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| ID | Type | Description | Link |
|---|---|---|---|
| 16SFRN30740010 | Other Grant/Funding Number | American Heart Association |
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| Name | Class |
|---|---|
| Duke Clinical Research Institute | OTHER |
| American Heart Association | OTHER |
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The overall objective of this study is to test a personalized mHealth intervention designed to increase physical activity and improve medication adherence in subjects with heart failure and diabetes mellitus. The study will leverage consumer technology as both an intervention and as a tool for data collection.
This is a multi-center randomized controlled study in eligible subjects with heart failure and diabetes mellitus. Step counts, self-reported quality of life, medication adherence, blood samples and relevant clinical measures will be collected from all study subjects. The mobile health (mHealth) intervention will combine personalized text messages to encourage physical activity and a medication adherence teaching tool. A total of approximately 200 eligible subjects will be randomized in in a 1:1 ratio to either mHealth intervention + usual care/data collection or the control group (usual care/data collection only). The study duration is 6 months for all subjects; those in the intervention group will receive the mHealth intervention during the initial 3 months followed by 3 months of data collection only. The underlying hypotheses is that the proposed mHealth intervention can favorably impact specific health behaviors (physical activity and medication adherence) and physiologic measures of disease status for both heart failure and diabetes. Additional hypotheses to be tested will assess the persistence of behavioral changes (daily physical activity and medication adherence) and physiologic measures (NT-proBNP, HbA1c) beyond the 3-month time point of the active mHealth intervention (i.e. through 6 months).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mHealth Intervention | Other | Subjects in this study arm will have data on activity levels, quality of life, medication adherence, and blood samples collected. In addition, they will receive personalized feedback on activity goals based on prior week step counts and participate in coaching sessions using the Pillbox medication tool. |
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| No intervention | No Intervention | Subjects in this study arm will have data on activity levels, quality of life, medication adherence, and blood samples collected. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mHealth | Behavioral | Personalized step count feedback and medication teaching tool. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in mean weekly step count | Increased activity | from baseline to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in medication adherence score | Improved medication adherence | from baseline to 3 and 6 months |
| Change in fill and refill performance rate | Change in fill and refill performance rate |
| Measure | Description | Time Frame |
|---|---|---|
| Change in plasma metabolic profile | biomarkers | from baseline to 3 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gary M Felker, MD | Duke University Medical Center/Duke Clinical Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States | ||
| Massachusetts General Hospital |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D017216 | Telemedicine |
| ID | Term |
|---|---|
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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| from baseline to 3 and 6 months |
| Change in mean weekly step count | Increased activity | from 3 to 6 months |
| Change in NT-proBNP levels | biomarkers | from baseline to 3 to 6 months |
| Change in HbA1C levels | biomarkers | from baseline to 3 to 6 months |
| Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score | QOL | from baseline to 3 to 6 months |
| Boston |
| Massachusetts |
| 02114 |
| United States |
| NewYork-Presbyterian Brooklyn Methodist Hospital | Brooklyn | New York | 11215 | United States |
| Duke University Medical Center | Durham | North Carolina | 27705 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| Inova Health System | Fairfax | Virginia | 22042-3300 | United States |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |