Moms@Home: A Storytelling-based Mobile Health Intervention to Improve Blood Pressure Management in Pregnancy
Purpose
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.
Conditions
- Hypertension in Pregnancy
- Chronic Hypertension
- Gestational Hypertension
Eligibility
- Eligible Ages
- Between 18 Years and 50 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Participants will be randomized to receive either the Moms@Home intervention or ESC through permuted blocked randomization, in blocks of multiples of 2 such that half of the participants will use Moms@Home and the other half ESC.
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
- Masking Description
- Outcome assessors will be blinded to the randomization assignments. Both investigators and participants will be aware of the randomization assignments to facilitate the implementation of the interventions.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 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. |
|
|
Active Comparator 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. |
|
Recruiting Locations
Worcester, Massachusetts 01655
Abigail Arthur, MBChB, MPH
More Details
- NCT ID
- NCT06835959
- Status
- Recruiting
- Sponsor
- University of Massachusetts, Worcester
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.