Pilot and Feasibility Studies最新文献

{"title":"Education and Music Intervention to Reduce Anxiety: feasibility, potential efficacy, and patient satisfaction in a pilot study.","authors":"Letícia de Carvalho Batista, Marina de Góes Salvetti, Milena Santos de Oliveira, Juliana Paulucci Reis, Youri Eliphas de Almeida, Rafael de Jesus Fonseca, Rita de Cassia Gengo E Silva Butcher","doi":"10.1186/s40814-025-01698-2","DOIUrl":"https://doi.org/10.1186/s40814-025-01698-2","url":null,"abstract":"<p><strong>Background: </strong>People undergoing cardiac catheterization experience anxiety. Musical and educational interventions have been tested separately and have been shown to reduce anxiety in this patient profile. This pilot study aimed to assess the feasibility and potential effectiveness of a complex intervention called Education and Music Intervention to Reduce Anxiety (EMIRA), in addition to participant credibility, expectations and satisfaction.</p><p><strong>Methods: </strong>This is a randomized, blind, pilot clinical trial, carried out in an emergency department specializing in cardiology. Feasibility was assessed according to recruitment, retention, attrition and recruitment time rates. The potential for efficacy was assessed through the effect of EMIRA on state anxiety, blood pressure, heart rate, respiratory rate and chest pain intensity, comparing the intervention group (IG) and control group (CG) before (T1), immediately after (T2) and two to four hours after (T3) the intervention. To estimate participant satisfaction with the intervention, a visual numerical scale was used. Participant credibility and expectations regarding EMIRA were determined using a previously validated instrument. No hypothesis testing was conducted.</p><p><strong>Results: </strong>A total of 47 potential participants were approached over a period of 54 days. Recruitment, retention, and attrition rates were, respectively, 93.6%, 90.9%, and 10%. No participants dropped out after enrollment. Descriptive analysis showed reductions in anxiety scores and physiological parameters over time in both groups, but no consistent trends favoring the intervention were observed. Participants reported high satisfaction, credibility, and expectations. One descriptive finding suggested a potential association between satisfaction and systolic blood pressure reduction, warranting further investigation.</p><p><strong>Conclusions: </strong>EMIRA is a complex intervention with an educational and musical component. The results suggest that a larger-scale clinical trial is feasible, participants were satisfied and had positive attitudes towards the intervention. Although no conclusions about its effectiveness can be drawn from this pilot study, the findings provide valuable information to guide the design of a larger randomized trial.</p><p><strong>Trial registration: </strong>RBR-857nczs.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"125"},"PeriodicalIF":1.6,"publicationDate":"2025-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145346386","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":"Virtual reality for relaxation in intensive care unit patients: feasibility, acceptability and intervention adaptation.","authors":"Ann Louise Hanifa, Pia Dreyer, Søren Aagaard, Anna Holm","doi":"10.1186/s40814-025-01707-4","DOIUrl":"10.1186/s40814-025-01707-4","url":null,"abstract":"<p><strong>Background: </strong>Less sedation has become the standard regimen in patients admitted to an intensive care unit. Consequently, conscious patients experience discomfort and anxiety during their admission. Virtual reality is used in other hospital settings to distract patients and reduce discomfort and anxiety; however, its acceptability in intensive care has yet to be explored. This study aimed to identify and adapt a virtual reality intervention for relaxation and distraction to meet the specific needs of patients admitted to an intensive care unit, focusing on patients' and nurses' acceptability of the intervention.</p><p><strong>Methods: </strong>This exploratory study was guided by the Medical Research Council's framework for developing or identifying, evaluating and implementing complex interventions. In the initial phase, combined knowledge from existing literature and experts in virtual reality for healthcare guided the preliminary identification process. Findings from think-aloud interviews with stakeholders guided the final adaptations. The data was analysed using the framework method.</p><p><strong>Results: </strong>The combined findings from the literature, stakeholder audit trails and interviews showed consensus that nature films with auditory stimuli were acceptable for inducing relaxation and distraction in critically ill patients, with few or no adverse effects. A key uncertainty regarding virtual reality's effect on delirium or its potential role in delirium development affected nurses' acceptability of virtual reality, highlighting a need to consider this risk.</p><p><strong>Conclusions: </strong>This intervention identification, adaptation, acceptability and feasibility study concludes that virtual reality for relaxation and distraction is an acceptable intervention in the intensive care unit setting. The identified and adapted virtual reality software intervention was a 10-min 360-degree natural beach film combined with nature sounds and calming music. The identified hardware intervention was a headset connected to a tablet, enabling nurses to control the software. A subsequent study should examine the preliminary short effectiveness and adapt the intervention according to the further findings.</p><p><strong>Trial registration: </strong>Retrospectively registered in Open Science Framework 14 Feb 2024. Registration DOI https://doi.org/10.17605/OSF.IO/BYZ42 .</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"124"},"PeriodicalIF":1.6,"publicationDate":"2025-10-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12538756/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145346377","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":"IDC-IMPROVE: protocol for a cluster randomised feasibility trial of a care bundle to improve indwelling catheter care (IDC) in residential aged care homes in Australia.","authors":"Joan Ostaszkiewicz, Andrew Simon Gilbert, Caitlin Tay, Elizabeth Watt, David Barry, Wendy Taylor, Jessica Cecil, Rowan Cockerell, Helen Crowe, Liza Lau, Michael Murray, Sigrid Nakrem, Catherine Paterson, Micah Peters, Ashlyn Sahay, Alyson Sweeney, Janie Thompson, Julie Westaway, Wendy Bower, Juliana Christina, Alan Zana, Frances Batchelor","doi":"10.1186/s40814-025-01700-x","DOIUrl":"10.1186/s40814-025-01700-x","url":null,"abstract":"<p><strong>Background: </strong>Indwelling urinary catheters (IDCs) are used by approximately 8% of Australian aged care residents. IDC use is often warranted but entails numerous risks, particularly if used longterm. Risks include catheter-associated urinary tract infections, catheter blockage, catheter leakage, bladder spasm, pain, urethral trauma and haematuria, and increased risk of hospitalisation. The Royal Commission into Aged Care Quality and Safety identified poor quality, unsafe practices related to IDCs in aged care homes. Enhancing the knowledge, confidence, and skills of aged care staff to deliver catheter care for residents with IDCs is fundamentally important. The IDC-IMPROVE project is supporting aged care providers to meet the care needs of people with IDCs in Australian aged care homes, by designing and validating a suite of resources titled the IDC-IMPROVE Catheter Care Bundle.</p><p><strong>Aims: </strong>This study aims to establish the feasibility of conducting a definitive randomised control trial to evaluate the effects of the IDC-IMPROVE Catheter Care Bundle in aged care homes in Australia.</p><p><strong>Method: </strong>A multi-centre, facility-level clustered randomised control (cRCT) feasibility trial in 24 aged care homes across Victoria, Queensland, and South Australia. Twelve homes will receive the intervention and 12 will continue usual care. The IDC-IMPROVE Catheter Care Bundle intervention comprises principles for person-centred catheter care, online training for nurses and personal care workers, a practical skills workshop for nurses, a toolkit for managers, and an evidence-to-practice support model. The feasibility of the intervention will be assessed through a mix of qualitative and quantitative methods, including surveys, interviews, and audits. Feasibility outcomes are: (i) The acceptability of the Bundle, (ii) The fidelity of the implementation, (iii) The compatibility of the Bundle with standard aged care home IDC care.</p><p><strong>Discussion: </strong>By enhancing the knowledge, confidence and skills of the aged care workforce, IDCIMPROVE aims to reduce IDC-related complications. This study will provide insights into the acceptability and implementation of the intervention, informing future large-scale trials and potential policy changes.</p><p><strong>Ethics: </strong>The study has been approved by Austin Health Human Research Ethics Committee (reg: HREC/107165/Austin-2024) and is registered on the Australian New Zealand Clinical Trials Registry (reg: ACTRN12624001178538p).