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

Sponsor
University of Michigan (Other)
Overall Status
Completed
CT.gov ID
NCT02950818
Collaborator
National Institute on Aging (NIA) (NIH), Detroit Medical Center (Other), Detroit Area Agency on Aging (Other)
453
1
2
34.2
13.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Take Heart
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
453 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Partnership to Translate an Evidence-based Intervention for Vulnerable Older Adults With Heart Disease
Actual Study Start Date :
Dec 10, 2016
Actual Primary Completion Date :
Oct 18, 2019
Actual Study Completion Date :
Oct 18, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Hospitalizations [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 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.

  2. Emergency Department Visits [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 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.

Secondary Outcome Measures

  1. Health-related Quality of Life [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://www.assessmentcenter.net/documents/PROMIS%20Profile%20Scoring%20Manual.pdf Change in HRQOL in each domain are indicated by the difference in T-scores between baseline and follow-up (12 months), and, for pain intensity, change is indicated by the difference in the raw score between baseline and follow-up (12 months).

  2. Cardiac Symptom Experience [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 indicated by the difference in mean frequency from baseline to follow-up.

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Michigan, School of Public Health Ann Arbor Michigan United States 48104

Sponsors and Collaborators

  • University of Michigan
  • 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

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Cathleen M Connell, Professor, University of Michigan
ClinicalTrials.gov Identifier:
NCT02950818
Other Study ID Numbers:
  • HUM00092196
  • 1R01AG047203-01A1
First Posted:
Nov 1, 2016
Last Update Posted:
Aug 25, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Cathleen M Connell, Professor, University of Michigan
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Take Heart Self-management Program Waitlist Control
Arm/Group Description Group and telephone-based educational program to enhance self-management of heart disease and related risk factors. 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. Control group participants will be offered the opportunity to participate in Take Heart following the conclusion of their study involvement.
Period Title: Overall Study
STARTED 228 225
COMPLETED 161 201
NOT COMPLETED 67 24

Baseline Characteristics

Arm/Group Title Take Heart Self-management Program Waitlist Control Total
Arm/Group Description Group and telephone-based educational program to enhance self-management of heart disease and related risk factors. 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. Control group participants will be offered the opportunity to participate in Take Heart following the conclusion of their study involvement. Total of all reporting groups
Overall Participants 228 225 453
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
65.5
(9.3)
65.3
(8.6)
65.4
(9)
Sex: Female, Male (Count of Participants)
Female
155
68%
179
79.6%
334
73.7%
Male
73
32%
45
20%
118
26%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
2
0.9%
2
0.9%
4
0.9%
Not Hispanic or Latino
203
89%
197
87.6%
400
88.3%
Unknown or Not Reported
23
10.1%
26
11.6%
49
10.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
1
0.4%
0
0%
1
0.2%
Asian
0
0%
0
0%
0
0%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
Black or African American
193
84.6%
187
83.1%
380
83.9%
White
10
4.4%
10
4.4%
20
4.4%
More than one race
20
8.8%
21
9.3%
41
9.1%
Unknown or Not Reported
4
1.8%
7
3.1%
11
2.4%
Region of Enrollment (Count of Participants)
United States
228
100%
225
100%
453
100%
Education (Count of Participants)
<High School
23
10.1%
30
13.3%
53
11.7%
High School Grad or GED
55
24.1%
56
24.9%
111
24.5%
Some College
107
46.9%
87
38.7%
194
42.8%
College Graduate or Higher
41
18%
52
23.1%
93
20.5%
Marital Status (Count of Participants)
Married/Partnered
24
10.5%
33
14.7%
57
12.6%
Single
200
87.7%
192
85.3%
392
86.5%
Employment Status (Count of Participants)
Employed
26
11.4%
19
8.4%
45
9.9%
Retired
107
46.9%
119
52.9%
226
49.9%
Unemployed
45
19.7%
41
18.2%
86
19%
Other
46
20.2%
46
20.4%
92
20.3%
Self-Rated Health (Count of Participants)
Excellent
2
0.9%
6
2.7%
8
1.8%
Very Good
22
9.6%
19
8.4%
41
9.1%
Good
79
34.6%
67
29.8%
146
32.2%
Fair
89
39%
88
39.1%
177
39.1%
Poor
35
15.4%
45
20%
80
17.7%
Heart Disease Diagnoses (participants) [Number]
Atrial Fibrilation
42
18.4%
44
19.6%
86
19%
Myocardial Infarction
41
18%
38
16.9%
79
17.4%
Valvular Disease
12
5.3%
22
9.8%
34
7.5%
Pulmonary Hypertension
11
4.8%
7
3.1%
18
4%
Angina
33
14.5%
44
19.6%
77
17%
Congestive Heart Failure
33
14.5%
45
20%
78
17.2%
Peripheral Vascular Disease
27
11.8%
26
11.6%
53
11.7%
Other Heart Disease Condition
9
3.9%
6
2.7%
15
3.3%
Heart Disease Risk Factors (participants) [Number]
High Cholesterol
184
80.7%
170
75.6%
354
78.1%
High Blood Pressure
210
92.1%
204
90.7%
414
91.4%
Diabetes
109
47.8%
88
39.1%
197
43.5%
Chronic Kidney Disease
10
4.4%
16
7.1%
26
5.7%
Current Smoker
63
27.6%
70
31.1%
133
29.4%
Comorbidities (particiapnts) [Number]
Depression
91
80
171
Cancer
35
35
70
Prediabetes
104
84
188
Stroke
33
42
75
Arthritis
146
158
304
COPD
50
71
121
Asthma
57
64
121
Healthcare Utilization - ED Visits (ED Visits in past 12 months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [ED Visits in past 12 months]
1.3
(1.7)
1.7
(3.9)
1.5
(3.1)
PROMIS-29 (units on a scale) [Mean (Standard Deviation) ]
Physical Functioning
33.1
(6.8)
34.5
(7.1)
33.9
(7)
Anxiety
53.7
(9.4)
54.1
(9.7)
53.9
(9.5)
Depression
50.3
(8.2)
51.2
(9.3)
50.8
(8.8)
Fatigue
51.8
(9.3)
53.5
(9.7)
52.7
(9.5)
Sleep
51.9
(3.3)
52.4
(3.6)
52.2
(3.5)
Social
38.9
(9.1)
38.8
(8.6)
38.8
(8.8)
Pain Interference
57.3
(10.1)
58.8
(10)
58.1
(10.1)
Pain Intensity
4.9
(2.6)
5.5
(2.7)
5.3
(2.7)
Heart Related Symptoms (symptoms) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [symptoms]
1.3
(1.5)
1.7
(1.5)
1.5
(1.5)
Healthcare Utilization - Hospitalizations (Hospitalizations in past 12 months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Hospitalizations in past 12 months]
1.8
(5)
2.4
(9.3)
2.1
(7.7)

