Contemporary Clinical Trials Communications最新文献_第6页

RESCUER mobile app to support pediatric resuscitation: Study protocol for a randomized controlled trial RESCUER移动应用程序支持儿科复苏：随机对照试验的研究方案

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-10-08 DOI: 10.1016/j.conctc.2025.101558

Samantha A. Lee , Diego Trujillo , Garth D. Meckler , Carl Eriksson , Trang Huynh , Nathan Bahr , Jyotsna Sanjeevi , Matt Hansen , Jeanne-Marie Guise

Background

Pediatric out-of-hospital cardiac arrest is a leading cause of death in children. This paper describes the study protocol for the randomized control trial to test a linear cognitive aid app (RESCUER) designed to support Emergency Medical Services (EMS) clinicians in responding to neonatal and pediatric out-of-hospital cardiac arrest (POHCA).

Objective

This randomized controlled trial (RCT) will investigate the effects of the RESCUER app compared with existing EMS practices and tools during simulated POHCAs.

Study design

This RCT will be conducted with EMS first responders from rural and urban EMS agencies in the United States (US). EMS teams will be randomized to respond to simulated neonatal and POHCAs using either (1) the RESCUER app or (2) their current standard of care and tools. In addition to randomized assignment to intervention and control, we also will randomize the order of simulation scenarios.

Main outcome measures

Primary outcomes include time to complete American Heart Association (AHA) recommended steps for NRP and PALS. Secondary outcomes include participants’ self-rated cognitive load, measured teamwork, and user-focused assessments of feasibility, usability and usefulness of tools.^1,2

Conclusion

We hypothesize that the app will decrease time to complete AHA recommended steps for NRP and PALS, compared to EMS teams’ current standard of care and tools. This study will examine whether an app used by EMS teams in responding to simulated neonatal and pediatric OHCAs will improve resuscitation performance and decrease cognitive load.

Trial Registration Number

NCT06768099 (ClinicalTrials.gov).

儿童院外心脏骤停是儿童死亡的主要原因。本文描述了随机对照试验的研究方案，该试验旨在测试线性认知辅助应用程序（RESCUER），该应用程序旨在支持紧急医疗服务（EMS）临床医生应对新生儿和儿科院外心脏骤停（POHCA）。目的：本随机对照试验（RCT）将研究RESCUER应用程序与现有EMS实践和工具在模拟pohca中的效果。研究设计本随机对照试验将在美国（US）农村和城市EMS机构的急救人员中进行。EMS团队将随机使用(1)RESCUER应用程序或(2)他们当前的护理标准和工具来应对模拟的新生儿和pohca。除了随机分配干预和控制，我们也将随机化模拟场景的顺序。主要结局指标主要结局包括完成美国心脏协会（AHA）推荐的NRP和PALS步骤的时间。次要结果包括参与者自评的认知负荷、测量的团队合作以及以用户为中心的工具可行性、可用性和有用性评估。结论：与EMS团队目前的护理标准和工具相比，我们假设该应用程序将减少完成AHA推荐的NRP和PALS步骤的时间。本研究将检验EMS团队在应对模拟新生儿和儿科ohca时使用的应用程序是否会改善复苏表现并降低认知负荷。试验注册号：06768099 （ClinicalTrials.gov）。

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引用次数: 0

Wellbeing for staff in UKCRC-registered Clinical Trials Units: Development of the Flourishing As Clinical Trial Staff (FACTS) guidance: a mixed-methods study ukcrc注册临床试验单位工作人员的福利：作为临床试验人员（FACTS）指导的繁荣发展：一项混合方法研究

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-10-03 DOI: 10.1016/j.conctc.2025.101556

Sophie S. Hall , Evgenia Riga , Eleanor J. Mitchell , Louise Thomson , Jodi Taylor , Lucy Carr , Pamela Hagan , Kirsty Sprange

Background

Evaluating healthcare interventions in clinical trials requires a skilled workforce. However, the demands of developing and running clinical trials make recruiting and retaining staff challenging. Flourishing, which focuses on positive aspects of well-being, may help staff manage these demands. This study introduces the Flourishing As Clinical Trial Staff (FACTS) guidance, offering practical strategies to support staff working in UK Clinical Research Collaboration (UKCRC) Clinical Trials Units (CTUs), to thrive at work.

