A Partnership to Translate an Evidence-based Intervention for Vulnerable Older Adults With Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 453
- 试验地点
- 1
- 主要终点
- Hospitalizations
研究概览
简要总结
To evaluate the effectiveness of Take Heart, a behavioral/educational program for adults age 50+ with heart disease, or with at least two risk factors for heart disease, that helps them to better manage their health condition(s). Take Heart is a new version of an evidence-based program that has recently been adapted to be suitable for the needs of adults residing in Detroit.
详细描述
In this study, a heart disease self-management program will be tested in a low-income, predominantly African-American community via a partnership with the Detroit Area Agency on Aging (DAAA), the Detroit Medical Center (DMC), and University of Michigan School of Public Health's Center for Managing Chronic Disease (CMCD). The specific aims of the research are to: (1) adapt existing program materials to be appropriate for the new target population, getting feedback from various sources including focus group interviews; (2) conduct a pilot study of the adapted "Take Heart" program; (3) refine the intervention and conduct a randomized trial with 376 participants age 50 years and over, to assess health outcomes; (4) assess the translation and implementation of the intervention in the target setting and identify factors that help and hinder the process; (5) assess cost savings associated with the intervention; and (6) develop guidelines for "scaling up", that is, for replicating the program in other low-income areas through the national network of Area Agencies on Aging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •50 years or older
- •1 or more diagnosed cardiovascular conditions, including:
- •Atrial fibrillation
- •Myocardial infarction
- •Congestive heart failure
- •Valvular disease (aortic stenosis or mitral regurgitation)
- •Peripheral vascular disease
- •Pulmonary hypertension
- •OR >2 major risk factors for cardiovascular disease (CVD; high cholesterol, high blood pressure, smoking, diabetes, chronic kidney disease-stage 3 or 4)
- •Must have access to a mobile or landline telephone
- •Must be able to travel to group sessions, with or without transportation assistance
排除标准
- •Limited fluency in English posing significant barrier to deriving program benefit
研究组 & 干预措施
Take Heart self-management program
Group and telephone-based educational program to enhance self-management of heart disease and related risk factors.
干预措施: Take Heart (Behavioral)
Waitlist control
Control group participants will be offered the opportunity to participate in Take Heart following the conclusion of their study involvement.
结局指标
主要结局
Hospitalizations
时间窗: Baseline and 12-month follow up
This will be measured by asking participants to report the number of nights they have stayed overnight in the hospital during the past year, for something related to their own health. We will ask this at baseline and then at the 12 month mark after the completion of the baseline survey, so that we can compare the year prior to the intervention to the year they completed the intervention. In addition, when possible, we will verify self-reported hospitalizations with Electronic Medical Record (EMR) data from our partners at the Detroit Medical Center (DMC). We will only be able to look into the EMRs of those participants that are patients at the DMC. Change will be indicated by difference between count at baseline and count at follow-up.
Emergency Department Visits
时间窗: Baseline and 12 month follow up
This will be measured by asking participants to report the number of times they went to the emergency department for something related to their own health, during the past year. We will ask this at baseline and then at the 12 month mark after the completion of the baseline survey, so that we can compare the year prior to the intervention to the year they completed the intervention. In addition, when possible, we will verify self-reported Emergency Department visits with Electronic Medical Record (EMR) data from our partners at the Detroit Medical Center (DMC). We will only be able to look into the EMRs of those participants that are patients at the DMC. Change will be indicated by difference between count at baseline and count at follow-up.
次要结局
- Health-related Quality of Life(Baseline and 12-month follow-up)
- Cardiac Symptom Experience(Baseline and 12-month follow-up)
研究者
Cathleen M Connell
Professor
University of Michigan