Outcome Measures

1. Primary Outcome
Title Hospitalizations
Description 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.
Time Frame Baseline and 12-month follow up

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Take Heart Self-management Program Waitlist Control
Arm/Group Description Group and telephone-based educational program to enhance self-management of heart disease and related risk factors. 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. Control group participants will be offered the opportunity to participate in Take Heart following the conclusion of their study involvement.
Measure Participants 161 201
Mean (95% Confidence Interval) [hospitalizations]
0.98
1.48
2. Primary Outcome
Title Emergency Department Visits
Description 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.
Time Frame Baseline and 12 month follow up

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Take Heart Self-management Program Waitlist Control
Arm/Group Description Group and telephone-based educational program to enhance self-management of heart disease and related risk factors. 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. Control group participants will be offered the opportunity to participate in Take Heart following the conclusion of their study involvement.
Measure Participants 161 201
Mean (95% Confidence Interval) [ED visits]
2.55
2.74
3. Secondary Outcome
Title Health-related Quality of Life
Description 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 Change in HRQOL in each domain are indicated by the difference in T-scores between baseline and follow-up (12 months), and, for pain intensity, change is indicated by the difference in the raw score between baseline and follow-up (12 months).
Time Frame Baseline and 12-month follow-up

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Take Heart Self-management Program Waitlist Control
Arm/Group Description Group and telephone-based educational program to enhance self-management of heart disease and related risk factors. 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. Control group participants will be offered the opportunity to participate in Take Heart following the conclusion of their study involvement.
Measure Participants 161 201
Physical Functioning
33
34.1
Anxiety
54.1
54.1
Depression
51
51.3
Fatigue
51.3
54.2
Sleep
51.9
52.6
Social
38.9
40.1
Pain Interference
57.6
58.9
Pain Intensity
5.1
5.4
4. Secondary Outcome
Title Cardiac Symptom Experience
Description 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.
Time Frame Baseline and 12-month follow-up

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Take Heart Self-management Program Waitlist Control
Arm/Group Description Group and telephone-based educational program to enhance self-management of heart disease and related risk factors. 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. Control group participants will be offered the opportunity to participate in Take Heart following the conclusion of their study involvement.
Measure Participants 161 201
Mean (95% Confidence Interval) [units on a scale]
1.96
2.74

Adverse Events

Time Frame Participants were assessed for adverse events from baseline through study completion, an average of 1 year.
Adverse Event Reporting Description
Arm/Group Title Take Heart Self-management Program Waitlist Control
Arm/Group Description Group and telephone-based educational program to enhance self-management of heart disease and related risk factors. 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. Control group participants will be offered the opportunity to participate in Take Heart following the conclusion of their study involvement.
All Cause Mortality
Take Heart Self-management Program Waitlist Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 1/228 (0.4%) 1/225 (0.4%)
Serious Adverse Events
Take Heart Self-management Program Waitlist Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 7/228 (3.1%) 0/225 (0%)
Cardiac disorders
Heart Attack 4/228 (1.8%) 0/225 (0%)
Stroke 2/228 (0.9%) 0/225 (0%)
Respiratory, thoracic and mediastinal disorders
ED Visit 1/228 (0.4%) 0/225 (0%)
Other (Not Including Serious) Adverse Events
Take Heart Self-management Program Waitlist Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/228 (0%) 0/225 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Cathleen Connell
Organization University of Michigan School of Public Health
Phone 734-647-3189
Email cathleen@umich.edu
Responsible Party:
Cathleen M Connell, Professor, University of Michigan
ClinicalTrials.gov Identifier:
NCT02950818
Other Study ID Numbers:
  • HUM00092196
  • 1R01AG047203-01A1
First Posted:
Nov 1, 2016
Last Update Posted:
Aug 25, 2022
Last Verified:
Aug 1, 2022