Contemporary clinical trials最新文献

Virtual Intervention for Binge Eating (VIBE): Study protocol for a user-informed mobile intervention for dysregulated eating and weight gain prevention in adolescents 暴饮暴食的虚拟干预（VIBE）：针对青少年饮食失调和体重增加预防的用户知情移动干预研究方案

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2025-12-18 DOI: 10.1016/j.cct.2025.108192

Andrea B. Goldschmidt , Adrian Ortega , Isabel R. Rooper , Katrina T. Obleada , Danielle A.N. Chapa , Basia Silverberg , Erin Stalvey , Macarena Kruger Camino , Michele D. Levine , Lan Yu , Dawn M. Eichen , Andrea K. Graham

Background

Pediatric overweight and obesity continue to be major public health issues. Loss of control (LOC) eating and overeating are two obesity-related phenotypes affecting approximately 30 % of adolescents with overweight/obesity that may undermine weight control treatment outcome. Cognitive-behavioral therapy (CBT) has promising effects on dysregulated eating, but effects on weight are modest, access is limited, and developmental changes in self-regulation (which may limit implementation of treatment skills) are often ignored. Methods: In the current proposal, we will apply human-centered design methods to design and test a novel CBT-based digital intervention, augmented with content and features to improve self-regulation, for weight gain prevention and dysregulated eating in adolescents. The first phase will involve design activities with adolescents (n = 25–30) who have body mass index (BMI; kg/m²) ≥ 75th percentile for age and sex and report dysregulated eating, to understand desired presentation, features, and barriers/facilitators to engagement. Research activities will include a needs assessment and iterative prototyping, usability testing, and refinement of the digital intervention. The second phase will be a multisite single arm open trial involving 50 adolescents who have or are at risk for overweight/obesity and report LOC and/or overeating to investigate intervention feasibility and preliminary efficacy, as well as putative treatment mechanisms and targets. Conclusions: Results of the study will inform the design of an adequately powered randomized controlled trial. The project has clear potential to significantly impact public health via development of a relevant, accessible, and scalable intervention for adolescents at risk for adverse physical and mental health outcomes.

Clinical trial registration number: NCT06819813

儿童超重和肥胖仍然是主要的公共卫生问题。饮食失控（LOC）和暴饮暴食是两种与肥胖相关的表型，影响了大约30%的超重/肥胖青少年，这可能会破坏体重控制治疗结果。认知行为疗法（CBT）对饮食失调有很好的效果，但对体重的影响不大，获取途径有限，而且自我调节的发育变化（这可能限制治疗技巧的实施）经常被忽视。方法：在当前的提案中，我们将应用以人为本的设计方法来设计和测试一种新的基于cbt的数字干预，增强内容和功能，以提高自我调节，预防青少年体重增加和饮食失调。第一阶段将涉及青少年（n = 25-30）的设计活动，他们的身体质量指数(BMI; kg/m2)≥年龄和性别的第75个百分位数，并报告饮食失调，以了解期望的表现、特征和参与的障碍/促进因素。研究活动将包括需求评估和迭代原型、可用性测试以及数字干预的细化。第二阶段将是一项多地点单臂开放试验，涉及50名患有或有超重/肥胖风险并报告LOC和/或暴饮暴食的青少年，以调查干预的可行性和初步疗效，以及假定的治疗机制和目标。结论：研究结果将为设计一项足够有力的随机对照试验提供信息。该项目显然有可能通过为面临不利身心健康结果风险的青少年制定相关、可获得和可扩展的干预措施，对公共卫生产生重大影响。临床试验注册号：NCT06819813

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引用次数: 0

Geographic location and clinical trial knowledge, invitation, and participation among adults in the United States. 美国成年人的地理位置和临床试验知识、邀请和参与。

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2025-12-18 DOI: 10.1016/j.cct.2025.108193

Henry K Onyeaka, Manfred N Mate-Kole, Irene A Acheampong, Abigail Arthur, M Tim Song, Ted O Akhiwu, Diana Mensah, Chioma Ozoalor, Onyema G Chido-Amajuoyi, Hermioni L Amonoo

Background/aims: Clinical trials are essential to evaluating novel treatments and improving disease-related outcomes through innovative therapies. Despite underrepresentation of rural communities in clinical trial outreach and participation, geographic disparities in clinical trials have been minimally explored. We examined clinical trial knowledge, invitation, and participation among participants in urban and rural geographic locations in the United States.

