Heart FailureiCardia4HFNCT03642275
Patient-centered Mobile Health Intervention to Improve Self-care in Patients With Chronic Heart Failure
A study testing iCardia4HF in people with Heart Failure, run by University of Illinois at Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- iCardia4HF
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jan 2019to 15 Feb 2021
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois Hospital & Health Sciences System
Chicago, Illinois, 60612
About this study
Official title: 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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- iCardia4HF
- Keywords
- heart failure, mHealth, smartphone, wearable electronic devices, text messaging, self-management, self-care
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iCardia4HFBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| iCardia4HF | Experimental | 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. Receives: Behavioral: iCardia4HF |
| Control Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Self-care at 30 and 60 Days
Self-care was measured with the Self-Care Heart Failure Index (SCHFI version 7.2) which includes 4 subscales: maintenance, symptom perception, management, and self-efficacy. Each scale is scored separately. Standardized scores in each scale range from 0 to 100. Higher scores indicate better self-care.
Note: According to the original protocol, we had planned to use SCHFI version 6.2 which had 3 subscales (maintenance, management, and self-efficacy). However, a newer version (SCHFI v 7.2) became available before the start of the study, and we decided to use the new version.
Measured: Baseline, 30 and 60 days
Secondary outcomes (3)
Change From Baseline in Health-related Quality of Life (HRQoL) at 30 and 60 Days
Self-reported Health-related Quality of Life was measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ-12). KCCQ has four domains: Physical limitation, Symptom frequency, Quality of life, and Social Limitation. An overall summary score is calculated as the average of all four domains. Scores in each domain range from a 0-to-100 points. Lower scores represent worse health status and higher scores indicate better health status. The results below present the mean difference from baseline to 30 days and to 60 days. Positive numbers indicate improvement in health status scores, while negative numbers indicate worsening of health status scores from baseline.
Measured: Baseline, 30 and 60 days
Hospitalizations
Number of unplanned hospitalizations due to any cause during the study (recorded from the electronic medical record and patient self-reports)
Measured: 60 days
ER Visits
Emergency room visits (tracked from the electronic medical record and patient self-reports)
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start21 Jan 2019
- Primary completion15 Feb 2020
- Study completion15 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Spyros Kitsiou, University of Illinois at Chicago
- Investigators
- Spyros Kitsiou, PhD, Principal investigator, University of Illinois at Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03642275
- Sponsor's protocol ID
- 2018-0307
- Acronym
- iCardia4HF
- Status last verified
- Oct 2026
- First submitted
- 15 Jun 2018
- Last updated
- 7 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39813671