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MindRegulation-SEL: randomized controlled trial of the effects of a relaxation and guided imagery intervention with socioemotional learning on the psychological and biophysiological well-being, socioemotional development, cognitive function and academic achievement of elementary school children. 心理调节- sel:放松和引导意象干预对小学生心理生理健康、社会情绪发展、认知功能和学习成绩影响的随机对照试验。
IF 2 4区 医学
Trials Pub Date : 2025-06-03 DOI: 10.1186/s13063-025-08899-3
Iolanda Costa Galinha, Joana Leite da Cunha Sampaio de Carvalho, Ana Cristina Pires de Oliveira, Patrícia Arriaga, Augusta D Gaspar, Hugo P Silva, Vitória Ortega
{"title":"MindRegulation-SEL: randomized controlled trial of the effects of a relaxation and guided imagery intervention with socioemotional learning on the psychological and biophysiological well-being, socioemotional development, cognitive function and academic achievement of elementary school children.","authors":"Iolanda Costa Galinha, Joana Leite da Cunha Sampaio de Carvalho, Ana Cristina Pires de Oliveira, Patrícia Arriaga, Augusta D Gaspar, Hugo P Silva, Vitória Ortega","doi":"10.1186/s13063-025-08899-3","DOIUrl":"10.1186/s13063-025-08899-3","url":null,"abstract":"<p><strong>Background: </strong>Mental imagery has long been used in psychological therapies, but only recently did research begin to provide a scientific background for it. Imagery interventions are inexpensive and a substantial body of research supports their effectiveness on anxiety reduction, behavior change, promotion of health outcomes, and adherence to medical interventions, in both adults and children. However, literature on the benefits of relaxation and guided imagery interventions for children in elementary school context is very scarce. This randomized controlled trial (RCT) aims to contribute to that knowledge by implementing and testing the benefits of an intervention program MindRegulation-Socioemotional Learning (MR-SEL) comprising breathing and progressive muscle relaxation, instructions for body posture, and guided imagery with socioemotional learning, conveying adaptive beliefs about oneself, the relationships with others and the environment.</p><p><strong>Method: </strong>The MR-SEL intervention will be developed in the classroom for 15 min before learning activities, three times per week, for 5 months, and its effects will be measured on a range of psychosocial and emotional, biophysiological, and cognitive outcomes. Seventeen classes will be randomly assigned to three conditions: (a) relaxation and guided imagery with SEL (MR-SEL); (b) relaxation only; and (c) waitlist control. The RCT includes four data collection times: pretest, intermediate, posttest, and a 6-month follow-up. The sample comprises 259 students, elementary school third and fourth graders, 8-11 years old. The variables measured are well-being, affect, anxiety, emotional regulation, socioemotional competencies, attention and processing speed, and perceived benefits of the intervention. Physiological indicators of emotional arousal, emotional regulation, stress, and well-being are also taken, specifically, heart rate variability, electrodermal activity, actigraphy, and salivary DHEA-S and cortisol. The validity of the measures will be tested for the population and objectives of the study.</p><p><strong>Discussion: </strong>Significant improvements on the children's well-being, socioemotional regulation, cognitive function, physiological activity, and academic performance are expected after 5 months' intervention at posttest and 11 months' follow-up at MR-SEL condition, compared to the relaxation and control conditions. Changes in physiological activity are expected during MR-SEL and relaxation sessions. Emotional regulation, well-being, and anxiety are expected to mediate the effects of the interventions over socioemotional competence, cognitive function, and academic performance. Well-being and anxiety levels at pretest are expected to moderate the interventions' effects.</p><p><strong>Trial registration: </strong>MINDREGULATION: https://ichgcp.net/clinical-trials-registry/NCT06101225 . Registered 5th October, 2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"187"},"PeriodicalIF":2.0,"publicationDate":"2025-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12131549/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144217069","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}
引用次数: 0
