Trial Outcomes & Findings for A Partnership to Translate an Evidence-based Intervention (Take Heart) for Vulnerable Older Adults With Heart Disease (NCT NCT02950818)
NCT ID: NCT02950818
Last Updated: 2022-09-23
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
453 participants
Primary outcome timeframe
Baseline and 12-month follow up
Results posted on
2022-09-23
Participant Flow
Participant milestones
| Measure |
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.
|
Waitlist Control
Control group participants will be offered the opportunity to participate in Take Heart following the conclusion of their study involvement.
|
|---|---|---|
|
Overall Study
STARTED
|
228
|
225
|
|
Overall Study
COMPLETED
|
161
|
201
|
|
Overall Study
NOT COMPLETED
|
67
|
24
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
We had missing data on sex for one participant.
Baseline characteristics by cohort
| Measure |
Take Heart Self-management Program
n=228 Participants
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.
|
Waitlist Control
n=225 Participants
Control group participants will be offered the opportunity to participate in Take Heart following the conclusion of their study involvement.
|
Total
n=453 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.5 years
STANDARD_DEVIATION 9.3 • n=228 Participants
|
65.3 years
STANDARD_DEVIATION 8.6 • n=225 Participants
|
65.4 years
STANDARD_DEVIATION 9 • n=453 Participants
|
|
Sex: Female, Male
Female
|
155 Participants
n=228 Participants • We had missing data on sex for one participant.
|
179 Participants
n=224 Participants • We had missing data on sex for one participant.
|
334 Participants
n=452 Participants • We had missing data on sex for one participant.
|
|
Sex: Female, Male
Male
|
73 Participants
n=228 Participants • We had missing data on sex for one participant.
|
45 Participants
n=224 Participants • We had missing data on sex for one participant.
|
118 Participants
n=452 Participants • We had missing data on sex for one participant.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=228 Participants
|
2 Participants
n=225 Participants
|
4 Participants
n=453 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
203 Participants
n=228 Participants
|
197 Participants
n=225 Participants
|
400 Participants
n=453 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
23 Participants
n=228 Participants
|
26 Participants
n=225 Participants
|
49 Participants
n=453 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=228 Participants
|
0 Participants
n=225 Participants
|
1 Participants
n=453 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=228 Participants
|
0 Participants
n=225 Participants
|
0 Participants
n=453 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=228 Participants
|
0 Participants
n=225 Participants
|
0 Participants
n=453 Participants
|
|
Race (NIH/OMB)
Black or African American
|
193 Participants
n=228 Participants
|
187 Participants
n=225 Participants
|
380 Participants
n=453 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=228 Participants
|
10 Participants
n=225 Participants
|
20 Participants
n=453 Participants
|
|
Race (NIH/OMB)
More than one race
|
20 Participants
n=228 Participants
|
21 Participants
n=225 Participants
|
41 Participants
n=453 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=228 Participants
|
7 Participants
n=225 Participants
|
11 Participants
n=453 Participants
|
|
Region of Enrollment
United States
|
228 Participants
n=228 Participants
|
225 Participants
n=225 Participants
|
453 Participants
n=453 Participants
|
|
Education
<High School
|
23 Participants
n=226 Participants • Missing education data on participants.
|
30 Participants
n=225 Participants • Missing education data on participants.
|
53 Participants
n=451 Participants • Missing education data on participants.
|
|
Education
High School Grad or GED
|
55 Participants
n=226 Participants • Missing education data on participants.
|
56 Participants
n=225 Participants • Missing education data on participants.
|
111 Participants
n=451 Participants • Missing education data on participants.
|
|
Education
Some College
|
107 Participants
n=226 Participants • Missing education data on participants.
|
87 Participants
n=225 Participants • Missing education data on participants.
|
194 Participants
n=451 Participants • Missing education data on participants.
|
|
Education
College Graduate or Higher
|
41 Participants
n=226 Participants • Missing education data on participants.
