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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02918175
Recruitment Status : Suspended (The study is halted due to COVID-19. Will update once enrollment resumes.)
First Posted : September 28, 2016
Last Update Posted : May 7, 2020
Sponsor:
Collaborators:
Duke Clinical Research Institute
American Heart Association
Information provided by (Responsible Party):
Duke University

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
Diabetes Mellitus Heart Failure Behavioral: mHealth Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 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 : August 2, 2017
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Change in mean weekly step count [ Time Frame: from baseline to 3 months ]
    Increased activity


Secondary Outcome Measures :
  1. Change in medication adherence score [ Time Frame: from baseline to 3 and 6 months ]
    Improved medication adherence

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

  3. Change in mean weekly step count [ Time Frame: from 3 to 6 months ]
    Increased activity

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

  5. Change in HbA1C levels [ Time Frame: from baseline to 3 to 6 months ]
    biomarkers

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


Other Outcome Measures:
  1. Change in plasma metabolic profile [ Time Frame: from baseline to 3 months ]
    biomarkers



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02918175


Locations
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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, New York
NewYork-Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, United States, 11215
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
United States, Virginia
Inova Health System
Fairfax, Virginia, United States, 22042-3300
Sponsors and Collaborators
Duke University
Duke Clinical Research Institute
American Heart Association
Investigators
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Principal Investigator: Gary M Felker, MD Duke University Medical Center/Duke Clinical Research Institute
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02918175    
Other Study ID Numbers: Pro00075572
16SFRN30740010 ( Other Grant/Funding Number: American Heart Association )
First Posted: September 28, 2016    Key Record Dates
Last Update Posted: May 7, 2020
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duke University:
mHealth
Additional relevant MeSH terms:
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Heart Failure
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Heart Diseases
Cardiovascular Diseases