</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"123"},"PeriodicalIF":1.6,"publicationDate":"2025-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12532438/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145313254","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":"Protocol for a feasibility randomized control trial of the Supporting Toddlers with a connection to autism or ADHD to develop Strong Attention, Regulation, and Thinking skills (START) programme.","authors":"Alexandra Hendry, Maryna Nosyk, Victoria Hulks, Jemma Hudson, Lynda Constable, Tony Charman, Sandra Mathers, Sinead Rhodes, Gaia Scerif","doi":"10.1186/s40814-025-01697-3","DOIUrl":"10.1186/s40814-025-01697-3","url":null,"abstract":"<p><strong>Background: </strong>Autism and ADHD are heritable, co-occurrent, and associated with difficulties with executive functioning (cognitive and self-regulation skills which enable us to set and work toward goals). Executive function difficulties, and their negative impacts across cognitive, health and social domains, extend to individuals with first-degree relatives who are autistic or have ADHD, even if they do not meet thresholds for a clinical diagnosis themselves. Supporting executive function development in children with elevated autism traits, or a first-degree relative with autism or ADHD, addresses community priorities for early support to help achieve the best mental health, education and life outcomes.</p><p><strong>Methods: </strong>This study will evaluate the feasibility and acceptability of a randomized controlled trial (RCT) of a parent-toddler programme entitled \"Supporting Toddlers with a connection to autism or ADHD to develop strong Attention, Regulation and Thinking skills\" (START). START is a neurodiversity-affirming programme, co-refined through extensive Patient and Public Involvement. Sixty parent-child dyads, in Oxford or Southampton (UK), will be randomized using Sealed Envelope by a researcher not involved in recruitment, delivery or outcome data collection to receive START or usual practice, on a 1:1 ratio. Children (20 months old) will be assessed using questionnaires completed by the parent (not blind to allocation) post-intervention (within 2 weeks of the end of the active intervention wave, when children are aged 27-31 months), and using parent questionnaires and a battery of executive function measures administered by researchers blind to allocation at baseline and follow-up (36 months old). START will be delivered in small groups to 30 parent-child dyads, in community settings.</p><p><strong>Discussion: </strong>We will assess the feasibility of recruiting eligible participants to the study, the reliability of measures of implementation fidelity and degree of implementation fidelity achieved, the appropriateness of proposed outcome and mechanism measures, the acceptability of an RCT of the programme, parental adherence to the programme, logistics of programme delivery, and the acceptability of START, using mixed-method measures of engagement and satisfaction. Results will inform the design and implementation of a definitive RCT of START, and yield broader insights into the delivery and evaluation of complex early-years interventions in community settings.</p><p><strong>Trial registration: </strong>ISRCTN registry ISRCTN99820028 https://doi.org/10.1186/ISRCTN99820028 .</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"122"},"PeriodicalIF":1.6,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12492924/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145213462","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":"Brief problem-solving therapy (PST) for women experiencing antenatal depressive symptoms: a randomised, controlled feasibility trial in (an) antenatal care setting in rural Ethiopia.","authors":"Tesera Bitew, Roxanne Keynejad, Katherine Sorsdahl, Bronwyn Myers, Simone Honikman, Girmay Medhin, Eshcolewyine Fekadu, Adiyam Mulushoa, Louise M Howard, Fikirte Girma, Charlotte Hanlon","doi":"10.1186/s40814-025-01672-y","DOIUrl":"10.1186/s40814-025-01672-y","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;We adapted non-specialist healthcare worker (HCW) delivered problem-solving therapy (PST) to support improved treatment of antenatal depression in maternal healthcare platforms in rural Ethiopia. In this study, we aimed to evaluate the feasibility, fidelity, and acceptability of PST for antenatal depression and the procedures required for the implementation of a fully-powered randomised controlled trial (RCT).