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
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iCardia4HF: A Patient-centered Mobile Health Intervention to Promote Self-care and Improve Patient Outcomes in Chronic Heart Failure
- ClinicalTrials.gov ID
- NCT03642275
- Acronym / sponsor ID
- iCardia4HF / 2018-0307
- Conditions
- Heart Failure
- Keywords
- heart failure, mHealth, smartphone, wearable electronic devices, text messaging, self-management, self-care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of Illinois at ChicagoUniversity, hospital or other
- Study start
- 21 Jan 2019 (actual)
- Primary completion
- 15 Feb 2020 (actual)
- Study completion
- 15 Feb 2021 (actual)
- First posted
- 22 Aug 2018 (actual)
- Results
- Posted 7 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iCardia4HF | Experimental | Behavioral: iCardia4HFParticipants 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 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iCardia4HFParticipants 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. | Behavioural | iCardia4HF |
Primary outcome
Mean Change in Self-care at 30 and 60 Days
Time frame: Baseline, 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.
3 secondary outcomes
Change From Baseline in Health-related Quality of Life (HRQoL) at 30 and 60 Days
Time frame: Baseline, 30 and 60 days
Hospitalizations
Time frame: 60 days
ER Visits
Time frame: 60 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39813671Kitsiou 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.
- Individual participant dataSharing planned: No
Related trials for Heart Failure
Enrolling by invitationObservational study
Multi-Scale Analysis of Phenotypes in Heart Failure (MAP-HEART)
Heart Failure
Active, not recruitingObservational study
REdo Transcatheter Aortic VALVE Implantation for the Management of Transcatheter Aortic Valve Failure
Aortic Valve Stenosis
RecruitingPhase 3
Optimal Diuretic Therapies for Acute Heart Failure With Volume Overload
Acute Heart Failure
Recruiting
Renal Denervation in Patients With Atrial Fibrillation and Hypertension
Atrial Fibrillation (Paroxysmal), Hypertension
Recruiting
Laser Acupuncture for Fatigue in Hemodialysis Patients
ESRD (End Stage Renal Disease), Dialysis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Spyros Kitsiou, PhD principal investigator
University of Illinois at Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iCardia4HF in people with Heart Failure, run by University of Illinois at Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in Self-care at 30 and 60 Days (time frame: Baseline, 30 and 60 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03642275, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.