Contemporary clinical trials最新文献_第10页

Qualitative understanding of experiences of people with cystic fibrosis in a treatment discontinuation trial: The QUEST study 定性了解囊性纤维化患者在停止治疗试验中的经历：QUEST 研究。

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2024-11-17 DOI: 10.1016/j.cct.2024.107752

Jill Maggs , Gregory S. Sawicki , Callie Bacon , Emma McWilliams , Dana Yablon , Benjamin Ertman , Liam Sweeney , Jennifer L. Butcher , Robin S. Everhart , Michelle Prickett , Christopher Siracusa , Alex H. Gifford , Nicole Mayer-Hamblett , David P. Nichols , Andrea Goodman , Tia Woo , Kristin A. Riekert

Background

As people with cystic fibrosis (PWCF) live longer due to the breakthrough drug elexacaftor-tezacaftor-ivacaftor (ETI), they have questioned whether other CF therapies could be safely discontinued. SIMPLIFY was the first prospective, randomized trial to evaluate non-inferiority of discontinuing versus continuing two therapies. The QUEST (Qualitative Understanding of Experiences in the SIMPLIFY Trial) study was conducted to understand experiences of PWCF enrolled in SIMPLIFY, including why they joined, perceptions of randomization, decision-making around study withdrawal, and considerations for future discontinuation studies.

Methods

QUEST enrolled SIMPLIFY participants 14 years or older stable on ETI and caregivers of the 14–17 year-olds. Interviews were audio-recorded, transcribed, and coded. A phenomenological approach was used to inductively develop codes with no a priori hypotheses; identified themes were then organized around current research and recruitment literature.

Results

114 interviews were completed (68 adults, 23 teenagers, and 23 caregivers). Among PWCF, median age was 27.8 years, 49 % were female and 80 % had participated in research before SIMPLIFY. Five themes were identified: (1) Experience with SIMPLIFY randomization, [2] Trust, [3] Altruism, [4] Perceived personal benefits, and [5]) Perceived risks and protocol burden.

Conclusion

QUEST findings highlight how a long-standing culture of research and thoughtful protocol design contributed to SIMPLIFY's successful recruitment and retention. This included understanding the importance of remaining in the trial despite not being randomized to their preferred treatment assignment. Using patient-centered approaches to select research questions, design a protocol to minimize participant barriers, and frame recruitment materials messaging contribute to successful research participation.

背景：由于突破性药物 elexacaftor-tezacaftor-ivacaftor (ETI)的问世，囊性纤维化患者（pwCF）的寿命延长了，他们对是否可以安全停用其他 CF 疗法提出了质疑。SIMPLIFY 是首个前瞻性随机试验，旨在评估停用两种疗法与继续使用两种疗法的非劣效性。QUEST（Qualitative Understanding of Experiences in the SIMPLIFY Trial）研究旨在了解加入 SIMPLIFY 的儿童患者的经历，包括他们加入的原因、对随机化的看法、围绕研究退出的决策以及未来停药研究的考虑因素：QUEST招募了SIMPLIFY的14岁或14岁以上稳定接受ETI的参与者以及14-17岁儿童的照顾者。对访谈进行了录音、转录和编码。在没有先验假设的情况下，采用现象学方法归纳出编码；然后根据当前的研究和招募文献对确定的主题进行整理：共完成了 114 次访谈（68 名成人、23 名青少年和 23 名护理人员）。在儿童和青少年中，年龄中位数为 27.8 岁，49% 为女性，80% 在 SIMPLIFY 之前参与过研究。研究确定了五个主题：(Gul和Ali，2010 [1]）SIMPLIFY随机化的经验，CFF患者注册年度数据报告[互联网]（2017）[2]信任，CFF患者注册年度数据报告[互联网]（2022）[3]利他主义，Goss等人（2008）[4]感知到的个人利益，以及（Goss等人，2002 [5]）感知到的风险和协议负担：QUEST 的研究结果突显了长期的研究文化和周到的方案设计是如何帮助 SIMPLIFY 成功招募和留住人才的。这包括理解在未被随机分配到首选治疗方案的情况下仍留在试验中的重要性。使用以患者为中心的方法来选择研究问题、设计方案以最大限度地减少参与者的障碍，以及编写招募材料信息，都有助于成功参与研究。

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引用次数: 0

INteractive survivorship program to improve health care REsources [INSPIRE]: A study protocol testing a digital intervention with stepped care telehealth to improve outcomes for adolescent and young adult survivors 改善医疗保健资源的互动式幸存者计划 [INSPIRE]：一项研究方案，通过测试分级护理远程保健的数字干预措施，改善青少年和年轻成人幸存者的治疗效果。

