50 Participants NeededMy employer runs this trial

Mobile Health Program for High Blood Pressure After Preeclampsia

SB
AT
Overseen ByAmy Travis
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: University of Pittsburgh
Must be taking: Antihypertensives
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new approach to managing high blood pressure in women who experienced gestational hypertension or preeclampsia during pregnancy. It will compare two groups: one using a smartphone app for coaching and home blood pressure monitoring, and another receiving enhanced usual care, including access to health information via WebMD. Women who had pregnancy-related high blood pressure 10-20 years ago and now have high blood pressure (140/90 mmHg or higher) can consider joining. The goal is to determine if the app and home monitoring can better control blood pressure than standard care. As an unphased trial, this study provides a unique opportunity to explore innovative solutions for managing high blood pressure.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It seems likely that you can continue your current treatment, as the study includes women with high blood pressure whether or not they are on medication.

What prior data suggests that this mobile health program is safe for managing high blood pressure after preeclampsia?

Research has shown that mobile health apps, such as the coaching app in this trial, are generally safe and easy to use. These apps assist users in tracking their blood pressure and offer helpful health tips. Studies have found that they can enhance communication with doctors and effectively manage blood pressure.

Home blood pressure monitoring has also been well-researched. It is considered safe and aids in controlling blood pressure effectively. Many people find it convenient, often resulting in fewer doctor visits. Overall, both the coaching app and home blood pressure monitoring are well-accepted and pose little risk to participants.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it leverages technology to enhance blood pressure management for women who experienced preeclampsia. Unlike traditional methods that rely heavily on in-person visits and medication, this trial uses a smartphone-based coaching application that interacts with a Bluetooth blood pressure cuff. This setup not only helps with accurate blood pressure monitoring at home but also provides real-time guidance and education on managing blood pressure effectively. This approach aims to improve adherence to monitoring and empower patients with personalized behavior modification strategies, potentially leading to better long-term health outcomes.

What evidence suggests that this trial's treatments could be effective for high blood pressure after preeclampsia?

This trial will compare two approaches to managing high blood pressure after preeclampsia. One group will use a smartphone-based, interactive coaching application combined with home-based blood pressure monitoring. Research has shown that mobile health (mHealth) apps can help people lower their blood pressure and adhere to medication plans, with studies finding a drop of 5–10 mmHg in systolic blood pressure. Home blood pressure monitoring has also shown promise for better control, as individuals using home monitors often visit the doctor less and manage their condition more effectively. The other group will receive enhanced usual care with access to WebMD and home-based blood pressure monitoring. Together, these tools could improve the management of high blood pressure after preeclampsia.12467

Who Is on the Research Team?

MC

Malamo Countouris, MD, MS

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for women in midlife who had high blood pressure during pregnancy (like preeclampsia) and now have high blood pressure again, 10-20 years after giving birth. Participants should not have other major health issues that would prevent them from joining.

Inclusion Criteria

Women with a history of HDP (gestational HTN or preeclampsia) diagnosed by ACOG guidelines at delivery at Magee-Womens Hospital between 2008 and 2015, 10 to 20 years from their index pregnancy complicated by HDP
I currently have high blood pressure at or above 140/90 mmHg.

Exclusion Criteria

I gave birth 10 to 20 years ago and am not a child.
I have a history of heart or blood vessel disease.
I am not male.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a smartphone-based, interactive coaching application and a Bluetooth blood pressure cuff for home-based blood pressure monitoring over a 3-month period

3 months
Virtual coaching sessions

Follow-up

Participants are monitored for changes in blood pressure and adherence to antihypertensive medications

3 months

Extended Follow-up

Participants continue to be monitored for blood pressure changes and medication adherence up to 6 months

3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Coaching application
  • Home-based blood pressure monitoring

Trial Overview

The study compares a new program using home blood pressure monitoring with a coaching app (including WebMD resources) to usual care. Women are randomly assigned to either the new program or standard care to see which helps control blood pressure better.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Coaching Application + HBPMExperimental Treatment2 Interventions
Group II: Enhanced usual care with WebMDActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials
1,820
Recruited
16,360,000+

McKamish Family Foundation

Collaborator

Citations

Effectiveness and equity of mHealth apps for preeclampsia ...

A study has found that an mHealth app improved patient provider communication, aiding in identifying pre-eclampsia risk and promoting a low dose ...

Home blood pressure monitoring and mobile health ...

mHealth applications provide a platform for pregnant persons to collect and trend blood pressure values, learn more about blood pressure, and share these values ...

Mobile Health Coaching for High Blood Pressure

The primary outcome of the study is to evaluate changes in systolic blood pressure after six months, with additional outcomes focusing on medication adherence ...

mHealth Apps for Hypertension to

mHealth apps are especially useful for tracking blood pressure readings, medication adherence, diet and exercise, and related data that provides insights about ...

HOME BLOOD PRESSURE MONITORING AND MOBILE ...

mHealth applications provide a platform for pregnant persons to collect and trend blood pressure values, learn more about blood pressure, and ...

study protocol for a randomized controlled trial

... safety. Our study investigates whether blood pressure monitoring through a mobile health (mHealth) application can aid in addressing the challenges of blood ...

(PDF) Usability and acceptability of a mobile application ...

What is your experience and perspective about using mobile applications to support your patients with high blood pressure during pregnancy?