Heart Diseases
Conditions
Keywords
self-care, health education, chronic disease, heart diseases, risk factors for heart disease
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.
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.
Interventions
BEHAVIORALTake 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.
Sponsors
National Institute on Aging (NIA)
Detroit Medical Center
Detroit Area Agency on Aging
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Take Heart Self-management Program 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. | 228 |
| Waitlist Control Control group participants will be offered the opportunity to participate in Take Heart following the conclusion of their study involvement. | 225 |
| Total | 453 |
Baseline characteristics
| Characteristic | Waitlist Control | Total | Take Heart Self-management Program |
|---|---|---|---|
| Age, Continuous | 65.3 years STANDARD_DEVIATION 8.6 | 65.4 years STANDARD_DEVIATION 9 | 65.5 years STANDARD_DEVIATION 9.3 |
| Comorbidities Arthritis | 158 particiapnts | 304 particiapnts | 146 particiapnts |
| Comorbidities Asthma | 64 particiapnts | 121 particiapnts | 57 particiapnts |
| Comorbidities Cancer | 35 particiapnts | 70 particiapnts | 35 particiapnts |
| Comorbidities COPD | 71 particiapnts | 121 particiapnts | 50 particiapnts |
| Comorbidities Depression | 80 particiapnts | 171 particiapnts | 91 particiapnts |
| Comorbidities Prediabetes | 84 particiapnts | 188 particiapnts | 104 particiapnts |
| Comorbidities Stroke | 42 particiapnts | 75 particiapnts | 33 particiapnts |
| Education College Graduate or Higher | 52 Participants | 93 Participants | 41 Participants |
| Education <High School | 30 Participants | 53 Participants | 23 Participants |
| Education High School Grad or GED | 56 Participants | 111 Participants | 55 Participants |
| Education Some College | 87 Participants | 194 Participants | 107 Participants |
| Employment Status Employed | 19 Participants | 45 Participants | 26 Participants |
| Employment Status Other | 46 Participants | 92 Participants | 46 Participants |
| Employment Status Retired | 119 Participants | 226 Participants | 107 Participants |
| Employment Status Unemployed | 41 Participants | 86 Participants | 45 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 4 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 197 Participants | 400 Participants | 203 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 26 Participants | 49 Participants | 23 Participants |
| Healthcare Utilization - ED Visits | 1.7 ED Visits in past 12 months STANDARD_DEVIATION 3.9 | 1.5 ED Visits in past 12 months STANDARD_DEVIATION 3.1 | 1.3 ED Visits in past 12 months STANDARD_DEVIATION 1.7 |
| Healthcare Utilization - Hospitalizations | 2.4 Hospitalizations in past 12 months STANDARD_DEVIATION 9.3 | 2.1 Hospitalizations in past 12 months STANDARD_DEVIATION 7.7 | 1.8 Hospitalizations in past 12 months STANDARD_DEVIATION 5 |
| Heart Disease Diagnoses Angina | 44 participants | 77 participants | 33 participants |
| Heart Disease Diagnoses Atrial Fibrilation | 44 participants | 86 participants | 42 participants |
| Heart Disease Diagnoses Congestive Heart Failure | 45 participants | 78 participants | 33 participants |
| Heart Disease Diagnoses Myocardial Infarction | 38 participants | 79 participants | 41 participants |
| Heart Disease Diagnoses Other Heart Disease Condition | 6 participants | 15 participants | 9 participants |
| Heart Disease Diagnoses Peripheral Vascular Disease | 26 participants | 53 participants | 27 participants |
| Heart Disease Diagnoses Pulmonary Hypertension | 7 participants | 18 participants | 11 participants |
| Heart Disease Diagnoses Valvular Disease | 22 participants | 34 participants | 12 participants |
| Heart Disease Risk Factors Chronic Kidney Disease | 16 participants | 26 participants | 10 participants |
| Heart Disease Risk Factors Current Smoker | 70 participants | 133 participants | 63 participants |
| Heart Disease Risk Factors Diabetes | 88 participants | 197 participants | 109 participants |
| Heart Disease Risk Factors High Blood Pressure | 204 participants | 414 participants | 210 participants |
| Heart Disease Risk Factors High Cholesterol | 170 participants | 354 participants | 184 participants |
| Heart Related Symptoms | 1.7 symptoms STANDARD_DEVIATION 1.5 | 1.5 symptoms STANDARD_DEVIATION 1.5 | 1.3 symptoms STANDARD_DEVIATION 1.5 |
| Marital Status Married/Partnered | 33 Participants | 57 Participants | 24 Participants |
| Marital Status Single | 192 Participants | 392 Participants | 200 Participants |
| PROMIS-29 Anxiety | 54.1 units on a scale STANDARD_DEVIATION 9.7 | 53.9 units on a scale STANDARD_DEVIATION 9.5 | 53.7 units on a scale STANDARD_DEVIATION 9.4 |
| PROMIS-29 Depression | 51.2 units on a scale STANDARD_DEVIATION 9.3 | 50.8 units on a scale STANDARD_DEVIATION 8.8 | 50.3 units on a scale STANDARD_DEVIATION 8.2 |
| PROMIS-29 Fatigue | 53.5 units on a scale STANDARD_DEVIATION 9.7 | 52.7 units on a scale STANDARD_DEVIATION 9.5 | 51.8 units on a scale STANDARD_DEVIATION 9.3 |
| PROMIS-29 Pain Intensity | 5.5 units on a scale STANDARD_DEVIATION 2.7 | 5.3 units on a scale STANDARD_DEVIATION 2.7 | 4.9 units on a scale STANDARD_DEVIATION 2.6 |
| PROMIS-29 Pain Interference | 58.8 units on a scale STANDARD_DEVIATION 10 | 58.1 units on a scale STANDARD_DEVIATION 10.1 | 57.3 units on a scale STANDARD_DEVIATION 10.1 |
