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

NCT ID: NCT06835959

Last Updated: 2025-06-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-16
• Study Completion Date: 2027-11-16

Brief 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.

Conditions

Hypertension in Pregnancy; Chronic Hypertension; Gestational Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Moms@Home arm

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.

Group Type: EXPERIMENTAL

Moms@Home

Intervention Type: BEHAVIORAL

Participants will use a storytelling mobile health app for daily home-based blood pressure monitoring and symptom/medication adherence tracking.

Enhanced Standard Care arm

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

Group Type: ACTIVE_COMPARATOR

Enhanced Standard of Care

Intervention Type: BEHAVIORAL

Participants will use a paper journal daily to track home-based blood pressure values

Interventions

Moms@Home

Participants will use a storytelling mobile health app for daily home-based blood pressure monitoring and symptom/medication adherence tracking.

Intervention Type: BEHAVIORAL

Enhanced Standard of Care

Participants will use a paper journal daily to track home-based blood pressure values

Intervention Type: BEHAVIORAL

Other Intervention Names

Peer Support Intervention; Self-tracking Journal

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Massachusetts, Worcester

OTHER

Sponsor Role: lead

Responsible Party

Lara Kovell

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lara Kovell, MD,MSc

Role: PRINCIPAL_INVESTIGATOR

University of Massachusetts Medical School, Worcester

Locations

UMass Memorial Medical Center - Memorial Campus

Worcester, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lara Kovell, MD,MSc

Role: CONTACT

lara.kovell2@umassmed.edu

(508) 856-2772

Abigail Arthur, MBChB, MPH

Role: CONTACT

abigail.arthur@umassmed.edu

(508) 856-4394

Facility Contacts

Abigail Arthur, MBChB, MPH

Role: primary

References

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Reference Type: BACKGROUND

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Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

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Study Documents

Document Type: Informed Consent Form

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Other Identifiers

K23HL163450

Identifier Type: NIH

Identifier Source: secondary_id

View Link

00001895

Identifier Type: -

Identifier Source: org_study_id