Methods: We conducted cross-sectional data analysis on self-reported data from Health Information National Trends Survey (HINTS) 5 Cycle 4. Population-level estimates were obtained using jack-knife replicate weights.

Results: Geographic location was not associated with clinical trial knowledge, invitation, and participation. However, the relatively low absolute invitation rates across urban and rural populations may suggest that substantial gaps in recruitment persist universally, regardless of geographic location in the United States.

Conclusions: In this nationally representative study, we found no statistically significant differences in clinical trial knowledge, invitation or participation by geographical location in the United States. Our findings suggest that geographic residence may not be a primary barrier to clinical trial engagement once sociodemographic differences are accounted for. Targeted efforts to improve awareness and reduce structural barriers, along with continued investment in equitable recruitment strategies, will be important to ensuring that clinical trials reflect the diversity of the populations they aim to serve.

背景/目的：临床试验对于评估新疗法和通过创新疗法改善疾病相关结局至关重要。尽管农村社区在临床试验推广和参与方面的代表性不足，但对临床试验的地理差异进行了最低限度的探索。我们检查了美国城乡参与者的临床试验知识、邀请和参与情况。方法：对健康信息全国趋势调查（HINTS） 5 Cycle 4的自报数据进行横断面数据分析。使用千斤顶重复权重获得种群水平估计值。结果：地理位置与临床试验知识、邀请和参与无关。然而，城市和农村人口相对较低的绝对邀请率可能表明，无论美国的地理位置如何，招聘方面的巨大差距都普遍存在。结论：在这项具有全国代表性的研究中，我们发现美国临床试验知识、邀请或参与的地理位置没有统计学上的显著差异。我们的研究结果表明，一旦考虑到社会人口统计学差异，地理居住地可能不是临床试验参与的主要障碍。提高认识和减少结构性障碍的有针对性的努力，以及对公平招聘战略的持续投资，对于确保临床试验反映其目标服务人群的多样性至关重要。

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引用次数: 0

Remotely-delivered exercise training program among older adults with multiple sclerosis: Feasibility results of a randomized controlled trial 老年多发性硬化症患者远程运动训练项目：一项随机对照试验的可行性结果

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2025-12-17 DOI: 10.1016/j.cct.2025.108190

Peixuan Zheng , Sydney R. DeJonge , Noah G. DuBose , Ariel Kidwell-Chandler , Trevor B. Martin , Trinh L.T. Huynh , Shane A. Phillips , Jennifer Duffecy , Robert W. Motl

Background

Older adults with multiple sclerosis (MS) are often physically inactive and present with walking and cognitive impairments that may be remediated through rehabilitation approaches such as exercise training.

Objectives

We conducted a phase-Ib, randomized controlled trial (RCT) that examined the feasibility and initial efficacy of a 16-week remotely-delivered, home-based exercise training program in older adults with MS who had moderate mobility disability.

Methods

This study utilized a parallel-group RCT design. Participants (n = 51; mean age = 60.5 years, 78 % females) were randomized into exercise training (aerobic and resistance) or active control (stretching) conditions. Both conditions were undertaken within a participant's home/community and remotely supported by a behavioral coach. Participants received training manuals and equipment, one-on-one behavioral coaching, action-planning calendars, self-monitoring logs, and social cognitive theory-based newsletters. Feasibility was assessed across process, resource, management, and scientific domains. Scientific outcomes focused on physical function, cognition, and physical activity, with data collected by treatment-blinded assessors.

Results

The intervention was cost-effective, accessible, well-received, and safe based on formative evaluation. Forty-one (80.4 %) participants completed the conditions, with adherence and compliance rates across conditions exceeding 80 %. There were moderate-to-large improvements in walking speed, functional mobility, lower-extremity function, and verbal learning and memory (p < 0.05, |d| = 0.58–0.80) in the exercise condition, but not in control (p > 0.05).

Conclusions

This study established the feasibility and initial efficacy of a theory-based, remotely-delivered exercise training intervention for older adults with MS. The promising results support the design and implementation of a subsequent, phase-II RCT for improving physical and cognitive functions in the older MS population.

背景：患有多发性硬化症（MS）的老年人通常缺乏运动，并且存在行走和认知障碍，这些障碍可以通过运动训练等康复方法来修复。目的：我们进行了一项ib期随机对照试验（RCT），研究了一项为期16周的远程递送、基于家庭的运动训练计划在患有中度行动障碍的老年MS患者中的可行性和初步疗效。方法采用平行组随机对照试验设计。参与者（n = 51，平均年龄= 60.5岁，78%为女性）被随机分为运动训练（有氧和阻力）和主动控制（拉伸）两组。这两种情况都是在参与者家中/社区进行的，并由行为教练远程支持。参与者收到了培训手册和设备、一对一的行为指导、行动计划日历、自我监控日志和基于社会认知理论的新闻通讯。可行性是跨过程、资源、管理和科学领域进行评估的。科学结果集中于身体功能、认知和身体活动，数据由治疗盲法评估者收集。结果在形成性评价的基础上，该干预具有成本效益、可及性、良好的接受度和安全性。41名（80.4%）参与者完成了条件，各条件的依从性和依从率超过80%。运动组在步行速度、功能活动能力、下肢功能和语言学习记忆方面均有中重度改善（p < 0.05, |d| = 0.58-0.80），对照组无显著改善（p > 0.05）。本研究建立了一种基于理论的远程运动训练干预对老年MS患者的可行性和初步疗效，这一令人鼓舞的结果支持了后续ii期随机对照试验的设计和实施，以改善老年MS人群的身体和认知功能。

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引用次数: 0

Basic needs navigation intervention to address multidimensional adversity in African Americans with diabetic kidney disease: A pilot randomized clinical trial protocol. 基本需求导航干预解决非裔美国糖尿病肾病患者的多维逆境：一项试点随机临床试验方案

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2025-12-17 DOI: 10.1016/j.cct.2025.108183

Mukoso N Ozieh, Charity G Patterson, Joni S Williams, Rebekah J Walker, Leonard E Egede

Background: Diabetic kidney disease (DKD) is the leading cause of end stage kidney disease (ESKD) in the United States. African Americans have a risk of developing chronic kidney disease and are almost four times more likely to progress to ESKD compared to non-Hispanic whites. The presence of social adversities impacts the complex self-management of DKD and negatively impacts health outcomes. Patient navigation interventions offer a promising strategy to improve health outcomes in individuals with chronic disease. However, it is not known whether a basic needs navigation intervention that addresses social adversities in combination with patient education and lifestyle coaching leads to improved clinical and patient-centered outcomes.

Methods and analysis: This ongoing 3-year two-arm pilot randomized clinical trial will test the feasibility of a basic needs navigation intervention in African American adults with DKD experiencing multidimensional adversity (having one or more social adversity). Fifty African American adults with DKD experiencing one or more social adversity and who have uncontrolled diabetes (HbA1c 8 % or more) will be randomized into one of two arms: 1) basic needs navigation intervention arm or 2) enhanced usual care arm. The primary clinical outcome is feasibility of the basic needs navigation intervention as measured by recruitment, session attendance and retention.

Discussion: The results of this study will serve as a first step in addressing current gaps in knowledge and will provide feasibility data for a large-scale appropriately powered, randomized clinical trial focused on addressing social adversity in African American adults with DKD.

Ethics and dissemination: This trial was approved by Medical College of Wisconsin IRB Protocol # PRO00041675.