dVP_FAM-development and evaluation of a transsectoral digital care platform for individuals with familial cancer risks: study protocol for a multi-centre, cluster-randomised, mixed-methods study. dvp_fam——针对家族性癌症风险个体的跨部门数字护理平台的开发和评估:多中心、集群随机、混合方法研究的研究方案。
IF 2 4区 医学
Trials Pub Date : 2025-06-02 DOI: 10.1186/s13063-025-08872-0
K Klein, F Kendel, S Schüürhuis, K Neumann, C Kowalski, P Thomas, T Reinhold, U Felbor, S Stegen, C Schmid, N Mehrhof, S Asmussen, F Diel, M A Feufel, D Speiser
{"title":"dVP_FAM-development and evaluation of a transsectoral digital care platform for individuals with familial cancer risks: study protocol for a multi-centre, cluster-randomised, mixed-methods study.","authors":"K Klein, F Kendel, S Schüürhuis, K Neumann, C Kowalski, P Thomas, T Reinhold, U Felbor, S Stegen, C Schmid, N Mehrhof, S Asmussen, F Diel, M A Feufel, D Speiser","doi":"10.1186/s13063-025-08872-0","DOIUrl":"10.1186/s13063-025-08872-0","url":null,"abstract":"<p><strong>Background: </strong>Individuals with a family history of cancer face an increased risk of developing breast and ovarian cancer. Up to 30% of the 70,000 annual breast cancer cases in Germany are associated with a familial cancer burden. Early identification of these risks is crucial as personalised measures can enable early detection or prevention of cancer. Primary care gynaecologists are uniquely suited to assess family histories and facilitate referrals to hereditary cancer centres. However, solutions on how to support early referral are still lacking. This study evaluates the impact of the digital care platform dVP_FAM as a potential remedy compared to standard care. The primary hypothesis is that the platform will increase the proportion of care-seeking women with a familial cancer risk who have not yet developed cancer. Secondary outcomes include improvements in care efficiency, patient empowerment, and health-related quality of life.</p><p><strong>Methods: </strong>The study is a multi-centre, cluster-randomised, mixed-method trial involving 44 gynaecological centres and 800 participants recruited through hereditary breast and ovarian cancer centres. All participants receive standard guideline-based care, while the intervention group also uses the dVP_FAM platform. The primary endpoint measures the proportion of participants with a familial cancer history who are cancer-free when seeking specialist counselling. Secondary outcomes are assessed using validated tools like the SF-12 and custom measures. Data collection employs a convergent mixed-methods approach, integrating quantitative and qualitative evidence.</p><p><strong>Discussion: </strong>The dVP_FAM platform represents an innovative approach to digitising cancer prevention in Germany, enhancing early detection and care coordination. If successful, dVP_FAM could serve as a scalable model for digital health innovations, improving efficiency and modernising the delivery of personalised care across health systems.</p><p><strong>Trial registration: </strong>German Clinical Trials Register, DRKS00030371 . Registered on 02 October 2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"185"},"PeriodicalIF":2.0,"publicationDate":"2025-06-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12128308/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144209622","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}
引用次数: 0
Digital vertigo therapy: study protocol for a confirmatory randomized controlled trial in patients with vestibular vertigo. 数字眩晕治疗:前庭眩晕患者的验证性随机对照试验的研究方案。
IF 2 4区 医学
Trials Pub Date : 2025-06-02 DOI: 10.1186/s13063-025-08775-0
Markus Wirth, Jannik Pieper, Ulrike Heller, Michael Bulitta, Daniel Schmitz, Barbara Wollenberg, Hubert Löwenheim, Stephan Wolpert
{"title":"Digital vertigo therapy: study protocol for a confirmatory randomized controlled trial in patients with vestibular vertigo.","authors":"Markus Wirth, Jannik Pieper, Ulrike Heller, Michael Bulitta, Daniel Schmitz, Barbara Wollenberg, Hubert Löwenheim, Stephan Wolpert","doi":"10.1186/s13063-025-08775-0","DOIUrl":"10.1186/s13063-025-08775-0","url":null,"abstract":"<p><strong>Background: </strong>Vestibular vertigo is one of the leading causes of disability. The clinical standard of care for vestibular vertigo includes physical activity producing central vestibular compensation (CVC). Home exercises are considered an integral part of physical therapy. However, a reliable solution is still needed to support the regular and correct execution of home exercises. For this purpose, VH-90-D DiGA was developed, which is a digital therapeutic (DTx) for multimodular in-home therapeutic training.