Methods

Building upon findings from a national survey of staff working in UKCRC CTUs, a three-phase consensus-based approach was used to develop recommendations to support flourishing in clinical trial staff; (1) focus groups with staff (n = 24), (2) a consensus survey (n = 21) and (3) a consensus workshop (n = 15).

Results

The focus groups identified strategies for supporting CTU staff to flourish, including factors relating to the environment (e.g., flexible working); interpersonal communication (e.g., supportive colleagues), growth (e.g., protected training time) and acknowledgement of everyone's contributions. These strategies were developed into 67 wellbeing recommendations which were further evaluated in a consensus survey and workshop. Following this, 61 recommendations were endorsed for inclusion in the guidance.

Conclusions

The FACTS guidance includes recommendations to support UKCRC CTU staff to flourish in their work and are likely to apply more broadly to research institutions conducting clinical trials. The recommendations provide a foundation for CTUs to review and adapt to their local needs over time. Implementing these recommendations may prove beneficial for increasing job satisfaction and commitment, which is likely to facilitate efficient trial delivery.

背景：在临床试验中评估医疗干预措施需要熟练的工作人员。然而，开发和运行临床试验的需求使得招聘和留住员工具有挑战性。“繁荣”侧重于幸福感的积极方面，可以帮助员工管理这些需求。本研究介绍了蓬勃发展的临床试验人员（FACTS）指南，提供实用的策略，以支持工作在英国临床研究合作（UKCRC）临床试验单位（ctu）的工作人员在工作中茁壮成长。方法根据对UKCRC ctu工作人员的全国调查结果，采用基于三阶段共识的方法来制定建议，以支持临床试验人员的繁荣；(1)与员工的焦点小组（n = 24），(2)共识调查（n = 21）和(3)共识研讨会（n = 15）。结果焦点小组确定了支持CTU员工蓬勃发展的策略，包括与环境相关的因素（例如，灵活工作）；人际沟通（例如，同事的支持），成长（例如，保护培训时间）和承认每个人的贡献。这些策略被发展成67项福利建议，并在共识调查和研讨会上进一步评估。在此之后，61项建议被核可列入指南。结论FACTS指南包括支持UKCRC CTU工作人员在工作中发挥作用的建议，并可能更广泛地应用于开展临床试验的研究机构。这些建议为中央大学提供了一个基础，以检讨和适应当地的需要。执行这些建议可能有助于提高工作满意度和承诺，这可能有助于有效地进行试验。

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引用次数: 0

Rationale and protocol for a prospective clinical trial enrollment improvement hybrid study within a trial 前瞻性临床试验入组改善试验内混合研究的基本原理和方案

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-09-20 DOI: 10.1016/j.conctc.2025.101548

Patrick Lewicki , Sabrina Clark , Elaina Shoemaker , Bingkai Wang , Jerison Ross , Stephanie Daignault-Newton , Noelle Carlozzi , Adam Martin-Schwarze , William Meurer , Anne Sales , Khurshid Ghani , Casey Dauw , Kristian Stensland

Introduction

Enrollment to clinical trials is challenging, and few evidence-based interventions to improve enrollment exist. Provider-facing advertising campaigns could help increase enrollment, but this type of intervention has not been prospectively evaluated in a clinical trial.

Methods

We designed a randomized clinical trial to evaluate the effect of a month-long email advertising campaign on enrollment to a clinical trial. This hybrid implementation-effectiveness Study Within a Trial tested the effect of precision audit and feedback techniques enrollment effectiveness outcomes (enrollment) and measured implementation outcomes (email opens, link clicks). This design is an application of a Study Within a Trial (SWAT) to evaluate an intervention intended to improve enrollment. The goal of this study was to inform both this advertising campaign and refine SWAT methods for evaluating future trial improvement interventions.

Discussion

This Study Within a Trial provides preliminary data on the effectiveness of email advertising campaigns for improving clinical trial enrollment. Additionally, the infrastructure built through this SWAT will inform future studies of clinical trial enrollment improvement. This protocol can serve as a template for other investigators seeking to evaluate enrollment improvement interventions.