|
52 Participants
n=225 Participants • Missing education data on participants.
|
93 Participants
n=451 Participants • Missing education data on participants.
|
|
Marital Status
Married/Partnered
|
24 Participants
n=224 Participants • Missing data on participants.
|
33 Participants
n=225 Participants • Missing data on participants.
|
57 Participants
n=449 Participants • Missing data on participants.
|
|
Marital Status
Single
|
200 Participants
n=224 Participants • Missing data on participants.
|
192 Participants
n=225 Participants • Missing data on participants.
|
392 Participants
n=449 Participants • Missing data on participants.
|
|
Employment Status
Employed
|
26 Participants
n=224 Participants • Missing data on some participants.
|
19 Participants
n=225 Participants • Missing data on some participants.
|
45 Participants
n=449 Participants • Missing data on some participants.
|
|
Employment Status
Retired
|
107 Participants
n=224 Participants • Missing data on some participants.
|
119 Participants
n=225 Participants • Missing data on some participants.
|
226 Participants
n=449 Participants • Missing data on some participants.
|
|
Employment Status
Unemployed
|
45 Participants
n=224 Participants • Missing data on some participants.
|
41 Participants
n=225 Participants • Missing data on some participants.
|
86 Participants
n=449 Participants • Missing data on some participants.
|
|
Employment Status
Other
|
46 Participants
n=224 Participants • Missing data on some participants.
|
46 Participants
n=225 Participants • Missing data on some participants.
|
92 Participants
n=449 Participants • Missing data on some participants.
|
|
Self-Rated Health
Excellent
|
2 Participants
n=227 Participants • Missing data on participant.
|
6 Participants
n=225 Participants • Missing data on participant.
|
8 Participants
n=452 Participants • Missing data on participant.
|
|
Self-Rated Health
Very Good
|
22 Participants
n=227 Participants • Missing data on participant.
|
19 Participants
n=225 Participants • Missing data on participant.
|
41 Participants
n=452 Participants • Missing data on participant.
|
|
Self-Rated Health
Good
|
79 Participants
n=227 Participants • Missing data on participant.
|
67 Participants
n=225 Participants • Missing data on participant.
|
146 Participants
n=452 Participants • Missing data on participant.
|
|
Self-Rated Health
Fair
|
89 Participants
n=227 Participants • Missing data on participant.
|
88 Participants
n=225 Participants • Missing data on participant.
|
177 Participants
n=452 Participants • Missing data on participant.
|
|
Self-Rated Health
Poor
|
35 Participants
n=227 Participants • Missing data on participant.
|
45 Participants
n=225 Participants • Missing data on participant.
|
80 Participants
n=452 Participants • Missing data on participant.
|
|
Heart Disease Diagnoses
Atrial Fibrilation
|
42 participants
n=228 Participants
|
44 participants
n=225 Participants
|
86 participants
n=453 Participants
|
|
Heart Disease Diagnoses
Myocardial Infarction
|
41 participants
n=228 Participants
|
38 participants
n=225 Participants
|
79 participants
n=453 Participants
|
|
Heart Disease Diagnoses
Valvular Disease
|
12 participants
n=228 Participants
|
22 participants
n=225 Participants
|
34 participants
n=453 Participants
|
|
Heart Disease Diagnoses
Pulmonary Hypertension
|
11 participants
n=228 Participants
|
7 participants
n=225 Participants
|
18 participants
n=453 Participants
|
|
Heart Disease Diagnoses
Angina
|
33 participants
n=228 Participants
|
44 participants
n=225 Participants
|
77 participants
n=453 Participants
|
|
Heart Disease Diagnoses
Congestive Heart Failure
|
33 participants
n=228 Participants
|
45 participants
n=225 Participants
|
78 participants
n=453 Participants
|
|
Heart Disease Diagnoses
Peripheral Vascular Disease
|
27 participants
n=228 Participants
|
26 participants
n=225 Participants
|
53 participants
n=453 Participants
|
|
Heart Disease Diagnoses
Other Heart Disease Condition
|
9 participants
n=228 Participants
|
6 participants
n=225 Participants
|
15 participants
n=453 Participants
|
|
Heart Disease Risk Factors
High Cholesterol
|
184 participants
n=228 Participants
|
170 participants
n=225 Participants
|
354 participants
n=453 Participants
|
|
Heart Disease Risk Factors
High Blood Pressure
|
210 participants
n=228 Participants
|
204 participants
n=225 Participants
|
414 participants
n=453 Participants
|
|
Heart Disease Risk Factors
Diabetes
|
109 participants
n=228 Participants
|
88 participants
n=225 Participants
|
197 participants
n=453 Participants
|
|
Heart Disease Risk Factors
Chronic Kidney Disease
|
10 participants
n=228 Participants
|
16 participants
n=225 Participants
|
26 participants
n=453 Participants
|
|
Heart Disease Risk Factors
Current Smoker
|
63 participants
n=228 Participants
|
70 participants
n=225 Participants
|
133 participants
n=453 Participants
|
|
Comorbidities
Depression
|
91 particiapnts
n=228 Participants
|
80 particiapnts
n=225 Participants
|
171 particiapnts
n=453 Participants
|
|
Comorbidities
Cancer
|
35 particiapnts
n=228 Participants
|
35 particiapnts
n=225 Participants
|
70 particiapnts
n=453 Participants
|
|
Comorbidities
Prediabetes
|
104 particiapnts
n=228 Participants
|
84 particiapnts
n=225 Participants
|
188 particiapnts
n=453 Participants
|
|
Comorbidities
Stroke
|
33 particiapnts
n=228 Participants
|
42 particiapnts
n=225 Participants
|
75 particiapnts
n=453 Participants
|
|
Comorbidities
Arthritis
|
146 particiapnts
n=228 Participants
|
158 particiapnts
n=225 Participants
|
304 particiapnts
n=453 Participants
|
|
Comorbidities
COPD
|
50 particiapnts
n=228 Participants
|
71 particiapnts
n=225 Participants
|
121 particiapnts
n=453 Participants
|
|
Comorbidities
Asthma
|
57 particiapnts
n=228 Participants
|
64 particiapnts
n=225 Participants
|
121 particiapnts
n=453 Participants
|
|
Healthcare Utilization - ED Visits
|
1.3 ED Visits in past 12 months
STANDARD_DEVIATION 1.7 • n=228 Participants
|
1.7 ED Visits in past 12 months
STANDARD_DEVIATION 3.9 • n=225 Participants
|
1.5 ED Visits in past 12 months
STANDARD_DEVIATION 3.1 • n=453 Participants
|
|
PROMIS-29
Physical Functioning
|
33.1 units on a scale
STANDARD_DEVIATION 6.8 • n=228 Participants
|
34.5 units on a scale
STANDARD_DEVIATION 7.1 • n=225 Participants
|
33.9 units on a scale
STANDARD_DEVIATION 7 • n=453 Participants
|
|
PROMIS-29
Anxiety
|
53.7 units on a scale
STANDARD_DEVIATION 9.4 • n=228 Participants
|
54.1 units on a scale
STANDARD_DEVIATION 9.7 • n=225 Participants
|
53.9 units on a scale
STANDARD_DEVIATION 9.5 • n=453 Participants
|
|
PROMIS-29
Depression
|
50.3 units on a scale
