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

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Diseases
• Intervention / Treatment: Behavioral: Take Heart

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.

• Study Type: Interventional
• Enrollment (Actual): 453
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48104
      • University of Michigan, School of Public Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Take Heart self-management program; Group and telephone-based educational program to enhance self-management of heart disease and related risk factors.	Behavioral: 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.
No Intervention: Waitlist control; Control group participants will be offered the opportunity to participate in Take Heart following the conclusion of their study involvement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalizations	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.	Baseline and 12-month follow up
Emergency Department Visits	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.	Baseline and 12 month follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-related Quality of Life	Health-related quality of life (HRQOL) was measured with the PROMIS-29 (Patient-Reported Outcomes Measurement Information System-29) profile measure, which assesses depression, anxiety, pain interference, physical function, fatigue, satisfaction with social role participation, and sleep disturbance (4 items each, 5 point Likert scales). Higher values indicate poorer health. One item (11 point scale) measures pain intensity on a scale of 0 -10, 0=no pain, 10=worst pain). The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. https://www.assessmentcenter.net/documents/PROMIS%20Profile%20Scoring%20Manual.pdf This table indicates the mean score in each domain at the 12-month follow up time point for both intervention and control groups, as well as the difference between the means of the two groups at the 12-month time point.	Baseline and 12-month follow-up
Cardiac Symptom Experience	The cardiac symptom subscale of the Symptom and Health Problem Profile (Janz et al., 1999) asks about the frequency of chest pain/discomfort; shortness of breath; waking up from sleep because of chest pain or pressure; waking up from sleep because of shortness of breath or difficulty breathing; and irregular heartbeat or palpitations (not present, once or twice/week, a few times/week, once/day, several times/day) in the prior 12 months. Symptom frequency (0 to 4) was summed, yielding an overall symptom burden score that ranged from 0 to 20. Higher scores indicate worse health. Change is indicated by the difference in mean frequency from baseline to follow-up.	Baseline and 12-month follow-up

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Institute on Aging (NIA); Detroit Medical Center; Detroit Area Agency on Aging
• Investigators: Principal Investigator: Cathleen M Connell, PhD, University of Michigan School of Public Health

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2016
• Primary Completion (Actual): October 18, 2019
• Study Completion (Actual): October 18, 2019

Study Registration Dates

• First Submitted: April 1, 2016
• First Submitted That Met QC Criteria: October 27, 2016
• First Posted (Estimate): November 1, 2016

Study Record Updates

• Last Update Posted (Actual): September 23, 2022
• Last Update Submitted That Met QC Criteria: August 29, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: chronic disease; health education; self-care; heart diseases; risk factors for heart disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases
• Other Study ID Numbers: HUM00092196; 1R01AG047203-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data sharing: We will have self-reported data (baseline and 12-month) on health, demographics, and psychosocial functioning from both intervention and control participants. An anonymized dataset will be created, which will be made available to other researchers who have appropriate approvals from all relevant Institutional Review Boards (IRBs) through a secure file transfer protocol (FTP) site, M+Box, whose encryption protocols allow secure uploading of files, with sharing limited to specified users (see: http://www.itcs.umich.edu/storage/box/faq.php#storage). Data dictionaries and data collection forms will also be made available. Researchers using the data will be instructed to delete their copy of the dataset once analyses are complete. An email address to reach University of Michigan investigators will be available for questions about the datasets.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No