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2024-11-17 DOI: 10.1016/j.cct.2024.107745

Jean C. Yi , Sheri Ballard , Casey Walsh , Danielle N. Friedman , Patricia A. Ganz , Linda A. Jacobs , Ann H. Partridge , Sandra A. Mitchell , Wendy M. Leisenring , Karen L. Syrjala , K. Scott Baker

Background

Adolescents and young adults with cancer (AYAs, ages 15–39 at the time of diagnosis) experience significant adverse health and psychosocial outcomes. AYAs live with emotional distress and health care demands that exceed those of their healthy peers but can have difficulty accessing care. Digitally delivered interventions are an attractive option for AYA survivors, a population that routinely utilizes online resources when seeking health information and support.

Aim

By improving access to survivorship resources and support and strengthening health literacy and self-management skills, the INteractive Survivorship Program to Improve Health care REsources [INSPIRE] is designed to improve adherence to AYA health care guidelines and reduce cancer-related distress. We describe the protocol for a two-arm randomized controlled trial (RCT) testing the AYA-adapted INSPIRE program.

Methods/Design

The intervention includes an interactive mobile app, study website, and social media platforms, adding telehealth for those with continued distress, lower survivorship health care literacy, or poor engagement with the digital program at 6 weeks. Participants are randomized to INSPIRE or an active control. In the active control arm, survivors receive access to a study website with links to existing AYA survivor resources followed by delayed access to the INSPIRE program. Participants are not blinded; study staff not providing telehealth are blinded. The primary outcomes are cancer-related distress and health care adherence specific to second cancer and cardiometabolic screenings.

Discussion

If effective, the program is positioned for accelerated implementation to improve care for AYA survivors by using a scalable informatics-based administration and largely digital intervention program.

背景：患有癌症的青少年和年轻成人（AYAs，确诊时年龄为 15-39 岁）在健康和社会心理方面会经历严重的不良后果。青少年和青年癌症患者的情绪困扰和医疗保健需求超过了健康的同龄人，但却很难获得医疗保健服务。目的："改善医疗保健资源的互动幸存者计划"[INSPIRE]旨在通过改善幸存者资源和支持的获取途径，加强健康素养和自我管理技能，从而提高亚裔幸存者对医疗保健指南的依从性，减少与癌症相关的困扰。我们介绍了一项双臂随机对照试验（RCT）的方案，该试验测试了适合亚裔青少年的 INSPIRE 计划：方法/设计：干预措施包括互动式移动应用程序、研究网站和社交媒体平台，并为那些持续感到痛苦、幸存者医疗保健知识水平较低或在 6 周内对数字程序参与度较低的人增加了远程医疗服务。参与者被随机分配到 INSPIRE 或积极对照组。在积极对照组中，幸存者会访问一个研究网站，该网站上有与现有 AYA 幸存者资源的链接，随后会延迟访问 INSPIRE 计划。参与者不会被蒙蔽；不提供远程保健服务的研究人员也不会被蒙蔽。主要结果是与癌症有关的痛苦以及坚持进行第二次癌症和心脏代谢筛查：讨论：如果该计划有效，则可加速实施，通过使用可扩展的基于信息学的管理和大体上数字化的干预计划，改善对青壮年幸存者的护理。

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引用次数: 0

Keep it Movin’: Design and methods of a church-based physical activity program to improve physical function among midlife and older black adults 保持运动：以教堂为基础的体育活动计划的设计和方法，以改善中老年黑人的身体机能。

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2024-11-13 DOI: 10.1016/j.cct.2024.107742

Brittney S. Lange-Maia , Amber Deckard , Sheila A. Dugan , Yolanda Cartwright , Steve M. Epting , LaDawne Jenkins , Sumihiro Suzuki , Valerie G. Press , Steven K. Rothschild , Elizabeth B. Lynch

Background

Older Black adults have high rates of physical function (PF) limitations. Physical activity (PA) is effective for improving PF and reducing mobility disability risk; however, community-based PA interventions focused on improving PF for older Black adults are lacking. Given the importance of churches as trusted institutions in Black communities, church-based interventions developed through community collaborations may help increase access to PA interventions.

