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

Heart Failure Clinical Trial

— iCardia4HF  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06205225
• Other study ID #: 2022-1592
• Secondary ID: R01HL168376
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: January 2024
• Source: University of Illinois at Chicago
• Contact: Timmy Agboola, PharmD
• Phone: 312-413-4227
• Email: oagboo2[@]uic.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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: 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 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 360
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Behavioral:
• Text4HF
Behavioral text messages about heart failure self-care
• MyApps
consumer mobile health apps and devices for heart failure self-care
• MyApps & Text4HF
Consumer mobile health apps and devices supplemented with behavioral text messages for heart failure self-care

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Illinois Hospital & Health Sciences System	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Chicago	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of days lost due to unplanned cardiovascular hospitalizations or all-cause death	Hospitalization is defined as hospital admission resulting in an overnight stay where the length of stay is at least 24 hours. Events leading to emergency department visit only with a length of stay under 24 hours will not be classified as hospitalization. For a hospitalization to be considered as unplanned the patient must present new symptoms and/or worsening of existing symptoms with the need for immediate admission in a hospital for intensified care. A hospitalization will be considered "cardiovascular" when it is due to cardiovascular causes which includes but is not limited to: HF deterioration, acute myocardial infarction, arrhythmia, HF, pulmonary embolism, cerebrovascular disease (e.g., stroke), severe bleeding, endocarditis, etc.	6 months
Secondary	All-cause mortality	Number of deaths from any cause	6 and 12 months
Secondary	Unplanned cardiovascular hospitalizations	Number of patients with one or more cardiovascular-related hospitalizations	6 and 12 months
Secondary	Unplanned HF hospitalizations	Number of patients with one or more hospitalizations due to acute decompensated heart failure	6 and 12 months
Secondary	Medication adherence	Percentage of days the correct number of doses were taken	6 and 12 months
Secondary	Weighing adherence	Percentage of days patients used the electronic scale to measure their weight	6 and 12 months
Secondary	Blood pressure monitoring adherence	Percentage of days patients used the electronic cuff to measure their blood pressure	6 and 12 months
Secondary	Steps	Mean number of steps per day	6 and 12 months
Secondary	Moderate-to-vigorous physical activity (MVPA) minutes	Average number of MVPA minutes per day assessed with the Fitbit activity tracker	6 and 12 months
Secondary	Self-care maintenance	Assessed with the Self-care Heart Failure Index v 7.2 (Subscale A)	6 and 12 months
Secondary	Symptom perception	Assessed with the Self-care Heart Failure Index v 7.2 (Subscale B)	6 and 12 months
Secondary	Self-care management	Assessed with the Self-care Heart Failure Index v 7.2 (Subscale B)	6 and 12 months
Secondary	Health Status	Assessed with the Kansas City Cardiomyopathy Questionnaire	6 and 12 months