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



Status:Recruiting
Conditions:Cardiology, Diabetes
Therapuetic Areas:Cardiology / Vascular Diseases, Endocrinology
Healthy:No
Age Range:18 - Any
Updated:11/10/2018
Start Date:August 2, 2017
End Date:May 2020
Contact:Lori Hudson, PhD
Email:lori.hudson@duke.edu
Phone:919-668-8547

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

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.

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).

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
We found this trial at
5
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Brooklyn, New York 11215
Principal Investigator: John Heitner, MD
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Maulik Majmudar, MD
Phone: 617-643-9324
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291 Campus Dr
Stanford, California 94305
(650) 725-3900
Principal Investigator: Dipanjan Banerjee, MD
Stanford University School of Medicine Vast in both its physical scale and its impact on...
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Principal Investigator: Robert Mentz, MD
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Fairfax, Virginia 22301
Principal Investigator: Lauren Cooper, MD
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Fairfax, VA
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