</p><p><strong>Objective: </strong>The purpose of this study is to assess the clinical efficacy and safety of a vestibular health app for patients with vestibular vertigo.</p><p><strong>Methods: </strong>A randomized group-controlled single-blinded clinical trial (RCT) has been designed. Patients will be randomly assigned to one of two treatment groups and the endpoints examined in a pre-determined order. The experimental group receives the DTx (around 15 min/daily for 90 days), and the control receives physiotherapy according to the German statutory health care plan (usually 6 × 20 min of live physiotherapy). The primary outcome will be vertigo intensity measured using the German version of the validated Vertigo Symptom Scale-short form VSS-sf-VER (0-32 score points). Evaluation is performed after 2, 6, and 12 weeks. Primary outcomes are determined by measuring the group differences of the VSS-sf-score point changes from baseline to week twelve. Including dropouts, the sample size has been determined to be 2 × 100.</p><p><strong>Expected results: </strong>It is expected that therapy with the DTx will be statistically superior to physiotherapy in terms of effect size.</p><p><strong>Discussion: </strong>This trial protocol marks a confirmatory RCT (GEVE II) to investigate the efficacy and safety of a digital vertigo treatment. The planned RCT is based on a series of primary and secondary efficacy variables. Examination of the endpoints in a pre-determined order ensures the rigor of confirmatory statistics and addresses the challenge of multiplicity. This sequential testing continues until significance is achieved. However, if a specific variable fails to reach significance, subsequent variables will be explored solely on a descriptive basis.</p><p><strong>Trial registration: </strong>German National Registry of Clinical Studies (DRKS00028026), a WHO ICRTP registry. Registered on December 12, 2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"184"},"PeriodicalIF":2.0,"publicationDate":"2025-06-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12128363/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144200061","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}
引用次数: 0
A community health worker-delivered intervention (STEPS) to support chronic pain self-management among older adults in an underserved urban community: protocol for a randomized trial. 社区卫生工作者提供的干预措施(STEPS)支持服务不足的城市社区老年人慢性疼痛自我管理:一项随机试验方案。
IF 2 4区 医学
Trials Pub Date : 2025-06-02 DOI: 10.1186/s13063-025-08892-w
Mary R Janevic, Rebecca Lindsay, Elizabeth Brines, Kimberlydawn Wisdom, Sheria G Robinson-Lane, Robin Brewer, Susan L Murphy, John Piette, Leslie Grijalva, Michael Anderson, Jaye Clement, Courtney Latimer
{"title":"A community health worker-delivered intervention (STEPS) to support chronic pain self-management among older adults in an underserved urban community: protocol for a randomized trial.","authors":"Mary R Janevic, Rebecca Lindsay, Elizabeth Brines, Kimberlydawn Wisdom, Sheria G Robinson-Lane, Robin Brewer, Susan L Murphy, John Piette, Leslie Grijalva, Michael Anderson, Jaye Clement, Courtney Latimer","doi":"10.1186/s13063-025-08892-w","DOIUrl":"10.1186/s13063-025-08892-w","url":null,"abstract":"<p><strong>Background: </strong>Older adults in disadvantaged urban communities contend with chronic psychosocial and environmental stressors that contribute to high levels of chronic pain-related disability. African American older adults are especially at risk due to the health-damaging effects of structural racism. The purpose of this study is to test the efficacy of a chronic pain self-management intervention tailored for this context. STEPS (Seniors using Technology to Engage in Pain Self-management) is a community health worker (CHW)-led chronic pain self-management program designed for older adults living in underserved communities. It is a 7-week intervention that includes (a) brief videos presenting pain self-management skills; (b) weekly telephone calls with a CHW to support the practice of new skills and goal setting; and (c) tracking daily step counts using a wearable activity tracker. CHWs also screen for social needs and make appropriate community referrals.</p><p><strong>Methods: </strong>We will randomly assign 414 participants to the STEPS intervention or a control condition in a 1:1 ratio, stratifying by gender and age group. We hypothesize that participants in the STEPS intervention will have greater improvements in pain interference and pain intensity, and a more positive Global Impression of Change immediately following the intervention and at 12 months from baseline. Control group members are invited to attend a workshop covering key intervention content after the final data collection point.