STANDARD_DEVIATION 8.2 • n=228 Participants
|
51.2 units on a scale
STANDARD_DEVIATION 9.3 • n=225 Participants
|
50.8 units on a scale
STANDARD_DEVIATION 8.8 • n=453 Participants
|
|
PROMIS-29
Fatigue
|
51.8 units on a scale
STANDARD_DEVIATION 9.3 • n=228 Participants
|
53.5 units on a scale
STANDARD_DEVIATION 9.7 • n=225 Participants
|
52.7 units on a scale
STANDARD_DEVIATION 9.5 • n=453 Participants
|
|
PROMIS-29
Sleep
|
51.9 units on a scale
STANDARD_DEVIATION 3.3 • n=228 Participants
|
52.4 units on a scale
STANDARD_DEVIATION 3.6 • n=225 Participants
|
52.2 units on a scale
STANDARD_DEVIATION 3.5 • n=453 Participants
|
|
PROMIS-29
Social
|
38.9 units on a scale
STANDARD_DEVIATION 9.1 • n=228 Participants
|
38.8 units on a scale
STANDARD_DEVIATION 8.6 • n=225 Participants
|
38.8 units on a scale
STANDARD_DEVIATION 8.8 • n=453 Participants
|
|
PROMIS-29
Pain Interference
|
57.3 units on a scale
STANDARD_DEVIATION 10.1 • n=228 Participants
|
58.8 units on a scale
STANDARD_DEVIATION 10 • n=225 Participants
|
58.1 units on a scale
STANDARD_DEVIATION 10.1 • n=453 Participants
|
|
PROMIS-29
Pain Intensity
|
4.9 units on a scale
STANDARD_DEVIATION 2.6 • n=228 Participants
|
5.5 units on a scale
STANDARD_DEVIATION 2.7 • n=225 Participants
|
5.3 units on a scale
STANDARD_DEVIATION 2.7 • n=453 Participants
|
|
Heart Related Symptoms
|
1.3 symptoms
STANDARD_DEVIATION 1.5 • n=228 Participants
|
1.7 symptoms
STANDARD_DEVIATION 1.5 • n=225 Participants
|
1.5 symptoms
STANDARD_DEVIATION 1.5 • n=453 Participants
|
|
Healthcare Utilization - Hospitalizations
|
1.8 Hospitalizations in past 12 months
STANDARD_DEVIATION 5 • n=228 Participants
|
2.4 Hospitalizations in past 12 months
STANDARD_DEVIATION 9.3 • n=225 Participants
|
2.1 Hospitalizations in past 12 months
STANDARD_DEVIATION 7.7 • n=453 Participants
|
PRIMARY outcome
Timeframe: Baseline and 12-month follow upThis 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.
Outcome measures
| Measure |
Take Heart Self-management Program
n=161 Participants
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.
|
Waitlist Control
n=201 Participants
Control group participants will be offered the opportunity to participate in Take Heart following the conclusion of their study involvement.
|
Means Difference Between Groups
Means differences at 12 months between intervention and control groups (Intervention minus control)
|
|---|---|---|---|
|
Hospitalizations
|
0.98 hospitalizations
Interval 0.98 to 1.6
|
1.48 hospitalizations
Interval 1.19 to 1.84
|
—
|
PRIMARY outcome
Timeframe: Baseline and 12 month follow upThis 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.
Outcome measures
| Measure |
Take Heart Self-management Program
n=161 Participants
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.
|
Waitlist Control
n=201 Participants
Control group participants will be offered the opportunity to participate in Take Heart following the conclusion of their study involvement.
|
Means Difference Between Groups
Means differences at 12 months between intervention and control groups (Intervention minus control)
|
|---|---|---|---|
|
Emergency Department Visits
|
2.55 ED visits
Interval 1.64 to 3.97
|
2.74 ED visits
Interval 1.76 to 4.27
|
—
|
SECONDARY outcome
Timeframe: Baseline and 12-month follow-upHealth-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.
