Mobile Health Interventions for Heart Disease Prevention After High Blood Pressure in Pregnancy

(mHEART Trial)

Overseen By Priya M Freaney, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: HELLP syndrome, Hypertension, Diabetes, others

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

Compensation: Varies

Number of Visits: 2

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this research is to study digital health interventions to prevent cardiovascular disease in individuals who have had a hypertensive disorder of pregnancy (HDP).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is it safe to use mobile health apps for heart disease prevention?

Mobile health apps have the potential to provide efficient healthcare services, but there are concerns about their safety, such as poor privacy and security practices, and inconsistent quality. Ensuring patient safety may require better regulation and transparency in app development. ^{1 2 3 4 5}

How is the mobile health intervention treatment for heart disease prevention after high blood pressure in pregnancy different from other treatments?

This treatment is unique because it uses mobile health applications and remote patient monitoring to allow patients to self-monitor their blood pressure and receive personalized health recommendations, which can be more convenient and accessible than frequent in-person clinic visits. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Mobile health application, mHealth Apps, Mobile Health Applications, Digital Health Tools, Remote patient monitoring (RPM) system, Telehealth Monitoring, Digital Health Monitoring, Remote Physiologic Monitoring for heart disease prevention after high blood pressure in pregnancy?

Remote patient monitoring (RPM) has been shown to improve management and outcomes for chronic diseases like hypertension and heart failure by allowing continuous health data collection and analysis, which can lead to better disease control and reduced health complications. ^{11 12 13 14 15}

Who Is on the Research Team?

Priya Freaney, MD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for individuals who gave birth at Northwestern Memorial Hospital with a live baby at any gestational age and had new-onset hypertensive disorders during pregnancy, like pre-eclampsia or eclampsia. It's not specified who can't join the trial.

Inclusion Criteria

I am pregnant and have been diagnosed with a high blood pressure disorder.

Delivery at Northwestern Memorial Hospital (Prentice Women's Hospital)

Live birth at any gestational age

Exclusion Criteria

HELLP syndrome

I had chronic conditions like hypertension or diabetes before pregnancy.

Current Omron remote patient monitoring or Noom user

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants in the intervention arm use a mobile health application and remote patient monitoring system for one year

12 months

Remote monitoring throughout the year

Follow-up

Participants are monitored for cardiovascular health and subclinical cardiac dysfunction at 3 months and 12 months postpartum

12 months

2 visits (in-person) at 3 and 12 months postpartum

What Are the Treatments Tested in This Trial?

Interventions

• Mobile health application
• Remote patient monitoring (RPM) system

Trial Overview The study is testing digital health tools to prevent heart disease in those who've experienced high blood pressure disorders during pregnancy. Participants will use a remote patient monitoring system and a mobile health application.

How Is the Trial Designed?

Group I: Bundled digital health intervention Experimental Treatment 2 Interventions

Participant will be enrolled in a digital blood pressure monitoring program and receive a subscription to a mobile health lifestyle change application (Noom) alongside usual care.

Group II: Usual Care (Control) Active Control 1 Intervention

Participant will receive usual care.

Mobile health application is already approved in United States, European Union for the following indications:

Approved in United States as mHealth Apps for:

• Type II Diabetes Management
• Health Monitoring

Approved in European Union as mHealth Apps for:

• Type II Diabetes Management
• Health Monitoring
• Chronic Disease Management

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Friends of Prentice

Collaborator

Trials

6

Recruited

880+

Northwestern Senior Faculty Academy

Collaborator

Trials

1

Recruited

120+

Senior Faculty Academy

Collaborator

Trials

1

Recruited

120+

Published Research Related to This Trial

Remote patient monitoring (RPM) is a practical tool for tracking physical activity in outpatient care, providing more reliable data than self-reports, as demonstrated in four pilot studies across various medical specialties.

RPM can enhance the management of chronic diseases and rehabilitation by offering clinicians objective feedback on patient progress, although attention must be given to ensure all populations can access these digital health services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing Remote Patient Monitoring of Physical Activity in Clinical Practice. McCarthy, M., Jevotovsky, D., Mann, D., et al.[2023]

The implementation of a remote patient monitoring (RPM) program for diabetes and hypertension in partnership with community health centers has successfully enrolled over 1350 patients, primarily from underserved populations, leading to improved chronic disease management.

More than 30% of patients continued to regularly transmit glucose readings after one year, and over 90% of patients provided hemoglobin A1c data at 6 and 12 months, indicating the program's effectiveness in engaging patients and monitoring their health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dissemination of Remote Patient Monitoring: An Academic-Community Primary Care Partnership in South Carolina. Kirkland, EB., Dericke, D., Bays, CC., et al.[2023]

Remote patient monitoring (RPM) can effectively identify early signs of COVID-19 infection in patients with chronic respiratory diseases, as demonstrated in three case reports involving 9 patients out of 1000 enrolled in a monitoring program.

The RPM system, which includes wearable health monitors and a smartphone app, detected physiological changes in patients at different stages of infection, allowing for earlier diagnosis and intervention, highlighting its potential for improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Identification of COVID-19 Infection Using Remote Cardiorespiratory Monitoring: Three Case Reports. Polsky, M., Moraveji, N.[2021]

The ETAPES funding program in France, initiated in 2016 and operational since 2018, supports remote patient monitoring (RPM) specifically for patients with chronic heart failure (CHF) who are at medium or high risk of re-hospitalization, emphasizing the importance of patient education and training in this model of care.

The Satelia® RPM solution focuses on symptomatic monitoring, allowing patients to report their health status through simple questionnaires rather than relying on connected devices, which may enhance patient engagement and ease of use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote patient monitoring for chronic heart failure in France: When an innovative funding program (ETAPES) meets an innovative solution (Satelia® Cardio). Pages, N., Picard, F., Barritault, F., et al.[2022]

Patients with hypertension at high-remote patient monitoring (RPM) practices experienced a 3.3% increase in medication fills and a 1.3% increase in unique medications received, indicating improved management of their condition.

Despite better medication management and fewer acute care encounters, patients at high-RPM practices had a $274 increase in total hypertension-related spending, suggesting that while RPM improves care, it may also lead to higher overall costs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Remote Patient Monitoring Use on Care Outcomes Among Medicare Patients With Hypertension : An Observational Study. Tang, M., Nakamoto, CH., Stern, AD., et al.[2023]

Out of 45 chronic disease management apps evaluated in China, 73% had a privacy policy, but the overall compliance with the Personal Information Security Specification was low, averaging only 40.4 out of 100.

The weakest area of compliance was in information storage and protection, with an average score of just 29.4%, highlighting significant privacy risks for users' health data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Privacy Policy Compliance of Chronic Disease Management Apps in China: Scale Development and Content Evaluation. Ni, Z., Wang, Y., Qian, Y.[2021]

Many mobile health apps, including insulin dose calculators and asthma management tools, have significant methodological weaknesses, such as poor user input validation and inappropriate recommendations, which can compromise patient safety.

A review of health apps revealed serious privacy and security issues, with 28% lacking a privacy policy and some transmitting personal data, highlighting the need for better regulation and transparency in app development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'Trust but verify'--five approaches to ensure safe medical apps. Wicks, P., Chiauzzi, E.[2022]

Mobile health (mHealth) apps are categorized by their functions, such as behavior change and self-management, but there is limited clinical guidance on their effective use in patient care, highlighting a gap in evidence-based recommendations.

Data security and patient privacy are major concerns when using mHealth apps, and there is a need for better involvement of patients in the development of guidelines to ensure that these apps meet their needs and improve clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What is the clinical value of mHealth for patients? Rowland, SP., Fitzgerald, JE., Holme, T., et al.[2023]

Mobile health (mHealth) is significantly advancing cardiovascular care through innovative strategies like SMS for smoking cessation and apps for monitoring health, showing promise in prevention and rehabilitation.

Despite the potential of mHealth, many apps lack regulation and evidence-based support, highlighting the need for robust systems to ensure safety and effectiveness in delivering healthcare services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

mHealth in Cardiovascular Health Care. Chow, CK., Ariyarathna, N., Islam, SM., et al.[2022]

Out of 223 COVID-19-related mobile apps assessed, only 58 (26%) met the inclusion criteria, indicating a significant gap in suitable apps for education and self-monitoring, with most apps lacking comprehensive educational content.

iOS apps tended to focus on infographic mapping of COVID-19 cases, while Android apps were more oriented towards home monitoring features, highlighting the need for better educational resources in both app categories.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Health Apps on COVID-19 Launched in the Early Days of the Pandemic: Content Analysis and Review. Ming, LC., Untong, N., Aliudin, NA., et al.[2020]

The MyWellSpan mobile application was found to be a feasible method for postpartum women who experienced preeclampsia to self-monitor their blood pressure, with 69% of participants submitting at least one measurement.

