search
Back to results

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

Primary Purpose

Diabetes Mellitus, Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
mHealth
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes Mellitus focused on measuring mHealth

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Stanford University School of Medicine
  • Massachusetts General Hospital
  • NewYork-Presbyterian Brooklyn Methodist Hospital
  • Duke University Medical Center
  • University of Texas Southwestern Medical Center
  • Inova Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

mHealth Intervention

No intervention

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Change in mean weekly step count
Increased activity

Secondary Outcome Measures

Change in medication adherence score
Improved medication adherence
Change in fill and refill performance rate
Change in fill and refill performance rate
Change in mean weekly step count
Increased activity
Change in NT-proBNP levels
biomarkers
Change in HbA1C levels
biomarkers
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score
QOL

Full Information

First Posted
September 27, 2016
Last Updated
November 2, 2020
Sponsor
Duke University
Collaborators
Duke Clinical Research Institute, American Heart Association
search

1. Study Identification

Unique Protocol Identification Number
NCT02918175
Brief Title
Mobile Health Behavioral Intervention in Patients With Heart Failure and Diabetes Mellitus
Acronym
TARGET-HFDM
Official Title
Technology to Improve Drug Adherence and Reinforce Guideline Based Exercise Targets in Patients With Heart Failure and Diabetes Mellitus (TARGET-HFDM)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
August 2, 2017 (Actual)
Primary Completion Date
September 9, 2020 (Actual)
Study Completion Date
September 9, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Duke Clinical Research Institute, American Heart Association

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Heart Failure
Keywords
mHealth

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
187 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mHealth Intervention
Arm Type
Other
Arm Description
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.
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
Subjects in this study arm will have data on activity levels, quality of life, medication adherence, and blood samples collected.
Intervention Type
Behavioral
Intervention Name(s)
mHealth
Other Intervention Name(s)
Feedback on step counts, Duke PillBox medication adherence teaching tool
Intervention Description
Personalized step count feedback and medication teaching tool.
Primary Outcome Measure Information:
Title
Change in mean weekly step count
Description
Increased activity
Time Frame
from baseline to 3 months
Secondary Outcome Measure Information:
Title
Change in medication adherence score
Description
Improved medication adherence
Time Frame
from baseline to 3 and 6 months
Title
Change in fill and refill performance rate
Description
Change in fill and refill performance rate
Time Frame
from baseline to 3 and 6 months
Title
Change in mean weekly step count
Description
Increased activity
Time Frame
from 3 to 6 months
Title
Change in NT-proBNP levels
Description
biomarkers
Time Frame
from baseline to 3 to 6 months
Title
Change in HbA1C levels
Description
biomarkers
Time Frame
from baseline to 3 to 6 months
Title
Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) score
Description
QOL
Time Frame
from baseline to 3 to 6 months
Other Pre-specified Outcome Measures:
Title
Change in plasma metabolic profile
Description
biomarkers
Time Frame
from baseline to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gary M Felker, MD
Organizational Affiliation
Duke University Medical Center/Duke Clinical Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
NewYork-Presbyterian Brooklyn Methodist Hospital
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11215
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Inova Health System
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22042-3300
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs