The improving ATTENDance to Cardiac Rehabilitation (iATTEND) Trial

改善心脏康复 ATTENDance (iATTEND) 试验

基本信息

批准号：
9791476
负责人：
STEVEN J. KETEYIAN
金额：
$ 58.77万
依托单位：
HENRY FORD HEALTH SYSTEM
依托单位国家：
美国
项目类别：
财政年份：
2018
资助国家：
美国
起止时间：
2018-08-01 至 2023-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9791476
关键词：
Activities of Daily Living Adopted Adoption African American Amendment American Behavioral Cardiac Cardiac rehabilitation Cardiovascular Diseases Caring Cause of Death Cessation of life Cities Clinical Clinical Trials Clinical Trials Data Monitoring Committees Computerized Medical Record Coronary heart disease Data Death Rate Economics Elements Enrollment Event Exercise General Population Goals Guidelines Habits Health Insurance Health Surveys Healthcare Home environment Hospitals Hybrids Individual Institutional Review Boards Insurance Intervention Knowledge Life Style Manuals Measures Medical center Methodology Methods Modeling Myocardial Infarction National Heart, Lung, and Blood Institute Neighborhoods Outcome Oxygen Patient Care Patient-Focused Outcomes Patients Pharmaceutical Preparations Phase Phase II Clinical Trials Physical activity Policies Protocols documentation Quality of life Randomized Recurrence Research Research Personnel Risk Schedule Secondary Prevention Site System Telecommunications Telemedicine Testing Time Training United States Walking base cardiovascular disorder prevention cohort compliance behavior cost effectiveness design exercise capacity experience group intervention health care service utilization healthy lifestyle home based service hospital readmission improved innovation low socioeconomic status mortality mortality risk operation programs prospective social treatment as usual uptake

项目摘要

PROJECT SUMMARY/ABSTRACT Despite center based cardiac rehabilitation (CBCR) representing guideline-based care for patients with cardiovascular disease, most patients do not complete the maximum number of sessions allowed by third party insurance payers. As such, many patients may not be receiving the full clinical benefit ascribed to CR. Several studies suggest that the number of CR sessions completed is directly and independently associated with lower mortality (an ~1% to 2% observed decrease in risk for each additional session of CR completed). The barriers to attendance in CBCR include those at the patient, program, policy, and system-levels. Among African Americans, participation and attendance to CR and adoption of healthier lifestyle changes are less likely. The iATTEND (improving ATTENDance to cardiac rehabilitation) Trial will assess the efficacy of an innovative approach to CR delivery on attendance. The intervention group combines CBCR and remote-/home-based CR (i.e., Hybrid CR, HYCR) and is tailored to the individual needs of each patient, accomplished with the assistance of an easy-to-access telecommunications methodology (telemedicine). iATTEND is also unique because it focuses on patients residing within (or proximal to) Detroit, MI., representing a predominately at-risk cohort (e.g., 79% African American) that often cannot regularly attend CR due to social (e.g., dependent care) and economic challenges. In addition to being understudied and likely associated with disparity in CR utilization, our cohort provides an opportunity to examine the adoption and efficacy of an innovative model to deliver CR, one that otherwise mimics traditional CBCR in terms of delivered content and expected outcomes. For the R61 start-up phase of iATTEND (year one), the primary aims will be to prepare and operationalize a clinical trial, including finalizing protocol, developing and finalizing the manual of operations, establishing data safety monitoring board, confirming partnerships, and demonstrating the ability to screen and enroll patients in to the trial. The primary aim for the R33 clinical trial phase (years 2-5) of iATTEND will be to assess the effect of a HYCR program on patient attendance [Primary Hypothesis: The number of CR sessions completed within 6 months will be significantly greater among patients randomized to HYCR than patients randomized to CBCR]. The secondary aim is to assess the effect of HYCR on exercise capacity and quality of life. The design of iATTEND is a single-site, prospective, controlled Phase II clinical trial that will randomize 270 urban patients to CBCR only or HYCR. Both groups will be scheduled to attend 36 CR sessions within 6 months. Patient assessments will be conducted at baseline, within 10 days after completing CR, and 6 months after completing CR. To strengthen the generalizability of iATTEND, for both study groups we plan to (a) deliver the same secondary prevention elements and (b) measure the common program outcomes expected of traditional CR. We plan to revise operations at our Detroit-based site in a manner that allows the unit to simultaneously offer both CBCR only and HYCR, using only existing CR staff (not additional research staff).

项目概要/摘要尽管基于中心的心脏康复 (CBCR) 代表了针对患有以下疾病的患者的基于指南的护理心血管疾病，大多数患者没有完成第三方允许的最大疗程数保险付款人。因此，许多患者可能无法获得 CR 带来的全部临床益处。一些研究表明，完成 CR 会话的次数与较低的死亡率直接且独立地相关。死亡率（每额外完成 CR 一次，观察到的风险就会降低 1% 到 2%）。障碍参加 CBCR 的人员包括患者、项目、政策和系统层面的人员。非洲人当中美国人参与和参加 CR 以及采取更健康的生活方式改变的可能性较小。这 iATTEND（改善心脏康复的 ATTENDance）试验将评估创新的功效出勤率的 CR 交付方法。干预组结合了 CBCR 和远程/家庭 CR （即混合 CR、HYCR），并根据每位患者的个人需求量身定制，通过易于使用的电信方法（远程医疗）的协助。 iATTEND 也是独一无二的因为它重点关注居住在密歇根州底特律市内（或附近）的患者，这些患者代表了主要的高危人群由于社会原因（例如，家属照顾）而经常无法定期参加 CR 的人群（例如，79% 的非裔美国人）和经济挑战。除了未被充分研究并且可能与 CR 差异相关之外利用，我们的队列提供了一个机会来检查创新模型的采用和有效性交付 CR，在交付内容和预期结果方面模仿传统 CBCR。对于 iATTEND 的 R61 启动阶段（第一年），主要目标是准备和实施临床试验，包括最终确定方案、制定和最终确定操作手册、建立数据安全监测委员会，确认合作伙伴关系，并展示筛选和招募患者的能力到审判。 iATTEND R33 临床试验阶段（第 2-5 年）的主要目标是评估效果 HYCR 计划对患者出勤率的影响 [主要假设：在随机接受 HYCR 治疗的患者的 6 个月时间明显长于随机接受治疗的患者 CBCR]。第二个目的是评估 HYCR 对运动能力和生活质量的影响。这 iATTEND 的设计是一项单中心、前瞻性、对照 II 期临床试验，将随机分组 270 个城市患者仅接受 CBCR 或 HYCR。两个小组将计划在 6 个月内参加 36 场 CR 会议。患者评估将在基线、完成 CR 后 10 天内以及完成 CR 后 6 个月内进行完成 CR。为了加强 iATTEND 的普遍性，我们计划为两个研究组 (a) 提供相同的二级预防要素，并 (b) 衡量传统方案预期的共同方案成果 CR。我们计划修改底特律工厂的运营方式，使该部门能够同时仅使用 CBCR 和 HYCR，仅使用现有的 CR 人员（而不是额外的研究人员）。