NCT02950818

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

Completed NA Results posted Last updated 23 September 2022

What this trial tests

NA trial testing Take Heart in Heart Diseases in 453 participants. Completed in 18 October 2019.

Timeline

10 December 2016

Primary endpoint
18 October 2019

18 October 2019

Quick facts

Lead sponsor	University of Michigan
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	453
Start date	10 December 2016
Primary completion	18 October 2019
Estimated completion	18 October 2019
Sites	1 location across United States

Drugs / interventions tested

• Take Heart

Conditions studied

• Heart Diseases — all drugs for Heart Diseases →

Sponsor

University of Michigan

Who can join

50 and older, any sex, with Heart Diseases. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Hospitalizations Primary · Baseline and 12-month follow up

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

Group	Value	95% CI
Take Heart Self-management Program	0.98	0.98 – 1.6
Waitlist Control	1.48	1.19 – 1.84

Emergency Department Visits Primary · Baseline and 12 month follow up

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

Group	Value	95% CI
Take Heart Self-management Program	2.55	1.64 – 3.97
Waitlist Control	2.74	1.76 – 4.27

Health-related Quality of Life Secondary · Baseline and 12-month follow-up

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://w

Physical Functioning

Group	Value	95% CI
Take Heart Self-management Program	33	31.9 – 34.2
Waitlist Control	34.1	33 – 35.2
Means Difference Between Groups	-1.1	-2.446 – 0.297

Anxiety

Group	Value	95% CI
Take Heart Self-management Program	54.1	52.5 – 55.7
Waitlist Control	54.1	52.6 – 55.6
Means Difference Between Groups	0.001	-1.907 – 1.910

Depression

Group	Value	95% CI
Take Heart Self-management Program	51	49.4 – 52.6
Waitlist Control	51.3	49.8 – 52.7
Means Difference Between Groups	-0.26	-2.116 – 1.600

Fatigue

Group	Value	95% CI
Take Heart Self-management Program	51.3	49.8 – 52.9
Waitlist Control	54.2	52.7 – 55.6
Means Difference Between Groups	-2.82	-4.697 – -0.947

Sleep

Group	Value	95% CI
Take Heart Self-management Program	51.9	51.3 – 52.5
Waitlist Control	52.6	52.1 – 53.2
Means Difference Between Groups	-0.727	-1.431 – -0.023

Social

Group	Value	95% CI
Take Heart Self-management Program	38.9	34.4 – 40.5
Waitlist Control	40.1	28.6 – 41.5
Means Difference Between Groups	-1.129	-2.977 – 0.718

Pain Interference

Group	Value	95% CI
Take Heart Self-management Program	57.6	55.8 – 59.4
Waitlist Control	58.9	57.2 – 60.6
Means Difference Between Groups	-1.332	-3.467 – 0.802

Pain Intensity

Group	Value	95% CI
Take Heart Self-management Program	5.1	4.6 – 5.5
Waitlist Control	5.4	4.9 – 5.8
Means Difference Between Groups	-0.318	-0.854 – 0.218

Cardiac Symptom Experience Secondary · Baseline and 12-month follow-up

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 indica

Group	Value	95% CI
Take Heart Self-management Program	1.96	1.35 – 2.58
Waitlist Control	2.74	2.17 – 3.32

Adverse events — posted to ClinicalTrials.gov

Time frame: Participants were assessed for adverse events from baseline through study completion, an average of 1 year.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Take Heart Self-management Program

Serious: 7/228 (3%)

Deaths: 1/228

Waitlist Control

Serious: 0/225 (0%)

Deaths: 1/225

Serious adverse events (3 terms)

Reaction	System	Take Heart Self-management…	Waitlist Control
Heart Attack	Cardiac disorders	—	—
Stroke	Cardiac disorders	—	—
ED Visit	Respiratory, thoracic and mediastinal disorders	—	—

Most-reported serious reactions: Heart Attack, Stroke, ED Visit.

Data from ClinicalTrials.gov NCT02950818 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Heart Disease Self-management for African American Older Adults: Outcomes of an Adapted Evidence-Based Intervention.
   Janevic MR, Ramsay JE, Allgood KL, Domazet A, et al · · 2022 · cited 1× · PMID 36267321 · DOI 10.1093/geroni/igac053