临床试验的入组具有挑战性，并且很少有基于证据的干预措施来改善入组。面向医疗服务提供者的广告活动可能有助于增加注册人数，但这种类型的干预尚未在临床试验中进行前瞻性评估。方法：我们设计了一项随机临床试验来评估为期一个月的电子邮件广告活动对临床试验报名的影响。这项混合实施-有效性的试验研究测试了精确审计和反馈技术的效果，登记有效性结果（登记）和测量实施结果（电子邮件打开，链接点击）。本设计是一项试验中研究（SWAT）的应用，旨在评估旨在提高入组率的干预措施。本研究的目的是为广告宣传和改进SWAT方法提供信息，以评估未来的试验改进干预措施。本试验研究为电子邮件广告活动对提高临床试验入组率的有效性提供了初步数据。此外，通过SWAT建立的基础设施将为临床试验注册改进的未来研究提供信息。该方案可以作为其他研究者寻求评估入组改善干预措施的模板。

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引用次数: 0

Randomized trial of multi-strain Lactobacillus crispatus vaginal live biotherapeutic products after antibiotic therapy for bacterial vaginosis: study protocol for VIBRANT (vaginal lIve biotherapeutic RANdomized trial) 细菌性阴道病抗生素治疗后多菌种crispr乳杆菌阴道活生物治疗产品的随机试验：研究方案（阴道活生物治疗随机试验）

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-09-16 DOI: 10.1016/j.conctc.2025.101554

Callin Chetty , Nomfuneko Mafunda , Anna-Ursula Happel , Anam Khan , Briah Cooley Demidkina , Nonhlanhla Yende-Zuma , Yusra Saidi , Asthu Mahabeer Polliah , Lara Lewis , Farzana Osman , Precious Radebe , Jo-Ann S. Passmore , Doug Kwon , Jacques Ravel , Sinaye Ngcapu , Lenine Liebenberg , Laura Symul , Susan Holmes , Caroline M. Mitchell , Disebo Potloane

Background

Globally, approximately 30 % of women have bacterial vaginosis (BV). Antibiotic treatment is frequently followed by recurrence, likely due to lack of colonization with beneficial lactobacilli.

Methods

This is a Phase 1, randomized, placebo-controlled trial of vaginal live biotherapeutic products (LBP) after antibiotic treatment for BV to establish Lactobacillus colonization. The LBP are vaginal tablets containing 6 L. crispatus strains (LC106) or 15 L. crispatus strains (LC115), at 2 x 10⁹ colony forming units (CFU) per dose. Participants with BV in the United States and South Africa will receive seven days of oral metronidazole twice daily and will be randomized 1:1:1:1:1 to: seven days placebo; seven days LC106; three days LC106/four days placebo; seven days LC106 starting day 3 of the metronidazole course; or seven days LC115. Safety will be assessed by the number and percentage of ≥ Grade 2 related adverse events during or after product use. The primary outcome is LBP colonization defined as relative abundance ≥5 % of any LBP strain or ≥10 % of a combination of LBP strains by metagenomic sequencing any time in the 5 weeks after randomization. A generalized linear model will measure the association between treatment group and colonization, adjusting for site.

Conclusions

This study seeks to establish proof of concept for a multi-strain LBP to promote vaginal L. crispatus colonization in two geographically distinct populations.

Trial registration

South African National Clinical Trials Registry (SANCTR DOH-27-102023-8342; October 27, 2023) and ClinicalTrials.gov (NCT06135974; November 11, 2023).

Protocol version

2.0 dated October 03, 2023.

在全球范围内，大约30%的女性患有细菌性阴道病（BV）。抗生素治疗后经常复发，可能是由于缺乏有益的乳酸菌定植。方法：这是一项随机、安慰剂对照的i期临床试验，研究阴道活生物治疗产品（LBP）在抗生素治疗细菌性阴道炎后建立乳杆菌定植。LBP是阴道片剂，含有6株葡萄球菌（LC106）或15株葡萄球菌（LC115），每剂量2 × 109菌落形成单位（CFU）。美国和南非的BV患者将接受为期7天的甲硝唑口服治疗，每日两次，并将按1:1:1:1:1随机分配至：7天安慰剂；7天LC106；3天LC106/ 4天安慰剂；7天LC106，甲硝唑疗程第3天开始；或7天LC115。安全性将通过产品使用期间或使用后≥2级相关不良事件的数量和百分比进行评估。主要终点是LBP定殖，定义为随机分组后5周内任何时间任何LBP菌株的相对丰度≥5%或LBP菌株组合的相对丰度≥10%。一个广义的线性模型将测量治疗组和定植之间的关系，调整地点。结论本研究旨在建立多菌株LBP在两个地理上不同的人群中促进阴道crispatus定植的概念证明。试验注册：南非国家临床试验注册中心（SANCTR DOH-27-102023-8342； 2023年10月27日）和ClinicalTrials.gov （NCT06135974； 2023年11月11日）。协议版本2.0，日期为2023年10月3日。

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引用次数: 0

Unmasking three blinding indices for randomized controlled trials: comparison and application 随机对照试验中三个盲指标的揭示：比较与应用

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-09-16 DOI: 10.1016/j.conctc.2025.101553

Javier Muñoz Laguna , Jafar Kolahi , Heejung Bang

Blinding is an important methodological aspect of randomized controlled trials. Although three blinding indices are available for the estimation of blinding in clinical trials, little guidance is available regarding their comparison and application. Here, we compared three blinding indices and applied them to hypothetical and real-world clinical trial data. Through this comparison and application tutorial, we identified strengths and limitations of each blinding index. Our findings provide insights into the assessment, estimation and reporting of blinding in randomized controlled trials.

盲法是随机对照试验的一个重要方法学方面。在临床试验中，虽然有三个盲化指标可用于盲化的估计，但在它们的比较和应用方面却缺乏指导。在这里，我们比较了三个盲法指标，并将它们应用于假设的和现实世界的临床试验数据。通过这个比较和应用教程，我们确定了每个盲化指标的优势和局限性。我们的研究结果为随机对照试验中盲法的评估、估计和报告提供了见解。

引用次数: 0

Efficacy of an integrated treatment for fathers with Co-occurring substance misuse and family violence 药物滥用与家庭暴力并存的父亲的综合治疗效果

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-09-16 DOI: 10.1016/j.conctc.2025.101555

Carla S. Stover , Sarah Meshberg-Cohen , Galina A. Portnoy , Satvika Char , Carter W. McCaskill , Quyen A. Do , James Dziura , Steve Martino

Substance Use (SU) and Family Violence (FV) are both critical public health concerns and often occur together. However, most existing interventions target only one of these problems, without consideration of the other, and fail to address when individuals with these issues are parents. The current Stage II randomized clinical trial (RCT) aims to compare two individually delivered interventions, Fathers for Change (F4C) and Individual Drug Counseling (IDC) in 280 fathers who have used physical or psychological violence towards a partner, have a substance use disorder, and have a biological child between the ages of 3 months and 12 years. They will be recruited from two locations (Department of Veteran Affairs [VA] and community substance use treatment clinic). This efficacy study aims to demonstrate that F4C can achieve comparable SU reductions to IDC, while also reducing FV, with increases in emotion regulation meditating the relationship between the intervention group and reduced SU and FV. Findings from this study have large scale clinical and public health implications that can help target and address co-occurring SU and FV and mitigate negative outcomes for affected children and families.

物质使用（SU）和家庭暴力（FV）都是严重的公共卫生问题，并且经常同时发生。然而，大多数现有的干预措施只针对其中一个问题，而没有考虑到其他问题，并且无法解决有这些问题的人是父母的问题。目前的II期随机临床试验（RCT）旨在比较两种单独提供的干预措施，父亲改变（F4C）和个人药物咨询（IDC）， 280名父亲对伴侣有身体或心理暴力，有物质使用障碍，有一个3个月到12岁的亲生孩子。他们将从两个地点（退伍军人事务部[VA]和社区药物使用治疗诊所）招募。本疗效研究旨在证明F4C可以达到与IDC相当的SU降低，同时也可以降低FV，情绪调节的增加可以解释干预组与SU和FV降低之间的关系。这项研究的结果具有大规模的临床和公共卫生意义，可以帮助瞄准和解决同时发生的SU和FV，并减轻受影响儿童和家庭的负面后果。

