NCT06205225 · University of Illinois at Chicago
iCardia4HF: Multi-component mHealth Intervention for Patients With Heart Failure
(iCardia4HF)
What this study is about
The goal of this factorial randomly assigned 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).
View original scientific description
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).
Interventions
BEHAVIORAL
Text4HF
Behavioral text messages about heart failure self-care
BEHAVIORAL
MyApps
consumer mobile health apps and devices for heart failure self-care
BEHAVIORAL
MyApps & Text4HF
Consumer mobile health apps and devices supplemented with behavioral text messages for heart failure self-care
BEHAVIORAL
Enhanced Usual Care
Participants assigned to the enhanced usual care group will receive (1) standard care, (2) patient education about HF self-care, and (3) three connected health devices (Withings weight scale and blood pressure monitor, and Fitbit activity tracker with Fitbit mobile app).
Primary outcome measures
Percentage of days lost due to unplanned cardiovascular hospitalizations or death from any cause
Time frame: 6 months
Hospitalization is defined as hospital admission resulting in an overnight stay where the length of stay is at least 24 hours. Events leading to emergency department visit only with a length of stay under 24 hours will not be classified as hospitalization. For a hospitalization to be considered as unplanned the patient must present new symptoms and/or worsening of existing symptoms with the need for immediate admission in a hospital for intensified care. A hospitalization will be considered "cardiovascular" when it is due to cardiovascular causes which includes but is not limited to: HF deterioration, acute myocardial infarction, arrhythmia, HF, pulmonary embolism, cerebrovascular disease (e.g., stroke), severe bleeding, endocarditis, etc.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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) *
Where
- Chicago, Illinois
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 30, 2026 · Source of record for eligibility and locations