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

NCT06205225 | Recruiting DMC

• 2 other identifiers: 2022-1592R01HL168376
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 2

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. 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. 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. 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

Keywords

mHealth, wearables, mobile apps, heart failure

Outcome Measures

Primary Outcomes (1)

• Percentage of days lost due to unplanned cardiovascular hospitalizations or death from any cause

  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.

  6 months

Secondary Outcomes (19)

• Percentage of days lost due to unplanned cardiovascular hospitalizations or death from any cause

  12 months

• Number of patients with unplanned cardiovascular hospitalizations

  6 and 12 months

• Mean number of unplanned cardiovascular hospitalizations

  6 and 12 months

• Unplanned heart failure hospitalizations

  6 and 12 months

• Mean number of unplanned heart failure hospitalizations

  6 and 12 months

Study Arms (4)

Enhanced usual care

ACTIVE COMPARATOR

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.

Behavioral: Enhanced Usual Care

Text4HF

EXPERIMENTAL

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

Behavioral: Text4HF

MyApps

EXPERIMENTAL

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).

Behavioral: MyApps

MyApps + Text4HF

EXPERIMENTAL

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

Behavioral: MyApps & Text4HF

Interventions

Text4HF BEHAVIORAL

Behavioral text messages about heart failure self-care

Text4HF

MyApps BEHAVIORAL

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

MyApps

MyApps & Text4HF BEHAVIORAL

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

MyApps + Text4HF

Enhanced Usual Care BEHAVIORAL

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).

Enhanced usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Chicago: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (2)

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

University of Illinois Hospital & Health Sciences System

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Spyros Kitsiou, PhD

  University of Illinois Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Spyros Kitsiou, PhD

CONTACT

312-413-4227; mhanif6@uic.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Care providers who provide usual care to study participants will be unaware of the study groups and group assignments. Outcome assessors will be masked to group assignment. Outcome assessors will work in a different office from other study investigators and will have limited access to the Electronic Data Capturing system used for data collection (REDCap).
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 2 x 2 factorial randomized controlled trial

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: January 12, 2024
• Study Start: October 4, 2024
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): September 30, 2028
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)