| PROMIS-29 Physical Functioning | 34.5 units on a scale STANDARD_DEVIATION 7.1 | 33.9 units on a scale STANDARD_DEVIATION 7 | 33.1 units on a scale STANDARD_DEVIATION 6.8 |
| PROMIS-29 Sleep | 52.4 units on a scale STANDARD_DEVIATION 3.6 | 52.2 units on a scale STANDARD_DEVIATION 3.5 | 51.9 units on a scale STANDARD_DEVIATION 3.3 |
| PROMIS-29 Social | 38.8 units on a scale STANDARD_DEVIATION 8.6 | 38.8 units on a scale STANDARD_DEVIATION 8.8 | 38.9 units on a scale STANDARD_DEVIATION 9.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 187 Participants | 380 Participants | 193 Participants |
| Race (NIH/OMB) More than one race | 21 Participants | 41 Participants | 20 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 11 Participants | 4 Participants |
| Race (NIH/OMB) White | 10 Participants | 20 Participants | 10 Participants |
| Region of Enrollment United States | 225 Participants | 453 Participants | 228 Participants |
| Self-Rated Health Excellent | 6 Participants | 8 Participants | 2 Participants |
| Self-Rated Health Fair | 88 Participants | 177 Participants | 89 Participants |
| Self-Rated Health Good | 67 Participants | 146 Participants | 79 Participants |
| Self-Rated Health Poor | 45 Participants | 80 Participants | 35 Participants |
| Self-Rated Health Very Good | 19 Participants | 41 Participants | 22 Participants |
| Sex: Female, Male Female | 179 Participants | 334 Participants | 155 Participants |
| Sex: Female, Male Male | 45 Participants | 118 Participants | 73 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 228 | 1 / 225 |
| other Total, other adverse events | 0 / 228 | 0 / 225 |
| serious Total, serious adverse events | 7 / 228 | 0 / 225 |
Outcome results
Primary
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.
Time frame: Baseline and 12 month follow up
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Take Heart Self-management Program | Emergency Department Visits | 2.55 ED visits |
| Waitlist Control | Emergency Department Visits | 2.74 ED visits |
Primary
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.
Time frame: Baseline and 12-month follow up
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Take Heart Self-management Program | Hospitalizations | 0.98 hospitalizations |
| Waitlist Control | Hospitalizations | 1.48 hospitalizations |
Secondary
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.
Time frame: Baseline and 12-month follow-up
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Take Heart Self-management Program | Cardiac Symptom Experience | 1.96 units on a scale |
| Waitlist Control | Cardiac Symptom Experience | 2.74 units on a scale |
Secondary
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.
Time frame: Baseline and 12-month follow-up
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Take Heart Self-management Program | Health-related Quality of Life | Depression | 51 units on a scale |
| Take Heart Self-management Program | Health-related Quality of Life | Fatigue | 51.3 units on a scale |
| Take Heart Self-management Program | Health-related Quality of Life | Pain Intensity | 5.1 units on a scale |
| Take Heart Self-management Program | Health-related Quality of Life | Anxiety | 54.1 units on a scale |
| Take Heart Self-management Program | Health-related Quality of Life | Sleep | 51.9 units on a scale |
| Take Heart Self-management Program | Health-related Quality of Life | Pain Interference | 57.6 units on a scale |
| Take Heart Self-management Program | Health-related Quality of Life | Physical Functioning | 33 units on a scale |
| Take Heart Self-management Program | Health-related Quality of Life | Social | 38.9 units on a scale |
| Waitlist Control | Health-related Quality of Life | Physical Functioning | 34.1 units on a scale |
| Waitlist Control | Health-related Quality of Life | Pain Interference | 58.9 units on a scale |
| Waitlist Control | Health-related Quality of Life | Pain Intensity | 5.4 units on a scale |
| Waitlist Control | Health-related Quality of Life | Depression | 51.3 units on a scale |
| Waitlist Control | Health-related Quality of Life | Social | 40.1 units on a scale |
| Waitlist Control | Health-related Quality of Life | Fatigue | 54.2 units on a scale |
| Waitlist Control | Health-related Quality of Life | Sleep | 52.6 units on a scale |
| Waitlist Control | Health-related Quality of Life | Anxiety | 54.1 units on a scale |
| Means Difference Between Groups | Health-related Quality of Life | Pain Intensity | -0.318 units on a scale |
| Means Difference Between Groups | Health-related Quality of Life | Anxiety | 0.001 units on a scale |
| Means Difference Between Groups | Health-related Quality of Life | Depression | -0.26 units on a scale |
| Means Difference Between Groups | Health-related Quality of Life | Fatigue | -2.82 units on a scale |
| Means Difference Between Groups | Health-related Quality of Life | Sleep | -0.727 units on a scale |
| Means Difference Between Groups | Health-related Quality of Life | Social | -1.129 units on a scale |
| Means Difference Between Groups | Health-related Quality of Life | Pain Interference | -1.332 units on a scale |
| Means Difference Between Groups | Health-related Quality of Life | Physical Functioning | -1.1 units on a scale |