Mobile Health Program for Post-Preeclampsia Hypertension

Multilevel Mobile Health Program to Improve Hypertension Among Midlife Women After Hypertensive Disorder of Pregnancy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Preeclampsia; Hypertension (HTN); Hypertensive Disorders of Pregnancy (HDP)
• Intervention / Treatment: Behavioral: Coaching application; Behavioral: Home-based blood pressure monitoring; Other: WebMD

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amy Travis; Phone Number: 4126413295; Email: travisam@upmc.edu
• Study Contact Backup: Name: Samantha Bryan; Phone Number: 412-641-1363; Email: myslinskisg@mwri.magee.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC Magee Womens Hospital
      • Contact: Amy Travis; Phone Number: 4126413295; Email: travisam@upmc.edu
      • Contact: Samantha Bryan; Email: myslinskisg@mwri.magee.edu
      • Principal Investigator: Malamo Countouris, MD, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: Coaching application; A digital application for providing education and support for home-based blood pressure monitoring.; Behavioral: Home-based blood pressure monitoring; Device for measuring blood pressure at home with blue tooth connectivity for automated collection.
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.	Behavioral: Home-based blood pressure monitoring; Device for measuring blood pressure at home with blue tooth connectivity for automated collection.; Other: WebMD; Smartphone-based application for health education and/or monitoring.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in diastolic BP and mean arterial pressure from baseline to 3 months	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	Adherence to antihypertensive medication from baseline to 6 months between the intervention and usual care arms using Proportion of Days Covered, ranging from 0 to 100%, where higher values indicate superior medication adherence.	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	Quantification of home blood pressure monitoring during the 3-month intervention phase, ranging from 0 to 100%, where higher values indicate superior adherence.	Baseline, 3 months
Feasibility of study measured using enrollment, survey completion, and retention of participants	Proportions of participants who complete all study visits and surveys out of all participants enrolled in the study	Baseline, 3 Month, 6 Month
Durable change in systolic blood pressure measures at 6 months	Durable change in SBP measures at 6 months between intervention and usual care arms	Baseline, 6 months
Durable change in diastolic BP measures at 6 months	Durable change in DBP measures at 6 months between intervention and usual care arms	Baseline, 6 months
Blood pressure at 3 months	Systolic, diastolic, and mean arterial blood pressure at 3 months	Baseline, 3 months
Blood pressure at 6 months	Systolic, diastolic, and mean arterial blood pressure at 6 months	Baseline, 6 months

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: McKamish Family Foundation
• Investigators: Principal Investigator: Malamo Countouris, MD, MS, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Estimated): May 14, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: May 14, 2026
• First Submitted That Met QC Criteria: May 14, 2026
• First Posted (Actual): May 20, 2026

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 14, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: hypertension; preeclampsia; home blood pressure monitoring; coaching
• Additional Relevant MeSH Terms: Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Hypertension, Pregnancy-Induced; Pre-Eclampsia; Hypertension
• Other Study ID Numbers: STUDY25070197

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study team will share all of the individual participant data collected during the trial, after deidentification.
• IPD Sharing Time Frame: The data will be available 12 months following publication of the primary results of this trial.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No