Mobile Health Behavioral Intervention in Patients With Heart Failure and Diabetes Mellitus
TARGET-HFDM
Technology to Improve Drug Adherence and Reinforce Guideline Based Exercise Targets in Patients With Heart Failure and Diabetes Mellitus (TARGET-HFDM)
2 other identifiers
interventional
187
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes-mellitus
Started Aug 2017
Typical duration for not_applicable diabetes-mellitus
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2016
CompletedFirst Posted
Study publicly available on registry
September 28, 2016
CompletedStudy Start
First participant enrolled
August 2, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 9, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 9, 2020
CompletedNovember 3, 2020
November 1, 2019
3.1 years
September 27, 2016
November 2, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in mean weekly step count
Increased activity
from baseline to 3 months
Secondary Outcomes (6)
Change in medication adherence score
from baseline to 3 and 6 months
Change in fill and refill performance rate
from baseline to 3 and 6 months
Change in mean weekly step count
from 3 to 6 months
Change in NT-proBNP levels
from baseline to 3 to 6 months
Change in HbA1C levels
from baseline to 3 to 6 months
- +1 more secondary outcomes
Other Outcomes (1)
Change in plasma metabolic profile
from baseline to 3 months
Study Arms (2)
mHealth Intervention
OTHERSubjects 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.
No intervention
NO INTERVENTIONSubjects in this study arm will have data on activity levels, quality of life, medication adherence, and blood samples collected.
Interventions
Personalized step count feedback and medication teaching tool.
Eligibility Criteria
You may qualify if:
- ≥ 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
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- Duke Clinical Research Institutecollaborator
- American Heart Associationcollaborator
Study Sites (6)
Stanford University School of Medicine
Stanford, California, 94305, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
NewYork-Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, 11215, United States
Duke University Medical Center
Durham, North Carolina, 27705, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Inova Health System
Fairfax, Virginia, 22042-3300, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gary M Felker, MD
Duke University Medical Center/Duke Clinical Research Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2016
First Posted
September 28, 2016
Study Start
August 2, 2017
Primary Completion
September 9, 2020
Study Completion
September 9, 2020
Last Updated
November 3, 2020
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will not share