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

NCT06205225 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2026-01-30

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • University of Illinois at Chicago

    lead OTHER

Principal Investigators

  • Spyros Kitsiou, PhD · University of Illinois Chicago

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-04
Primary Completion
2028-03-31
Completion
2028-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06205225 on ClinicalTrials.gov