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Participants were consecutive antenatal care (ANC) attendees in two primary healthcare (PHC)-based healthcare facilities, based on pre-established eligibility criteria. We employed a randomised, controlled feasibility trial design with two parallel groups. Participants in the intervention arm received four sessions of a contextually adapted version of PST; the control group received enhanced usual care (EUC) that involved routine antenatal care and information about sources of support. Assessments were conducted at baseline (T&lt;sub&gt;0&lt;/sub&gt;) and at 9 weeks after randomisation (T&lt;sub&gt;1&lt;/sub&gt;). Assessment at T&lt;sub&gt;1&lt;/sub&gt; mainly comprised of preliminary clinical outcomes and hypothesized mediators. At T&lt;sub&gt;2&lt;/sub&gt;, feasibility parameters were assessed in addition to T&lt;sub&gt;1&lt;/sub&gt; assessments. A recruitment rate of 80% of the expected sample size within a month, retention rate of ≥ 50%, provider competence of ≥ 60%, less than 10% adverse events and mean session duration of 30 min were assumed for feasibility success. We summarised participant characteristics, feasibility outcomes, and preliminary clinical outcomes using descriptive statistics.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;After screening and the consent process, we randomised 50 eligible women to PST and EUC arms. Trial procedures such as participant recruitment and allocation concealment were feasible. Most (64%) completed all four sessions of the intervention. About 58% of HCWs attained expected scores on Enhancing Assessment of Common Therapeutic factors (ENACT) scale. No adverse events occurred during the trial. Supervision reports indicated that HCWs appreciated skills gained from PST and adhered to most of the PST content, except challenging women who reported not having problems or worries. However, they recommended pre-recorded videos of role play demonstrations and shorter trainer demonstrations, to increase trainees' opportunities to practise skills.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;Participant recruitment, screening, randomisation, masking, as well as the intervention delivery process, were feasible. Future training should prioritise opportunities for HCWs to practise skills as much as possible. https://pilotfeasibilitystudies.biomedcentral.com/articles/10.1186/s40814-021-00773-8 TRIAL REGISTRATION: The protocol was registered in the Pan-African clinical trials registry, (PACTR): registration number: PACTR202008712234907 on 18/08/2020; URL: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=9578 . The protocol has","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"121"},"PeriodicalIF":1.6,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12486535/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145207145","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":"Culinary medicine for caregivers: protocol for a mixed-methods feasibility study to improve pediatric cancer patient and caregiver outcomes through nutrition and culinary support.","authors":"Brandy-Joe Milliron, Paige Mountain, Khulood Salman, Gabrielle Longo, Haley Schlechter, Jonathan M Deutsch, Tracey Jubelirer","doi":"10.1186/s40814-025-01703-8","DOIUrl":"10.1186/s40814-025-01703-8","url":null,"abstract":"<p><strong>Introduction: </strong>Pediatric cancer and its treatment can negatively affect nutritional status, impacting treatment tolerance, survival, and overall well-being. Poorly managed side effects often lead to lasting poor dietary habits. Caregivers, who bear the psychosocial burden of these effects, are also at risk for diminished health. Interventions that support caregivers' capacity to provide quality care while maintaining their own health are critically needed. Culinary medicine interventions have shown promise in improving cooking confidence, dietary quality, and symptom management. We developed an 8-week culinary medicine intervention, including caregiver coaching, to support pediatric cancer patients and their caregivers.