Trials最新文献

{"title":"Protocol update to a study protocol for the Multimodal Approach to Preventing Suicide in Schools (MAPSS) project: a regionally based randomised trial of an integrated response to suicide risk among secondary school students.","authors":"Samuel McKay, Michelle Lamblin, India Bellairs-Walsh, Maria Veresova, Bridget Kenny, Eleanor Bailey, Sadhbh J Byrne, Jane Pirkis, Cathrine Mihalopoulos, Matthew J Spittal, Simon Rice, Ellie Brown, Sarah Hetrick, Matthew Hamilton, Hok Pan Yuen, Yong Yi Lee, Jo Robinson","doi":"10.1186/s13063-025-09118-9","DOIUrl":"10.1186/s13063-025-09118-9","url":null,"abstract":"<p><strong>Background: </strong>This update outlines amendments to the MAPSS trial protocol in response to both the COVID-19 pandemic and broader feasibility considerations. While many changes were necessary to navigate pandemic-related disruptions-such as school closures and remote learning-others were made to improve feasibility in the school-based setting, independent of COVID-19. The protocol was updated to align with public health guidelines and general school practices, ensuring feasibility for continued school participation and increased support and flexibility for school communities.</p><p><strong>Methods: </strong>Key adjustments included changes to participant-facing documentation, including implementing digital consent processes, extending timelines for participant recruitment and participation, and enhancing remote engagement strategies. Modifying outcome measures and risk management protocols, including adverse event reporting, ensured both participant safety and data continuity. Lastly, new study measures were added, such as a custom-designed questionnaire to assess study acceptability. Despite the updates, the core trial design, eligibility criteria, and primary outcomes remained unchanged.</p><p><strong>Conclusion: </strong>These protocol amendments reflect the pragmatic challenges of conducting school-based mental health research during a global pandemic and as part of ongoing efforts to enhance feasibility. The adjustments enabled the trial to proceed safely, prioritizing participant engagement and maintaining alignment with public health measures.</p><p><strong>Trial registrations: </strong>Australian New Zealand Clinical Trial Registry, ACTRN12621000279820, originally registered on 12 March 2021, and currently awaiting update approval. Australian New Zealand Clinical Trial Registry, ACTRN12621000770864, originally registered on 21st June 2021, and updated on 16th February 2025.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"351"},"PeriodicalIF":2.0,"publicationDate":"2025-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12462089/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145138521","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Ultrasound-guided nerve block anesthesia improves perioperative pain in patients undergoing free flap reconstruction for head-and-neck tumor: a randomized, controlled trial.","authors":"Mingzhe Bao, Dan Zhang, Le Liu, Jie Lin, Le Zhao, Chunjie Li","doi":"10.1186/s13063-025-09079-z","DOIUrl":"10.1186/s13063-025-09079-z","url":null,"abstract":"<p><strong>Objective: </strong>The study attempted to explore the postoperative pain control of ultrasound-guided iliac fascia and trigeminus block anesthesia among patients undergoing free flap reconstruction for head-and-neck tumors.</p><p><strong>Methods: </strong>This research implemented a prospective, double-blinded, randomized, and placebo-controlled clinical trial. Patients between 18 and 85 years who had accepted a radical head-and-neck tumor resection while simultaneously undergoing the vascularized anterolateral femoral free flap reconstruction for the surgical coloboma were recruited. The subjects were randomly divided into nerve block and blank groups. Faciocervical pain while speaking was the primary outcome variable. It was measured using the visual analog scale (VAS) during the perioperative period up to postoperative 7 days. Descriptive statistics and logistic regression analysis were performed. The data were analyzed using the Mann-Whitney U test, linear mixed-effects model, chi-square test, and Fisher's exact test. The statistically significant level was set at P < 0.05.</p><p><strong>Results: </strong>The sample comprised 145 subjects with a mean age of 58.4 (SD = 12.7), 102 (70.3%) males. There were 71 (49.0%) and 74 (51.0%) participants in the nerve block and blank groups. Nerve block anesthesia reduced postoperative pain, depicted by VASS (0.99 ± 1.72 P < 0.0001). The out-of-bed mobilization started before within the nerve block group (47.45 ± 19.68 P = 0.017). The high expression of IL-6 could decrease the efficacy of this protocol (P = 0.0176).</p><p><strong>Conclusion: </strong>Ultrasound-guided iliac fascia combined with trigeminus block anesthesia is an effective method for pain management in patients who underwent head-and-neck tumor surgery in conjunction with the simultaneous repair using the vascularized anterolateral femoral free flap.</p><p><strong>Trial registration: </strong>The Institutional Ethics Review Board approved the study and retrospectively registered it with the Chinese Clinical Trial Registry at January 10, 2024 (ChiCTR2400079720).