Methods

Keep it Movin’ is a church-based cluster randomized controlled trial testing the effectiveness of a 24-week group-based (intervention arm) versus a self-guided (comparator arm) program in improving PF among Black adults aged ≥ 40 years with PF limitations (short physical performance battery [SPPB] score ≤ 9). A church-wide virtual walking program is available to congregants in both arms. The intervention arm receives weekly group-based classes held at the church that include education, goal setting, and structured PA (walking, lower-extremity strength, balance, and stretching). The comparator arm receives educational materials about PA appropriate for people with PF limitations. Outcomes are assessed at 6 (program completion) and 12 months (maintenance). The primary outcome is PF change as measured by the SPPB at 6 months. Secondary outcomes include change in moderate-to-vigorous PA, social support and self-efficacy for PA, quality of life, and self-reported PF. Factors related to successful adoption, implementation, and maintenance are assessed using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework.

Conclusion

This is the first study to evaluate the effectiveness of a group-based PA program delivered in Black churches to improve PF.

背景：黑人老年人的身体功能（PF）受限率很高。体力活动（PA）可有效改善身体功能并降低行动不便的风险；然而，以社区为基础、专注于改善黑人老年人身体功能的体力活动干预措施却很缺乏。鉴于教会作为黑人社区中值得信赖的机构的重要性，通过社区合作开发基于教会的干预措施可能有助于增加获得 PA 干预措施的机会：Keep it Movin'是一项以教堂为基础的群组随机对照试验，该试验测试了为期 24 周的集体计划（干预组）与自我指导计划（比较组）在改善年龄≥40 岁、有运动能力限制（短期体能测试 [SPPB] 得分≤9）的黑人成年人的运动能力方面的效果。两组参与者均可参加全教会范围内的虚拟步行计划。干预组每周在教堂举办一次小组课程，内容包括教育、目标设定和有组织的体育锻炼（步行、下肢力量、平衡和伸展）。对比组则接受适合有运动功能障碍的人的体育锻炼教育材料。结果在 6 个月（计划完成）和 12 个月（维持）时进行评估。主要结果是 6 个月时通过 SPPB 测定的 PF 变化。次要结果包括中度到剧烈运动的变化、社会支持和运动自我效能、生活质量以及自我报告的 PF。与成功采用、实施和维持有关的因素将使用 "到达、效果、采用、实施和维持"（RE-AIM）框架进行评估：这是第一项评估在黑人教堂开展的以小组为基础的锻炼计划对改善 PF 的有效性的研究。

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引用次数: 0

Challenges and prospects of clinical trials in Nigeria - Lessons from the WHO COVID-19 solidarity plus trial 尼日利亚临床试验的挑战和前景--世界卫生组织 COVID-19 团结加试验的经验教训。

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2024-11-13 DOI: 10.1016/j.cct.2024.107743

Adefolarin Opawoye , Vivian Kwaghe , Zaiyad G. Habib , Yusuf Jibrin , Ibrahim Maigari , Bashir Hussaini , Olukemi Adekanmbi , Uche Unigwe , Olusola Ayoola , Akin Osibogun , Kolawole Salami , Marie-Pierre Preziosi , Abdulrazaq G. Habib

Conducting randomized clinical trials (RCTs) during a pandemic is essential for obtaining timely evidence on safe and effective treatments, but it presents numerous obstacles. During the COVID-19 pandemic, the World Health Organization (WHO) sponsored multinational RCTs investigating repurposed drugs among hospitalized COVID-19 patients across countries with varying clinical research capacities. In Nigeria, several challenges hindered our progress, including inadequate infrastructure, initial insufficient investigator certification and expertise, and delays in securing regulatory approvals due to bureaucratic hurdles. Despite these challenges, the WHO-sponsored Solidarity Plus Trial (SPT) offered valuable opportunities to enhance research capacity, streamline participant enrolment through electronic randomization, and bolster infection prevention and control measures for healthcare workers. Moreover, the trial enabled us to upgrade infrastructure at multiple sites, facilitating improved case detection through more testing and data collection. A crucial lesson learned was the importance of expediting trial initiation to capitalize on the limited window for data collection during an outbreak. To optimize RCTs during pandemics, we advocate for enhanced community engagement, collaborative efforts across sectors, strengthened research capacity, flexible regulatory frameworks, and the establishment of adaptive clinical trial units. By addressing these challenges and leveraging opportunities, we can significantly enhance the efficiency and impact of RCTs during public health emergencies.