</p><p><strong>Methods: </strong>Let's Cook Together is designed to increase caregivers' knowledge of a whole foods dietary approach, improve caregiving preparedness, and boost self-efficacy in managing treatment side effects. Caregivers with children undergoing cancer treatment will be recruited from the Children's Hospital of Philadelphia. The program includes four remote, biweekly cooking sessions led by a medical chef educator and a registered dietitian nutritionist, along with alternating coaching calls focused on caregiving goals and challenges. Participants will also receive written nutrition and cooking resources. This is a single-arm, explanatory sequential mixed-methods feasibility study. Quantitative assessments will be conducted at baseline, post-intervention, and 3-month post-intervention; qualitative interviews will follow the intervention. The primary objective is to assess feasibility and acceptability. Secondary objectives include collecting exploratory outcome data on caregiving preparedness, caregiver self-efficacy, pediatric feeding behaviors, and dietary intake to inform the design and sample size calculations for a future trial and to identify potential signals of intervention effect.</p><p><strong>Discussion: </strong>Results will inform refinement of the intervention and study design and guide the development of a future trial. Findings may be relevant to oncology and allied health professionals involved in supportive care for families navigating pediatric cancer treatment.</p><p><strong>Trial registration: </strong> ClinicalTrials.gov, NCT06523322, Registered 22 July 2024, https://clinicaltrials.gov/study/NCT06523322 .</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"120"},"PeriodicalIF":1.6,"publicationDate":"2025-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12487249/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145200762","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 Health Navigator intervention to address the unmet social needs of caregivers of hospitalised children in South Australia: protocol for a mixed-methods pilot study.","authors":"Kate Emily Neadley, Maeve Downes, Lily Chan, Brianna Poirier, John Lynch, Mark Boyd, Cheryl Shoubridge","doi":"10.1186/s40814-025-01702-9","DOIUrl":"10.1186/s40814-025-01702-9","url":null,"abstract":"<p><strong>Background: </strong>Interventions that identify patients' unmet social needs and provide referrals to government and community resources are growing rapidly across healthcare settings. In Australia, research is limited. This protocol paper presents the methodology for a pilot study assessing the feasibility and acceptability of integrating a Health Navigator (HN) intervention into an inpatient paediatric setting that serves a socially disadvantaged population in South Australia.</p><p><strong>Methods: </strong>We will conduct a mixed-methods feasibility and acceptability study of a HN intervention designed to respond to the unmet social needs identified by caregivers of children admitted to the Children's Ward of the Lyell McEwin Hospital. We will recruit a maximum of 60 participants over a three-month recruitment period, to be assisted by two HNs over a four-month follow-up period. Our primary feasibility outcomes are rates of 1) intervention recruitment, 2) intervention retention and 3) intervention completion. We have selected a ≥ 80% threshold for feasibility success across all outcomes. Feasibility and acceptability will also be assessed using focus groups with clinicians, participants and community service providers, to explore barriers and enablers to integrating the HN intervention in the ward setting. Secondary outcomes include screening rates for unmet social needs, changes in participants' unmet social needs pre/post-HN intervention and participant satisfaction with the HN service.</p><p><strong>Discussion: </strong>This study will contribute to the understanding of how HN interventions establish holistic 'community-facing' hospitals, connecting vulnerable populations to appropriate resources for the enhancement of participants' overall health and wellbeing. Our feasibility and acceptability data will inform the design of future trials, as we refine the HN intervention to better suit the needs of socially disadvantaged populations in South Australia.</p><p><strong>Protocol version: </strong>Version 1, date 23/01/2024.</p><p><strong>Trial registration: </strong>This trial was prospectively registered in the Australian New Zealand Clinical Trial Registry (registration ID: ACTRN12624000494538).