Trial registration number: Registration for this trial can be found under ID: NCT05357742 and online (https://clinicaltrials.gov/ct2/show/NCT05357742?id=NCT05357742&draw=2&rank=1) on the NIH U.S. National Library of Medicine Clinical Trials Database.

背景：糖尿病肾病（DKD）是美国终末期肾病（ESKD）的主要原因。非裔美国人有患慢性肾脏疾病的风险，与非西班牙裔白人相比，他们发展为ESKD的可能性几乎是后者的四倍。社会逆境的存在影响了DKD复杂的自我管理，并对健康结果产生负面影响。患者导航干预提供了一个有希望的策略，以改善个人健康结果与慢性疾病。然而，目前尚不清楚的是，解决社会逆境的基本需求导航干预与患者教育和生活方式指导相结合是否会改善临床和以患者为中心的结果。方法和分析：这项正在进行的为期3年的两组随机临床试验将测试基本需求导航干预在经历多维逆境（有一个或多个社会逆境）的非洲裔美国成人DKD患者中的可行性。50名患有DKD的非裔美国成年人经历一个或多个社会逆境，并患有未控制的糖尿病（HbA1c为8.0 %或更高），将被随机分为两组：1)基本需求导航干预组或2)强化常规护理组。主要临床结果是基本需求导航干预的可行性，通过招募，会议出席率和保留来衡量。讨论：本研究的结果将作为解决当前知识空白的第一步，并将为大规模适当的随机临床试验提供可行性数据，该试验的重点是解决非洲裔美国成人DKD患者的社会逆境。伦理与传播：该试验已获得威斯康星医学院IRB协议# PRO00041675的批准。试验注册号：该试验的注册可以在ID: NCT05357742和NIH美国国家医学临床试验数据库在线（https://clinicaltrials.gov/ct2/show/NCT05357742?id=NCT05357742&draw=2&rank=1）上找到。

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引用次数: 0

Corrigendum to “Engaging fathers in the first 1000 days to improve perinatal outcomes and prevent obesity: Rationale and design of the First Heroes randomized trial,” [Contemp Clin Trials 101 (2021) 106253] “让父亲参与前1000天改善围产期结局和预防肥胖：第一英雄随机试验的基本原理和设计”的勘误表[当代临床试验101(2021)106253]。

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2025-12-17 DOI: 10.1016/j.cct.2025.108181

Rachel C. Whooten , Gracia M. Kwete , Haley Farrar-Muir , Rachel N. Cournoyer , Elizabeth A. Barth , Milton Kotelchuck , Elsie M. Taveras

引用次数: 0

Sequential choice vs colonoscopy outreach for colorectal cancer screening: Design and rationale of a pragmatic randomized clinical trial 顺序选择vs结肠镜外展结直肠癌筛查：一项实用的随机临床试验的设计和基本原理。

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2025-12-16 DOI: 10.1016/j.cct.2025.108188

Shivan J. Mehta , Pamela A. Shaw , Catherine Reitz , Caitlin Brophy , Evelyn Okorie , Keyirah Williams , Abraham Segura , Jinming Tao , Christopher K. Snider , Colin Wollack , Sadie Friday , Katharine A. Rendle , Tamar Klaiman , Karen Glanz , Corinne Rhodes , David A. Asch

Background

Colorectal cancer (CRC) screening rates remain limited, and effective methods for offering the choice of colonoscopy or stool testing through outreach have not been identified. We evaluate the effect of sequential choice compared to colonoscopy outreach on screening completion, and further evaluate behavioral nudges in the electronic health record (EHR).

Methods

In this pragmatic randomized clinical trial, patients were randomly allocated in a 1:2:2 ratio to 1) usual care (no outreach), 2) colonoscopy only, or 3) sequential choice of colonoscopy, then fecal immunochemical testing (FIT). Patients in arms 2 and 3 were additionally randomized to receive either (a) usual care, or (b) a visit-based, clinician-directed nudge facilitated by the EHR with follow-up texting to the patient. The primary outcome is CRC screening completion within 3 years by either colonoscopy, 2 negative fecal immunochemical tests (FIT), or 1 positive FIT followed by colonoscopy within one year.

