iCardia4HF: Multi-component mHealth Intervention for Patients With Heart Failure
NCT06205225
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
Eligibility
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, MoCA\<18, impaired self-determination, lacking ability to communicate) * Major physical impairment (e.g., inability to walk, bound on a wheelchair) * Unwillingness to use study equipment * Active substance abuse * Currently pregnant, less than 3-month post-partum or pregnancy anticipated during the study * Participation in other treatment studies or remote patient management programs * Participation in the iCardia4H pilot trial (conducted before this study)
Conditions2
Locations2 sites
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NCT06205225