</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"119"},"PeriodicalIF":1.6,"publicationDate":"2025-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12466061/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145177619","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":"Control, Fludrocortisone or Midodrine for the treatment of Orthostatic Hypotension (CONFORM-OH): results from an internal pilot randomised controlled trial.","authors":"Helen Mossop, Sarah Al-Ashmori, Tumi Sotire, Emma Clark, Gillian Watson, Miles D Witham, Luke Vale, Naomi McGregor, Julia Phillipson, James M S Wason, Alison J Yarnall, Steve Parry, Helen Hancock, Rose Anne Kenny, James Frith","doi":"10.1186/s40814-025-01704-7","DOIUrl":"10.1186/s40814-025-01704-7","url":null,"abstract":"<p><strong>Background: </strong>Orthostatic hypotension (OH) is a common debilitating condition characterised by a significant drop in blood pressure (BP) on standing upright. Adults with OH are typically offered non-pharmacologic therapies, either alone or in combination with medication. The two most used agents are fludrocortisone and midodrine. There is a lack of good quality evidence for any of these treatments, all of which are in widespread clinical use. The aim of this internal pilot trial was to evaluate recruitment, attrition, treatment crossover and quality of outcomes.</p><p><strong>Methods: </strong>The trial was designed as a pragmatic, open-label, randomised, prospective, multicentre, superior and multi-arm internal pilot. Recruitment was for 10 months, during which we aimed to open 14 sites and recruit a target of 64 adults with OH to evaluate feasibility of recruitment. Attrition, crossover and data collection were also assessed. Participants were randomised to one of three treatments: nondrug therapies (control), fludrocortisone plus nondrug therapies or midodrine plus nondrug therapies. Outcomes measured included symptoms, quality of life, activities of daily living, postural BP, use of health and care services, falls and safety. Participants received treatment and were followed up for 12 months. Pre-planned criteria to progress from internal pilot were defined for recruitment, retention, crossover and outcome completion.</p><p><strong>Results: </strong>Between the 3rd December 2021 and 31st August 2022, 13 participants were randomised from 4 of 9 recruiting centres. Redeployment of clinical and research staff, due to COVID-19, limited the number of available sites. Participants already receiving fludrocortisone or midodrine accounted for 120 of 233 eligible participants being excluded. Due to the low sample size, the rates of attrition and crossover are of limited value. Apart from the falls diaries, completion rates of the outcome measures were high (> 80%). Due to low recruitment rates, the pilot did not progress to the planned multi-arm multistage trial.</p><p><strong>Conclusions: </strong>In its current design, this trial was not feasible. The main barriers to success were participants already receiving treatment and redeployment of clinical and academic staff during and after the COVID-19 pandemic.</p><p><strong>Trial registration: </strong>ISRCTN 87213295, 23 July 2021, https://www.isrctn.com/ISRCTN87213295.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"118"},"PeriodicalIF":1.6,"publicationDate":"2025-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12465824/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145177650","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 cluster randomised feasibility trial assessing an interactive film intervention to improve wellbeing of young people in school settings in the North of England.","authors":"F Christie-de Jong, E Walker, H Corlett, C Hardarce, E Soulsby, B Arnott, K Franks, J Ling, J Stephenson, L B Azevedo","doi":"10.1186/s40814-025-01699-1","DOIUrl":"10.1186/s40814-025-01699-1","url":null,"abstract":"<p><strong>Background: </strong>Adolescence is a critical period for the onset of mental illness. A partnership of a health and care network and filmmakers developed an interactive film for youth wellbeing. While such films have potential as a cost-effective preventative tool, their effectiveness remains unproven. This study aimed to assess the feasibility and acceptability of a randomised controlled trial of the interactive film intervention to improve wellbeing in school-aged youth.</p><p><strong>Methods: </strong>In a mixed-methods cluster randomised feasibility trial in North East England (2021-2022), students in years 10 (14-15 years) and 12 (16-17 years) from three schools were recruited and randomised to the following conditions: (1) watching the film in class, (2) watching the film in class with support from youth workers or (3) regular class activities. Feasibility outcomes included willingness of schools to participate, participant recruitment, and retention, which were assessed quantitatively and qualitatively. Data were analysed descriptively and with the use of thematic analysis.