在大流行期间开展随机临床试验（RCT）对于及时获得安全有效的治疗证据至关重要，但也存在诸多障碍。在 COVID-19 大流行期间，世界卫生组织（WHO）赞助了多国 RCT，在临床研究能力各不相同的国家对 COVID-19 住院患者中的再利用药物进行调查。在尼日利亚，有几项挑战阻碍了我们的进展，包括基础设施不足、最初的研究人员认证和专业知识不足，以及由于官僚主义障碍而导致的监管审批延误。尽管存在这些挑战，但世界卫生组织赞助的 "团结加试验"（SPT）为我们提供了宝贵的机会，使我们能够提高研究能力，通过电子随机化简化参与者注册程序，并加强医护人员的感染预防和控制措施。此外，该试验还使我们能够升级多个地点的基础设施，通过更多的检测和数据收集来改进病例检测。我们学到的一个重要经验是，在疫情爆发期间，必须加快试验的启动，以充分利用有限的数据收集时间。为了优化大流行期间的临床试验，我们主张加强社区参与、跨部门合作、加强研究能力、灵活的监管框架以及建立适应性临床试验单位。通过应对这些挑战和利用各种机遇，我们可以大大提高公共卫生突发事件期间 RCT 的效率和影响。

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引用次数: 0

Protocol for a randomized controlled trial to evaluate the effectiveness of a telehealth group intervention to reduce perinatal depressive symptoms 随机对照试验方案，评估远程保健小组干预对减轻围产期抑郁症状的效果。

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2024-11-13 DOI: 10.1016/j.cct.2024.107738

Eli Iacob , Ryoko Kausler , Marcia Williams , Sara Simonsen , Marcela Smid , Kristen Weissinger , Gwen Latendresse

Background

Perinatal depression and anxiety (PDA) affect approximately 20 % of individuals and are associated with adverse outcomes, including preterm birth, low birth weight, and impaired cognitive development of the child. Telehealth may reduce access barriers to needed mental health services. However, lack of disseminated, standardized study protocols aimed at investigating the role of telehealth in reducing PDA symptoms limits the ability to compare findings across studies. The purpose of this paper is to provide a conceptual framework and a randomized controlled trial protocol (RCT) for use in future studies.

Methods and analysis

An RCT was designed to evaluate the effectiveness of a group videoconference intervention (VCI) to reduce PDA symptoms across pregnancy and postpartum period. Participants are randomly assigned to study groups: VCI + standard of care, or attention control (AC) + standard of care. Both groups have weekly one-hour group videoconference sessions for 9 weeks. The VCI groups are facilitated by a mental health professional using a manualized program based on mindfulness-based practices and cognitive behavioral therapy (MBCT). The AC groups are facilitated by a registered nurse using a manualized program for childbirth and parenting education. The primary outcomes are depressive symptoms as measured by the Edinburgh Postnatal Depression Scale (EPDS) and anxiety symptoms as measured by the Generalized Anxiety Disorder (GAD-7).

Conclusion

This RCT study protocol can be used as a standard approach to improve the ability to compare findings across studies, applied in any setting (e.g., rural or urban), and adapted to diverse communities.

Trial Registration: ClinicalTrials.gov NCT03932760

背景：围产期抑郁和焦虑（PDA）影响着约 20% 的人，并与早产、出生体重不足和儿童认知发展受损等不良后果相关。远程保健可减少获得所需心理健康服务的障碍。然而，由于缺乏旨在研究远程保健在减少 PDA 症状方面作用的标准化研究方案，因此无法对不同研究的结果进行比较。本文旨在提供一个概念框架和随机对照试验方案（RCT），供未来研究使用：设计了一项随机对照试验，以评估小组视频会议干预（VCI）对减轻孕期和产后 PDA 症状的效果。参与者被随机分配到研究小组：VCI + 标准护理，或注意力控制 (AC) + 标准护理。两组均每周进行一小时的小组视频会议，为期 9 周。VCI 小组由一名心理健康专业人士主持，使用基于正念实践和认知行为疗法 (MBCT) 的手册化程序。AC 小组由一名注册护士主持，使用的是分娩和育儿教育手册程序。主要结果为爱丁堡产后抑郁量表（EPDS）测量的抑郁症状和广泛性焦虑症（GAD-7）测量的焦虑症状：该 RCT 研究方案可用作标准方法，以提高比较不同研究结果的能力，适用于任何环境（如农村或城市），并适用于不同社区：试验注册：ClinicalTrials.govNCT03932760。

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引用次数: 0

Design and methodology of a randomized clinical trial of quetiapine to reduce central nervous system polypharmacy in veterans with postconcussive syndrome symptoms 喹硫平随机临床试验的设计与方法，以减少有震颤后综合征症状的退伍军人中枢神经系统的多重药物治疗。