</p><p><strong>Discussion: </strong>Growing evidence supports the effectiveness of CHWs as culturally sensitive liaisons between healthcare systems and underserved communities. If the STEPS program is shown to significantly improve pain-related outcomes, STEPS could be integrated into healthcare systems to more comprehensively treat chronic pain while reducing barriers to care and promoting non-pharmacological pain management strategies.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov, NCT05278234. Registered on March 3, 2022.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"186"},"PeriodicalIF":2.0,"publicationDate":"2025-06-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12128255/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144209621","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}
引用次数: 0
Perioperative sildenafil citrate administration in hepatectomy: a study protocol of randomized controlled trial. 肝切除术围手术期给予枸橼酸西地那非:一项随机对照试验的研究方案。
IF 2 4区 医学
Trials Pub Date : 2025-06-01 DOI: 10.1186/s13063-025-08870-2
Qisheng Chen, Shixuan Peng, Yingying Zhou, Shuzhai Li, Feng Xu, Yi Yu, Pan Wang, Xinran Peng, Chunbo Zhao, Aowen Xie, Zhiming Zhang
{"title":"Perioperative sildenafil citrate administration in hepatectomy: a study protocol of randomized controlled trial.","authors":"Qisheng Chen, Shixuan Peng, Yingying Zhou, Shuzhai Li, Feng Xu, Yi Yu, Pan Wang, Xinran Peng, Chunbo Zhao, Aowen Xie, Zhiming Zhang","doi":"10.1186/s13063-025-08870-2","DOIUrl":"10.1186/s13063-025-08870-2","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Intraoperative blood loss (IBL) is the major concern in hepatectomy, which was closely relating to the central venous pressure (CVP). The controlled low central venous pressure (CLCVP) technique is moderately required for minimizing hemorrhage during hepatectomy nowadays. Nevertheless, an excessive reduction in CVP might give rise to the jeopardy of inadequate perfusion of vital organs. Sildenafil, being a first-line pharmaceutical for treating pulmonary hypertension, its mechanism of action lies in diminishing pulmonary vascular resistance (PVR) by dilating pulmonary arteries, and thereby alleviating the afterload of the right ventricle. We initially postulate that administration of sildenafil citrate in combination with intermittent Pringle's maneuver (IPM) can exert a notable impact in efficaciously reducing intraoperative blood loss (IBL), enhancing the surgical field of vision, and augmenting the safety of the operation.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This research constitutes a double-blind, randomized, controlled trial. All patients fulfilling the criteria for open or laparoscopic hepatectomy will be randomly allocated to the sildenafil (S) group and the placebo (C) group via the block randomization approach. All surgeons, anesthesiologists, and outcome assessors will remain oblivious to the patient's group details. The primary outcome is the intraoperative blood loss (IBL). Secondary outcomes include the classification of the surgical field, the cumulative consumption of nitroglycerine, hemodynamic parameters, blood gas analysis, coagulation function (comprising thromboelastogram (TEG), activated partial thromboplastin time (APTT), and prothrombin time (PT)), intraoperative urine output, adverse events in the recovery room (hypotension, hypoxemia and hematuria), biochemical markers (total bilirubin, total albumin, alanine aminotransferase, aspartate aminotransferase, creatinine, urea nitrogen), complete blood count (Hb, Plt, and Hct), cardiac function (brain natriuretic peptide, creatine kinase isoenzyme, troponin), postoperative hospital stay and indwelling time of drainage tube, and postoperative complications. These parameters will be comprehensively compared and analyzed in-depth through appropriate statistical means.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Discussion: &lt;/strong&gt;This trial evaluated the influence of administration of sildenafil citrate combined with IPM on IBL and surgical results during open or laparoscopic hepatectomy, as well as its safety and feasibility. It is expected to provide an innovative management optimization plan for reducing the bleeding in hepatectomy, and to provide empirical support for the potential value of sildenafil citrate or sildenafil-like drugs in improving the safety and quality of perioperative hepatectomy patients.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Trial registration: &lt;/strong&gt;This trial was registered on June 25, 2024, in the US Clinical Trials Registry ( https://register.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Clinicaltrials:","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"183"},"PeriodicalIF":2.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12126887/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144192292","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}
