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

NCT ID: NCT02950818

Last Updated: 2022-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 453 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-10
• Study Completion Date: 2019-10-18

Brief Summary

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.

Detailed 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.

Conditions

Heart Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Take Heart self-management program

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

Group Type: EXPERIMENTAL

Take Heart

Intervention Type: BEHAVIORAL

Participants receive an evidence-based heart disease self management program consisting of a combination of five two and a half hour group sessions and telephone counseling offered by a trained facilitator employed by the Detroit Area Agency on Aging. The program is designed so that participants select an area to work on (e.g., diet, exercise, medication taking, communication with health care professionals) and receive support, information, and encouragement from group members and program facilitators, to help them reach their goals.

Waitlist control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Take Heart

Participants receive an evidence-based heart disease self management program consisting of a combination of five two and a half hour group sessions and telephone counseling offered by a trained facilitator employed by the Detroit Area Agency on Aging. The program is designed so that participants select an area to work on (e.g., diet, exercise, medication taking, communication with health care professionals) and receive support, information, and encouragement from group members and program facilitators, to help them reach their goals.

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Detroit Medical Center

OTHER

Sponsor Role: collaborator

Detroit Area Agency on Aging

OTHER

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Cathleen M Connell

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cathleen M Connell, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan School of Public Health

Locations

University of Michigan, School of Public Health

Ann Arbor, Michigan, United States

Countries

United States

References

Janevic MR, Ramsay JE, Allgood KL, Domazet A, Cardozo S, Connell CM. Heart Disease Self-management for African American Older Adults: Outcomes of an Adapted Evidence-Based Intervention. Innov Aging. 2022 Aug 19;6(7):igac053. doi: 10.1093/geroni/igac053. eCollection 2022.

Reference Type: DERIVED

PMID: 36267321 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R01AG047203-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00092196

Identifier Type: -

Identifier Source: org_study_id