Analysis

For the patient-directed analysis, the primary outcome will be evaluated by comparing CRC screening completion among patients randomized to either outreach arm (2 or 3) to the no outreach arm (1). We will also compare completion between the colonoscopy only arm (1) and the sequential choice arm (2). For the visit-based analysis, we will compare CRC screening completion among patients between the usual care arms (2a and 3a) and the nudge arms (2b and 3b).

Conclusion

This trial is unique in evaluating the long-term effectiveness of offering sequential choice to colonoscopy alone through a multi-level, centralized outreach and visit-based design.

Clinical Trials Identifier: NCT05693649

背景：结直肠癌（CRC）筛查率仍然有限，通过外展提供结肠镜检查或粪便检查选择的有效方法尚未确定。我们评估了顺序选择与结肠镜检查外展对筛查完成的影响，并进一步评估了电子健康记录（EHR）中的行为推动。方法：在这项实用的随机临床试验中，患者按1:2:2的比例随机分配到1)常规护理（无外诊），2)仅结肠镜检查，或3)结肠镜检查和粪便免疫化学检查（FIT）的顺序选择。第2组和第3组的患者另外随机接受(a)常规护理，或(b)由EHR促进的以就诊为基础的临床指导的轻推，并向患者发送后续短信。主要结局是在3 年内通过结肠镜检查完成CRC筛查，2例粪便免疫化学试验（FIT）阴性，或1例FIT阳性并在一年内进行结肠镜检查。分析：对于以患者为导向的分析，将通过比较随机分配到外展组（2或3）和未外展组(1)的患者的CRC筛查完成情况来评估主要结果。我们还将比较结肠镜组(1)和顺序选择组(2)的结肠镜完成情况。对于基于访问的分析，我们将比较常规护理组（2a和3a）和助推组（2b和3b）患者的CRC筛查完成情况。结论：该试验通过多层次、集中的外展和基于访问的设计，在评估单独结肠镜检查的顺序选择的长期有效性方面是独一无二的。临床试验标识符：NCT05693649。

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引用次数: 0

Design of the FRESH-LC study: Caregivers as the agent of change for childhood obesity and chronic disease risk among Latino families. FRESH-LC研究的设计：照顾者作为拉丁裔家庭儿童肥胖和慢性疾病风险变化的中介。

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2025-12-16 DOI: 10.1016/j.cct.2025.108191

Kerri N Boutelle, Dawn M Eichen, Michael Manzano, Noe C Crespo, Ingrid Rivera-Iniguez, Eduardo Castro, David R Strong, Isabella Newell, Kristie Reed, Becky Marquez, Kyung E Rhee

Latino children are disproportionally affected by overweight and obesity (OW/OB). Family-based behavioral treatment (FBT) is the most empirically supported treatment for children with OW/OB and traditionally includes a child and a caregiver. Very few FBT programs have been tested among Latino families, and to date, outcomes are inconsistent and/or show small effects. Familismo is a core value in Latino culture highlighting the importance of family functioning over any individual members, and it is possible that by adapting the treatment and including other family members, FBT outcomes could be enhanced for Latino families. Randomized trials show that parent-only FBT programs (PBT) are similarly effective to FBT and can be easier to disseminate and cost less. The current trial is a two-arm randomized controlled trial comparing the effect of a telehealth PBT program tailored to Latino families (PBT-LC) with a health education (HE) comparator on the child's weight over the 18 months of the study. We randomized 167 Latino families with a child with OW/OB to either six-months of telehealth PBT-LC or HE treatment delivered to the parent and additional caregiver in English or Spanish with 12-months of follow-up. This ongoing study may provide a translatable evidence-based cost-effective program tailored for Latino families with a child with OW/OB. Clinical trials # NCT05437406.