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2024-11-10 DOI: 10.1016/j.cct.2024.107741

Muhammad R. Baig , Gerardo Villarreal , Lizette Aviles , Adeel Meraj , Betsy Davis , Eric C. Meyer , Casey Straud , Stacey Young-McCaughan , Alan L. Peterson , John D. Roache

Lack of evidence to guide medication treatments for mild traumatic brain injury (mTBI) in veterans too often results in polypharmacy practices attempting to provide symptomatic relief from multiple postconcussive syndrome symptoms. Therefore, the field needs to find an effective medication that reduces the burden of postconcussive symptoms without complicating the treatment burden of veterans. This clinical trial seeks to determine whether switching veterans to quetiapine monotherapy (intervention) is superior to continuing to receive treatment as usual (TAU, control) polypharmacy for veterans with symptoms of postconcussive syndrome and posttraumatic stress disorder who are receiving rehabilitation treatment for mTBI. This study will test the conceptual mediation model hypothesis that quetiapine monotherapy may enhance recovery from mTBI by (1) increasing engagement in rehabilitation services, and/or (2) reducing the adverse effects of TAU polypharmacy. This study will enroll 146 patients from two Veterans Administration Medical Centers into a 12- week phase III, randomized, pragmatic clinical trial comparing outcomes from treatment with quetiapine monotherapy and TAU. Quetiapine will be cross tapered up to a maximum dose of 200 mg (as tolerated) as other medications are discontinued. The primary outcome measures are postconcussive syndrome symptoms (Neurobehavioral Symptom Inventory), functional disability (World Health Organization Disability Assessment), and quality of life (World Health Organization Quality of Life Assessment). Overall, this study aims to determine whether quetiapine monotherapy is superior to TAU polypharmacy and improves the quality of life for veterans with comorbid postconcussive syndrome and posttraumatic stress disorder symptoms who are receiving rehabilitation treatment for mTBI.

由于缺乏指导退伍军人轻度脑外伤（mTBI）药物治疗的证据，退伍军人往往会尝试使用多种药物来缓解多种撞击后综合征症状。因此，该领域需要找到一种有效的药物，既能减轻撞击后症状的负担，又不会加重退伍军人的治疗负担。本临床试验旨在确定，对于有撞击后综合征和创伤后应激障碍症状并正在接受创伤后应激障碍康复治疗的退伍军人来说，让他们改用喹硫平单药治疗（干预）是否优于继续接受常规治疗（TAU，对照组）。本研究将验证概念中介模型假设，即奎硫平单药治疗可通过（1）提高康复服务的参与度，和/或（2）减少TAU多药治疗的不良反应，从而促进mTBI的康复。这项研究将从两家退伍军人管理局医疗中心招募 146 名患者，进行为期 12 周的 III 期随机实用临床试验，比较喹硫平单药治疗和 TAU 治疗的效果。在停用其他药物的同时，喹硫平将交叉减量，最大剂量为200毫克（视耐受情况而定）。主要结果测量指标包括：震后综合征症状（神经行为症状量表）、功能性残疾（世界卫生组织残疾评估）和生活质量（世界卫生组织生活质量评估）。总之，本研究旨在确定喹硫平单药治疗是否优于TAU多药治疗，以及是否能改善正在接受创伤后应激障碍康复治疗的合并有撞击后综合征和创伤后应激障碍症状的退伍军人的生活质量。

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引用次数: 0

The eACT study design and methods: A sequential, multiple assignment, randomized trial of A novel adherence intervention for youth with epilepsy eACT 研究的设计和方法：一项针对青少年癫痫患者的新型坚持治疗干预的连续、多重分配、随机试验。

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2024-11-10 DOI: 10.1016/j.cct.2024.107739

Janelle L. Wagner , Anup D. Patel , Heather Huszti , Matthew Schmidt , Gigi Smith , Sonal Bhatia , Shanna M. Guilfoyle , Amy Lang , Stacy Buschhaus , Shannon Williams , Jessica Ardo , Marie Davidian , Avani C. Modi

Background

Epilepsy is a common, chronic pediatric neurological condition predominately treated with anti-seizure medications (ASMs) to control or reduce seizures. Approximately 60 % of youth with epilepsy demonstrate suboptimal adherence to their ASM. This paper describes the methodology, recruitment, design, and baseline participant characteristics of a sequential, multiple assignment, randomized trial (SMART) designed to test the effectiveness of a behavioral health intervention to improve adherence in families of young children with epilepsy.

