iCardia4HF: A Multi-component mHealth App and Tailored Text-messaging Intervention to Promote Self-care Adherence and Improve Health Outcomes in Patients With Chronic Heart Failure

Status: Recruiting

Location: See all (2) locations...

Intervention Type: Behavioral

Study Type: Interventional

Study Phase: Phase 2/Phase 3

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

Eligibility

Participation Requirements

Sex: All

Minimum Age: 18

Healthy Volunteers: f

View:

• 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

Locations

United States

Illinois

Rush University Medical Center

RECRUITING

Chicago

University of Illinois Hospital & Health Sciences System

RECRUITING

Chicago

Contact Information

Primary

Mike Haniff, PhD

mhanif6@uic.edu

312-413-4227

Time Frame

Start Date: 2024-10-04

Estimated Completion Date: 2028-09-30

Participants

Target number of participants: 360

Treatments

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.

Related Therapeutic Areas

Heart Failure

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