A Partnership to Translate an Evidence-based Intervention (Take Heart) for Vulnerable Older Adults With Heart Disease
2 other identifiers
interventional
453
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 1, 2016
CompletedFirst Posted
Study publicly available on registry
November 1, 2016
CompletedStudy Start
First participant enrolled
December 10, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 18, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 18, 2019
CompletedResults Posted
Study results publicly available
August 25, 2022
CompletedSeptember 23, 2022
August 1, 2022
2.9 years
April 1, 2016
July 6, 2022
August 29, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Health-related Quality of Life
Baseline and 12-month follow-up
Cardiac Symptom Experience
Baseline and 12-month follow-up
Study Arms (2)
Take Heart self-management program
EXPERIMENTALGroup and telephone-based educational program to enhance self-management of heart disease and related risk factors.
Waitlist control
NO INTERVENTIONControl group participants will be offered the opportunity to participate in Take Heart following the conclusion of their study involvement.
Interventions
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.
Eligibility Criteria
You may qualify if:
- years or older
- 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
You may not qualify if:
- Limited fluency in English posing significant barrier to deriving program benefit
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Michiganlead
- National Institute on Aging (NIA)collaborator
- Detroit Medical Centercollaborator
- Detroit Area Agency on Agingcollaborator
Study Sites (1)
University of Michigan, School of Public Health
Ann Arbor, Michigan, 48104, United States
Related Publications (1)
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.
PMID: 36267321DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Cathleen Connell
- Organization
- University of Michigan School of Public Health
Study Officials
- PRINCIPAL INVESTIGATOR
Cathleen M Connell, PhD
University of Michigan School of Public Health
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 1, 2016
First Posted
November 1, 2016
Study Start
December 10, 2016
Primary Completion
October 18, 2019
Study Completion
October 18, 2019
Last Updated
September 23, 2022
Results First Posted
August 25, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will share
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.