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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AG047203-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| Detroit Medical Center | OTHER |
| Detroit Area Agency on Aging | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Take Heart self-management program | Experimental | Group and telephone-based educational program to enhance self-management of heart disease and related risk factors. |
|
| Waitlist control | No Intervention | Control group participants will be offered the opportunity to participate in Take Heart following the conclusion of their study involvement. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Take Heart | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and 12-month follow up |
| 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. | Baseline and 12 month follow up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion criteria:
50 years or older
1 or more diagnosed cardiovascular conditions, including:
Exclusion Criteria
• Limited fluency in English posing significant barrier to deriving program benefit
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| Name | Affiliation | Role |
|---|---|---|
| Cathleen M Connell, PhD | University of Michigan School of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan, School of Public Health | Ann Arbor | Michigan | 48104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36267321 | Derived | Janevic MR, Ramsay JE, Allgood KL, Domazet A, Cardozo S, Connell CM. Heart Disease Self-management for African American Older Adults: Outcomes of an Adapted Evidence-Based Intervention. Innov Aging. 2022 Aug 19;6(7):igac053. doi: 10.1093/geroni/igac053. eCollection 2022. |
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Data sharing: We will have self-reported data (baseline and 12-month) on health, demographics, and psychosocial functioning from both intervention and control participants. An anonymized dataset will be created, which will be made available to other researchers who have appropriate approvals from all relevant Institutional Review Boards (IRBs) through a secure file transfer protocol (FTP) site, M+Box, whose encryption protocols allow secure uploading of files, with sharing limited to specified users (see: http://www.itcs.umich.edu/storage/box/faq.php#storage). Data dictionaries and data collection forms will also be made available. Researchers using the data will be instructed to delete their copy of the dataset once analyses are complete. An email address to reach University of Michigan investigators will be available for questions about the datasets.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Waitlist Control | Control group participants will be offered the opportunity to participate in Take Heart following the conclusion of their study involvement. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | 95% Confidence Interval | hospitalizations | Baseline and 12-month follow up |
|
Participants were assessed for adverse events from baseline through study completion, an average of 1 year.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ED Visit | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cathleen Connell | University of Michigan School of Public Health | 734-647-3189 | cathleen@umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 21, 2019 | Jul 5, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 20, 2016 | Jul 5, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D006266 | Health Education |
| D002908 | Chronic Disease |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D000099060 | Adherence Interventions |
| D055118 | Medication Adherence |
| D010349 | Patient Compliance |
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|
| Baseline and 12-month follow-up |
| 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. | Baseline and 12-month follow-up |
| BG001 | Waitlist Control | Control group participants will be offered the opportunity to participate in Take Heart following the conclusion of their study involvement. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | We had missing data on sex for one participant. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Education | Missing education data on participants. | Count of Participants | Participants |
|
| Marital Status | Missing data on participants. | Count of Participants | Participants |
|
| Employment Status | Missing data on some participants. | Count of Participants | Participants |
|
| Self-Rated Health | Missing data on participant. | Count of Participants | Participants |
|
| Heart Disease Diagnoses | Number | participants |
|
| Heart Disease Risk Factors | Number | participants |
|
| Comorbidities | Number | particiapnts |
|
| Healthcare Utilization - ED Visits | Mean | Standard Deviation | ED Visits in past 12 months |
|
| PROMIS-29 | PROMIS-29 measures 8 domains of health-related qualify of life among adults.Domains have 4 items ranked on Likert scales: physical functioning, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles/activities, pain interference, pain intensity.All domains except pain intensity, raw subscale are summed and converted to T-scores (standardized score, mean 50, SD 10) using HealthMeasures.net conversion tables, lower=better.Pain intensity measured on11 point scale (0 -10, 0=no pain, 10=worst pain).T-score rescales raw score into standardized score, mean 50, SD 10. | Mean | Standard Deviation | units on a scale |
|
| Heart Related Symptoms | 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 is worse). Means are reported. | Mean | Standard Deviation | symptoms |
|
| Healthcare Utilization - Hospitalizations | Mean | Standard Deviation | Hospitalizations in past 12 months |
|
| OG001 | Waitlist Control | Control group participants will be offered the opportunity to participate in Take Heart following the conclusion of their study involvement. |
|
|
| 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. | Posted | Mean | 95% Confidence Interval | ED visits | Baseline and 12 month follow up |
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and 12-month follow-up |
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and 12-month follow-up |
|
|
|
| 1 |
| 228 |
| 7 |
| 228 |
| 0 |
| 228 |
| EG001 | Waitlist Control | Control group participants will be offered the opportunity to participate in Take Heart following the conclusion of their study involvement. | 1 | 225 | 0 | 225 | 0 | 225 |
| Heart Attack | Cardiac disorders | Non-systematic Assessment |
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| Stroke | Cardiac disorders | Non-systematic Assessment |
|
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| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Some College |
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| College Graduate or Higher |
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| Unemployed |
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| Other |
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| Good |
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| Fair |
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| Poor |
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| Depression |
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| Fatigue |
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| Sleep |
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| Social |
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| Pain Interference |
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| Pain Intensity |
|