Heart Failure Clinical Trial

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

Summary

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 daily 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:

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?
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?
Can the combined use of MyApps and Text4HF lead to greater improvements in heart failure self-care and days lost due to cardiovascular hospitalization or death for any cause

View Full Description

Full Description

Heart failure (HF) remains one of the most frequent principal diagnoses for hospitalization and a leading cause of death in the United States. Up to 65% of HF readmissions are the result of insufficient self-care. Existing HF self-care interventions delivered face-to-face or via telephone have had limited impact and reach. They require significant provider time and are not always accessible to patients. There is an urgent need for accessible and scalable interventions that are designed to assist patients with HF self-care while in the community to reduce HF readmissions. Consumer mobile health (mHealth) technologies (e.g., mobile apps and sensor devices) hold promise for promoting HF self-care and expanding intervention delivery. However, their efficacy remains largely underexplored.

To address this gap, our team developed a patient-centered HF self-care intervention (iCardia4HF) that combines the use of three consumer mobile health apps and connected health devices (MyApps) with a program of individually tailored text messages (Text4HF) targeting modifiable behavioral factors to promote HF self-care adherence and improve clinical outcomes.

This study aims to conduct a fully powered, 2x2 factorial randomized controlled trial to determine the independent and combined efficacy of the two iCardia4HF intervention components (MyApps and Text4HF) at 6 months, as well as their maintenance efficacy at 6 months post-intervention. 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. Specific aims are:

Aim 1: Determine the independent and combined efficacies of MyApps and Text4HF at 6-months on the primary outcome of days lost due to cardiovascular hospitalization or death for any cause, and secondary outcomes of HF self-care and health status.

Hypothesis 1a: MyApps and Text4HF will have significant main effects on the primary outcome at 6 months.

Hypothesis 1b: MyApps and Text4HF will have significant main effects on objectively assessed measures of HF self-care adherence, self-reported HF self-care, and health status, at 6 months.

Aim 2: Determine the independent and combined maintenance efficacies of MyApps and Text4HF at 12 months (6 months post-intervention).

Hypothesis 2a: Text4HF and MyApps will have significant main effects on the primary outcome at 12 months.

Hypothesis 2b: Text4HF and MyApps will have significant main effects on objectively assessed measures of HF self-care adherence, self-reported HF self-care, and health status, at 12 months.

Aim 3: Investigate the mediating effect of intervention targets (health beliefs, HF knowledge, self-efficacy), and moderating effect of multi-level determinants of HF self-care adherence on the efficacy of the intervention, across individual (e.g., age, race/ethnicity), illness-related (e.g., depression, comorbidities), and socioeconomic factors (e.g., insurance, income, employment, and access to care).

Impact statement: This study will provide important new knowledge that will critically shape our understanding about the potential of commercially available mHealth technologies and tailored text messages to improve HF self-care adherence and reduce hospital readmissions in patients with HF.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Diagnosis with Heart Failure (Stage C)
Echocardiographically determined LVEF≤40% or if >40%, patient must be treated with oral 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
≥ 18 years of age
Ability to speak and read English

Exclusion Criteria:

Implanted cardiac assist system/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 treated with chemotherapy
Existence of any disease reducing life expectancy to less than 1 year
Impairment or unwillingness to use the study equipment (e.g., cognitive impairment, dementia, inability to walk - on wheel-chair, lacking ability to communicate).
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

Study is for people with:

Heart Failure

Estimated Enrollment:

360

Study ID:

NCT06205225

Recruitment Status:

Not yet recruiting

Sponsor:

University of Illinois at Chicago

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There is 1 Location for this study

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Rush University Medical Center
Chicago Illinois, 60612, United States More Info
Sachin Vispute, MPH, MSEd
Contact
312-947-3870
[email protected]
Todd Ruppar, PhD
Principal Investigator
University of Illinois Hospital & Health Sciences System
Chicago Illinois, 60612, United States More Info
Timmy Agboola, PharmD
Contact
312-413-4227
[email protected]
Spyros Kitsiou, PhD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

360

Study ID:

NCT06205225

Recruitment Status:

Not yet recruiting

Sponsor:


University of Illinois at Chicago

How clear is this clinincal trial information?

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