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NCT06835959NARecruiting

Moms@Home: A Storytelling-based Mobile Health Intervention to Improve Blood Pressure Management in Pregnancy

University of Massachusetts, Worcester

Start Date

5/16/2025

Completion Date

11/16/2027

Summary

This pilot study will examine the effects of a digital health approach, Moms@Home, on home blood pressure monitoring in a diverse population of pregnant women with hypertension.

Detailed Description

The study aims to standardize and test a storytelling approach to promote HBPM and improve BP management and pregnancy-specific outcomes in pregnant women with Hypertension (HTN). The study will integrate three components to improve BP care and outcomes: 1) the Moms@Home mobile app to promote HBPM through storytelling videos and a patient dashboard of BP data, 2) a digital BP monitor for HBPM, and 3) an HBPM report that curates and shares key health data with the right provider at the right time. Designed by and for pregnant women with HTN across racial/ethnic groups, the Moms@Home intervention is novel because it leverages digital health, behavior change techniques, and culturally relevant storytelling to improve HTN self-care while facilitating patient/caregiver communication through an HBPM report. Investigators are conducting a pilot randomized controlled trial (RCT) of Moms@Home vs. enhanced standard care, with plans to enroll 100 pregnant women (50% from racial/ethnic minority groups) with gestational or chronic HTN to determine whether Moms@Home vs. enhanced standard care (BP monitor, diary) improves HBPM adherence (primary outcome) and to evaluate the feasibility, acceptability, and sustainability of the intervention.

Eligibility Criteria

Age Range: 18 years to 50 years

Inclusion Criteria: * Age 18-50 * English or Spanish speaking * A diagnosis of gestational (20-26 weeks gestational age) or chronic hypertension (8-26 weeks gestational age) * Singleton or multiple gestation pregnancy, * A patient of the University of Massachusetts Memorial Health Obstetrics/Maternal and Fetal Medicine clinics in Worcester, Massachusetts * Willing to share home blood pressure monitoring data * Comfortable with the use of smartphones and mobile apps Exclusion Criteria: * Severe hypertension (Systolic blood pressure ≥160 mmHg or Diastolic blood pressure ≥100 mmHg) * Current diagnosis of preeclampsia * Active substance use * Serious physical illness (e.g., unable to interact with a smart device) * Enrolled in another home blood pressure monitoring program * Excluded from study participation by their provider * Inability to provide informed consent * Prisoners/institutionalized individuals

Interventions

BEHAVIORAL

Moms@Home

BEHAVIORAL

Enhanced Standard of Care

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Conditions

Hypertension in PregnancyChronic HypertensionGestational Hypertension

Locations

UMass Memorial Medical Center - Memorial Campus

Worcester, Massachusetts 01655

United States