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Heart DiseasesNCT02950818

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

A study testing Take Heart in people with Heart Diseases, run by University of Michigan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Heart Diseases
What is being tested?
Take Heart
Could I receive a placebo?
No, everyone receives an active treatment
How many people
453 participants
Where
1 siteUnited States
Study dates
10 Dec 2016to 18 Oct 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 50 years or older
  • 1 or more diagnosed cardiovascular conditions, including:
  • Atrial fibrillation
  • Angina
  • Myocardial infarction
  • Congestive heart failure
Show all 12Show fewer
  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Michigan, School of Public Health

    Ann Arbor, Michigan, 48104

Other trials in United States

About this study

Official title: 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.

Read the 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
Being tested
Take Heart
Keywords
self-care, health education, chronic disease, heart diseases, risk factors for heart disease
Medical subject headings
Heart Diseases, Health Education, Chronic Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Take HeartBehavioural

    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.

Study groups in NCT02950818
Study groupRoleWhat they receive
Take Heart self-management programExperimentalGroup and telephone-based educational program to enhance self-management of heart disease and related risk factors.
Receives: Behavioral: Take Heart
Waitlist controlNo interventionControl group participants will be offered the opportunity to participate in Take Heart following the conclusion of their study involvement.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and 12-month follow up

  2. 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.

    Measured: Baseline and 12 month follow up

Secondary outcomes (2)

  1. 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.

    Measured: Baseline and 12-month follow-up

  2. 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.

    Measured: Baseline and 12-month follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2016 (estimated)
  2. Study start10 Dec 2016
  3. Primary completion18 Oct 2019
  4. Study completion18 Oct 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
453 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02950818
Sponsor's protocol ID
HUM00092196
Other IDs
1R01AG047203-01A1
Status last verified
Aug 2022
First submitted
1 Apr 2016
Last updated
23 Sep 2022
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

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.

    PubMed 36267321

Questions about this trial

What is this clinical trial studying?

A study testing Take Heart in people with Heart Diseases, run by University of Michigan at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hospitalizations (time frame: Baseline and 12-month follow up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02950818, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2022; AzTrials last refreshed its copy on 6 Nov 2026.

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