Mobile Health Program for High Blood Pressure After Preeclampsia
What You Need to Know Before You Apply
What is the purpose of this trial?
Strategies targeted to optimize hypertension (HTN) control for midlife women after hypertensive disorders of pregnancy (HDP) have not been studied, despite evidence of a critical need. This proposal targets the 10-20 years postpartum as a key time when women have subclinical cardiovascular (CV) sequelae of uncontrolled HTN and are primed for CV prevention interventions. Before proceeding with large-scale intervention trials of a home blood pressure monitoring (HBPM) and coaching intervention following HDP, further pilot testing is necessary. The overarching hypothesis of this proposal is that a new monitoring and treatment paradigm utilizing HBPM combined with a virtual coaching intervention would be better than standard of care for mid-life women with prior HDP who develop HTN. Women will be assigned in an unblinded manner to the intervention or standard of care control group.
Who Is on the Research Team?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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
Follow-up
Participants are monitored for changes in blood pressure and adherence to antihypertensive medications
Extended Follow-up
Participants continue to be monitored for blood pressure changes and medication adherence up to 6 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
A smartphone-based, interactive coaching application designed to enhance adherence to home-based blood pressure monitoring and provide guidance on blood pressure management, patient-facing education, and assistance with modifying behaviors associated with poor blood pressure control. The application is connected to a wireless blood pressure cuff for accurate blood pressure measurement and automated storage on a digital platform. All participants in the experimental arm receive a smartphone for the 3-month intervention duration and a Bluetooth blood pressure cuff.
Enhanced usual care participants will receive a smartphone for the 3-month intervention duration and the wireless Bluetooth blood pressure cuff. Through this, enhanced usual care participants will have access to WebMD, a smartphone-based tool for learning about blood pressure and other health conditions. Enhanced usual care participants will also receive a wireless blood pressure cuff for accurate blood pressure measurement and automated storage on a digital platform.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pittsburgh
Lead Sponsor
McKamish Family Foundation
Collaborator
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