Mobile Health Behavioral Intervention in Patients With Heart Failure and Diabetes Mellitus
Trial ID or NCT#
NCT02918175
Status
RECRUITING
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 Criteria
Ages Eligible for Study: Older than 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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
Contact us to find out if this trial is right for you.
Contact
Jhina Patro
View on ClinicalTrials.gov