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引用次数: 0

Project Safe Guard–Trauma (PSG-T): Protocol for a randomized controlled trial of lethal means safety counseling to promote secure firearm storage among individuals with PTSD 项目安全保护-创伤（PSG-T）：一项随机对照试验的方案，致命手段安全咨询，以促进创伤后应激障碍患者的安全枪支储存

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-09-10 DOI: 10.1016/j.conctc.2025.101549

Ian H. Stanley , Julia Finn , Kathleen M. Flarity , Mengli Xiao , Rachel L. Johnson , Jaclyn C. Kearns , Natalie L. Wilver , Steven J. Berkowitz , Michael D. Anestis , Marian E. Betz , Joseph A. Simonetti

Firearm injury is the most common suicide method. When firearms are stored in a non-secure manner (e.g., unlocked, loaded), risk for suicide may be elevated. Accordingly, clinical, public health, and firearm industry stakeholders recommend efforts to promote secure firearm storage, such as lethal means safety counseling (LMSC). One LMSC intervention, Project Safe Guard (PSG), has demonstrated efficacy in prompting use of firearm locking devices in a sample of military service members; however, subsequent analyses show that PSG has diminished efficacy for individuals with elevated symptoms of posttraumatic stress disorder (PTSD). PTSD, characterized in part by hypervigilance to threat, is associated with elevated suicide risk as well as a greater likelihood of storing firearms using less secure methods. In response, our group developed an adaptation of PSG, termed Project Safe Guard-Trauma (PSG-T). This paper describes the design, methodology, and protocol of a randomized controlled trial comparing PSG-T to PSG among adults who screen positive for PTSD related to a victimization trauma (e.g., physical assault, sexual assault, combat) and who do not currently store all their personally owned firearms in a secure manner. PSG and PSG-T will be delivered by licensed clinical psychologists. Assessments will occur at pre-intervention, post-intervention, and 1-, 3-, and 6-month follow-up. The primary objective is to determine the efficacy of PSG-T in prompting greater beliefs and practices regarding secure storage of personal firearms.

枪械伤害是最常见的自杀方式。当枪支以不安全的方式储存时（如未上锁、未上膛），自杀的风险可能会增加。因此，临床、公共卫生和枪支行业利益相关者建议努力促进安全枪支储存，例如致命手段安全咨询（LMSC）。一项LMSC干预，项目安全保护（PSG），已经证明了在军事服务成员样本中促使使用枪支锁定装置的有效性；然而，随后的分析表明，PSG对创伤后应激障碍（PTSD）症状升高的个体的疗效降低。创伤后应激障碍的部分特征是对威胁的高度警惕，与自杀风险增加以及使用不太安全的方法储存枪支的可能性增加有关。作为回应，我们的小组开发了PSG的改编，称为项目安全保护-创伤（PSG- t）。本文描述了一项随机对照试验的设计、方法和方案，比较PSG- t和PSG在与受害创伤（例如，身体攻击、性侵犯、战斗）相关的创伤后应激障碍筛查呈阳性的成年人中，以及目前没有以安全的方式储存所有个人拥有的枪支。PSG和PSG- t将由持牌临床心理学家提供。评估将在干预前、干预后以及1个月、3个月和6个月的随访中进行。主要目标是确定PSG-T在促进更多关于个人枪支安全储存的信念和做法方面的功效。

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引用次数: 0

Use of patient-reported outcomes version of the common terminology criteria for adverse events in oncology clinical trials 肿瘤临床试验中不良事件通用术语标准的患者报告结果版本的使用

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-09-02 DOI: 10.1016/j.conctc.2025.101547

Lauren Rogak , Jamie K. Forschmiedt , Ethan Basch , Gina L. Mazza , Minji K. Lee , Eric A. Meek , Brenda Ginos , Blake T. Langlais , Brie N. Noble , Allison M. Deal , Claire Yee , Gita Thanarajasingam , Amylou C. Dueck

The Patient-Reported Outcomes version of the Common Terminology for Adverse Events® (PRO-CTCAE®) item library enables patient self-reporting of symptoms in cancer clinical trials. It was developed as a companion to CTCAE v4.0. The aim of this analysis is to understand how PRO-CTCAE has been used since its release. Trials using PRO-CTCAE were identified on clinicaltrials.gov. Trial characteristics were descriptively analyzed. Number of trials by year posted on clinicaltrials.gov was tested for increasing trend using Poisson regression. Among 327 identified trials, 318 (97 %) were in oncology, 269 (82 %) were interventional, and 170 (52 %) were randomized. Number of trials significantly increased over time (P < .001). PRO-CTCAE has had substantial and growing use in oncology trials since its release.

