Clinical trial NCT02950818: A Partnership to Translate an Evidence-based Intervention (Take Heart) for Vulnerable Older Adults With Heart Disease
Official title: A Partnership to Translate an Evidence-based Intervention for Vulnerable Older Adults With Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Diseases
Keywords: self-care
health education
chronic disease
heart diseases
risk factors for heart disease
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: Detroit Medical Center
name: Detroit Area Agency on Aging
First posted: 2016-11-01
Enrollment: 453
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Hospitalizations
timeFrame: Baseline and 12-month follow up
measure: Emergency Department Visits
timeFrame: Baseline and 12 month follow up
Secondary outcomes:
measure: Health-related Quality of Life
timeFrame: Baseline and 12-month follow-up
measure: Cardiac Symptom Experience
timeFrame: Baseline and 12-month follow-up
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan, School of Public Health
state: Michigan
Study officials:
affiliation: University of Michigan School of Public Health
name: Cathleen M Connell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.