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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Heart Failure

Intervention / Treatment
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* Behavioral: iCardia4HF


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iCardia4HF<br>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<br>* 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.<br>|
| No Intervention: Control Group<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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self-management, heart failure, mHealth, smartphone, wearable electronic devices, text messaging, self-care