Increasing Enrollment in Clinical Trials through Faith-Based Intitiative

通过基于信仰的举措增加临床试验的注册人数

• 批准号: 8048337
• 负责人: Ken A. Resnicow
• 金额: $ 22.13万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-30 至 2012-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8048337
• 关键词: Address; Adoption; Adult; African American; Age; Attitude; Catchment Area; Characteristics; Church; Clinical Trials; Collaborations; Communities; Control Groups; Education; Enrollment; Evaluation; Exposure to; Feeling; Future; Gender Identity; Happiness; Health Promotion; Health behavior; Healthcare; Individual; Institution; Intervention; Lead; Link; Mails; Measures; Mediating; Medical Research; Michigan; Minority; Modeling; Outcome; Participant; Process; Questionnaires; Randomized; Recruitment Activity; Registries; Research Project Grants; Role; Secure; Testing; Time; Training; Trust; Universities; Work; abstracting; base; design; evidence base; experience; faith-based intervention; follow-up; indexing; intervention effect; member; primary outcome; programs; secondary outcome; web site; willingness

DESCRIPTION (provided by applicant): The primary aim of this study is to evaluate the impact of a university-church partnership to increase minority participation in clinical trials. Specifically, we will work with local black churches, through a participatory process, to implement the Body & Soul faith-based health promotion program. Through this collaborative effort, we aim to achieve two outcomes: 1) Enhance trust between local church members and the University of Michigan, and thereby, 2) Increase willingness to enroll in a clinical trial registry. 12 churches from Southeast Michigan, with no prior Body & Soul (B &S) adoption, will be randomized to receive the Body & Soul program (6 intervention churches) or a delayed Body and Soul program (6 control churches). Beginning approximately 2 months after initial installation of B & S (which will be expanded to address clinical trial participation), we will send participants from BOTH intervention and control churches a mailed invitation to enroll in our ENGAGE clinical trial registry. The invitation will provide a church specific URL to allow us to track enrollment. Over the course of the year, another 4 invitations will be mailed. The primary outcome will be verified enrollment in the ENGAGE registry. Secondary outcomes will include attitudes toward medical research and the University of Michigan as well as future intentions to enroll in a clinical trial. Baseline Treatment (6 churches) 01 Comparison (6 churches) 01 1-Year Follow-up Body & Soul 02 02 Body & Soul E E E E E E=Bimonthly mailed invitations to enroll in ENGAGE 01=Baseline Assessment 02=Posttest Assessment Hypothesis 1) : Providing a culturally-sensitive, evidence-based health promotion program to local black churches will lead to greater trust and positive attitude toward the University of Michigan, and thereby increase willingness among church members to enroll in clinical trials (measured by actual enrollment in our ENGAGE clinical trial registry, attitudes toward clinical trials, and future intentions for trial participation) Hypothesis 2) Effects on ENGAGE enrollment and other outcomes will be mediated by changes in trust toward the University, health care institutions in general, and an index of exposure to B & S activities. Exploratory Hypothesis 3) We will examine whether effects of the intervention are moderated by baseline characteristics such as ethnic identity, gender, age, education, and attitudes toward medical research. PUBLIC HEALTH RELEVANCE: Project Narrative This study will test an academic-community partnership model to increase African American enrollment in clinical trials. We propose that in order to increase minority participation in clinical trials, we must first inculcate feelings of trust, mutual respect, and collaboration. We propose that by collaboratively planning and implementing an evidence-based health promotion program designed for black churches, we can build a relationship characterized by mutual trust and respect. Over time, as a result of these positive experiences as well as the content and spirit of Body & Soul, we think that individuals whose churches received Body & Soul will be more willing to enroll in clinical trials.

描述（由申请人提供）：本研究的主要目的是评估大学与教会合作伙伴关系对增加少数族裔参与临床试验的影响。具体来说，我们将与当地黑人教会合作，通过参与式过程，实施基于信仰的身体与灵魂健康促进计划。通过这种合作努力，我们的目标是实现两个成果：1) 增强当地教会成员和密歇根大学之间的信任，从而，2) 提高参加临床试验注册的意愿。来自密歇根州东南部的 12 个教会，之前没有采用“身体与灵魂”(B&S) 计划，将被随机分配接受“身体与灵魂”计划（6 个干预教会）或延迟的“身体与灵魂”计划（6 个对照教会）。从初次安装 B&S（将扩展以解决临床试验参与问题）后大约 2 个月开始，我们将向干预教会和控制教会的参与者发送邮寄邀请，邀请他们加入我们的 ENGAGE 临床试验注册中心。邀请函将提供教会特定的 URL，以便我们跟踪注册情况。年内，还将邮寄另外 4 份邀请函。主要结果将是验证 ENGAGE 注册表中的注册情况。次要结果将包括对医学研究和密歇根大学的态度以及未来参加临床试验的意图。 基线治疗（6 个教会） 01 比较（6 个教会） 01 1 年随访 Body & Soul 02 02 Body & Soul E E E E E E=每两个月邮寄一次参加 ENGAGE 的邀请 01=基线评估 02=测试后评估 假设 1) ：向当地黑人教会提供文化敏感、基于证据的健康促进计划将带来对密歇根大学更大的信任和积极态度，从而增加 教会成员参加临床试验的意愿（通过 ENGAGE 临床试验登记处的实际报名情况、对临床试验的态度以及未来参与试验的意向来衡量） 假设 2）对 ENGAGE 报名和其他结果的影响将通过对大学、总体医疗保健机构的信任变化以及接触 B&S 活动的指数来调节。探索性假设 3) 我们将检查干预的效果是否受到种族认同、性别、年龄、教育和对医学研究的态度等基线特征的调节。 公共卫生相关性：项目叙述 这项研究将测试学术界合作模式，以增加非裔美国人参加临床试验的人数。我们建议，为了增加少数群体参与临床试验，我们必须首先灌输信任、相互尊重和协作的感觉。我们建议，通过合作规划和实施专为黑人教会设计的循证健康促进计划，我们可以建立一种以相互信任和尊重为特征的关系。随着时间的推移，由于这些积极的经历以及身体与灵魂的内容和精神，我们认为教会接受身体与灵魂的个人将更愿意参加临床试验。