Clinical trial NCT02918175: Mobile Health Behavioral Intervention in Patients With Heart Failure and Diabetes Mellitus
Official title: Technology to Improve Drug Adherence and Reinforce Guideline Based Exercise Targets in Patients With Heart Failure and Diabetes Mellitus (TARGET-HFDM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Heart Failure
Keywords: mHealth
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Duke Clinical Research Institute
name: American Heart Association
First posted: 2016-09-28
Enrollment: 187
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed 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).

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

Primary outcomes:
measure: Change in mean weekly step count
timeFrame: from baseline to 3 months
Secondary outcomes:
measure: Change in medication adherence score
timeFrame: from baseline to 3 and 6 months
measure: Change in fill and refill performance rate
timeFrame: from baseline to 3 and 6 months
measure: Change in mean weekly step count
timeFrame: from 3 to 6 months
measure: Change in NT-proBNP levels
timeFrame: from baseline to 3 to 6 months
measure: Change in HbA1C levels
timeFrame: from baseline to 3 to 6 months
measure: Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score
timeFrame: from baseline to 3 to 6 months
Other outcomes:
measure: Change in plasma metabolic profile
timeFrame: from baseline to 3 months
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Brooklyn
country: United States
facility: NewYork-Presbyterian Brooklyn Methodist Hospital
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Fairfax
country: United States
facility: Inova Health System
state: Virginia
Study officials:
affiliation: Duke University Medical Center/Duke Clinical Research Institute
name: Gary M Felker, MD
role: PRINCIPAL_INVESTIGATOR
References: