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

Recruiting

I'm Interested

Trial ID: NCT02918175

Purpose

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.

Official Title

Technology to Improve Drug Adherence and Reinforce Guideline Based Exercise Targets in Patients With Heart Failure and Diabetes Mellitus (TARGET-HFDM)

Eligibility


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

Intervention(s):

behavioral: mHealth

Recruiting

I'm Interested

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Jhina Patro