the risk of progression to severe disease in high-risk patients during an acute SARS-CoV-2 infection and have improved outcomes in those living with LC. Research testing the feasibility and efficacy of antiviral medications is ongoing, and clinical trials should determine the use of Remdesivir and its impact on LC symptoms, patient-reported outcomes, quality of life and functional status.</p><p><strong>Methods: </strong>Seventy-two patients ≥ 18 years of age who have a confirmed LC diagnosis will be recruited across two sites to trial Remdesivir_TM treatment delivered via intravenous infusion over 5 days. This feasibility study will provide high-quality data to estimate screening rates, recruitment through different pathways, retention and treatment adherence. The study will also determine the definitive trial's most clinically relevant primary outcome. After a detailed screening process, patient-reported and clinical outcome measures (including EQ-5D-5L, Symptom Burden Questionnaire™ for LC (SBQ™), cardiopulmonary exercise tests (CPET), lung function, biomarkers and inflammatory profiles) will be collected to determine symptoms and impact of their condition, which will be repeated post-treatment. A subset of 20 participants will undergo whole-body parametric Fluorodeoxyglucose (FDG) PET/CT to measure multi-organ metabolic activity. Due to the established physical, cognitive and clinical impairment impacts of LC, patient involvement has been extensively embedded within the design and implementation of all study processes to increase patient safety and delivery.</p><p><strong>Discussion: </strong>This study will provide data on the feasibility of a trial of 5-day intravenous treatment with Remdesivir for patients with LC. The treatment is already effective in the treatment of patients with acute severe cases of SARS-CoV-2. Remdesivir has an established safety profile and carries no higher risk to patients than standard medical care. The findings will inform the design of a future definitive study.</p><p><strong>Trial registration: </strong>ISRCTN Number: 72940450. Date registered: 07/06/2024. URL: https://www.isrctn.com/ISRCTN72940450 .</p><p><strong>Clinicaltrials: </strong>gov Number: NCT05911906.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13281550/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147819172","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 protocol paper for a pilot randomized controlled trial assessing the feasibility and acceptability of group medical visits for anxiety and depression in adults.","authors":"Christian Kordan, Jennifer Hensel, Jitender Sareen, Jane Moody, Tia H Alsaidi, Olawale F Ayilara, Kirsten Penner-Goeke","doi":"10.1186/s40814-026-01802-0","DOIUrl":"10.1186/s40814-026-01802-0","url":null,"abstract":"<p><strong>Background: </strong>Group medical visits (GMVs) offer a promising approach to address mental health challenges, particularly in settings with limited access to psychiatric care. Although GMVs have been studied in chronic disease management, their application in mental health, especially through randomized controlled trials (RCTs), remains sparse. This paper describes a study protocol for a pilot study evaluating GMVs as a potential solution to the high demand for mental health services exacerbated by long wait times and resource limitations.</p><p><strong>Objectives: </strong>This protocol paper for a pilot RCT aims to assess whether GMVs will be feasible and acceptable to patients. This pilot RCT will also collect implementation feedback from patients and primary care providers, as well as initial data on clinical outcomes to inform a potential future larger RCT of GMVs for mental health care.</p><p><strong>Methods: </strong>The pilot RCT will enroll 20 participants, randomized to either biweekly GMVs or resumed standard client services. The GMVs will consist of 45-min group sessions and 5-min individual check-ins, facilitated by a psychiatrist for 6 months. Data will be collected on recruitment rates and retention rates, as well as participant satisfaction using the Client Satisfaction Questionnaire-4 (CSQ-4). Clinical outcomes will be measured using the GAD-7, PHQ-9, Mental Health Quality of Life Scale (MHQoL), and Recovery Assessment Scale-24 (RAS-24). Primary care providers will be asked for feedback on their experience with GMVs versus standard client services as well at the end of the intervention.</p><p><strong>Discussion: </strong>This RCT protocol investigates GMVs as a potential solution to alleviate the strain on mental health services, which face long wait times and limited resources. By offering structured group sessions through GMVs, the study aims to enhance access to and quality of mental health care. Designed as an RCT due to limited existing evidence, the study will measure GMV feasibility, patient acceptability, and symptom response. If successful, this pilot study could provide a scalable model to improve accessibility, reduce costs, and enhance patient satisfaction in mental health care, particularly in resource-limited settings. TRIAL REGISTRATION {2A}: ClinicalTrials.gov, NCT06651801 . Registered 22 October 2024.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13276985/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147778444","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 perceived impact of a clinician-led bimanual training program using joystick-operated ride-on toys incorporated into an intensive task-oriented hybrid summer camp for children with unilateral cerebral palsy.","authors":"Kush Kataria, Patrick D Kumavor, Sudha Srinivasan","doi":"10.1186/s40814-026-01824-8","DOIUrl":"10.1186/s40814-026-01824-8","url":null,"abstract":"<p><strong>Background: </strong>Children with Unilateral Cerebral Palsy (UCP) have significant limitations in upper extremity (UE) function impacting their independence and quality of life. Our study objectives were to assess (a) the feasibility and acceptability of incorporating a novel, bimanual ride-on-toy navigation (RNT) training program within a 3-week intensive, hybrid UE training camp (modified constraint induced movement therapy + bimanual training) and (b) the combined benefits of the comprehensive camp training model as perceived by clinicians.