</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"345"},"PeriodicalIF":2.0,"publicationDate":"2025-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12462181/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145138592","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparison of methods for identifying the optimal treatment duration in randomized trials for antibiotics.","authors":"Suzanne M Dufault, Brian H Aldana, Patrick P J Phillips","doi":"10.1186/s13063-025-09050-y","DOIUrl":"10.1186/s13063-025-09050-y","url":null,"abstract":"<p><strong>Background: </strong>The optimal duration of antibiotic treatment must strike a delicate balance: it must be long enough to achieve desirable efficacy yet short enough to prevent the development of toxicities, adverse events, and mitigate other arduous aspects related to patient burden. Historically, the approach used to determine duration of antibiotic treatment has been inefficient, severely impacting the refinement of therapeutics for tuberculosis (TB) where treatment duration, and its complications, can be extensive. Many of the challenges in duration-ranging have parallels and proposed solutions in the field of dose-ranging where the literature is substantially more established and where the traditions of qualitative, pairwise comparison studies have been replaced with model-based approaches. Such methods are more efficient and allow for interpolation between the doses observed.</p><p><strong>Methods: </strong>This work examines the utility of cutting-edge dose-finding methods (such as MCP-Mod) for duration-ranging of TB treatments. We compare the operating characteristics of the adapted model-based duration-ranging methodologies against standard qualitative methods for the purposes of estimating optimal duration and describing the duration-response relationship, using a simulation study motivated by a Multi-Arm Multi-Stage Response Over Continuous Intervention (MAMS-ROCI) clinical trial design. We explore three specific targets: (1) power to detect a duration-response relationship, (2) ability to accurately reproduce the duration-response curve, and (3) ability to estimate the optimal duration within an acceptable margin of error.</p><p><strong>Results: </strong>We find that model-based methods outperform standard qualitative comparisons on every target examined, particularly when the sample size is constrained to that of a typical Phase II trial.</p><p><strong>Conclusions: </strong>We conclude that the success of the next era in TB therapeutics duration evaluation trials, and antibiotics duration-ranging more broadly, will meaningfully rely on the ability to simultaneously pair innovative model-based statistical methods with re-imagined study designs such as MAMS-ROCI.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"352"},"PeriodicalIF":2.0,"publicationDate":"2025-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12462354/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145137569","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Conventional probe trabeculotomy versus microcatheter-assisted 360° trabeculotomy (PIRATE) in childhood glaucoma-study protocol for a randomized controlled trial.","authors":"Julia V Stingl, Irene M Schmidtmann, Markus Schepers, Alexander K Schuster, Jasmin Rezapour, Anna M Welzel, Angi L Mendoza-Moreira, Heike Elflein, Anne Ehrlich, Claudia Wolf, Michael Hopp, Ingeborg Stalmans, Sophie Lemmens, Thomas Dietlein, Silvia Schrittenlocher, Alexandra Lappas, Claudia Schuart, Hagen Thieme, Esther M Hoffmann","doi":"10.1186/s13063-025-09091-3","DOIUrl":"10.1186/s13063-025-09091-3","url":null,"abstract":"<p><strong>Background: </strong>To compare the success and safety of microcatheter-assisted 360° trabeculotomy (MCAT) with conventional probe trabeculotomy in a large, heterogeneous cohort of children with primary or secondary glaucoma.</p><p><strong>Methods: </strong>In this prospective, multicenter, observer-blinded, randomized controlled trial, 76 children (152 eyes) with bilateral primary or secondary childhood glaucoma aged ≤ 12 years will be included. Each child acts as own control using a paired-eye design: One eye is allocated to MCAT (experimental intervention), achieving a 360° trabeculotomy, the other eye to the probe trabeculotomy (control intervention) which enables a trabeculotomy over 90 to 120°. Each child receives both procedures (paired-eye design). The worse eye is treated first; the surgical method is randomized. Patients and observers are masked to the procedures. The patients are followed up for 24 months. The primary endpoint is complete success (IOP < 18 mmHg at 24 months without medication and revision surgery; with MCAT: successful probing of > 120° is also required for success) at 24 months of follow-up. The primary analysis is performed in the intention-to-treat population using McNemar test stratified by center.</p><p><strong>Discussion: </strong>The PIRATE study is a multicenter randomized controlled study comparing MCAT with conventional probe trabeculotomy in a large and heterogeneous childhood glaucoma population. It will provide data on the success and safety of both techniques and clarify if MCAT is superior to probe trabeculotomy.