拉丁裔儿童受到超重和肥胖（OW/OB）的影响不成比例。以家庭为基础的行为治疗（FBT）是经验支持最多的OW/OB儿童治疗方法，传统上包括儿童和照顾者。很少有FBT项目在拉丁裔家庭中进行过测试，到目前为止，结果并不一致，或者效果很小。Familismo是拉丁美洲文化的核心价值观，强调家庭功能比任何个人成员都重要，通过调整治疗并包括其他家庭成员，拉丁美洲家庭的FBT结果可能会得到提高。随机试验表明，只有家长参与的FBT项目（PBT）与FBT同样有效，而且更容易传播，成本更低。目前的试验是一项两组随机对照试验，比较了为拉丁裔家庭量身定制的远程医疗PBT项目（PBT- lc）和健康教育（HE）比较器在18个 月的研究期间对儿童体重的影响。我们随机选取167个有OW/OB患儿的拉丁裔家庭，对其进行为期6个月的远程PBT-LC或HE治疗，以英语或西班牙语向父母和其他护理人员提供治疗，随访12个月。这项正在进行的研究可能为有OW/OB儿童的拉丁裔家庭提供可翻译的循证成本效益方案。临床试验# NCT05437406。

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引用次数: 0

Study protocol for a type I hybrid effectiveness trial of strategies to prevent suicide attempts among adults recently released from jail 预防刚从监狱释放的成年人自杀企图策略的I型混合有效性试验研究方案

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2025-12-15 DOI: 10.1016/j.cct.2025.108184

Diane M. Wisnieski , Rebecca C. Rossom , Lauren M. Weinstock , Jennifer Johnson , Kathleen Miley , Brandon A. Gaudiano , Madeline B. Benz , Caitlin Borgert-Spaniol , Hannah R. Graves , Rachael Norwood , Rowyda Kazan , Colleen Starkey , Hanmin Kim , Linda Fletcher , Sheryl Kane , Yong Hu , Zachary Farrell , Sarah Strong , Hsueh-Han Yeh , Ted Miller , Brian K. Ahmedani

Background

Over 20 % of all adult suicide deaths in the U.S. occur within one year following jail release. Individuals may have increased access to lethal means, be faced with numerous financial, legal, and social stressors, and encounter a resurgence of legal problems. Suicide prevention interventions have demonstrated effects. Widespread implementation of these interventions for individuals leaving jail detention could have a significant impact on national suicide rates.

Methods

The 5S Study (Syncing, Screening, and Services for Suicide Prevention among Health & Jail Systems) aims to prevent suicide attempts among adults aged 18+ who are recently released from jail. Data from public jail release reports are synced with electronic health record (EHR) systems to enable proactive health system outreach. Those randomized to the intervention are contacted and consented, undergo a suicide risk screening and create a safety plan. Care Coordinators connect participants to health services. High risk participants, identified by the Patient Health Questionnaire (PHQ-9), are offered the Coping Long Term with Active Suicide Program (CLASP), an evidence-based suicide prevention intervention. Those randomized to control are never contacted and receive usual care. There is a waiver of consent for the control condition and a waiver of written consent for the intervention condition.

Discussion

The 5S Study uses data linkage between EHRs and jails to identify and connect with those recently released from jail, a population historically at high risk. Trial results will highlight best practices for syncing these data and offering support during the transition back to the community.

Trial Registration: https://clinicaltrials.gov/study/NCT06506344.