不良事件通用术语®（PRO-CTCAE®）项目库的患者报告结果版本使患者能够在癌症临床试验中自我报告症状。它是作为CTCAE v4.0的伙伴开发的。本分析的目的是了解PRO-CTCAE自发布以来的使用情况。使用PRO-CTCAE的试验已在clinicaltrials.gov上确认。对试验特征进行描述性分析。使用泊松回归对发布在clinicaltrials.gov上的年度试验数量进行了增加趋势测试。在327项确定的试验中，318项（97%）为肿瘤学试验，269项（82%）为介入性试验，170项（52%）为随机试验。试验数量随时间显著增加（P < .001）。自发布以来，PRO-CTCAE在肿瘤学试验中有了大量且不断增长的应用。

引用次数: 0

Optimising clinical trial management in Spain: The CARABELA-Clinical trials framework integrating healthcare models and subject experiences 优化西班牙的临床试验管理：carabela -临床试验框架整合了医疗模式和受试者经验

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-09-01 DOI: 10.1016/j.conctc.2025.101544

Carlos Almonacid , Borja G. Cosío , Xavier Muñoz Gall , Manuel Santiñà Vila , Jaime Signes-Costa , José Luis Velasco Garrido , Mercedes Luz , Marta Rodríguez , Alberto Godos , Ana Pérez Domínguez , Eunice Funenga , Carmen Moreno

Clinical trials (CT) are the framework upon which novel treatments' safety and efficacy are assessed. The CARABELA-CT initiative aims to optimise Spanish CT procedures by improving efficiency, quality, and subject well-being. To this, it characterised CT healthcare models, identified improvement areas, proposed solutions, and gathered important insights from CT subjects. CARABELA-CT took a three-phase approach. Phase I involved CT healthcare models’ characterisation, including all clinical investigation processes in Spain, across six pilot hospitals, identifying improvement areas and solutions. Phase II validated these findings, defining key healthcare quality indicators. Phase III focused on dissemination and implementation. Additionally, seven randomly invited CT subjects participated in a focus group to share their experiences regarding communication, coordination, and CT impact on quality of life. Three CT healthcare models were identified, distinguished according to access, infrastructure, and resources. Twelve improvement areas were defined, leading to 38 solutions addressing subject education, professional training, organisation, protocols, resources, and technology. Twenty-four healthcare quality indicators were established to monitor CT processes. Subject experiences highlighted the need for clearer communication, digitalised information, and improved subject support, and revealed the emotional and psychological benefits of CT participation, despite the challenges. CARABELA-CT provides a comprehensive framework to enhance Spanish CT processes. This initiative integrates potential solutions in improvement areas in CT development and the corresponding healthcare quality indicators, and prioritises subject experiences to foster efficiency, participant engagement, and a sustainable, patient-centric clinical research model. These findings contribute to the continuous improvement of CT management, ultimately optimising research execution and healthcare outcomes.

临床试验（CT）是评估新疗法安全性和有效性的框架。CARABELA-CT计划旨在通过提高效率、质量和受试者福祉来优化西班牙CT程序。为此，本文描述了CT医疗模式，确定了改进领域，提出了解决方案，并从CT受试者那里收集了重要的见解。CARABELA-CT采用三阶段方法。第一阶段涉及CT医疗模式的特征，包括西班牙六家试点医院的所有临床调查过程，确定改进领域和解决方案。第二阶段验证了这些发现，定义了关键的医疗质量指标。第三阶段侧重于传播和执行。此外，随机邀请7名CT受试者参加焦点小组，分享他们在沟通、协调和CT对生活质量影响方面的经验。确定了三种CT医疗保健模式，并根据访问、基础设施和资源进行了区分。确定了12个改进领域，导致38个解决方案，涉及学科教育、专业培训、组织、协议、资源和技术。建立了24项保健质量指标来监测CT过程。受试者体验强调了对更清晰的沟通、数字化信息和改进的受试者支持的需求，并揭示了参与CT的情感和心理益处，尽管存在挑战。CARABELA-CT提供了一个全面的框架，以加强西班牙CT过程。该计划整合了CT开发改进领域的潜在解决方案和相应的医疗质量指标，并优先考虑受试者体验，以提高效率、参与者参与度和可持续的、以患者为中心的临床研究模式。这些发现有助于持续改进CT管理，最终优化研究执行和医疗保健结果。

