Mobile health intervention for heart failure patients
iCardia4HF: A Multi-component mHealth App and Tailored Text-messaging Intervention to Promote Self-care Adherence and Improve Health Outcomes in Patients With Chronic Heart Failure
This study is testing two mobile health tools to see if they can help people with chronic heart failure take better care of themselves and reduce hospital visits.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 360 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Illinois at Chicago Academic / other |
| Drugs / interventions | immunotherapy, radiation |
| Locations | 2 sites (Chicago, Illinois and 1 other locations) |
| Trial ID | NCT06205225 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effectiveness of two mobile health technology interventions for individuals with chronic heart failure. The first intervention utilizes consumer mHealth apps and sensor devices to enhance self-care, while the second involves tailored text messages aimed at improving adherence to self-care practices. The study employs a factorial randomized controlled design to assess the independent and combined effects of these interventions on reducing hospitalizations and improving self-care over a six-month period. A total of 360 patients will be recruited to evaluate the efficacy of these innovative approaches.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older diagnosed with Stage C Heart Failure who have experienced recent hospitalization due to heart failure.
Not a fit: Patients with implanted ventricular assist devices or those who are hospice candidates are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve heart failure self-care and reduce hospitalizations for patients.
How similar studies have performed: Previous studies have shown promise in using mobile health technologies for chronic disease management, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of Stage C Heart Failure * ≥ 18 years of age * Transthoracic Echocardiogram or Cardiac MRI performed in the last 3 years and LVEF results available * Patient is actively treated with oral loop diuretics for chronic heart failure * Hospitalization due to acute decompensated heart failure within 24 months before randomization and/or insufficient self-care per SCHFI assessment (score of ≤3, in at least two items of the SCHFI v7.2 maintenance, symptom monitoring, or self-care management subscale) * Ability to speak and read English Exclusion Criteria: * Implanted ventricular assist device * High urgent listed for heart transplantation * Acute coronary syndrome within the last 7 days before randomization * Revascularization and/or CRT implantation within 28 days before randomization * Planned revascularization, transcatheter aortic valve implantation, MitraClip and/or CRT implantation within 3 months after randomization * End-stage HF (hospice candidate) * Discharge to a setting other than home * Individuals who have a home nurse or are not able to take care of self (eat, dress, walk, bathe, take medications, or use the toilet) * Chronic renal insufficiency with hemodialysis or estimated Glomerular Filtration Rate \<25 mL * Active cancer, currently undergoing treatment (e.g. radiation immunotherapy) * Existence of any disease reducing life expectancy to less than 1 year * Cognitive impairment (e.g., Dementia, Parkinson disease, Alzheimer disease, MoCA\<18, impaired self-determination, lacking ability to communicate) * Major physical impairment (e.g., inability to walk, bound on a wheelchair) * Unwillingness to use study equipment * Active substance abuse * Currently pregnant, less than 3-month post-partum or pregnancy anticipated during the study * Participation in other treatment studies or remote patient management programs * Participation in the iCardia4H pilot trial (conducted before this study)
Where this trial is running
Chicago, Illinois and 1 other locations
- Rush University Medical Center — Chicago, Illinois, United States (Recruiting)
- University of Illinois Hospital & Health Sciences System — Chicago, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Spyros Kitsiou, PhD — University of Illinois at Chicago
- Study coordinator: Spyros Kitsiou, PhD
- Email: mhanif6@uic.edu
- Phone: 312-413-4227
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.