</p><p><strong>Trial registration: </strong>German Clinical Trials Register, DRKS-ID: DRKS00034139. Registered on April 24, 2024. https://drks.de/search/en/trial/DRKS00034139 . https://trialsearch.who.int/Trial2.aspx?TrialID=DRKS00034139 .</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"342"},"PeriodicalIF":2.0,"publicationDate":"2025-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12455798/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145126008","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Preference-oriented quality of life monitoring and linkage with clinical registry data: study protocol of a randomised clinical trial in patients with lung cancer (LePaLuMo Study).","authors":"Patricia Lindberg-Scharf, Martin Emmert, Michael Koller, Florian Gürtler, Brunhilde Steinger, Jacqueline Müller-Nordhorn, Florian Zeman, Sophie Friebel, Ksenia Ibler, Jan Kurz, Thomas Stangl, Monika Klinkhammer-Schalke, Vinzenz Völkel","doi":"10.1186/s13063-025-09102-3","DOIUrl":"10.1186/s13063-025-09102-3","url":null,"abstract":"<p><strong>Background: </strong>In routine oncological care, the implementation of disease-related quality of life (QoL) is still an open matter. In a complex intervention, a QoL monitoring system including tailored therapeutic options has been designed, implemented, and its effectiveness has been demonstrated in two randomised trials in patients with breast and colorectal cancer. The next step is to extend the usability of the QoL monitoring system for patients with other cancer diagnoses and in other regions. Necessary adaptations include an electronic measurement of QoL and consideration of patient and physician preferences. The present randomised trial investigates the effectiveness of this adapted QoL monitoring system in patients with lung cancer in two regions in Bavaria, Germany.</p><p><strong>Methods: </strong>In this 2-arm randomised, prospective, pragmatic, multicentre clinical trial with one intervention and one control group, QoL of primary lung cancer patients is assessed with an electronic patient- and physician-oriented QoL monitoring system using the EORTC QLQ-C30 and QLQ-LC29 questionnaires at study entry and at 1, 2, 3, 4, 5, and 6 months during follow-up care. The QoL data of each patient are linked with clinical data from the Bavarian Cancer Registry for the purpose of data analysis. In the intervention group, the results of QoL monitoring are automatically transferred to a QoL profile including 8 dimensions on scales of 0-100 (cut-off \"need for QoL therapy\" < 50 points). QoL results are obtained in real-time by patients and their treating physicians. To treat QoL deficits, a multi-professional network of healthcare providers is established. In the control group, QoL is also measured, but neither patients nor treating physicians have access to the results. The investigators expect that the proportion of patients in both groups with a need for QoL therapy (< 50 points in at least one dimension of the QoL profile) will be lower in the intervention group than in the control group at the primary endpoint 6 months after study entry.</p><p><strong>Discussion: </strong>This is the first study investigating the effectiveness of a QoL monitoring system based on patient- and physician-oriented preferences with a high degree of generalisability by including inpatient and outpatient care as well as different study regions.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06252233. Registered on February 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"339"},"PeriodicalIF":2.0,"publicationDate":"2025-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12439385/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145076213","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A cross-sectoral, short-stay hospital model in general medicine (STATAMED): study protocol for a cluster-randomised, stepped-wedge controlled trial.","authors":"Johannes Jahn, Eva-Maria Wild","doi":"10.1186/s13063-025-09072-6","DOIUrl":"10.1186/s13063-025-09072-6","url":null,"abstract":"<p><strong>Background: </strong>Ageing populations and the increasing prevalence of chronic diseases pose major challenges to health care systems in high-income countries, especially in rural areas affected by a decline in public services. This trial investigates a new short-stay hospital model, STATAMED, which adopts a general medical approach to addressing the needs of adult patients (18 years or older) with chronic diseases and/or acute infections, with a particular focus on the elderly. STATAMED short-stay wards will incorporate a mandatory case review between the referring physician and the lead STATAMED physician, as well as support from case managers and mobile nurses to ensure coordination and continuity of care after hospital discharge. The primary aim of the trial is to determine whether the care provided in STATAMED wards is more effective than usual hospital care in improving the combined primary outcome of hospital length of stay and 30-day hospital readmission rates.