Patient-centered Mobile Health Intervention to Improve Self-care in Patients With Chronic Heart Failure (iCardia4HF)

University of Illinois

Status: Completed

Conditions: Heart Failure

Treatments: Behavioral: iCardia4HF

Study type: Interventional

Funder types: Other

Identifiers

NCT03642275

2018-0307

Details and patient eligibility

About

Approximately 6.5 million people have heart failure (HF) in the United States, and 960,000 new cases are reported each year. HF is one of the most common hospital diagnosis among older adults. About 40% of patients are readmitted within 1-year following their first admission for HF and hospitalization accounts for approximately 80% of the costs of HF management. This pilot study aims to assess the feasibility, acceptability, and preliminary efficacy of a patient-centered mobile health (mHealth) technology intervention in older adults with chronic heart failure.

Full description

This is a single site, two-arm, pilot randomized controlled trial that aims to examine the feasibility, acceptability and preliminary efficacy of a mobile phone-based intervention compared to usual care in older adult patients with HF (≥50 years). Forty (n=40) patients from the University of Illinois Hospital & Health Sciences system will be enrolled in the study, randomly assigned to the intervention or usual care group, and followed for 60 days. Patients in the intervention group will receive the Heart Failure Health Storylines mobile app developed by Self Care Catalysts in collaboration with the Heart Failure Society of America, three connected health devices from Fitbit and Nokia that interface with the mobile app, and tailored text-messages targeting health beliefs, self-care efficacy, and knowledge about HF. The control group will receive standard care which involves patient education and outpatient follow up with physical and laboratory examinations as needed. The primary study outcome is change in self-care and quality of life. Secondary outcomes include hospital re-admissions and emergency room visits.

Enrollment: 27 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Inpatients or outpatients with a diagnosis of HF as defined by the International Classification of Diseases (ICD-10) codes
• Stage C, NYHA I, II or III
• ≥ 40 years of age
• Own a smartphone with text-messaging and internet plan
• Ability to speak and read English
• Live within 30 miles from UI Health

Exclusion criteria

• On an active waiting list for implanted ventricular assist device or heart transplant
• Advanced renal disease (dialysis or creatinine >4.0mg/dL)
• End-stage HF (hospice candidate)
• Active cancer
• Individuals who are not their own primary caregiver
• Discharge to a setting other than home
• Patients with baseline Montreal Cognitive Assessment (MoCA) score of < 22

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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27 participants in 2 patient groups

iCardia4HF

Experimental group

Description:

Participants will be using a heart failure mobile app, wearable activity tracking device, Bluetooth-enabled blood pressure monitor and weight scale for self-monitoring, and receive tailored text-messages about self-care.

Treatment:

Behavioral: iCardia4HF

Control Group

No Intervention group

Description:

Participants assigned to the usual care group will receive standard medical care, which includes nurse-led patient education about HF self-care before discharge, and follow-up visits at the UI Health, outpatient Heart Failure program.