Clinical trial NCT06205225: iCardia4HF: Multi-component mHealth Intervention for Patients With Heart Failure
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Heart Failure
Keywords: mHealth, wearables, mobile apps, heart failure
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2024-01-12
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2 x 2 factorial randomized controlled trial
Primary purpose: TREATMENT

Brief 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 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

Detailed 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\&amp;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.

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)

Primary outcomes:
measure: Percentage of days lost due to unplanned cardiovascular hospitalizations or death from any cause
timeFrame: 6 months
Secondary outcomes:
measure: Percentage of days lost due to unplanned cardiovascular hospitalizations or death from any cause
timeFrame: 12 months
measure: Number of patients with unplanned cardiovascular hospitalizations
timeFrame: 6 and 12 months
measure: Mean number of unplanned cardiovascular hospitalizations
timeFrame: 6 and 12 months
measure: Unplanned heart failure hospitalizations
timeFrame: 6 and 12 months
measure: Mean number of unplanned heart failure hospitalizations
timeFrame: 6 and 12 months
measure: Emergency Room visits
timeFrame: 6 and 12 months
measure: All-cause mortality
timeFrame: 6 and 12 months
measure: Medication adherence - Dose count
timeFrame: 6 and 12 months
measure: Medication adherence - Dose days
timeFrame: 6 and 12 months
measure: Weighing adherence
timeFrame: 6 and 12 months
measure: Blood pressure monitoring adherence
timeFrame: 6 and 12 months
measure: Steps
timeFrame: 6 and 12 months
measure: Moderate-to-vigorous physical activity (MVPA) minutes
timeFrame: 6 and 12 months
measure: Self-care maintenance
timeFrame: 3, 6, 9, and 12 months
measure: Symptom perception
timeFrame: 3, 6, 9, and 12 months
measure: Self-care management
timeFrame: 3, 6, 9, and 12 months
measure: Self-care efficacy
timeFrame: 3, 6, 9, and 12 months
measure: Health Status
timeFrame: 3, 6, 9, and 12 months
measure: Heart Failure Knowledge
timeFrame: 3, 6, 9, and 12 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Illinois Hospital & Health Sciences System
state: Illinois
Study officials:
affiliation: University of Illinois Chicago
name: Spyros Kitsiou, PhD
role: PRINCIPAL_INVESTIGATOR
References: