Mobile Health Interventions for Heart Disease Prevention After High Blood Pressure in Pregnancy
(mHEART Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Northwestern University
Disqualifiers: HELLP syndrome, Hypertension, Diabetes, others
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
678910How 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.
1112131415Eligibility Criteria
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
+2 more
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Bundled digital health interventionExperimental Treatment2 Interventions
Participant will be enrolled in a remote patient monitoring program (Omron) and receive a subscription to a mobile health lifestyle change application (Noom) alongside usual care.
Group II: Usual Care (Control)Active Control1 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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Northwestern University, Dept. of CardiologyChicago, IL
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Who Is Running the Clinical Trial?
Northwestern UniversityLead Sponsor
Friends of PrenticeCollaborator
Northwestern Senior Faculty AcademyCollaborator
Senior Faculty AcademyCollaborator
References
Implementing Remote Patient Monitoring of Physical Activity in Clinical Practice. [2023]Remote patient monitoring (RPM) is a tool for patients to share data collected outside of office visits. RPM uses technology and the digital transmission of data to inform clinician decision-making in patient care. Using RPM to track routine physical activity is feasible to operationalize, given contemporary consumer-grade devices that can sync to the electronic health record. Objective monitoring through RPM can be more reliable than patient self-reporting for physical activity.
Dissemination of Remote Patient Monitoring: An Academic-Community Primary Care Partnership in South Carolina. [2023]Remote patient monitoring (RPM) for diabetes and hypertension may reduce barriers to patient care, leading to improved disease control and decreased morbidity and mortality.
Early Identification of COVID-19 Infection Using Remote Cardiorespiratory Monitoring: Three Case Reports. [2021]The adoption of remote patient monitoring (RPM) in routine medical care requires increased understanding of the physiologic changes accompanying disease development and the proactive interventions that will improve outcomes.
Remote patient monitoring for chronic heart failure in France: When an innovative funding program (ETAPES) meets an innovative solution (Satelia® Cardio). [2022]Remote patient monitoring (RPM) is a telehealth activity to collect and analyze patient health or medical data. Its use has expanded in the past decade and has improved medical outcomes and care management of non-communicable chronic diseases. However, implementation of RPM into routine clinical activities has been limited. The objective of this study was to describe the French funding program for RPM (known as ETAPES) and one of the RPM solution providers (Satelia®) dedicated to chronic heart failure (CHF).
Effects of Remote Patient Monitoring Use on Care Outcomes Among Medicare Patients With Hypertension : An Observational Study. [2023]Remote patient monitoring (RPM) is a promising tool for improving chronic disease management. Use of RPM for hypertension monitoring is growing rapidly, raising concerns about increased spending. However, the effects of RPM are still unclear.
Privacy Policy Compliance of Chronic Disease Management Apps in China: Scale Development and Content Evaluation. [2021]With the development of mobile health (mHealth), chronic disease management apps have brought not only the possibility of reducing the burden of chronic diseases but also huge privacy risks to patients' health data.
'Trust but verify'--five approaches to ensure safe medical apps. [2022]Mobile health apps are health and wellness programs available on mobile devices such as smartphones or tablets. In three systematic assessments published in BMC Medicine, Huckvale and colleagues demonstrate that widely available health apps meant to help patients calculate their appropriate insulin dosage, educate themselves about asthma, or perform other important functions are methodologically weak. Insulin dose calculators lacked user input validation and made inappropriate dose recommendations, with a lack of documentation throughout. Since 2011, asthma apps have become more interactive, but have not improved in quality; peak flow calculators have the same issues as the insulin calculators. A review of the accredited National Health Service Health Apps Library found poor and inconsistent implementation of privacy and security, with 28% of apps lacking a privacy policy and one even transmitting personally identifying data the policy claimed would be anonymous. Ensuring patient safety might require a new approach, whether that be a consumer education program at one extreme or government regulation at the other. App store owners could ensure transparency of algorithms (whiteboxing), data sharing, and data quality. While a proper balance must be struck between innovation and caution, patient safety must be paramount.Please see related articles: http://dx.doi.org/10.1186/s12916-015-0444-y , http://www.biomedcentral.com/1741-7015/13/106 and http://www.biomedcentral.com/1741-7015/13/58.
What is the clinical value of mHealth for patients? [2023]Despite growing interest from both patients and healthcare providers, there is little clinical guidance on how mobile apps should be utilized to add value to patient care. We categorize apps according to their functionality (e.g. preventative behavior change, digital self-management of a specific condition, diagnostic) and discuss evidence for effectiveness from published systematic reviews and meta-analyses and the relevance to patient care. We discuss the limitations of the current literature describing clinical outcomes from mHealth apps, what FDA clearance means now (510(k)/de novo FDA clearance) and in the future. We discuss data security and privacy as a major concern for patients when using mHealth apps. Patients are often not involved in the development of mobile health guidelines, and professionals' views regarding high-quality health apps may not reflect patients' views. We discuss efforts to develop guidelines for the development of safe and effective mHealth apps in the US and elsewhere and the role of independent app reviews sites in identifying mHealth apps for patient care. There are only a small number of clinical scenarios where published evidence suggests that mHealth apps may improve patient outcomes.
mHealth in Cardiovascular Health Care. [2022]Mobile health (mHealth) has been defined as medical and public health practice supported by mobile devices, such as mobile phones, patient monitoring devices and personal digital assistants. Cardiovascular mHealth is, arguably, leading the mHealth space, through innovation, research and implementation, and especially in the areas of prevention, cardiac rehabilitation and education. mHealth includes simple strategies, such as the use of short message service (SMS) or text messages in successful short-term smoking-cessation, weight loss and diabetes management programs. The recent Australian Tobacco, Exercise and Diet Messages (TEXT ME) randomised clinical trial addressed multiple cardiovascular risk factors. mHealth can also involve more complex strategies, such as smart phone applications (apps), global positioning systems (GPS) and Bluetooth technologies. Although many apps could be considered suitable for primary prevention, they are largely unregulated and most are not evidence-based. Some have been well-developed, such as the Food Switch app and an iPhone electrocardiogram (ECG) system. The "explosion" of apps has driven initiatives such as the Mobile Applications Rating Scale (MARS). More recently, the use of sensors to monitor and provide feedback to patients and healthcare providers is being explored. With almost two billion people currently owning a Smartphone, and 50% of adults (globally) predicted to own one by 2018, mHealth provides the prospect of delivering efficient, affordable healthcare services to widespread populations both locally and globally. In particular, it has the potential to reduce socioeconomic disparity and alleviate the burden of cardiovascular disease. There is now a need to rethink traditional health service structures and bioengineering capacity, to ensure mHealth systems are also safe, secure and robust.
Mobile Health Apps on COVID-19 Launched in the Early Days of the Pandemic: Content Analysis and Review. [2020]Mobile health (mHealth) app use is a major concern because of the possible dissemination of misinformation that could harm the users. Particularly, it can be difficult for health care professionals to recommend a suitable app for coronavirus disease (COVID-19) education and self-monitoring purposes.
Feasibility of Using Blood Pressure Self-Monitoring and the Epic MyChart Blood Pressure Flowsheet to Monitor Blood Pressure After Preeclampsia. [2023]Preeclampsia is associated with significant morbidity and mortality. Women who experienced preeclampsia require close blood pressure surveillance postpartum. Remote monitoring of blood pressure using a mobile health application may be a viable method of surveillance in this population. The purpose of this project was to assess the feasibility of using the MyWellSpan mobile application to engage postpartum women who experienced preeclampsia in blood pressure self-monitoring. Women who chose to participate were provided an automatic blood pressure cuff and educational materials and were enrolled in MyWellSpan. A survey created by the authors asked participants to rate by Likert scale their satisfaction with the program and ease of use of the blood pressure cuff and self-monitoring. The electronic health record was reviewed retrospectively to assess utilization of the MyWellSpan mobile application to document blood pressure. The majority of women who participated reported that operating the blood pressure cuff was very easy and felt that it would be very easy to monitor their blood pressure twice daily. Sixty-nine percent of those women in the program electronically submitted at least 1 blood pressure measurement, thus confirming the feasibility of self-monitoring and reporting using a mobile application.
Patient Perspectives on a Pilot Virtual Follow-up Program After Hypertensive Disorders of Pregnancy: A Qualitative Study. [2023]Hypertensive disorders of pregnancy (HDPs) are a risk factor for future cardiovascular disease; therefore, follow-up and implementation of early interventions is recommended. We performed a qualitative study to assess the feasibility and user response to a mobile-health tool and virtual consultation aimed at educating people with an HDP on future cardiovascular risk, and at better understanding patients' priorities for postpartum care.
User Experiences With and Recommendations for Mobile Health Technology for Hypertensive Disorders of Pregnancy: Mixed Methods Study. [2021]Hypertensive disorders of pregnancy (HDP) are a primary cause of adverse maternal and neonatal outcomes worldwide. For women at risk of hypertensive complications, guidelines recommend frequent surveillance of blood pressure and signs of preeclampsia. Clinic visits range from every 2 weeks to several times a week. Given the wide ubiquity of smartphones and computers in most countries and a growing attention for self-management, digital technologies, including mobile health (mHealth), constitute a promising component of monitoring (self-measured) blood pressure during pregnancy. Currently, little is known about the experiences of women using such platforms and how mHealth can be aligned with their needs and preferences.
Development of mHealth applications for pre-eclampsia triage. [2022]The development of mobile applications for the diagnosis and management of pregnant women with pre-eclampsia is described. These applications are designed for use by community-based health care providers (c-HCPs) in health facilities and during home visits to collect symptoms and perform clinical measurements (including pulse oximeter readings). The clinical data collected in women with pre-eclampsia are used as the inputs to a predictive model providing a risk score for the development of adverse outcomes. Based on this risk, the applications provide recommendations on treatment, referral, and reassessment. c-HCPs can access patient records across multiple visits, using multiple devices that are synchronized using a secure Research Electronic Data Capture server. A unique feature of these applications is the ability to measure oxygen saturation with a pulse oximeter connected to a smartphone (Phone Oximeter). The mobile health application development process, including challenges encountered and solutions are described.
Supporting rural midwifery practice using a mobile health (mHealth) intervention: a qualitative descriptive study. [2020]Hypertensive disorders in pregnancy account for 12% of all maternal deaths globally. The risks of suboptimal outcomes from these disorders might be greater in rural and remote locations. These potential risks might be related to poor intra- and interprofessional communications due to geographic and digital isolation. Studies in low- and middle-income countries suggest that improving communications is essential and that mobile health (m-health) interventions can improve outcomes. However, for such interventions to be successful they must involve midwives in any design and software development. This study explored how an m-health intervention might support midwives in the management of women with pre-eclampsia in Scottish rural and remote locations.