NOT_YET_RECRUITING
iCardia4HF: Multi-component mHealth Intervention for Patients With Heart Failure
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 daily 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 the combined use of MyApps and Text4HF lead to greater improvements in heart failure self-care and days lost due to cardiovascular hospitalization or death for any cause
Conditions:
🦠 Heart Failure
🗓️ Study Start (Actual) 1 July 2024
🗓️ Primary Completion (Estimated) 31 December 2027
✅ Study Completion (Estimated) 31 December 2027
👥 Enrollment (Estimated) 360
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Chicago, Illinois, United States
📍 Chicago, Illinois, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Diagnosis with Heart Failure (Stage C)
    • * Echocardiographically determined LVEF≤40% or if \>40%, patient must be treated with oral 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
    • * ≥ 18 years of age
    • * Ability to speak and read English

    Exclusion Criteria:

    • * Implanted cardiac assist system/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 treated with chemotherapy
    • * Existence of any disease reducing life expectancy to less than 1 year
    • * Impairment or unwillingness to use the study equipment (e.g., cognitive impairment, dementia, inability to walk - on wheel-chair, lacking ability to communicate).
    • * 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
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 3 January 2024
  • First Submitted that Met QC Criteria 3 January 2024
  • First Posted 12 January 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 31 January 2024
  • Last Update Posted 2 February 2024
  • Last Verified January 2024