TARGET-HFDM: Mobile Health Behavioral Intervention in Patients With Heart Failure and Diabetes Mellitus

Sponsor
Duke University (Other)
Overall Status
Completed
CT.gov ID
NCT02918175
Collaborator
Duke Clinical Research Institute (Other), American Heart Association (Other)
187
6
2
37.3
31.2
0.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: mHealth
N/A

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).

Study Design

Study Type:
Interventional
Actual Enrollment :
187 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Technology to Improve Drug Adherence and Reinforce Guideline Based Exercise Targets in Patients With Heart Failure and Diabetes Mellitus (TARGET-HFDM)
Actual Study Start Date :
Aug 2, 2017
Actual Primary Completion Date :
Sep 9, 2020
Actual Study Completion Date :
Sep 9, 2020

Arms and Interventions

Arm Intervention/Treatment
Other: mHealth Intervention

Subjects in this study arm will have data on activity levels, quality of life, medication adherence, and blood samples collected. In addition, they will receive personalized feedback on activity goals based on prior week step counts and participate in coaching sessions using the Pillbox medication tool.

Behavioral: mHealth
Personalized step count feedback and medication teaching tool.
Other Names:
  • Feedback on step counts
  • Duke PillBox medication adherence teaching tool
  • No Intervention: No intervention

    Subjects in this study arm will have data on activity levels, quality of life, medication adherence, and blood samples collected.

    Outcome Measures

    Primary Outcome Measures

    1. Change in mean weekly step count [from baseline to 3 months]

      Increased activity

    Secondary Outcome Measures

    1. Change in medication adherence score [from baseline to 3 and 6 months]

      Improved medication adherence

    2. Change in fill and refill performance rate [from baseline to 3 and 6 months]

      Change in fill and refill performance rate

    3. Change in mean weekly step count [from 3 to 6 months]

      Increased activity

    4. Change in NT-proBNP levels [from baseline to 3 to 6 months]

      biomarkers

    5. Change in HbA1C levels [from baseline to 3 to 6 months]

      biomarkers

    6. Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score [from baseline to 3 to 6 months]

      QOL

    Other Outcome Measures

    1. Change in plasma metabolic profile [from baseline to 3 months]

      biomarkers

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stanford University School of Medicine Stanford California United States 94305
    2 Massachusetts General Hospital Boston Massachusetts United States 02114
    3 NewYork-Presbyterian Brooklyn Methodist Hospital Brooklyn New York United States 11215
    4 Duke University Medical Center Durham North Carolina United States 27705
    5 University of Texas Southwestern Medical Center Dallas Texas United States 75390
    6 Inova Health System Fairfax Virginia United States 22042-3300

    Sponsors and Collaborators

    • Duke University
    • Duke Clinical Research Institute
    • American Heart Association

    Investigators

    • Principal Investigator: Gary M Felker, MD, Duke University Medical Center/Duke Clinical Research Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Duke University
    ClinicalTrials.gov Identifier:
    NCT02918175
    Other Study ID Numbers:
    • Pro00075572
    • 16SFRN30740010
    First Posted:
    Sep 28, 2016
    Last Update Posted:
    Nov 3, 2020
    Last Verified:
    Nov 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Duke University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 3, 2020