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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two mobile health technologies to help individuals with chronic heart failure manage their condition more effectively. One treatment, MyApps, uses health apps and devices to track and manage heart health. The other, Text4HF, sends personalized text messages to encourage better self-care habits. Researchers aim to determine if these tools, alone or combined, can reduce hospitalizations and improve daily management of heart failure. Individuals with Stage C heart failure, currently managing their condition with medication and having had recent heart-related hospital stays, might be suitable for this trial. As a Phase 2/3 trial, this research measures the treatment's effectiveness in an initial, smaller group and represents the final step before FDA approval, offering participants a chance to contribute to advancing heart failure care.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both the MyApps and Text4HF programs are generally safe for people with heart failure. Studies have found that using mobile health apps and devices, like MyApps, is usually easy for people to manage. These tools help track and manage heart health without major issues. Research on similar apps has shown they can reduce risks without causing significant side effects.

The Text4HF program, which sends personalized text messages to encourage better self-care, has also been tested in other studies. These studies found it to be a safe way to support heart health by helping people adhere to their self-care routines, with no major safety concerns.

Using MyApps and Text4HF together is also considered safe. Early findings suggest this combined approach works well and is user-friendly. Overall, these programs appear to be safe options for managing heart failure. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about exploring mHealth technologies like MyApps and Text4HF for heart failure management because these tools offer a fresh approach to self-care. Unlike traditional treatments that mainly focus on medication and regular clinical visits, MyApps uses a combination of health apps and connected devices to help patients monitor and manage their condition daily. Text4HF takes it a step further by providing personalized text messages to boost patients' knowledge and confidence in managing heart failure. Both treatments aim to empower patients with real-time data and support, potentially improving self-management and outcomes in a way that standard care alone might not achieve.

What evidence suggests that this trial's treatments could be effective for heart failure?

Research has shown that mobile health apps like MyApps, which participants in this trial may receive, help people with heart failure take better care of themselves. These apps improve self-care, enabling people to manage their health better and potentially reduce hospital visits. Studies indicate that using these apps and devices can decrease time spent in the hospital and lower the risk of heart-related issues.

Similarly, personalized text messages from programs like Text4HF, another treatment option in this trial, assist heart failure patients by reminding them to follow their care routines. This method encourages healthy habits and helps people maintain consistency in their self-care.

When MyApps and Text4HF are used together, as in one of the trial arms, early research suggests they may be even more effective in enhancing self-care and reducing hospital stays. This combination leverages both technology and personalized messages to promote better health habits. ^{2 3 4 6 7}

Who Is on the Research Team?

Spyros Kitsiou, PhD

Principal Investigator

University of Illinois Chicago

Are You a Good Fit for This Trial?

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 have been diagnosed with Stage C heart failure.

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

My heart's pumping ability is low, or I am on water pills for heart failure.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39813671/

Patient-Centered mHealth Intervention to Improve Self-Care in ... The primary efficacy outcome was change in HF self-care subscale scores (maintenance, symptom perception, and self-care management) at 8 weeks, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06205225

iCardia4HF: Multi-component mHealth Intervention for ... 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 ...

3. mhealth.jmir.org mhealth.jmir.org/2019/11/e13173/

Evaluation of Heart Failure Apps to Promote Self-Care We conducted a systematic search of all apps available exclusively for HF self-care across Google Play and the App Store.

4. withpower.com withpower.com/trial/mhealth-technologies-for-heart-failure-d71a8

mHealth Technologies for Heart Failure (iCardia4HF Trial) Research suggests that mobile health apps can help people with heart failure manage their condition better by reducing hospital visits and improving their ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1438887125000688

Patient-Centered mHealth Intervention to Improve Self ... MyApps consisted of 3 popular consumer-grade mHealth apps (Heart Failure ... heart failure based on the data I collect from the mobile app and smart devices ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10466157/

Patients' Experiences Using a Mobile Health App for Self ... Publicly available patient-focused mobile health (mHealth) apps are being increasingly integrated into routine heart failure (HF)–related ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2352013224000292

Effectiveness of mobile health applications on clinical ... Mobile health apps have the potential to lower the incidence of major adverse cardiac events (MACEs), readmission rates, and blood lipids in patients with CHD.