</p><p><strong>Methodology: </strong>We employed a single-group, pretest-posttest design. Ten children with UCP (M(SD): 6.99(2.13) years) and 6 clinicians/camp staff were recruited through convenience sampling from an annually held intensive therapy camp for children with UCP. In the 3-week camp, children practiced goal-oriented and task-focused activities for 6 h/day (5 h of UE practice with a constraint on the less-affected arm and 1-h of bimanual practice without the constraint). Following an initial training session, camp staff delivered fourteen RNT sessions (~ 20 min/session) per child over the 3 weeks as part of the bimanual portion of the camp. Feasibility and acceptability of the RNT program were assessed by monitoring adherence, through child and camp staff exit questionnaires, the Physical Activity Enjoyment Scale, and video-based behavioral coding. Clinician-perceived benefits of the overall camp programming, inclusive of RNT, was assessed using an exit questionnaire administered with camp staff and the ABILHAND-Kids Questionnaire. Given the pilot nature of this study and the small sample size, we report descriptive data, effect sizes, and 95% confidence intervals around the effect sizes.</p><p><strong>Results: </strong>All 10 participants completed the study (Adherence: Mean(SD): 90.7% (13.5%)). Staff were able to successfully deliver RNT with minimal issues and wanted to repeat it in subsequent camp iterations. Children found RNT enjoyable and were highly engaged across sessions. In combination with other camp programming, RNT led to clinician-perceived improvements in children's bimanual function and spontaneous affected UE use during daily activities.</p><p><strong>Conclusions: </strong>Our work suggests that RNT is an engaging, versatile, and easy-to-implement therapy adjunct that clinicians may use to incentivize affected UE use and motor practice in children with UCP.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13326004/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147778485","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 hybrid online/in-person implementation of the complete health improvement program on biomarkers, biometrics, and drug utilization in type 2 diabetes mellitus: a pilot randomized-controlled trial.","authors":"Thomas Morland, Ryan McNally, Erin VanEnkevort, Taryn Wilk, James Persing, Avery Schulze, Kristina Blessing, Sheila Packer, H Lester Kirchner","doi":"10.1186/s40814-026-01828-4","DOIUrl":"10.1186/s40814-026-01828-4","url":null,"abstract":"<p><strong>Background: </strong>Randomized-controlled trials of the Complete Health Improvement Program (CHIP) were conducted before new-generation pharmacotherapies, such as GLP-1 and SGLT2 agents, were available. Other attempts to characterize the impact of CHIP since the advent of modern therapies lacked control groups. A new study is needed to evaluate the impact of CHIP on a population with access to modern pharmacotherapies.</p><p><strong>Methods: </strong>Patients with type 2 diabetes mellitus (T2DM) were enrolled. Patients were randomly assigned to CHIP over 12 weeks in a hybrid online/in-person format plus usual care or usual care alone, which consisted of access to standard Geisinger Health Plan diabetes-related services. Feasibility measures included recruitment, retention and participation rates. Clinical efficacy outcomes included change in HbA1c, weight, waist circumference, lifestyle survey results, and diabetes drug utilization by drug class at 3 and 6 months versus baseline.</p><p><strong>Results: </strong>Recruitment fell short of the targeted 60 patients (N = 25 enrolled, 13 and 12 patients randomized to the intervention and control groups, respectively). 69% of intervention participants who attended baseline visits completed at least 50% of classes, which was slightly below the target of ≥ 70%. Lifestyle survey participation was low but suggested improvements in nutrition, exercise, and sleep among intervention participants who did complete surveys. At 6 months, change in HbA1c was - 0.46% [95% CI - 0.93, 0.01] and - 0.58% [95% CI - 0.95, - 0.22] for the intervention and control groups, respectively. Patients in the intervention group collectively weaned off insulin therapy vs. escalated insulin therapy in the control group. There was a reduction in waist circumference in the intervention group compared to an increase in the control group (- 4.65 [95% CI - 9.71, 0.41] vs. 0.56 [95% CI - 1.66, 2.78] inches, respectively).</p><p><strong>Conclusions: </strong>Lifestyle and clinical data from this pilot clinical trial mostly aligned with previous studies. A larger trial is needed to confirm the benefits of CHIP for body composition, to further characterize the clinical effects of CHIP participation, and to understand interactions between lifestyle intervention and modern T2DM pharmacotherapy. Feasibility issues identified in this pilot study would need to be overcome to accomplish such a trial.</p><p><strong>Trial registration: </strong>This study was registered with ClinicalTrials.gov on 05/20/2021.</p><p><strong>Registration number: </strong>NCT04924400 .</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13195929/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147778488","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}