Status:
TERMINATED
A Mobile Application to Promote Self-management and Improve Outcomes in Heart Failure
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will investigate the effectiveness of two contextual just-in-time adaptive interventions (JITAIs) delivered via a mobile app for heart failure patients.
Detailed Description
The Manage HF study is a multicenter 12-week randomized controlled double-blind 2x2 factorial clinical trial. This study will investigate the effectiveness of two contextual just-in-time adaptive inte...
Eligibility Criteria
Inclusion
- Age 18 years and older at screening
- Currently admitted or discharged from the hospital within the last 14 days with a diagnosis of acute or acute on chronic decompensated HF.
- Based on one of the EF criteria (LVEF within 12 months of randomization. BNP or NT-proBNP criteria within 30 days prior to randomization):
- Left ventricular ejection fraction (LVEF) ≤ 40%.
- LVEF \>40% and BNP \> 175 pg/ml or NT-proBNP \> 700 pg/ml. Thresholds for NT-proBNP and BNP for LVEF \> 40% will be corrected for body mass index (BMI) using a 4% reduction per BMI unit over 25 kg/m2.
- Have a personal physician for follow-up
- A smartphone with a compatible Apple or Android operating system installed and able to download and use ManageHF including accepting all permissions
- A valid email address
- Fluent in spoken and written English
Exclusion
- Contraindication to recommending a sodium restriction diet
- Scheduled intervention for primary valvular heart disease will occur during the study period.
- Cardiac resynchronization therapy (CRT) within 3 months prior to screening or current plan to implant CRT device during the study period.
- Dialysis
- Previous cardiac transplantation or implantation of a ventricular assistance device or similar device.
- Listed status 1, 2 or 3 for heart transplant
- Implantation of a ventricular assistance device is expected within 3 months after randomization
- Non-cardiac illness with expected survival of less than 3 months
- Discharge to a setting other than home
- Requirement for chronic inotropic therapy (e.g. milrinone, dobutamine)
- Inability to use Withings devices due to equipment limitations or contraindications
- Currently pregnant or intend to become pregnant during the study period.
Key Trial Info
Start Date :
June 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 17 2023
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT04755816
Start Date
June 14 2021
End Date
May 17 2023
Last Update
September 19 2024
Active Locations (9)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Stanford University
Stanford, California, United States, 94305
3
Emory University
Atlanta, Georgia, United States, 30322
4
Atlanta VA Health Care System
Decatur, Georgia, United States, 30033