iCardia4HF: Multi-component mHealth Intervention for Patients With Heart Failure (NCT06205225)
🩺 Plain-English Summary (8th-Grade Level)
The goal of this factorial randomized trial is to examine the independent and synergistic efficacies of two mobile health technology interventions in people with chronic heart failure. The first intervention involves the use of multiple consumer mHealth apps and sensor devices (MyApps) for heart failure self-care (maintenance, monitoring, and management). The second intervention is a program of tailored text messages (Text4HF) targeting modifiable behavioral factors associated with heart failure self-care non-adherence. The main questions this study aims to answer are: 1. Can the use of consumer mHealth apps and devices (MyApps) improve heart failure self-care and reduce days lost due to cardiovascular hospitalization or death for any cause? 2. Can a program of individually tailored text messages (Text4HF) improve heart failure self-care and reduce the days lost due to cardiovascular hospitalization or death for any cause? 3. Can MyApps and Text4HF combined lead to greater improvements in heart failure self-care and days lost due to cardiovascular hospitalization or death for any cause
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (19 items).
Location: Rush University Medical Center — Chicago, Illinois
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Implanted ventricular assist device
- High urgent listed for heart transplantation
- Acute coronary syndrome within the last 7 days before randomization
- Revascularization and/or CRT implantation within 28 days before randomization
- Planned revascularization, transcatheter aortic valve implantation, MitraClip and/or CRT implantation within 3 months after randomization
- End-stage HF (hospice candidate)
- Discharge to a setting other than home
- Individuals who have a home nurse or are not able to take care of self (eat, dress, walk, bathe, take medications, or use the toilet)
- Chronic renal insufficiency with hemodialysis or estimated Glomerular Filtration Rate \<25 mL
- Active cancer, currently undergoing treatment (e.g. radiation immunotherapy)
- Existence of any disease reducing life expectancy to less than 1 year
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (2 Sites)
- Rush University Medical Center — Chicago, Illinois
- University of Illinois Hospital & Health Sciences System — Chicago, Illinois
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.