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引用次数: 0

Study protocol for Project SHINE (Sleep Health INitiative for Equity): A community-based pilot RCT to promote sleep and physical activity among Black/African American adults SHINE项目（促进公平睡眠健康倡议）的研究方案：一项以社区为基础的试验随机对照试验，旨在促进黑人/非裔美国成年人的睡眠和体育活动

IF 1.4 Q4 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary Clinical Trials Communications

Pub Date : 2025-08-29 DOI: 10.1016/j.conctc.2025.101541

Ivan HC. Wu , Lorna McNeill , Kristen Knutson , Yisheng Li , Diwakar Balachandran , Rhonda Jones-Webb , Pamela L. Lutsey , Darin Erikson , Shikha Bista , Rachel Price , Vanessa Anyanso , Taylor Smith , Rev Melvin Miller

Background

Black/African American (AA) adults experience shorter sleep duration and poorer sleep quality compared to White counterparts, contributing to higher risks of chronic diseases. Project SHINE (Sleep Health INitiative for Equity) aims to address these sleep disparities by evaluating the feasibility, satisfaction, and plausibility (i.e., preliminary efficacy) of a culturally tailored sleep intervention designed to improve sleep duration and physical activity among AA adults with body mass index (BMI) ≥ 25 not meeting physical activity and sleep guideline recommendations.

Methods

This pilot community-based randomized controlled trial (RCT) includes two phases. Phase 1 involves qualitative interviews with AA adults to explore sleep-related sociocontextual factors to refine the intervention. Phase 2 is an RCT (n = 80) assigning participants to a four-week sleep extension intervention or a contact control. The sleep extension intervention aims to improve sleep duration and physical activity. Sessions occur via Zoom, with in-person baseline and follow-up visits. Primary outcomes include feasibility and satisfaction of the intervention. Secondary outcomes include self-reported and objective sleep and physical activity measures, plus exploratory biomarkers for cancer and cardiovascular risk. Additional self-reports assess sleep-related psychosocial factors and health behaviors.

Discussion

This study will assess the feasibility and implementation of a culturally tailored, virtual sleep intervention for AA adults. By integrating behavior change theories, cultural adaptation frameworks, and community-based participatory principles, Project SHINE aims to inform a larger-scale trial and support scalable behavioral interventions to improve sleep health and reduce disparities.

背景：与白人相比，黑人/非裔美国人（AA）成年人的睡眠时间更短，睡眠质量更差，这导致他们患慢性病的风险更高。SHINE项目（Sleep Health INitiative for Equity，睡眠健康公平倡议）旨在通过评估一种文化量身定制的睡眠干预的可行性、满意度和合理性（即初步疗效）来解决这些睡眠差异，该干预旨在改善体重指数(BMI)≥25的AA级成人的睡眠时间和身体活动，这些成年人不符合身体活动和睡眠指南的建议。方法以社区为基础的随机对照试验（RCT）分为两个阶段。第一阶段包括对AA成人进行定性访谈，以探索与睡眠相关的社会背景因素，以完善干预措施。第二阶段是一项随机对照试验（n = 80），分配参与者进行为期四周的睡眠延长干预或接触控制。睡眠延长干预旨在改善睡眠时间和身体活动。会议通过Zoom进行，包括面对面的基线和后续访问。主要结局包括干预的可行性和满意度。次要结果包括自我报告和客观的睡眠和身体活动测量，以及癌症和心血管风险的探索性生物标志物。额外的自我报告评估睡眠相关的心理社会因素和健康行为。本研究将评估一种针对嗜酒者的虚拟睡眠干预的可行性和实施。通过整合行为改变理论、文化适应框架和社区参与原则，SHINE项目旨在为更大规模的试验提供信息，并支持可扩展的行为干预措施，以改善睡眠健康并减少差异。

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引用次数: 0