Methods

Using a two-stage SMART, youth ages 2–12 years old with newly diagnosed epilepsy and their families were enrolled. Following an 8-week run-in phase, families with ≤95 % adherence were randomized to control (education + automated digital reminders) or intervention (education + automated digital reminders + individualized feedback) arms. After three months, families in the intervention group who remained non-adherent (i.e., ≤ 95 %) were re-randomized to 1) continue with same intervention or 2) receive two telehealth problem-solving sessions with an interventionist over the next two months. Study measures were completed at baseline, 8-, 14-, and 20-months post-baseline.

Results

Of the n = 466 ethnically and racially diverse study participants, n = 268 participants were non-adherent and were randomized. The primary outcome was electronically monitored ASM adherence at post-intervention, while secondary outcomes included seizure freedom, health care utilization, and epilepsy-specific health-related quality of life.

Conclusions

Novel aspects of the trial design (e.g., sequential, recruitment of racial and ethnic diverse youth), modifications to the protocol related to the COVID-19 pandemic and evolving socio-political and medical climate, as well as recruitment and retention challenges are discussed.

ClinicalTrials.gov Number: NCT03817229

背景：癫痫是一种常见的慢性儿科神经系统疾病，主要通过抗癫痫药物（ASM）来控制或减少癫痫发作。约 60% 的青少年癫痫患者对抗癫痫药物的依从性不佳。本文介绍了一项顺序、多重分配、随机试验（SMART）的方法、招募、设计和基线参与者特征，该试验旨在测试行为健康干预对改善癫痫幼儿家庭依从性的有效性：方法：采用两阶段 SMART，招募 2-12 岁新确诊癫痫的青少年及其家庭。在为期8周的磨合阶段后，依从性低于95%的家庭被随机分配到对照组（教育+自动数字提醒）或干预组（教育+自动数字提醒+个性化反馈）。三个月后，干预组中仍未坚持治疗的家庭（即坚持率低于 95%）被重新随机分配为：1）继续接受相同的干预；或 2）在接下来的两个月中接受两次由干预专家提供的远程医疗问题解决课程。在基线、基线后 8 个月、14 个月和 20 个月完成研究测量：在 n = 466 名不同民族和种族的研究参与者中，n = 268 名参与者未坚持治疗，他们被随机分组。主要结果是干预后电子监测的ASM依从性，次要结果包括癫痫发作自由度、医疗保健利用率以及与癫痫相关的健康生活质量：讨论了试验设计的新颖之处（如顺序、招募不同种族和民族的青少年）、与 COVID-19 大流行和不断变化的社会政治和医疗环境相关的方案修改，以及招募和留住人员方面的挑战：NCT03817229。

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引用次数: 0

A pilot randomized clinical trial of a smartphone-based application to support at-home PSA screening and culturally tailored prostate cancer education for African American men: A study protocol 基于智能手机的应用程序支持非裔美国男性在家进行前列腺特异抗原（PSA）筛查和针对其文化背景的前列腺癌教育的试点随机临床试验：研究方案。

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2024-11-10 DOI: 10.1016/j.cct.2024.107737

Jordan Neil , Bingjing Mao , Ruosi Shao , Motolani E. Ogunsanya , Summer Frank-Pearce , Michael Businelle , Michael Cookson , Kelly Stratton , Mark Doescher , Stephanie Pharr , Valerie Moise , Brianna Fleshman , Jack Fronheiser , Kimberly Estrada , Iván Flores , David Bradley , Ashley Kendrick , Adam C. Alexander

Background

Prostate cancer is the most diagnosed cancer in Black/African American men (AA) and the second‑leading cause of cancer-related deaths. A prostate-specific antigen (PSA) blood test is an early detection screening tool for prostate cancer, but uptake of PSA screening remains low among AA men. Greater PSA screening rates among AA men, coupled with earlier treatment, may reduce disparities in prostate cancer outcomes, including mortality. The current pilot study will test the first-of-its-kind mobile health (mHealth) app to improve prostate cancer knowledge and increase PSA screening uptake among AA men using home-based screening methods.

Methods

AA men aged 55 to 69 and are not up to date with PSA screening will be randomly assigned 1:1 to receive a prostate cancer screening app: Prevention Taskforce App (Taskforce App; control condition) or the Prostate Cancer Genius App (Genius App; intervention condition), which was developed specifically for AA men.

Results

We will evaluate the preliminary efficacy of the apps via post-intervention group differences on the validated 18-item Prostate Cancer Knowledge Scale (primary outcome). We will also explore post-intervention group differences in perceived engagement, accessibility, and acceptability between the apps. Finally, we will derive preliminary estimates of PSA screening rates between study conditions and identify mechanisms of screening adherence.

Discussion

mHealth apps offer promise to improve prostate cancer knowledge and screening rates among AA men. Demonstrating the preliminary efficacy of the Genius App will support future fully-powered mHealth interventions to address health disparities.

背景：前列腺癌是美国黑人/非洲裔男性（AA）中确诊率最高的癌症，也是癌症相关死亡的第二大原因。前列腺特异性抗原（PSA）血液检测是前列腺癌的早期检测筛查工具，但 AA 族男性中接受 PSA 筛查的比例仍然很低。提高非裔男性的 PSA 筛查率，再加上早期治疗，可以减少前列腺癌结果（包括死亡率）的差异。目前的试点研究将测试首款移动医疗（mHealth）应用程序，以提高AA族男性对前列腺癌的认识，并增加采用家庭筛查方法的PSA筛查率：方法：年龄在 55 岁至 69 岁之间、尚未进行 PSA 筛查的 AA 族男性将按 1:1 的比例随机分配接受前列腺癌筛查应用程序：结果：我们将评估前列腺癌筛查应用程序的初步效果：我们将通过经过验证的 18 项前列腺癌知识量表（主要结果）的干预后组间差异来评估应用程序的初步效果。我们还将探讨干预后各组在应用的参与感、可及性和可接受性方面的差异。最后，我们将得出不同研究条件下 PSA 筛查率的初步估计值，并确定筛查坚持率的机制。讨论：移动医疗应用程序有望提高 AA 族男性的前列腺癌知识水平和筛查率。展示 Genius 应用程序的初步疗效将为未来解决健康差异问题的全功能移动医疗干预措施提供支持。

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引用次数: 0

The Mobile lifestyle intervention for food and exercise (mLife) study: Protocol of a remote behavioral weight loss randomized clinical trial for type 2 diabetes prevention 移动饮食和运动生活方式干预（mLife）研究：预防 2 型糖尿病的远程行为减肥随机临床试验方案。

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2024-11-09 DOI: 10.1016/j.cct.2024.107735

K.E. DuBois , D.C. Delgado-Díaz , M. McGrievy , H. Valafar , C. Monroe , S. Wilcox , G. Turner-McGrievy

Background

Emerging research has examined electronic and mobile health (e/mHealth) technologies for weight loss and manage of type 2 diabetes mellitus (T2DM), but few studies have focused specifically on ways to target social support behaviors that have proven to be effective. While gamifying an mHealth behavioral weight loss intervention holds promise to promote and sustain social support, there has been very little research in this area. The mobile Lifestyle Intervention for Food and Exercise study (mLife) was designed to test if receiving points for social support is an effective way to promote sustained weight loss.

Objective

To describe the design of the 12-month mLife study, a randomized clinical trial, which compares the differential long-term effect of a behavioral weight loss program with and without gamification among adults with overweight or obesity.

Methods

Participants (target N = 240) in two consecutive cohorts were randomized to either the mLife+points or mLife group. The weight loss intervention for both groups included diet and physical activity (PA) recommendations, education, daily diet logging, visualization of PA and body weight readings captured with a wearable tracker and e-scale, and facilitation of social interaction among participants. The mLife+points group earned points for social support activities. Remote follow-up assessments of weight, anthropometric measures, diet (24 h dietary recalls), PA, social support provision, receipt and enjoyment, factors driving self-monitoring adherence and study compliance/responsiveness occurred at 6 and 12-months post-baseline.

Conclusion

The mLife study informs the expansion of gamification within mHealth programs to enhance social support provision and receipt during weight loss.

Trial registration

This study was registered on clintrials.gov on the 30th of October 2017, under the trial registration number: NCT05176847.

