NCT07599579

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
17mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
May 2026Oct 2027

First Submitted

Initial submission to the registry

May 14, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

May 14, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 20, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

May 20, 2026

Status Verified

May 1, 2026

Enrollment Period

1.1 years

First QC Date

May 14, 2026

Last Update Submit

May 14, 2026

Conditions

Hypertension (HTN)PreeclampsiaHypertensive Disorders of Pregnancy (HDP)

Keywords

hypertensionpreeclampsiacoachinghome blood pressure monitoring

Outcome Measures

Primary Outcomes (1)

  • Change in systolic blood pressure from baseline to 3 months

    Change in home-based systolic blood pressure from baseline to 3 months between the intervention and usual care arms.

    Baseline, 3 Months

Secondary Outcomes (9)

  • Change in diastolic BP and mean arterial pressure from baseline to 3 months

    Baseline, 3 months

  • Adherence to antihypertensive medications at 3 months and 6 months

    Baseline, 6 months

  • Proportion with BP controlled <130/80 mmHg at 3 months and 6 months

    Baseline, 3 months, 6 months

  • Adherence to home blood pressure monitoring

    Baseline, 3 months

  • Feasibility of study measured using enrollment, survey completion, and retention of participants

    Baseline, 3 Month, 6 Month

  • +4 more secondary outcomes

Study Arms (2)

Coaching Application + HBPM

EXPERIMENTAL

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.

Behavioral: Coaching applicationBehavioral: Home-based blood pressure monitoring

Enhanced usual care with WebMD

ACTIVE COMPARATOR

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.

Behavioral: Home-based blood pressure monitoringOther: WebMD

Interventions

Coaching applicationBEHAVIORAL

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

Coaching Application + HBPM
Home-based blood pressure monitoringBEHAVIORAL

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

Coaching Application + HBPMEnhanced usual care with WebMD
WebMDOTHER

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

Enhanced usual care with WebMD

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UPMC Magee Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

HypertensionPre-Eclampsia

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHypertension, Pregnancy-InducedPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Malamo Countouris, MD, MS

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy Travis

CONTACT

4126413295travisam@upmc.edu

Samantha Bryan

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be assigned to the intervention or usual care by the study team, and they will be informed at the time of consent what group they will participate in
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 14, 2026

First Posted

May 20, 2026

Study Start

May 14, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

May 20, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

The study team will share all of the individual participant data collected during the trial, after deidentification.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
The data will be available 12 months following publication of the primary results of this trial.
Access Criteria
Researchers who provide a methodologically sound proposal. Proposals should be directed to the Principal Investigator at countourisme@upmc.edu. To gain access, data requestors will need to sign a data access agreement. Data will be provided directly by the study investigators. Costs associated with producing datasets and analysis will be the responsibility of investigators seeking the data.

Locations

US(1)