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

iCardia4HF: A Patient-centered Mobile Health Intervention to Promote Self-care and Improve Patient Outcomes in Chronic Heart Failure

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Behavioral: iCardia4HF

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois Hospital & Health Sciences System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: iCardia4HF; 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.	Behavioral: iCardia4HF; Participants in the intervention group will receive the Heart Failure Health Storylines mobile app, three connected health devices that interface with the app (Fitbit Charge 2 activity tracker, and FDA-approved Nokia BP monitor and Cardio Body weight scale), and a program of tailored self-care text-messages, in addition to usual care. Participants will be asked to use the app and devices to record and self-monitor their daily symptoms, blood pressure, weight, and physical activity.
NO_INTERVENTION: Control Group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Self-care at 30 and 60 days	Self-care will be measured with the Self-Care Heart Failure Index (SCHFI) v.6.2,87 which includes 3 subscales: self-care maintenance (10-items), self-care confidence (6-items), and self-care management (6-items). Standardized scores in each scale range from 0 to 100. A total score of ≥70 indicates adequate self-care.	Baseline, 30 and 60 days
Change from Baseline in Health-related Quality of Life (HRQoL) at 30 and 60 days	HRQoL will be measured with the Kansas City Cardiomyopathy Questionnaire (23-items) that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Lower scores indicate worse HRQoL.	Baseline, 30 and 60 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalizations	The number of hospitalizations during the study will be measured with both self-report and the electronic medical record.	60 days
ER visits	The number of emergency room visits will be collected based on both self-reports and the electronic medical record	60 days

Collaborators and Investigators

• Sponsor: University of Illinois at Chicago
• Investigators: Principal Investigator: Spyros Kitsiou, PhD, University of Illinois at Chicago

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 21, 2019
• Primary Completion (ACTUAL): February 15, 2020
• Study Completion (ACTUAL): February 15, 2021

Study Registration Dates

• First Submitted: June 15, 2018
• First Submitted That Met QC Criteria: August 20, 2018
• First Posted (ACTUAL): August 22, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 9, 2021
• Last Update Submitted That Met QC Criteria: April 8, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: self-management; smartphone; heart failure; mHealth; text messaging; self-care; wearable electronic devices
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 2018-0307

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No