RECRUITING

ICardia4HF: Multi-component MHealth Intervention for Patients with Heart Failure

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Conditions

Heart FailuremHealth, wearables, mobile apps, heart failure

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this factorial randomized trial is to examine the independent and synergistic efficacies of two mobile health technology interventions in people with chronic heart failure. The first intervention involves the use of multiple consumer mHealth apps and sensor devices (MyApps) for heart failure self-care (maintenance, monitoring, and management). The second intervention is a program of tailored text messages (Text4HF) targeting modifiable behavioral factors associated with heart failure self-care non-adherence. The main questions this study aims to answer are: 1. Can the use of consumer mHealth apps and devices (MyApps) improve heart failure self-care and reduce days lost due to cardiovascular hospitalization or death for any cause? 2. Can a program of individually tailored text messages (Text4HF) improve heart failure self-care and reduce the days lost due to cardiovascular hospitalization or death for any cause? 3. Can MyApps and Text4HF combined lead to greater improvements in heart failure self-care and days lost due to cardiovascular hospitalization or death for any cause

Official Title

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

Quick Facts

Study Start:2024-10-01
Study Completion:2029-03-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06205225

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of Stage C Heart Failure
  2. * ≥ 18 years of age
  3. * Transthoracic Echocardiogram or Cardiac MRI performed in the last 3 years and LVEF results available
  4. * Patient is actively treated with oral loop diuretics for chronic heart failure
  5. * 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)
  6. * Ability to speak and read English
  1. * Implanted ventricular assist device
  2. * High urgent listed for heart transplantation
  3. * Acute coronary syndrome within the last 7 days before randomization
  4. * Revascularization and/or CRT implantation within 28 days before randomization
  5. * Planned revascularization, transcatheter aortic valve implantation, MitraClip and/or CRT implantation within 3 months after randomization
  6. * End-stage HF (hospice candidate)
  7. * Discharge to a setting other than home
  8. * 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)
  9. * Chronic renal insufficiency with hemodialysis or estimated Glomerular Filtration Rate \<25 mL
  10. * Active cancer, currently undergoing treatment (e.g. radiation immunotherapy)
  11. * Existence of any disease reducing life expectancy to less than 1 year
  12. * Cognitive impairment (e.g., Dementia, Parkinson disease, Alzheimer disease, MoCA\<18, impaired self-determination, lacking ability to communicate)
  13. * Major physical impairment (e.g., inability to walk, bound on a wheelchair)
  14. * Unwillingness to use study equipment
  15. * Active substance abuse
  16. * Currently pregnant, less than 3-month post-partum or pregnancy anticipated during the study
  17. * Participation in other treatment studies or remote patient management programs
  18. * Participation in the iCardia4H pilot trial (conducted before this study)

Contacts and Locations

Study Contact

Mike Haniff, PhD
CONTACT
312-413-4227
mhanif6@uic.edu

Principal Investigator

Spyros Kitsiou, PhD
PRINCIPAL_INVESTIGATOR
University of Illinois Chicago

Study Locations (Sites)

Rush University Medical Center
Chicago, Illinois, 60612
United States
University of Illinois Hospital & Health Sciences System
Chicago, Illinois, 60612
United States

Collaborators and Investigators

Sponsor: University of Illinois at Chicago

  • Spyros Kitsiou, PhD, PRINCIPAL_INVESTIGATOR, University of Illinois Chicago

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-01
Study Completion Date2029-03-30

Study Record Updates

Study Start Date2024-10-01
Study Completion Date2029-03-30

Terms related to this study

Keywords Provided by Researchers

  • mHealth, wearables, mobile apps, heart failure

Additional Relevant MeSH Terms

  • Heart Failure