引用次数: 0
Effects of passive blood-flow-restriction and electromyostimulation on ICU-acquired weakness (ICUAW): a study protocol for a randomized-controlled, parallel-group clinical trial. 被动血流限制和肌电刺激对icu获得性虚弱(ICUAW)的影响:一项随机对照、平行组临床试验的研究方案
IF 2 4区 医学
Trials Pub Date : 2025-06-01 DOI: 10.1186/s13063-025-08874-y
Alexander Franz, Katharina Friederike Wolf, Julika Behrens, Björn Koos, Michael Adamzik, Stefan Felix Ehrentraut
{"title":"Effects of passive blood-flow-restriction and electromyostimulation on ICU-acquired weakness (ICUAW): a study protocol for a randomized-controlled, parallel-group clinical trial.","authors":"Alexander Franz, Katharina Friederike Wolf, Julika Behrens, Björn Koos, Michael Adamzik, Stefan Felix Ehrentraut","doi":"10.1186/s13063-025-08874-y","DOIUrl":"10.1186/s13063-025-08874-y","url":null,"abstract":"<p><strong>Background: </strong>Intensive care unit-acquired weakness (ICUAW) is a prevalent secondary disorder in critically ill patients, characterized by significant loss of muscle mass and strength, often leading to prolonged ICU stays, increased mortality, and reduced post-discharge quality of life. Despite guidelines recommending early mobilization, logistical challenges and inconclusive efficacy have limited its impact on ICUAW prevalence. This study aims to assess the feasibility, safety, and clinical efficacy of exclusively passive physiotherapeutic interventions, including blood flow restriction/ischemic preconditioning (BFR/IPC) and electromyostimulation (EStim), as potential alternatives for muscle preservation in ICU patients who are often sedated or unable to participate in active rehabilitation.</p><p><strong>Methods: </strong>This prospective, randomized controlled trial will recruit 120 patients from the surgical ICU at the University Hospital Bonn, who meet the inclusion criteria of a > 48-h ICU stay. Patients will be randomized into four groups: Sham-Control, BFR/IPC, EStim, and combined BFR/IPC + EStim. The study's primary endpoints include feasibility and safety metrics, such as patient compliance and stress response, alongside secondary endpoints related to clinical outcomes like ICU length of stay, ICUAW prevalence, muscle mass preservation, and rehabilitation efficacy. Measurements include non-invasive assessments of muscle mass, intramuscular microdialysis to monitor metabolic and inflammatory markers, and health-related quality of life evaluations post-discharge.</p><p><strong>Discussion: </strong>Preliminary literature and a systematic review underscore the need for resource-efficient, non-invasive interventions in ICU settings. BFR/IPC and EStim present promising results, but existing data on their efficacy in ICU populations are limited. This study's findings will provide foundational data on the viability of passive physiotherapy techniques in ICU settings, potentially improving patient outcomes and reducing healthcare costs associated with prolonged ICU stays. If successful, these results will inform a multicenter randomized trial to further evaluate these interventions. This research represents a crucial step in developing feasible rehabilitation protocols to mitigate ICUAW, addressing a critical gap in critical care management and rehabilitation.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov DRKS00033592. Registered on March 05, 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"182"},"PeriodicalIF":2.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12126856/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144192291","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}
引用次数: 0
Research assistants' experiences recruiting patients with psychosis into clinical trials: a qualitative study. 研究助理招募精神病患者参加临床试验的经验:一项质性研究。
IF 2 4区 医学
Trials Pub Date : 2025-05-30 DOI: 10.1186/s13063-025-08882-y
Ariane Beckley, Margaret Glogowska, Felicity Waite, Penny Bee, Daniel Freeman
