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iCardia4HF: Multi-component mHealth Intervention for Patients With Heart Failure

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Mentioned in the study description

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 12 months

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "A total of 360 patients with HF will be recruited and randomized to one of four conditions for 12 months: (1) Usual care, (2) Text4HF, (3) MyApps, or (4) MyApps\&Text4HF."
Compensation
Mentioned in the study description
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility 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)

Study sites (2)

IL