Heart Failure Clinical Trial

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

Summary

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.

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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.

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Eligibility Criteria

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 is for people with:

Heart Failure

Estimated Enrollment:

27

Study ID:

NCT03642275

Recruitment Status:

Completed

Sponsor:

University of Illinois at Chicago

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There is 1 Location for this study

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

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Study is for people with:

Heart Failure

Estimated Enrollment:

27

Study ID:

NCT03642275

Recruitment Status:

Completed

Sponsor:


University of Illinois at Chicago

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