Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06205225

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

Led by University of Illinois at Chicago · Updated on 2026-01-30

360

Participants Needed

2

Research Sites

208 weeks

Total Duration

On this page

Sponsors

U

University of Illinois at Chicago

Lead Sponsor

N

National Heart, Lung, and Blood Institute (NHLBI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of Stage C Heart Failure
  • 18 years of age or older
  • Transthoracic Echocardiogram or Cardiac MRI performed in the last 3 years with LVEF results available
  • 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
  • Ability to speak and read English
Not Eligible

You will not qualify if you...

  • Implanted ventricular assist device
  • High urgent status for heart transplantation
  • Acute coronary syndrome within 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 heart failure (hospice candidate)
  • Discharge to a setting other than home
  • Having a home nurse or inability to take care of self (eat, dress, walk, bathe, take medications, or use the toilet)
  • Chronic renal insufficiency requiring hemodialysis or estimated Glomerular Filtration Rate less than 25 mL
  • Active cancer under treatment (e.g., radiation, immunotherapy)
  • Any disease reducing life expectancy to less than 1 year
  • Cognitive impairment (e.g., dementia, Parkinson's disease, Alzheimer's disease, MoCA <18, impaired self-determination, or inability to communicate)
  • Major physical impairment (e.g., inability to walk, wheelchair bound)
  • Unwillingness to use study equipment
  • Active substance abuse
  • Currently pregnant, less than 3 months postpartum, or planning pregnancy during the study
  • Participation in other treatment studies or remote patient management programs
  • Participation in the iCardia4HF pilot trial conducted before this study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Rush University Medical Center

Chicago, Illinois, United States, 60612

Actively Recruiting

2

University of Illinois Hospital & Health Sciences System

Chicago, Illinois, United States, 60612

Actively Recruiting

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Research Team

S

Spyros Kitsiou, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

TREATMENT

Number of Arms

4

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