</p><p><strong>Results: </strong>School recruitment targets were met, although this was challenging due to resource constraints and the COVID-19 pandemic. Questionnaires were completed before watching the film by 172 students (48% of the recruitment target). Follow-up targets for retention were met at 3 months (n = 138) and 6 months (n = 136). Retention of year 10 students was high (96%), but year 12 students had lower retention (60%). Qualitative findings showed students and teachers supported the intervention and trial and measurements; however, consent-taking required more time. Communication and resource issues within schools were challenging and need addressing before moving to a larger trial.</p><p><strong>Conclusion: </strong>Although some trial aspects were feasible and acceptable, particularly the intervention, others, such as recruitment, retention and school communication, posed challenges. We recommend future feasibility studies should address barriers such as randomisation, communication with schools, recruitment of older students (16-18 years), consent and measurement alignment before moving to a larger-scale trial.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov Identifier: NCT06807931. Retrospectively registered 04 February 2025 https://clinicaltrials.gov/study/NCT06807931 .</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"117"},"PeriodicalIF":1.6,"publicationDate":"2025-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12406547/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144965061","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":"Robot-assisted gait training for improved gait independence in individuals with acute hemiparetic stroke: study protocol for a randomized controlled pilot trial.","authors":"Daisuke Kato, Satoshi Hirano, Daisuke Imoto, Takuma Ii, Daisuke Matsuura, Takuma Ishihara, Yohei Otaka","doi":"10.1186/s40814-025-01694-6","DOIUrl":"10.1186/s40814-025-01694-6","url":null,"abstract":"<p><strong>Background: </strong>Robot-assisted gait training (RAGT) has proven effective in addressing gait disorders in patients with stroke. However, its efficacy in patients with acute stroke has not yet been demonstrated. This pilot study is designed to evaluate the following: (1) feasibility of conducting a randomized controlled trial on RAGT for enhancing gait postacute stroke and (2) to obtain preliminary estimates regarding the potential efficacy of RAGT for achieving gait independence during the acute phase.</p><p><strong>Methods: </strong>We will conduct an assessor-blinded, single-center, randomized controlled pilot trial involving 32 patients with acute stroke who are unable to walk. Participants will be randomly assigned to either the RAGT or the conventional gait training (CGT) groups. Each participant will receive 180 min of daily rehabilitation, including 60 min dedicated to gait training. The RAGT group will receive 40 min of RAGT and 20 min of CGT, while the CGT group will engage in 60 min of CGT. Interventions will continue for up to 8 weeks, or until participants achieve gait independence, as indicated by a Functional Ambulation Category score of ≥ 3. Feasibility outcomes will include recruitment, enrollment, protocol adherence, and retention rates. The primary clinical outcome will be the incidence of achieving gait independence during the intervention period. Secondary clinical outcomes will include gait performance measures, assessments of physical function and activity, and intervention dose. Adverse events associated with RAGT and CGT will also be documented to evaluate the safety of both interventions.</p><p><strong>Discussion: </strong>Implementing RAGT during the acute phase of stroke may facilitate earlier attainment of gait independence compared to CGT. We aim to provide valuable insights into the feasibility of the proposed study design and generate preliminary data on the potential effects of RAGT on gait independence in the acute phase of stroke, providing a framework for future larger-scale trials.</p><p><strong>Trial registration: </strong>This clinical trial was registered with the Japan Clinical Trials Registry (jRCT) on 19 June 2023 (registration number: jRCTs042230040). The study protocol was initially registered as version 1.0 and has since undergone minor amendments-currently on version 4.0. This protocol was written based on the latest version (ver. 4.0) registered with jRCT.</p>","PeriodicalId":20176,"journal":{"name":"Pilot and Feasibility Studies","volume":"11 1","pages":"116"},"PeriodicalIF":1.6,"publicationDate":"2025-08-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12395691/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144965118","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}