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
1 other identifier
interventional
27
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable heart-failure
Started Jan 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 15, 2018
CompletedFirst Posted
Study publicly available on registry
August 22, 2018
CompletedStudy Start
First participant enrolled
January 21, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2021
CompletedApril 9, 2021
April 1, 2021
1.1 years
June 15, 2018
April 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (2)
Hospitalizations
60 days
ER visits
60 days
Study Arms (2)
iCardia4HF
EXPERIMENTALParticipants 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.
Control Group
NO INTERVENTIONParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Illinois Hospital & Health Sciences System
Chicago, Illinois, 60612, United States
Related Publications (1)
Kitsiou S, Gerber BS, Buchholz SW, Kansal MM, Sun J, Pressler SJ. Patient-Centered mHealth Intervention to Improve Self-Care in Patients With Chronic Heart Failure: Phase 1 Randomized Controlled Trial. J Med Internet Res. 2025 Jan 15;27:e55586. doi: 10.2196/55586.
PMID: 39813671DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Spyros Kitsiou, PhD
University of Illinois at Chicago
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Outcome assessors will be blinded to patients' randomization assignment
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
June 15, 2018
First Posted
August 22, 2018
Study Start
January 21, 2019
Primary Completion
February 15, 2020
Study Completion
February 15, 2021
Last Updated
April 9, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share