Clinical trial NCT06835959: Moms@Home: A Storytelling-based Mobile Health Intervention to Improve Blood Pressure Management in Pregnancy
Official title: Development of a Mobile Health Intervention to Improve Blood Pressure Management in Pregnancy (Moms@Home)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension in Pregnancy
Chronic Hypertension
Gestational Hypertension
Keywords: Hypertension in pregnancy
Moms@Home
Mobile health intervention
Blood pressure
Blood pressure management
Hypertension
Gestational hypertension
Storytelling
Home blood pressure monitoring
Storytelling mobile intervention
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2025-02-19
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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.

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

Primary outcomes:
measure: Home Blood Pressure Monitoring Adherence
timeFrame: 8 weeks
measure: Feasibility of the Moms@Home intervention
timeFrame: 8 weeks
measure: Acceptability
timeFrame: 8 weeks
Secondary outcomes:
measure: Self-Efficacy
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Sustainability
timeFrame: 8 weeks
measure: Blood Pressure (BP) measures
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Engagement with Moms@Home
timeFrame: 4 weeks, 8 weeks
measure: Medication Adherence
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Medication titration
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Goal attainment
timeFrame: Baseline, 8 weeks
measure: Physical Activity
timeFrame: Baseline, 4 weeks, 8 weeks
Other outcomes:
measure: Focus group interviews
timeFrame: At least 3 months after randomization
Locations:
city: Worcester
country: United States
facility: UMass Memorial Medical Center - Memorial Campus
state: Massachusetts
Study officials:
affiliation: University of Massachusetts Medical School, Worcester
name: Lara Kovell, MD,MSc
role: PRINCIPAL_INVESTIGATOR
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