Outcome measures
| Measure |
Take Heart Self-management Program
n=161 Participants
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.
|
Waitlist Control
n=201 Participants
Control group participants will be offered the opportunity to participate in Take Heart following the conclusion of their study involvement.
|
Means Difference Between Groups
n=362 Participants
Means differences at 12 months between intervention and control groups (Intervention minus control)
|
|---|---|---|---|
|
Health-related Quality of Life
Physical Functioning
|
33 units on a scale
Interval 31.9 to 34.2
|
34.1 units on a scale
Interval 33.0 to 35.2
|
-1.1 units on a scale
Interval -2.446 to 0.297
|
|
Health-related Quality of Life
Anxiety
|
54.1 units on a scale
Interval 52.5 to 55.7
|
54.1 units on a scale
Interval 52.6 to 55.6
|
0.001 units on a scale
Interval -1.907 to 1.91
|
|
Health-related Quality of Life
Pain Interference
|
57.6 units on a scale
Interval 55.8 to 59.4
|
58.9 units on a scale
Interval 57.2 to 60.6
|
-1.332 units on a scale
Interval -3.467 to 0.802
|
|
Health-related Quality of Life
Depression
|
51 units on a scale
Interval 49.4 to 52.6
|
51.3 units on a scale
Interval 49.8 to 52.7
|
-0.26 units on a scale
Interval -2.116 to 1.6
|
|
Health-related Quality of Life
Fatigue
|
51.3 units on a scale
Interval 49.8 to 52.9
|
54.2 units on a scale
Interval 52.7 to 55.6
|
-2.82 units on a scale
Interval -4.697 to -0.947
|
|
Health-related Quality of Life
Sleep
|
51.9 units on a scale
Interval 51.3 to 52.5
|
52.6 units on a scale
Interval 52.1 to 53.2
|
-0.727 units on a scale
Interval -1.431 to -0.023
|
|
Health-related Quality of Life
Social
|
38.9 units on a scale
Interval 34.4 to 40.5
|
40.1 units on a scale
Interval 28.6 to 41.5
|
-1.129 units on a scale
Interval -2.977 to 0.718
|
|
Health-related Quality of Life
Pain Intensity
|
5.1 units on a scale
Interval 4.6 to 5.5
|
5.4 units on a scale
Interval 4.9 to 5.8
|
-0.318 units on a scale
Interval -0.854 to 0.218
|
SECONDARY outcome
Timeframe: Baseline and 12-month follow-upThe 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.
Outcome measures
| Measure |
Take Heart Self-management Program
n=161 Participants
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.
|
Waitlist Control
n=201 Participants
Control group participants will be offered the opportunity to participate in Take Heart following the conclusion of their study involvement.
|
Means Difference Between Groups
Means differences at 12 months between intervention and control groups (Intervention minus control)
|
|---|---|---|---|
|
Cardiac Symptom Experience
|
1.96 units on a scale
Interval 1.35 to 2.58
|
2.74 units on a scale
Interval 2.17 to 3.32
|
—
|
Adverse Events
Take Heart Self-management Program
Serious events: 7 serious events
Other events: 0 other events
Deaths: 1 deaths
Waitlist Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Take Heart Self-management Program
n=228 participants at risk
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.
|
Waitlist Control
n=225 participants at risk
Control group participants will be offered the opportunity to participate in Take Heart following the conclusion of their study involvement.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
ED Visit
|
0.44%
1/228 • Participants were assessed for adverse events from baseline through study completion, an average of 1 year.
|
0.00%
0/225 • Participants were assessed for adverse events from baseline through study completion, an average of 1 year.
|
|
Cardiac disorders
Heart Attack
|
1.8%
4/228 • Participants were assessed for adverse events from baseline through study completion, an average of 1 year.
|
0.00%
0/225 • Participants were assessed for adverse events from baseline through study completion, an average of 1 year.
|
|
Cardiac disorders
Stroke
|
0.88%
2/228 • Participants were assessed for adverse events from baseline through study completion, an average of 1 year.
|
0.00%
0/225 • Participants were assessed for adverse events from baseline through study completion, an average of 1 year.
|
Other adverse events
Adverse event data not reported
Additional Information
Cathleen Connell
University of Michigan School of Public Health
Phone: 734-647-3189
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place