背景：新近的研究对电子和移动医疗（e/mHealth）技术在减肥和控制 2 型糖尿病（T2DM）方面的应用进行了探讨，但很少有研究特别关注针对社会支持行为的方法，而这些方法已被证明是有效的。虽然将移动医疗行为减肥干预游戏化有望促进和维持社会支持，但这方面的研究却很少。针对食物和运动的移动生活方式干预研究（mLife）旨在测试获得社会支持积分是否是促进持续减肥的有效方法：描述为期 12 个月的 mLife 研究的设计，该研究是一项随机临床试验，比较了在超重或肥胖成年人中实施和不实施游戏化的行为减肥计划的不同长期效果：连续两组参与者（目标人数 = 240）被随机分配到 mLife+points 组或 mLife 组。两组的减肥干预措施都包括饮食和体力活动（PA）建议、教育、每日饮食记录、通过可穿戴追踪器和电子秤采集的体力活动和体重读数的可视化，以及促进参与者之间的社交互动。mLife+ 积分组则通过社会支持活动获得积分。在基线后6个月和12个月对体重、人体测量指标、饮食（24小时饮食回顾）、活动量、社会支持的提供、接受和享受情况、促使坚持自我监测的因素以及研究依从性/反应性进行了远程跟踪评估：mLife研究为在移动医疗项目中扩展游戏化提供了信息，以加强减肥期间社会支持的提供和接收：本研究于2017年10月30日在clintrials.gov上注册，试验注册号为：NCT05176847：NCT05176847。

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引用次数: 0

A parallel-group randomized controlled trial of blue light versus red light for improving sleep, fatigue, and cognition following stroke: Pilot results and recommendations for further study 蓝光与红光改善中风后睡眠、疲劳和认知的平行组随机对照试验：试验结果和进一步研究的建议。

IF 2 3区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Contemporary clinical trials

Pub Date : 2024-11-06 DOI: 10.1016/j.cct.2024.107736

Douglas L. Weeks , Elena Crooks , Katie E. O'Brien , Gina Sprint , Gregory T. Carter , Kimberly A. Honn

Background

Disordered sleep and fatigue are common in the acute phase of stroke and can impede recovery.

Objective

A randomized parallel group placebo-controlled pilot study compared daily morning exposure to blue light or red light (placebo) for improving daytime sleepiness, fatigue, nocturnal sleep, and cognition in patients receiving inpatient rehabilitation for acute stroke.

Methods

43 patients with disordered sleep secondary to first episode stroke (n = 34 ischemic, n = 9 hemorrhagic; aged 66.2 ± 14.1 years) were randomized to receive 25 min of blue or red light for 5 or more days depending on inpatient rehabilitation length of stay (blue-light n = 21, red-light n = 22). At baseline and study discharge, daytime sleepiness was measured with the Karolinska Sleepiness Scale and Wits Pictorial Sleepiness Scale, fatigue with a visual analogue scale, and cognitive function with the Rey Auditory Verbal Learning Test and Trail Making Test (TMT). Wrist actigraphs measured nocturnal sleep parameters. Effect sizes were used to estimate sample sizes for larger studies.

Results

Blue light exposure led to significant improvements in daytime sleepiness, fatigue, auditory verbal learning, and time to sleep onset (all p < .05) relative to red light exposure (effect size range 0.75 to 1.83). Change in TMT, minutes of nocturnal sleep, and number of awakenings after sleep onset were not statistically significant (effect sizes range 0.38 to 0.57).

Conclusion

Morning blue light exposure for 5 or more days after acute stroke led to greater improvements than red light exposure. Effect sizes suggest a larger study is warranted to confirm generalizability of pilot findings.

Trial Registration: ClinicalTrials.gov NCT03125967 (Registered 01/01/2017).

背景：睡眠障碍和疲劳是中风急性期的常见症状，会阻碍患者的康复：睡眠障碍和疲劳是中风急性期的常见症状，会阻碍患者的康复：一项随机平行分组安慰剂对照试验研究比较了每天早晨照射蓝光或红光（安慰剂）对改善急性中风住院康复患者白天嗜睡、疲劳、夜间睡眠和认知能力的作用。方法：根据住院康复时间的长短，43 名因首次中风（缺血性 34 人，出血性 9 人；年龄 66.2 ± 14.1 岁）而继发睡眠障碍的患者被随机分配接受 5 天或更长时间的 25 分钟蓝光或红光照射（蓝光 21 人，红光 22 人）。在基线和出院时，使用卡罗林斯卡嗜睡量表和维茨图形嗜睡量表测量白天嗜睡程度，使用视觉模拟量表测量疲劳程度，使用雷伊听觉言语学习测试和追踪测试（TMT）测量认知功能。腕动仪测量夜间睡眠参数。研究结果表明，蓝光照射能显著改善睡眠质量：结果：暴露于蓝光可明显改善白天嗜睡、疲劳、听觉言语学习和睡眠开始时间（均为 p）：急性中风后持续 5 天或更长时间的晨间蓝光照射比红光照射有更大的改善作用。效应大小表明，有必要进行更大规模的研究，以确认试验结果的普遍性：试验注册：ClinicalTrials.govNCT03125967（注册日期：2017年1月1日）。

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引用次数: 0