在美国，20%的成年人自杀死亡发生在出狱后的一年内。个人可能有更多的机会获得致命的手段，面临无数的财政、法律和社会压力，并遇到法律问题的重新出现。自杀预防干预措施已显示出效果。对离开拘留所的个人广泛实施这些干预措施可能对全国自杀率产生重大影响。方法5S研究（卫生和监狱系统自杀预防的同步、筛查和服务）旨在预防18岁以上刚从监狱释放的成年人的自杀企图。公开监狱释放报告的数据与电子健康记录（EHR）系统同步，以实现主动的卫生系统外展。那些被随机分配到干预组的人会得到联系和同意，接受自杀风险筛查，并制定安全计划。护理协调员将参与者与卫生服务联系起来。通过患者健康问卷（PHQ-9）确定高危参与者，对其进行以证据为基础的自杀预防干预——长期积极自杀应对计划（CLASP）。那些随机分配到对照组的人从未接触过，并接受常规护理。对控制条件和干预条件的书面同意均需弃权。5S研究使用电子病历和监狱之间的数据联系来识别和联系那些最近从监狱释放出来的人，这是一个历史上高风险的人群。试验结果将突出同步这些数据的最佳实践，并在过渡回社区期间提供支持。试验注册：https://clinicaltrials.gov/study/NCT06506344。

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引用次数: 0

Improving diagnostic safety through steatosis identification, risk stratification, and referral pathway in the ED (STIRRED): Protocol for an effectiveness implementation trial 在ED （stir）中通过脂肪变性识别、风险分层和转诊途径提高诊断安全性：有效性实施试验方案。

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2025-12-15 DOI: 10.1016/j.cct.2025.108187

Danielle M. McCarthy , Lisa B. VanWagner , Miriam R. Rafferty , Kenzie A. Cameron , Jungwha Lee , Siyuan Dong , Anuva Fellner , Amy V. Kontrick

Background

Up to a quarter of emergency department (ED) patients have incidental hepatic steatosis (fatty liver) noted on imaging studies; however, patients are infrequently notified about this new finding. This lack of communication may have consequences including delayed diagnosis of metabolic associated steatotic liver disease (MASLD) and disease progression.

Methods

This type-2 hybrid effectiveness-implementation study uses a Stepped Wedge-Cluster Randomized Trial design across 11 EDs to evaluate an electronic health record (EHR) delivered intervention. The STeatosis Identification, Risk stratification, and Referral pathway in the ED (STIRRED) clinical decision support system leverages the EHR to identify cases of hepatic steatosis and deliver risk-stratified communication to clinicians supporting patient notification about hepatic steatosis in the ED. The primary effectiveness outcome will be receipt of a new steatotic liver disease-related diagnosis among high-risk patients within 120 days post-ED discharge; the primary implementation outcome is fidelity, defined as the degree to which STIRRED was delivered as intended. Over the study period, ∼4700 patients with incidental hepatic steatosis will be analyzed, including 616 high-risk patients, providing 80 % power to detect a risk difference of 5.6 % (odds ratio of 3.5) between STIRRED and usual care in the receipt of a new steatotic liver disease-related diagnosis.

Discussion

This trial uses the electronic health record to deliver an evidence-based risk stratification score and referral recommendation to the bedside clinician in patients with incidentally noted hepatic steatosis. Rigorous implementation science methodology used in both the intervention development and assessment will increase the usability of the intervention and future scalability.

Trial Registration: This trial was prospectively registered on 10/9/2024 with ClinicalTrials.gov (# NCT06944353).

背景：高达四分之一的急诊科（ED）患者在影像学检查中发现有偶发性肝脂肪变性（脂肪肝）；然而，患者很少被告知这一新发现。缺乏沟通可能会导致代谢性脂肪变性肝病（MASLD）的诊断延迟和疾病进展。方法：这项2型混合有效性实施研究采用阶梯楔形聚类随机试验设计，横跨11个急诊室，评估电子健康记录（EHR）提供的干预措施。急诊科的脂肪变性识别、风险分层和转诊途径（简称“烦扰”）临床决策支持系统利用电子病历识别肝脂肪变性病例，并向临床医生提供风险分层沟通，以支持急诊科的肝脂肪变性患者通知。主要有效结果将是在急诊科出院后120 天内接受高风险患者的新的脂肪变性肝病相关诊断；主要的实现结果是保真度，定义为按照预期交付的程度。在研究期间，将分析约4700例偶发性肝脂肪变性患者，其中包括616例高危患者，在接受新的脂肪变性肝病相关诊断时，在stir和常规治疗之间检测到5.6% %（优势比为3.5）的风险差异的能力为80% %。讨论：本试验使用电子健康记录为偶然发现肝脂肪变性的患者提供循证风险分层评分，并向床边临床医生推荐转诊。在干预开发和评估中采用严格的实施科学方法将增加干预的可用性和未来的可扩展性。试验注册：该试验于2024年10月9日在ClinicalTrials.gov （# NCT06944353）前瞻性注册。

