A Mobile Application to Promote Self-management and Improve Outcomes in Heart Failure

Stopped early · Phase 3

Conditions studied: Heart Failure

In brief

This study will investigate the effectiveness of two contextual just-in-time adaptive interventions (JITAIs) delivered via a mobile app for heart failure patients.

Key facts

Study ID

NCT04755816

Run by

University of Michigan

People needed

62

Starts

2021-06-14

Expected to finish

2023-05-17

Last updated by the study team

2024-09-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Stanford University — Stanford, California, United States
• Emory University — Atlanta, Georgia, United States
• Atlanta VA Health Care System — Decatur, Georgia, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Henry Ford Hospital System — Detroit, Michigan, United States
• Washington University in St. Louis — St Louis, Missouri, United States
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Virginia Commonwealth University — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.