{"title":"Research assistants' experiences recruiting patients with psychosis into clinical trials: a qualitative study.","authors":"Ariane Beckley, Margaret Glogowska, Felicity Waite, Penny Bee, Daniel Freeman","doi":"10.1186/s13063-025-08882-y","DOIUrl":"10.1186/s13063-025-08882-y","url":null,"abstract":"<p><strong>Objectives: </strong>Treatments for patients diagnosed with psychosis need to be improved. Clinical trials are an important way of assessing the efficacy of new treatments. However, recruiting patients into trials is challenging. This study sought to better understand the reasons for this from the perspective of research assistants.</p><p><strong>Design: </strong>A qualitative study underpinned by a critical realist ontology and contextualist epistemology.</p><p><strong>Methods: </strong>Research assistants who had recruited patients with psychosis into trials, primarily of psychological interventions, were interviewed. Reflexive thematic analysis was used to identify themes.</p><p><strong>Results: </strong>Overarching themes representing four types of factors influencing recruitment of patients with psychosis into clinical trials were generated: patient, clinical team, research team, and NHS infrastructure. Patients largely wished to take part in trials but needed time to build trust with research assistants. Clinical teams held the power in suggesting patients for trials; therefore, it was essential for research teams to build strong relationships with clinical staff. Research teams recruiting into trials benefited from lived experience expertise, support systems, and institutional knowledge. A key NHS infrastructure factor was that mental health staff had limited time to consider trials for their patients.</p><p><strong>Conclusions: </strong>Trial participation needs to be made more accessible to patients with psychosis, who often want to take part but lack opportunities. Methods of increasing accessibility could include identifying and addressing barriers to referral from clinical teams, employing multiple recruitment strategies, and flexible appointment formats. Qualitative research with clinical teams and patients will also help in developing the understanding of barriers to recruitment.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"180"},"PeriodicalIF":2.0,"publicationDate":"2025-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12124033/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144188073","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}
引用次数: 0
A phase 3 study of ravulizumab to protect patients with chronic kidney disease from cardiac surgery-associated acute kidney injury and major adverse kidney events (ARTEMIS). 一项ravulizumab保护慢性肾病患者免受心脏手术相关急性肾损伤和主要肾脏不良事件(ARTEMIS)的3期研究。
IF 2 4区 医学
Trials Pub Date : 2025-05-30 DOI: 10.1186/s13063-025-08895-7
Marlies Ostermann, David C Corteville, Kent Doi, Jay L Koyner, Andre Lamy, Gerry Li, Christine M Solinsky, Pamela D Winterberg, William T Smith, Ravindra L Mehta, Patrick T Murray, Andrew D Shaw, Alexander Zarbock, Daniel T Engelman
{"title":"A phase 3 study of ravulizumab to protect patients with chronic kidney disease from cardiac surgery-associated acute kidney injury and major adverse kidney events (ARTEMIS).","authors":"Marlies Ostermann, David C Corteville, Kent Doi, Jay L Koyner, Andre Lamy, Gerry Li, Christine M Solinsky, Pamela D Winterberg, William T Smith, Ravindra L Mehta, Patrick T Murray, Andrew D Shaw, Alexander Zarbock, Daniel T Engelman","doi":"10.1186/s13063-025-08895-7","DOIUrl":"10.1186/s13063-025-08895-7","url":null,"abstract":"<p><strong>Background: </strong>Cardiac procedures, particularly those requiring cardiopulmonary bypass (CPB), are associated with the development of cardiac surgery-associated acute kidney injury (CSA-AKI). Development of CSA-AKI occurs as a result of inflammation, uncontrolled complement activation, and kidney cell damage. In patients with preoperative renal impairment, such as those with chronic kidney disease (CKD), there is an increased risk of both CSA-AKI and poorer clinical outcomes. Currently, there are limited effective, targeted pharmacological interventions for the prevention or treatment of CSA-AKI, although emerging therapies are being investigated, particularly in patients with existing CKD. The ARTEMIS (RAvulizumab to PRotect PaTients with Chronic Kidney DisEase froM CSA-AKI and Subsequent Major Adverse Kidney Events) trial will assess the efficacy and safety of ravulizumab (a complement C5 inhibitor) in reducing the risk of major adverse kidney events (MAKE) in patients with preoperative CKD undergoing non-emergent cardiac surgery with CPB.</p><p><strong>Methods: </strong>This trial is currently recruiting patients with CKD who have planned cardiac surgery requiring CPB including coronary artery bypass grafting, valve replacement or repair, or combined procedures. This is a phase 3, randomized, double-blind, placebo-controlled, global study assessing the efficacy and safety of a single preoperative dose of ravulizumab. These outcomes will be assessed using the occurrence of MAKE and its components, as well as the occurrence and severity of CSA-AKI throughout the study period.</p><p><strong>Discussion: </strong>Complement activation is known to occur during and after cardiac procedures as a result of CPB and ischemia-reperfusion injury, leading to a cycle of cell damage and death. Therefore, it is hypothesized that preoperative administration of ravulizumab will provide immediate and complete complement inhibition, which will be sustained throughout the surgical period, preventing the uncontrolled complement activation associated with the development of CSA-AKI, thus minimizing poor outcomes for patients.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT05746559. Registered on February 27, 2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"181"},"PeriodicalIF":2.0,"publicationDate":"2025-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12125780/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144188072","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}
引用次数: 0
The role of stakeholder mapping and engagement in Mongolia during the implementation of the STREAM clinical trial for MDR-TB. 在实施耐多药结核病STREAM临床试验期间,蒙古利益攸关方测绘和参与的作用。
IF 2 4区 医学
Trials Pub Date : 2025-05-29 DOI: 10.1186/s13063-025-08887-7
Bazarragchaa Tsogt, Meera Gurumurthy, Elisa Giallongo, Karen Sanders, Ganzorig Munkhjargal, Zayakhuu Khukhuukhen, Enkhjin Bolormaa, Enkhtuvshin Raash, Naranbat Nyamdavaa, Gay Bronson
{"title":"The role of stakeholder mapping and engagement in Mongolia during the implementation of the STREAM clinical trial for MDR-TB.","authors":"Bazarragchaa Tsogt, Meera Gurumurthy, Elisa Giallongo, Karen Sanders, Ganzorig Munkhjargal, Zayakhuu Khukhuukhen, Enkhjin Bolormaa, Enkhtuvshin Raash, Naranbat Nyamdavaa, Gay Bronson","doi":"10.1186/s13063-025-08887-7","DOIUrl":"10.1186/s13063-025-08887-7","url":null,"abstract":"<p><strong>Background: </strong>Clinical trials evaluating new regimens for multidrug-resistant tuberculosis (MDR-TB) are typically conducted in multiple countries because global registration of new TB drugs requires evaluation in diverse populations. The complexity of multi-site trials makes implementation challenging, especially in lower-resource settings, where the burden of MDR-TB is highest. Stakeholder engagement can improve trial implementation and outcomes. Here, we describe the Mongolia site's stakeholder engagement during STREAM, a phase III clinical trial evaluating novel treatment regimens for MDR-TB.</p><p><strong>Main body: </strong>We assessed our stakeholder engagement against the PCORI rubric. Engagement at all phases of the trial aligned well with the PCORI engagement principles of reciprocal relationships; co-learning; building partnerships; and transparency, honesty, and trust. In the planning phase, we formed a key partnership with a civil society organization to co-lead the trial, undertook stakeholder mapping, and developed an overall engagement strategy. During trial implementation, we undertook activities aimed at ensuring feasibility of the study, improving recruitment, ensuring viability of the study, and ensuring authenticity/value of stakeholder engagement. Activities, which included continuous communication with the national TB program to ensure referral of potential trial participants, implementation of a comprehensive community engagement (CE) program, delivery in collaboration with partners of psychosocial support for trial participants, capacity-building and knowledge sharing, regular communications on trial developments and progress, and community advisory board (CAB) participation in CE assessment, contributed to achieving a 98% retention rate and the highest participant recruitment across all STREAM trial sites. In the dissemination phase, CAB members worked together with the site and sponsor to ensure strategies and materials were tailored to stakeholders' needs, including participants; communities; frontline healthworkers; and national-level stakeholders. Stakeholder participation in research and in improving routine TB care in the country has been sustained since completion of the trial.</p><p><strong>Conclusions: </strong>Significant and sustainable gains can be made through stakeholder collaboration. We recommend that trial sites in lower-resourced settings take an expansive view of relevant stakeholders when planning engagement; undertake capacity-building and knowledge sharing; plan for long-term sustainability of CE; design engagement around specific objectives; tailor and optimize communication strategies; and design stakeholder engagement to involve key policy makers.</p><p><strong>Trial registration: </strong>ISRCTN78372190 - Registration date is October 14, 2010 (Stage 1) and ISRCTN18148631 - Registration date is February 10, 2016 (Stage 2).</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"179"},"PeriodicalIF":2.0,"publicationDate":"2025-05-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12123710/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144180302","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}
引用次数: 0
Efficacy and safety of a house dust mites allergoid in patients with allergic rhinitis-PROACAROS study: protocol for a randomized controlled trial. 屋尘螨类过敏原对变应性鼻炎患者的疗效和安全性——proacaros研究:随机对照试验方案
IF 2 4区 医学
Trials Pub Date : 2025-05-28 DOI: 10.1186/s13063-025-08875-x
Inmaculada Buendía-Jiménez, María Matas-Ros, Teresa Garriga-Baraut, Albert Roger-Reig, Ana Tabar-Purroy
{"title":"Efficacy and safety of a house dust mites allergoid in patients with allergic rhinitis-PROACAROS study: protocol for a randomized controlled trial.","authors":"Inmaculada Buendía-Jiménez, María Matas-Ros, Teresa Garriga-Baraut, Albert Roger-Reig, Ana Tabar-Purroy","doi":"10.1186/s13063-025-08875-x","DOIUrl":"10.1186/s13063-025-08875-x","url":null,"abstract":"<p><strong>Background: </strong>There is an important heterogeneity of the clinical research done to date for allergen immunotherapy (AIT). We plan to assess the safety and efficacy of a house dust mite (HDM) polymerized allergen extract mixture for allergic rhinoconjunctivitis (AR) according to both the EMA and European Academy of Allergy and Clinical Immunology (EAACI) guidelines for the clinical development of products for the treatment of AR.</p><p><strong>Methods: </strong>We will perform a double-blind, placebo-controlled, randomized parallel group phase III clinical trial to assess the clinical efficacy and safety of a polymerized Dermatophagoides pteronyssinus and Dermatophagoides farinae allergen extract mixture (Beltavac®) to treat perennial AR in children and adults. Patients with moderate or severe rhinitis symptoms, either associated or not with asthma and confirmed HDM sensitization and without relevant concomitant conditions that may interfere with the planned evaluations test are eligible. Patients will be randomized in a 1:1 ratio to either the active AIT or placebo. The experimental group will receive 12 monthly AIT doses via subcutaneous route with a potency of 2 RC/ml per allergen. The expected sample size is 250 patients from 16 sites in Spain. The main efficacy outcome is the Combined Symptom and Medication Score (CSMS) for rhinitis. It will be patients' self-assessed and collected through a phone App developed ad hoc for the study to improve the patient adherence and the quality of data. Main secondary outcomes include expanded CSMS for rhinoconjunctivitis symptoms, control of rhinitis, specific IgE and IgG<sub>4</sub> values, quality of life, and the number of adverse reactions. Health-related direct and indirect costs will be also evaluated. Finally, several exploratory parameters will be used to assess the severity of asthma.</p><p><strong>Discussion: </strong>This phase III clinical trial will be of interest to contribute to the scientific evidence about the efficacy and safety of AIT with allergoids. Our working hypothesis is that the investigational product in patients with AR associated or not with asthma is superior to placebo in providing a clinically significant improvement according to the standards defined by the EAACI. This trial will also supply valuable information about patients reported outcomes using health technology for rhinoconjunctivitis and asthma assessment.</p><p><strong>Trial registration: </strong>EudraCT 2018-003427-11. Date on which this record was first entered in the: 2021-06-14.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"176"},"PeriodicalIF":2.0,"publicationDate":"2025-05-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12117739/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144209623","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}
引用次数: 0
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