Participants reported high satisfaction with the ease of use of the blood pressure cuff and the monitoring process, indicating that mobile health applications could effectively engage this population in their postpartum care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Using Blood Pressure Self-Monitoring and the Epic MyChart Blood Pressure Flowsheet to Monitor Blood Pressure After Preeclampsia. Burgess, A., Gartrell, K., Anderson, T.[2023]

A qualitative study involving 20 women with a history of hypertensive disorders of pregnancy (HDP) demonstrated that many were unaware of their increased future cardiovascular disease risks before participating in the Her-HEART program.

Participants found the virtual consultation and educational tool effective for counseling on long-term cardiovascular risks, emphasizing the need for coordinated care and mental health support in postpartum follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Perspectives on a Pilot Virtual Follow-up Program After Hypertensive Disorders of Pregnancy: A Qualitative Study. Dubrofsky, L., Gundy, S., Boesch, L., et al.[2023]

A study involving 52 questionnaires and 11 interviews with Dutch women at risk for hypertensive disorders of pregnancy found that a blended care approach using mobile health (mHealth) technology for self-monitoring blood pressure was well-received, with users reporting high satisfaction and usability of the digital platform.

Participants appreciated the increased autonomy and insight into their health, which allowed them to influence clinical decisions, while also recognizing the importance of healthcare professionals in interpreting the data for effective management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

User Experiences With and Recommendations for Mobile Health Technology for Hypertensive Disorders of Pregnancy: Mixed Methods Study. Jongsma, KR., van den Heuvel, JFM., Rake, J., et al.[2021]

Mobile applications have been developed to help community-based healthcare providers diagnose and manage pre-eclampsia in pregnant women by collecting clinical data and symptoms, which are then used to generate risk scores for adverse outcomes.

A key feature of these applications is the integration of a pulse oximeter that connects to smartphones, allowing for real-time monitoring of oxygen saturation, which enhances the management of pre-eclampsia during home visits and health facility consultations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of mHealth applications for pre-eclampsia triage. Dunsmuir, DT., Payne, BA., Cloete, G., et al.[2022]

The study involved 18 community midwives from rural and remote areas in Scotland, highlighting that geographic and digital isolation significantly challenges their ability to manage pre-eclampsia effectively.

Involving midwives in the design of mobile health (m-health) interventions is crucial for their acceptance and effectiveness, as these tools can enhance professional development and support care in areas with limited internet access, despite some resistance to new technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supporting rural midwifery practice using a mobile health (mHealth) intervention: a qualitative descriptive study. White, AH., Crowther, SA., Lee, SH.[2020]

Citations

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

Implementing Remote Patient Monitoring of Physical Activity in Clinical Practice. [2023]

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

Dissemination of Remote Patient Monitoring: An Academic-Community Primary Care Partnership in South Carolina. [2023]

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

Early Identification of COVID-19 Infection Using Remote Cardiorespiratory Monitoring: Three Case Reports. [2021]

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

Remote patient monitoring for chronic heart failure in France: When an innovative funding program (ETAPES) meets an innovative solution (Satelia® Cardio). [2022]

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

Effects of Remote Patient Monitoring Use on Care Outcomes Among Medicare Patients With Hypertension : An Observational Study. [2023]

6. Canada pubmed.ncbi.nlm.nih.gov

Privacy Policy Compliance of Chronic Disease Management Apps in China: Scale Development and Content Evaluation. [2021]

7. England pubmed.ncbi.nlm.nih.gov

'Trust but verify'--five approaches to ensure safe medical apps. [2022]

8. England pubmed.ncbi.nlm.nih.gov

What is the clinical value of mHealth for patients? [2023]

9. Australia pubmed.ncbi.nlm.nih.gov

mHealth in Cardiovascular Health Care. [2022]

10. Canada pubmed.ncbi.nlm.nih.gov

Mobile Health Apps on COVID-19 Launched in the Early Days of the Pandemic: Content Analysis and Review. [2020]

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

Feasibility of Using Blood Pressure Self-Monitoring and the Epic MyChart Blood Pressure Flowsheet to Monitor Blood Pressure After Preeclampsia. [2023]

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

Patient Perspectives on a Pilot Virtual Follow-up Program After Hypertensive Disorders of Pregnancy: A Qualitative Study. [2023]

13. Canada pubmed.ncbi.nlm.nih.gov

User Experiences With and Recommendations for Mobile Health Technology for Hypertensive Disorders of Pregnancy: Mixed Methods Study. [2021]

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

Development of mHealth applications for pre-eclampsia triage. [2022]

15. Australia pubmed.ncbi.nlm.nih.gov

Supporting rural midwifery practice using a mobile health (mHealth) intervention: a qualitative descriptive study. [2020]