Recruiting

HBPM with Coaching

Sponsor:

University of Pittsburgh

Code:

NCT07599579

Conditions

Hypertension (HTN)

Preeclampsia

Hypertensive Disorders of Pregnancy (HDP)

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Coaching application

Home-based blood pressure monitoring

WebMD

Study Details

Brief summary:

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.

Conditions

Hypertension (HTN)

Preeclampsia

Hypertensive Disorders of Pregnancy (HDP)

Study ID

NCT07599579

Start date

Jul 22, 2026

Status verified date

Jul, 2026

Completion date

Oct, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Women who had a history of HDP (either gestational HTN or preeclampsia) diagnosed by ACOG guidelines at the time of delivery at Magee-Womens Hospital between 2008 and 2015, thus 10 to 20 years from their index pregnancy complicated by HDP.
  • Evidence of current stage 2 HTN (BP ≥ 140/90 mmHg with or without treatment with antihypertensive medication).

Exclusion Criteria:

  • Known clinical CVD (prior myocardial infarction, stroke, heart failure, or peripheral arterial disease).
  • Males will also be excluded from this study as it focuses on pregnancy related conditions.
  • Children will be excluded as the study is only recruiting people who are 10-20 years postpartum.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Coaching Application + HBPM

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.

active comparator: Enhanced usual care with WebMD

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.

Interventions

Coaching application

A digital application for providing education and support for home-based blood pressure monitoring.

Home-based blood pressure monitoring

Device for measuring blood pressure at home with blue tooth connectivity for automated collection.

WebMD

Smartphone-based application for health education and/or monitoring.

Primary outcome measure

  • Change in systolic blood pressure from baseline to 3 months [ Time Frame: Baseline, 3 Months ]

Central Contacts and Locations

Central contacts

Amy Travis

4126413295travisam@upmc.edu

Samantha Bryan

412-641-1363myslinskisg@mwri.magee.edu

Locations

UPMC Magee Womens Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Amy Travis

4126413295travisam@upmc.edu

Samantha Bryan

myslinskisg@mwri.magee.edu

Principal Investigator:

Malamo Countouris, MD, MS

More Information

Sponsor

University of Pittsburgh

Last update posted

Jul 29, 2026

Last verified

Jul, 2026

Keywords

  • hypertension
  • preeclampsia
  • coaching
  • home blood pressure monitoring

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-07-29.