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

Conditions

• Heart Failure

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Text4HF — BEHAVIORAL
  Behavioral text messages about heart failure self-care
• MyApps — BEHAVIORAL
  consumer mobile health apps and devices for heart failure self-care
• MyApps & Text4HF — BEHAVIORAL
  Consumer mobile health apps and devices supplemented with behavioral text messages for heart failure self-care
• 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).

Study Details

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

Key Dates

Start date

Oct 4, 2024

Status verified

Jan 2026

Primary completion

Mar 31, 2028

Completion

Sep 30, 2028

Study Design

Enrollment

360 participants (estimated)

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

• Spyros Kitsiou, PhD
  312-413-4227
  [email protected]

Locations (2)

Find similar trials in Chicago, IL

Related Studies

• The EMPOWER Trial - The Carillon Mitral Contour System® in Treating Heart Failure With FMR
  Recruiting · Cardiac Dimensions, Inc. · Gilbert, Arizona
• Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS)
  Recruiting · Duke University · Phoenix, Arizona
• His-Bundle Corrective Pacing in Heart Failure
  Recruiting · University of Rochester · Phoenix, Arizona
• EXCOR Active Driving System for the EXCOR Pediatric VAD IDE Study
  Enrolling By Invitation · Berlin Heart, Inc · Los Angeles, California