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

University of Massachusetts, Worcester

Status: Enrolling

Conditions: Gestational Hypertension; Chronic Hypertension; Hypertension in Pregnancy

Treatments: Behavioral: Enhanced Standard of Care; Behavioral: Moms@Home

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06835959

K23HL163450 (U.S. NIH Grant/Contract)

00001895

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Moms@Home arm

Experimental group

Description:

Participants randomized to Moms@Home will receive the Moms@Home app (± Samsung smartphone) to self-report data including home blood pressure monitoring values from a digital blood pressure monitor and physical activity data from a FitBit activity tracker.

Treatment:

Behavioral: Moms@Home

Enhanced Standard Care arm

Active Comparator group

Description:

Participants randomized to Enhanced Standard Care (ESC) will receive a paper diary to self-report data including measurements from a digital blood pressure monitor.

Treatment:

Behavioral: Enhanced Standard of Care