RecruitingNot Applicable

iCardia4HF: Multi-component mHealth Intervention for Patients With Heart Failure

United States360 participantsStarted 2024-10-04

Plain-language summary

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 participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Diagnosis of Stage C Heart Failure * ≥ 18 years of age * Transthoracic Echocardiogram or Cardiac MRI performed in the last 3 years and LVEF results available * Patient is actively treated with oral loop diuretics for chronic heart failure * Hospitalization due to acute decompensated heart failure within 24 months before randomization and/or insufficient self-care per SCHFI assessment (score of ≤3, in at least two items of the SCHFI v7.2 maintenance, symptom monitoring, or self-care management subscale) * Ability to speak and read English 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 * Cognitive impairment (e.g., Dementia, Parkinson disease, Alzheimer disease,…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of days lost due to unplanned cardiovascular hospitalizations or death from any cause

Timeframe: 6 months

Trial details

NCT IDNCT06205225

SponsorUniversity of Illinois at Chicago

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-03-31

Contact for this trial

Spyros Kitsiou, PhD

312-413-4227 mhanif6@uic.edu

View on ClinicalTrials.gov More Heart Failure trials