Heart Failure Clinical Trial

Mobile Health Behavioral Intervention in Patients With Heart Failure and Diabetes Mellitus

Summary

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.

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Full Description

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).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

≥ 18 years of age
Chronic heart failure, New York Heart Association (NYHA) class II-IV, with ongoing treatment with medications for heart failure for at least 1 month prior to enrollment
Prior diabetes mellitus diagnosis, with ongoing treatment with anti-diabetes medications for at least 1 month prior to enrollment
Adequate clinical stability in the judgment of the investigator to allow participation in study assessments and the intervention
Independent with basic activities of daily living (ADLs), including the ability to ambulate independently
No plan for revascularization (cardiac or peripheral), outpatient continuous intravenous inotrope administration, cardiac transplant or ventricular assist device implantation, or other cardiac surgery within 6 months of randomization
Access to a compatible smart phone (iOS or Android)
Signed informed consent

Exclusion Criteria:

Acute myocardial infarction within prior 4 weeks
Already actively participating in formal, facility-based cardiac rehabilitation
Severe stenotic valvular disease (e.g., severe aortic stenosis)
Implanted left ventricular assist device (LVAD)
Recipient of a heart transplant
Terminal illness other than heart failure with life expectancy < 6 months
Impairment from stroke, injury or other medical disorder that precludes participation in the intervention
Inability or unwillingness to comply with the study requirements

Study is for people with:

Heart Failure

Estimated Enrollment:

187

Study ID:

NCT02918175

Recruitment Status:

Completed

Sponsor:

Duke University

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There are 6 Locations for this study

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Stanford University School of Medicine
Stanford California, 94305, United States
Massachusetts General Hospital
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, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

187

Study ID:

NCT02918175

Recruitment Status:

Completed

Sponsor:


Duke University

How clear is this clinincal trial information?

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