Mobile Health Behavioral Intervention in Patients With Heart Failure and Diabetes Mellitus
NCT ID: NCT02918175
Last Updated: 2020-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
187 participants
INTERVENTIONAL
2017-08-02
2020-09-09
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
mHealth
Personalized step count feedback and medication teaching tool.
No intervention
Subjects in this study arm will have data on activity levels, quality of life, medication adherence, and blood samples collected.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
mHealth
Personalized step count feedback and medication teaching tool.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Duke Clinical Research Institute
OTHER
American Heart Association
OTHER
Duke University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gary M Felker, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University Medical Center/Duke Clinical Research Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Stanford University School of Medicine
Stanford, California, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
NewYork-Presbyterian Brooklyn Methodist Hospital
Brooklyn, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Inova Health System
Fairfax, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
16SFRN30740010
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
Pro00075572
Identifier Type: -
Identifier Source: org_study_id