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: 8147751
• 负责人: Ken A. Resnicow
• 金额: $ 18.06万
• 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 2013-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8147751
• 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; Role; Secure; Testing; Time; Training; Trust; Universities; Work; base; design; evidence base; experience; faith-based intervention; follow-up; indexing; intervention effect; member; primary outcome; programs; public health relevance; 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-教会伙伴关系的影响，以增加少数民族参与临床试验。具体来说，我们将与当地黑人教会合作，通过参与性的过程，实施身体和灵魂信仰为基础的健康促进计划。通过这种合作努力，我们的目标是实现两个结果：1）增强当地教会成员和密歇根大学之间的信任，从而，2）增加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，没有事先采用身体和灵魂（B &S），将被随机接受身体和灵魂计划（6个干预教会）或延迟身体和灵魂计划（6个对照教会）。从B & S（将扩展到解决临床试验参与）的初始安装后约2个月开始，我们将向来自干预和控制教会的参与者发送邮件邀请，以注册我们的ENGAGE临床试验注册表。邀请将提供一个教会的具体网址，让我们跟踪登记。在这一年中，将再发出4份邀请函。主要结局将是在ENGAGE登记研究中验证入组情况。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教堂）01比较（6个教会）01 1年随访身体和灵魂02 02身体和灵魂E 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）：提供一个文化敏感，以证据为基础的健康促进计划，以当地黑人教会将导致更大的信任和积极的态度，密歇根大学，从而提高教会成员参加临床试验的意愿（通过我们的ENGAGE临床试验登记处的实际登记人数，对临床试验的态度，和未来参与试验的意图）假设2）对参与招生和其他结果的影响将通过对大学信任的变化来调节，一般的医疗保健机构，以及接触B & S活动的指数。探索性假设3）我们将检查干预的效果是否受到基线特征（如种族身份、性别、年龄、教育和对医学研究的态度）的调节。 公共卫生关系：项目叙述本研究将测试学术社区合作模式，以增加非裔美国人在临床试验中的入学率。我们建议，为了增加少数人参与临床试验，我们必须首先灌输信任，相互尊重和合作的感觉。我们建议，通过合作规划和实施一个以证据为基础的健康促进计划，为黑人教会设计，我们可以建立一个相互信任和尊重的关系。随着时间的推移，由于这些积极的经验以及身体和灵魂的内容和精神，我们认为那些接受身体和灵魂的教会的个人将更愿意参加临床试验。