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引用次数: 0

A cluster randomised controlled trial to test the effectiveness and cost-effectiveness of a self-management intervention to support women with breast cancer to return to work: A study protocol. 一项测试自我管理干预支持乳腺癌妇女重返工作岗位的有效性和成本效益的整群随机对照试验：一项研究方案。

IF 1.9 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2025-12-15 DOI: 10.1016/j.cct.2025.108185

Nickola D Pallin, Naomi Algeo, Mary Eileen O'Connor, Hayley Connolly, Michelle Lowry, Kathleen Bennett, Patrick Gillespie, Anna Hobbins, Pamela Gallagher, Louise Mullen, Kathleen D Lyons, Sheena M McHugh, Deirdre Connolly

Introduction: Women living with and beyond breast cancer (LWBBC) often experience challenges in returning to work (RTW) because of disease and treatment-related side effects. Therefore, interventions to enhance RTW for those LWBBC are a recommended component of cancer survivorship care. CanWork is a six-week, self-management support programme designed to facilitate women LWBBC in developing knowledge and skills to manage cancer-related symptoms that interfere with RTW. This paper presents the protocol for a cluster randomised controlled trial that will test the effectiveness and cost effectiveness of CanWork in supporting women LWBBC in RTW following completion of cancer treatment.

Methods: A cluster-randomised controlled trial will be conducted through community cancer support centres in the Republic of Ireland. Centres will be assigned to the control or intervention arms by randomisation and the aim is to recruit 248 women. The two primary outcomes are changes in RTW (yes: returned to work; no: not returned to work) and self-efficacy to manage physical, psychological and emotional demands of work at 12 months follow up post-intervention. Secondary outcomes are readiness to return to work, self-efficacy for managing cancer-related symptoms that interfere with work, health related quality of life and absence from work for cancer-related reasons at 12 months follow up post-intervention. Cost effectiveness will also be measured. Follow-up will occur up to 12-months post-intervention using self-reported questionnaires.

Discussion: Findings will determine whether CanWork is an effective and cost-effective intervention in supporting women with breast cancer to return to work.

Trial registration number: NCT06723899.

导读：由于疾病和治疗相关的副作用，患有乳腺癌（LWBBC）的妇女在重返工作岗位（RTW）时经常遇到挑战。因此，干预措施，以提高那些低wbbc的RTW是癌症生存护理的一个推荐组成部分。CanWork是一项为期六周的自我管理支助方案，旨在帮助低死亡率妇女发展知识和技能，以管理与癌症有关的、干扰生殖生殖的症状。本文提出了一项集群随机对照试验的方案，该试验将测试CanWork在完成癌症治疗后的RTW中支持女性LWBBC的有效性和成本效益。方法：将通过爱尔兰共和国的社区癌症支持中心进行一项集群随机对照试验。中心将被随机分配到对照组或干预组，目标是招募248名妇女。两个主要结果是RTW（是：重返工作岗位；否：未重返工作岗位）的变化和干预后随访12 个月时管理工作的身体、心理和情感需求的自我效能感。次要结果是在干预后随访12个 月时重返工作岗位的准备情况、管理干扰工作的癌症相关症状的自我效能、与健康相关的生活质量以及因癌症相关原因缺工。成本效益也将被衡量。随访将在干预后12个月使用自我报告问卷进行。讨论：研究结果将决定CanWork在支持乳腺癌妇女重返工作岗位方面是否有效且具有成本效益。试验注册号：NCT06723899。

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