Mobile Health Behavioral Intervention in Patients With Heart Failure and Diabetes Mellitus
Completed · Not applicable
Conditions studied: Diabetes Mellitus, Heart Failure
In brief
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.
Key facts
- Study ID
- NCT02918175
- Run by
- Duke University
- People needed
- 187
- Starts
- 2017-08-02
- Expected to finish
- 2020-09-09
- Last updated by the study team
- 2020-11-03
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- ≥ 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
You may not qualify if…
- 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
Where it is running
- Stanford University School of Medicine — Stanford, California, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- NewYork-Presbyterian Brooklyn Methodist Hospital — Brooklyn, New York, United States
- Duke University Medical Center — Durham, North Carolina, United States
- University of Texas Southwestern Medical Center — Dallas, Texas, United States
- Inova Health System — Fairfax, Virginia, United States
Full record on ClinicalTrials.gov
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