Recruiting

ICardia4HF

Sponsor:

University of Illinois at Chicago

Code:

NCT06205225

Conditions

Heart Failure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Text4HF

MyApps

MyApps & Text4HF

Enhanced Usual Care

Study Details

Brief 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

Conditions

Heart Failure

Study ID

NCT06205225

Start date

Oct 4, 2024

Status verified date

Jan, 2026

Completion date

Sep 30, 2028

Anticipated

Primary completion date

Mar 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

360 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Enhanced usual care

Participants assigned to the usual care group will receive (1) standard care, (2) patient education about HF self-care, and (3) three connected health devices. Usual care includes follow-up appointments every 2-3 months with a multidisciplinary team at the outpatient HF clinic. Patient education includes resources about HF self-care from the American Heart Association and Heart Failure Society of America. Connected health devices include the Withings Weight Scale, Withings blood pressure monitor, and Fitbit Charge 6 activity tracker (wrist-based with heart rate sensor). Participants will receive the devices at baseline along with training by research staff on how to use the devices to perform daily self-monitoring of weight, blood pressure, and physical activity/inactivity. The Withings devices have a cellular antenna for automatic transmission of data to our study server (iCardia). Fitbit will be paired with the participant's smartphone.

experimental: Text4HF

Participants allocated to the Text4HF group will receive the same components and devices as the usual care group (usual care, patient education, and connected health devices), plus individually tailored Text Messages targeting health beliefs, HF-knowledge, and self-efficacy about HF self-care. Participants will receive 4-6 TMs/week during the induction phase (0 to 3 months), and 2-4 TMs per week during the adoption period (3 to 6 months).Tailoring of the TMs is guided by participants' responses to validated instruments assessing intervention target variables at baseline and 3 months

experimental: MyApps

In addition to usual care and patient education resources, participants in the MyApps group will receive three commercially available apps (Heart Failure Storylines, Withings Health Mate, and Fitbit), and three connected health devices (Withings Body Cardio Scale, Withings BP monitor, and Fitbit activity tracker). The apps interface with the devices via Bluetooth offering patients a comprehensive set of mHealth tools that support the core elements of HF self-care (maintenance, self-monitoring, and self-management).

experimental: MyApps + Text4HF

Participants in this group will receive the MyApps and Text4HF intervention components, combined.

Interventions

Text4HF

Behavioral text messages about heart failure self-care

MyApps

consumer mobile health apps and devices for heart failure self-care

MyApps & Text4HF

Consumer mobile health apps and devices supplemented with behavioral text messages for heart failure self-care

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 measure

  • Percentage of days lost due to unplanned cardiovascular hospitalizations or death from any cause [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Spyros Kitsiou, PhD

312-413-4227mhanif6@uic.edu

Locations

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Sachin Vispute, MPH, MSEd

312-947-3870Sachin_Vispute@rush.edu

Principal Investigator:

Todd Ruppar, PhD

University of Illinois Hospital & Health Sciences System

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Mike Haniff, PhD

312-413-4227mhanif6@uic.edu

Principal Investigator:

Spyros Kitsiou, PhD

More Information

Sponsor

University of Illinois at Chicago

Last update posted

Jan 30, 2026

Last verified

Jan, 2026

Keywords

  • mHealth, wearables, mobile apps, heart failure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Illinois at Chicago on 2026-01-30.