Mobile health intervention for heart failure patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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 Chicago
• Study coordinator: Spyros Kitsiou, PhD
• Email: mhanif6@uic.edu
• Phone: 312-413-4227

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• NT-proBNP–guided heart failure screening for people 65+ in rural China

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• Voice-based detection of heart failure deterioration using Noah Labs Vox

  This study tests whether a voice-analysis app can flag worsening heart failure in adults by comparing its alerts to standard weight-based monitoring.

  Recruiting Noah Labs · Boston, Massachusetts · NCT07870395

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.