A Partnership to Translate an Evidence-based Intervention (Take Heart) for Vulnerable Older Adults With Heart Disease
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 |
---|---|---|
|
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
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
- 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.
- 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
- 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).
- 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
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.- HUM00092196
- 1R01AG047203-01A1
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
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
|
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
|
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
|
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
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 |
cathleen@umich.edu |
- HUM00092196
- 1R01AG047203-01A1