Mobile Health Program for Post-Preeclampsia Hypertension
Part of paid clinical trials in Pittsburgh, Pennsylvania.
- Sponsor
- University of Pittsburgh
- Study ID
- NCT07599579
- Status
- Not Yet Recruiting
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Conditions
- Hypertension (HTN)
- Hypertensive Disorders of Pregnancy (HDP)
- Preeclampsia
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Coaching application — BEHAVIORALA digital application for providing education and support for home-based blood pressure monitoring.
- Home-based blood pressure monitoring — BEHAVIORALDevice for measuring blood pressure at home with blue tooth connectivity for automated collection.
- WebMD — OTHERSmartphone-based application for health education and/or monitoring.
Study Details
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.
Key Dates
- Start date
- Jun 30, 2026
- Status verified
- Jun 2026
- Primary completion
- Jul 31, 2027
- Completion
- Oct 31, 2027
Study Design
- Enrollment
- 50 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Coaching Application + HBPMA 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.
- Active Comparator: Enhanced usual care with WebMDEnhanced 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.
Primary Outcome Measure
Change in systolic blood pressure from baseline to 3 months [ Time Frame: Baseline, 3 Months ]
Central Contacts
- Amy Travis4126413295
- Samantha Bryan412-641-1363
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UPMC Magee Womens Hospital | Pittsburgh | Pennsylvania | 15213 | Samantha Bryan Malamo Countouris, MD, MS (PRINCIPAL_INVESTIGATOR) |
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