Clinical trial NCT03642275: Patient-centered Mobile Health Intervention to Improve Self-care in Patients With Chronic Heart Failure
Official title: iCardia4HF: A Patient-centered Mobile Health Intervention to Promote Self-care and Improve Patient Outcomes in Chronic Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: heart failure
mHealth
smartphone
wearable electronic devices
text messaging
self-management
self-care
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2018-08-22
Enrollment: 27
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

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

Primary outcomes:
measure: Change from Baseline in Self-care at 30 and 60 days
timeFrame: Baseline, 30 and 60 days
measure: Change from Baseline in Health-related Quality of Life (HRQoL) at 30 and 60 days
timeFrame: Baseline, 30 and 60 days
Secondary outcomes:
measure: Hospitalizations
timeFrame: 60 days
measure: ER visits
timeFrame: 60 days
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois Hospital & Health Sciences System
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Spyros Kitsiou, PhD
role: PRINCIPAL_INVESTIGATOR
References: