mHealth Technologies for Heart Failure

(iCardia4HF Trial)

Recruiting at 1 trial location

Overseen By Mike Haniff, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: University of Illinois at Chicago

Must be taking: Loop diuretics

Disqualifiers: Ventricular assist device, End-stage HF, Cognitive impairment, Active cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

360 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Do I need to stop my current medications for this trial?

The trial does not specify if you need to stop your current medications. However, it mentions that participants must be actively treated with oral loop diuretics for chronic heart failure, so you may need to continue those.

What data supports the effectiveness of the treatment MyApps, MyApps, Consumer mHealth Apps and Devices, Text4HF, Text4HF, Tailored Text Messages for Heart Failure Self-Care?

Research suggests that mobile health apps can help people with heart failure manage their condition better by reducing hospital visits and improving their quality of life. These apps support self-care by helping patients stay engaged with their health management and communicate more effectively with healthcare providers. ^{1 2 3 4 5}

Is the mHealth app for heart failure safe for humans?

The research does not provide specific safety data for the mHealth app used in heart failure management, but it focuses on improving self-care and patient outcomes, suggesting it is generally considered safe for use. ^{1 2 3 4 6}

How is the mHealth treatment for heart failure unique?

The mHealth treatment for heart failure, including MyApps and Text4HF, is unique because it uses mobile health apps to support self-care by providing tailored text messages and consumer-friendly apps designed with input from patients and caregivers, which helps patients manage their condition more effectively in their daily lives. ^{1 2 3 4 6}

Research Team

Spyros Kitsiou, PhD

Principal Investigator

University of Illinois Chicago

Eligibility Criteria

This trial is for people with chronic heart failure. Participants should be willing to use mobile health apps and devices daily for self-care, and receive tailored text messages aimed at improving their adherence to self-care routines.

Inclusion Criteria

I am 18 years old or older.

I have been diagnosed with Stage C heart failure.

I was hospitalized for heart failure or struggle with self-care recently.

Exclusion Criteria

Active substance abuse

I have had a heart attack or other heart issue in the last week.

I have had a heart procedure or a CRT device implanted within the last 28 days.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction

Participants receive the MyApps and/or Text4HF interventions to promote heart failure self-care adherence

3 months

Weekly virtual check-ins

Adoption

Continued use of MyApps and/or Text4HF interventions with reduced frequency of text messages

3 months

Bi-weekly virtual check-ins

Follow-up

Participants are monitored for maintenance efficacy of interventions and health outcomes

6 months

Monthly virtual check-ins

Treatment Details

Interventions

• MyApps
• Text4HF

Trial Overview The study tests two interventions: 'MyApps', which involves using mHealth apps and devices for daily heart failure care, and 'Text4HF', a series of personalized text messages. It will assess if these can improve self-care and reduce hospitalization or death from cardiovascular causes.

Participant Groups

Group I: Text4HF Experimental Treatment 1 Intervention

Participants allocated to the Text4HF group will receive the same components and devices as the usual care group (usual care, patient education, and connected health devices), plus individually tailored Text Messages targeting health beliefs, HF-knowledge, and self-efficacy about HF self-care. Participants will receive 4-6 TMs/week during the induction phase (0 to 3 months), and 2-4 TMs per week during the adoption period (3 to 6 months).Tailoring of the TMs is guided by participants' responses to validated instruments assessing intervention target variables at baseline and 3 months

Group II: MyApps + Text4HF Experimental Treatment 1 Intervention

Participants in this group will receive the MyApps and Text4HF intervention components, combined.

Group III: MyApps Experimental Treatment 1 Intervention

In addition to usual care and patient education resources, participants in the MyApps group will receive three commercially available apps (Heart Failure Storylines, Withings Health Mate, and Fitbit), and three connected health devices (Withings Body Cardio Scale, Withings BP monitor, and Fitbit activity tracker). The apps interface with the devices via Bluetooth offering patients a comprehensive set of mHealth tools that support the core elements of HF self-care (maintenance, self-monitoring, and self-management).

Group IV: Enhanced usual care Active Control 1 Intervention

Participants assigned to the usual care group will receive (1) standard care, (2) patient education about HF self-care, and (3) three connected health devices. Usual care includes follow-up appointments every 2-3 months with a multidisciplinary team at the outpatient HF clinic. Patient education includes resources about HF self-care from the American Heart Association and Heart Failure Society of America. Connected health devices include the Withings Weight Scale, Withings blood pressure monitor, and Fitbit Charge 6 activity tracker (wrist-based with heart rate sensor). Participants will receive the devices at baseline along with training by research staff on how to use the devices to perform daily self-monitoring of weight, blood pressure, and physical activity/inactivity. The Withings devices have a cellular antenna for automatic transmission of data to our study server (iCardia). Fitbit will be paired with the participant's smartphone.