</p><p><strong>Methods: </strong>The study will be conducted as a prospective, cluster-randomised controlled trial using a stepped-wedge design. STATAMED wards will be implemented at six hospital sites, and the catchment areas will be divided into clusters. All referring entities in a catchment area-including general practitioners (GPs), office-based specialists, nursing homes, ambulatory care services, and emergency services-will be potential candidates for cluster formation. The intervention group is expected to consist of 4481 patients. Primary and secondary outcomes will be assessed using claims data from participating statutory health insurers. A health economic evaluation will also be conducted using these data to compare costs associated with STATAMED and usual care. To minimise the risk of bias, analyses will be conducted on both an intention-to-treat and actual treatment basis.</p><p><strong>Discussion: </strong>This trial will assess whether STATAMED improves health care utilisation outcomes that reflect the efficiency and quality of inpatient care and discharge planning compared to usual hospital care. The findings will provide novel evidence about how best to improve health care for patients with chronic diseases and/or acute infections and may offer evidence for cost-effective strategies to improve health care delivery.</p><p><strong>Trial registration: </strong>German Clinical Trials Register DRKS00033096. Registered on 27 November 2023, last updated on 26 May 2025.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"340"},"PeriodicalIF":2.0,"publicationDate":"2025-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12439374/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145076233","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparison of standard circular stapler anastomosis with or without circumferential suture enhancement in patients with robot-assisted Ivor-Lewis oesophagectomy due to malignant tumours of the oesophagus and oesophagogastric junction-a multi-centre, randomised, superiority study (STITCHES).","authors":"Janik Hinkelmann, Helena Reitberger, Bruno Bancke Laverde, Andreas R R Weiß, Maximilian Brunner, Robert Grützmann, Georg F Weber, Christian Krautz","doi":"10.1186/s13063-025-08995-4","DOIUrl":"10.1186/s13063-025-08995-4","url":null,"abstract":"<p><strong>Background: </strong>Morbidity due to anastomotic leakage is a major concern in transthoracic oesophagectomy. The aim of this randomised trial is to evaluate whether a circumferential suture reinforcement of the stapled end-to-side anastomosis in robot-assisted minimally invasive Ivor-Lewis oesophagectomy (RAMIE) leads to a reduced incidence of anastomotic leakages in the postoperative course.</p><p><strong>Methods/design: </strong>This is a multi-centre randomised, double-blind, superiority trial with an adaptive sample size design undergoing RAMIE for malignant tumours. Patients will be randomised 1:1 into two study arms. In study arm A, participants will receive a standard circular-stapled end-to-side oesophagogastric anastomosis, while in study arm B, the anastomosis will have a circumferential suture reinforcement. The primary endpoint is the rate of anastomotic leakage. Secondary endpoints are incision-to-suture time, duration of circumferential suture reinforcement, anastomotic stenosis rate, postoperative morbidity and mortality, and quality of life.</p><p><strong>Discussion: </strong>This randomised controlled trial will assess the impact of circumferential suture reinforcement of the oesophagogastric anastomosis on short-term outcomes and quality of life of patients undergoing robot-assisted minimally invasive Ivor-Lewis oesophagectomy.</p><p><strong>Trial regsitration: </strong>DRKS00034787. Registered on 7 October 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"341"},"PeriodicalIF":2.0,"publicationDate":"2025-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12439365/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145076244","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Who is in your trial? Improving the reporting of participant characteristics in trial protocols and results.","authors":"Shaun Treweek, Shoba Dawson, Kamlesh Khunti, Murat Akand, Matthias Briel, Bruno da Costa, Cheney Drew, Sara Elias, Hossein Fatemian, Kiranpreet Gill, Alexander Gough, Sophie Greenwood, Jack Hall, Sayeed Haque, Karla Hemming, Mona Kanaan, William Meurer, Lisasha Poudel, Riaz Qureshi, Kate Roberts, Aldana Rosso, Francesca Schiavone, Matthew R Sydes, Muslim Syed, Victoria Vickerstaff, Tianjing Li","doi":"10.1186/s13063-025-08938-z","DOIUrl":"10.1186/s13063-025-08938-z","url":null,"abstract":"","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"338"},"PeriodicalIF":2.0,"publicationDate":"2025-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12421759/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145030615","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"\"SPHERE\" multi-component novel psychosocial intervention for people with HIV: study protocol for a randomised controlled trial.","authors":"Vasiliki Papageorgiou, Fiona C Lampe, Janey Sewell, Colette J Smith, Andrew Briggs, Ryan Ottridge, Vanessa Apea, Michael Brady, Suzanne Lockyer, David Asboe, Gabriel Schembri, Eileen Nixon, Charlie Hughes, Claire Ryan, Megan Jenkins, Shrushma Loi, Alex Sparrowhawk, Rebecca Woolley, Versha Cheed, Natalie Ives, Serena Dhir, Simon Jones, Lorraine Sherr, Marc Lipman, Andrew N Phillips, Richard Harding, Fiona Burns, Carl May, Alison J Rodger","doi":"10.1186/s13063-025-08904-9","DOIUrl":"10.1186/s13063-025-08904-9","url":null,"abstract":"<p><strong>Background: </strong>Antiretroviral therapy (ART) has transformed HIV into a manageable health condition with normal life expectancy. However, people with HIV continue to have poorer mental health compared to background populations, which may be linked to stigma, lack of social support, or socioeconomic challenges. Personalised care aims to improve the outcomes of people with long-term health conditions and the National Health Service (NHS) Long Term Plan looks to implement this (including access to health coaching and social prescribing). The SPHERE trial aims to assess whether a health and well-being coaching and social prescribing intervention improves patient-reported health and well-being among people living with HIV who have psychosocial needs.</p><p><strong>Methods: </strong>SPHERE will be conducted across seven HIV outpatient clinics in England and is a pragmatic, two-arm, parallel group randomised controlled trial (RCT) embedding a routine assessment of psychosocial needs in HIV care. Eligibility criteria are people living with HIV aged 18 or older, available for the duration of study follow-up and scoring 16 or more on an assessment of psychosocial need: \"Positive-Outcomes-11\" (PO-11), covering physical, psychological, social and socioeconomic aspects of health and well-being. The RCT requires 568 participants who will be individually randomised in a 1:1 ratio to either a health and well-being coaching and social prescribing intervention or usual care. The intervention consists of up to eight coaching sessions that will be delivered by health professionals (e.g. HIV nurses) who have received specialist training to become health and well-being coaches. The trial will also include an internal pilot phase, process evaluation (to evaluate intervention feasibility, acceptability and mechanisms of action), economic evaluation (to assess the cost-effectiveness of the intervention and impact on NHS resource use) and parallel observational study (to assess subsequent development of psychosocial needs among those not initially eligible for the trial). The primary outcome is defined as achieving a reduction in PO-11 score of at least 40% from baseline to 6 months post-randomisation. Secondary outcomes include symptoms of depression and anxiety, social support, self-stigma, coping self-efficacy, resilience, lifestyle factors and health-related quality of life.</p><p><strong>Discussion: </strong>The SPHERE trial will evaluate the effectiveness and cost-effectiveness of implementing psychosocial health and well-being coaching in a secondary HIV care setting. If effective, this model of personalised care could be transferable to other long-term health conditions.</p><p><strong>Trial registration: </strong>International Standard Randomised Controlled Trials Number (ISRCTN) Registry: ISRCTN47187932 [registered 12 July 2024].</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"337"},"PeriodicalIF":2.0,"publicationDate":"2025-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12406414/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144970692","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"BodyBalance as an exercise therapy for knee osteoarthritis in older women: a study protocol for a randomized controlled trial.","authors":"Farzaneh Saki, Parvin Safarpour, Farzaneh Ramezani, Leila Youzbashi","doi":"10.1186/s13063-025-09036-w","DOIUrl":"10.1186/s13063-025-09036-w","url":null,"abstract":"<p><strong>Background: </strong>Knee osteoarthritis (OA) is a prevalent degenerative condition among older women, frequently causing pain, decreased mobility, and reduced quality of life. As the global population ages, effective and accessible non-pharmacological interventions are urgently needed. This randomized controlled trial aims to evaluate the clinical and statistical effects of a 12-week BodyBalance exercise program on symptoms and complications associated with OA in older women.</p><p><strong>Methods: </strong>A total of 40 older women aged 60-80 years with clinically diagnosed knee OA will be randomly assigned to either the intervention group or the control group. The intervention group will participate in a supervised BodyBalance training program, while the control group will maintain their usual activities without any structured exercise. Outcomes include evaluations of knee pain, balance, postural control, lower limb muscle strength, proprioception (knee and ankle), fear of falling, and overall quality of life.</p><p><strong>Discussion: </strong>The study is expected to demonstrate that BodyBalance significantly improves balance, reduces pain, and enhances functional mobility in older women with OA compared to no intervention. These findings may support the clinical adoption of mind-body exercise as a cost-effective strategy for improving independence and well-being in the aging population.</p><p><strong>Trial registration: </strong>https://irct.behdasht.gov.ir/trial/68467 . Registered on 15 April 2023. Retrospectively registered.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"336"},"PeriodicalIF":2.0,"publicationDate":"2025-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12406377/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144970717","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}