The improving ATTENDance to Cardiac Rehabilitation (iATTEND) Trial

改进心脏康复 ATTENDance (iATTEND) 试验

• 批准号: 10199009
• 负责人: STEVEN J. KETEYIAN
• 金额: $ 51.12万
• 依托单位: HENRY FORD HEALTH SYSTEM
• 依托单位国家: 美国
• 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/10199009
• 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; 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

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).