Who Is Running the Clinical Trial?

University of Illinois at Chicago

Lead Sponsor

Trials

653

Recruited

1,574,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Findings from Research

Patients with heart failure reported high satisfaction using the OnTrack to Health app, with all participants recommending it for self-care, indicating its potential effectiveness in managing their condition.

The app's features, such as medication tracking and performance feedback, were perceived as beneficial for improving self-care and potentially reducing hospitalization rates, highlighting the importance of user-centered design in mHealth applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' Experiences Using a Mobile Health App for Self-Care of Heart Failure in a Real-World Setting: Qualitative Analysis. Madujibeya, I., Lennie, TA., Pelzel, J., et al.[2023]

This review analyzed 18 studies on mobile health (mHealth) apps for heart failure management, revealing that many studies had low-quality designs and small sample sizes, which raises concerns about their reliability and efficacy.

Despite the challenges, the review suggests that mHealth apps could provide a cost-effective solution for heart failure self-care, offering patients 24/7 access to symptom monitoring and promoting engagement in their own health management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Phone Apps to Support Heart Failure Self-Care Management: Integrative Review. Athilingam, P., Jenkins, B.[2023]

The Care4myHeart app was developed through a collaborative design process involving 18 stakeholders, including patients, family caregivers, and clinicians, ensuring that it meets the real needs of users for heart failure self-management.

The app features essential components for managing heart failure, such as health management tools, appointment scheduling, and personalized self-management plans, demonstrating the importance of stakeholder involvement in creating effective health technology solutions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design of a Consumer Mobile Health App for Heart Failure: Findings From the Nurse-Led Co-Design of Care4myHeart. Woods, L., Duff, J., Roehrer, E., et al.[2022]

The Care4myHeart app, designed for self-management of heart failure, received an overall quality score of 3.53 out of 5, indicating it is considered 'acceptable' by users, particularly excelling in aesthetics and information delivery.

While the app showed potential for improving self-management through features like weight tracking and data visualization, its impact on health behavior change was perceived as low, highlighting a barrier to adoption due to the need for integration into existing routines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' Experiences of Using a Consumer mHealth App for Self-Management of Heart Failure: Mixed-Methods Study. Woods, LS., Duff, J., Roehrer, E., et al.[2020]

The iHeartU mobile health app was developed to enhance self-management for heart failure patients, aiming to improve communication with healthcare providers and reduce hospital readmission rates.

Initial usability testing is underway, and the app is designed to be user-friendly and accessible, particularly for low-income patients, potentially leading to better health outcomes and lower healthcare costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Patient-Centered Mobile Phone App (iHeartU) With a Virtual Human Assistant for Self-Management of Heart Failure: Protocol for a Usability Assessment Study. Zhang, L., Babu, SV., Jindal, M., et al.[2020]

A study of 10 mobile health applications (mHealth apps) for heart failure patients found that most apps had a readability level above the recommended 6th grade, which may hinder patient understanding and engagement.

Only a few apps provided clear links to trustworthy evidence-based sources and advanced functions like interoperability with electronic health records, suggesting that future app designs should focus on improving readability and functionality to enhance patient self-care and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved readability and functions needed for mHealth apps targeting patients with heart failure: An app store review. Dunn Lopez, K., Chae, S., Michele, G., et al.[2023]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Patients' Experiences Using a Mobile Health App for Self-Care of Heart Failure in a Real-World Setting: Qualitative Analysis. [2023]

2. Canada pubmed.ncbi.nlm.nih.gov

Mobile Phone Apps to Support Heart Failure Self-Care Management: Integrative Review. [2023]

3. Canada pubmed.ncbi.nlm.nih.gov

Design of a Consumer Mobile Health App for Heart Failure: Findings From the Nurse-Led Co-Design of Care4myHeart. [2022]

4. Canada pubmed.ncbi.nlm.nih.gov

Patients' Experiences of Using a Consumer mHealth App for Self-Management of Heart Failure: Mixed-Methods Study. [2020]

5. Canada pubmed.ncbi.nlm.nih.gov

A Patient-Centered Mobile Phone App (iHeartU) With a Virtual Human Assistant for Self-Management of Heart Failure: Protocol for a Usability Assessment Study. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Improved readability and functions needed for mHealth apps targeting patients with heart failure: An app store review. [2023]