A Partnership to Translate an Evidence-based Intervention (Take Heart) for Vulnerable Older Adults With Heart Disease

University of Michigan

Status: Completed

Conditions: Heart Diseases

Treatments: Behavioral: Take Heart

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02950818

HUM00092196

1R01AG047203-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 453 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria:

50 years or older

1 or more diagnosed cardiovascular conditions, including:

• Atrial fibrillation
• Angina
• 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

Exclusion Criteria

• Limited fluency in English posing significant barrier to deriving program benefit

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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453 participants in 2 patient groups

Take Heart self-management program

Experimental group

Description:

Group and telephone-based educational program to enhance self-management of heart disease and related risk factors.

Treatment:

Behavioral: Take Heart

Waitlist control

No Intervention group

Description:

Control group participants will be offered the opportunity to participate in Take Heart following the conclusion of their study involvement.