Design and Preliminary Findings From a New Electronic Cohort Embedded in the Framingham Heart Study.
David D McManus, Ludovic Trinquart, Emelia J Benjamin...
https://pubmed.ncbi.nlm.nih.gov/30821691Actively Recruiting
Phase Not Applicable
Age: 18Years - 50Years
FEMALE
ID06835959
Development of a Mobile Health Intervention to Improve Blood Pressure Management in Pregnancy (Moms@Home)
Led by University of Massachusetts, Worcester · Updated on 2025-06-04
100
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
Sponsors
U
University of Massachusetts, Worcester
Lead Sponsor
N
National Heart, Lung, and Blood Institute (NHLBI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the effects of a digital health intervention called Moms@Home on home blood pressure monitoring in pregnant women with hypertension, including gestational and chronic hypertension. The study focuses on improving blood pressure management and pregnancy outcomes in a diverse group of women aged 18 to 50. It is a pilot randomized controlled trial enrolling 100 pregnant women, with half from racial or ethnic minority groups, to assess the intervention's impact compared to enhanced standard care. Participants are assigned to one of two groups: the Moms@Home group or the Enhanced Standard Care group. Those in the Moms@Home group will use a mobile app featuring storytelling videos and a patient dashboard to promote home blood pressure monitoring, along with a digital blood pressure monitor and a Fitbit activity tracker to report physical activity. Participants in the Enhanced Standard Care group will use a paper diary to log blood pressure readings from a digital monitor. The study lasts for 8 weeks, during which adherence to home blood pressure monitoring and other outcomes are tracked. Throughout the study, participants will self-report blood pressure readings, medication adherence, physical activity, and symptoms using their assigned tools. Researchers will assess home blood pressure monitoring adherence, feasibility, acceptability, and sustainability of the Moms@Home intervention. Additional measurements include blood pressure values, self-efficacy, medication titration, engagement with the app, and goal attainment at baseline, 4 weeks, and 8 weeks. The study also monitors participant safety and evaluates overall experience during the trial period.
CONDITIONS
Brief Title
Moms@Home: A Storytelling-based Mobile Health Intervention to Improve Blood Pressure Management in Pregnancy
Who Can Participate
Age: 18Years - 50Years
FEMALE
Eligibility Criteria
You may qualify if you...
- Age 18-50 years
- English or Spanish speaking
- Diagnosis of gestational hypertension (20-26 weeks gestational age) or chronic hypertension (8-26 weeks gestational age)
- Singleton or multiple pregnancy
- Patient of University of Massachusetts Memorial Health Obstetrics/Maternal and Fetal Medicine clinics
- Willing to share home blood pressure monitoring data
- Comfortable using smartphones and mobile apps
You will not qualify if you...
- Severe hypertension (Systolic 60 mmHg or Diastolic 100 mmHg)
- Current diagnosis of preeclampsia
- Active substance use
- Serious physical illness preventing interaction with smart devices
- Enrolled in another home blood pressure monitoring program
- Excluded by provider
- Unable to provide informed consent
- Prisoners or institutionalized individuals
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 8 weeks
Participants use either the Moms@Home mobile app or a paper diary to track home blood pressure values and related health data during pregnancy.
Weekly visits for up to 8 weeks
Trial Site Locations
Total: 1 location
1
UMass Memorial Medical Center - Memorial Campus
Worcester, Massachusetts, United States, 01655
Actively Recruiting
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Research Team
L
Lara Kovell, MD,MSc
A
Abigail Arthur, MBChB, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/29703800Barriers and facilitators to home blood pressure monitoring in women with pregnancies complicated by hypertensive disorders: a qualitative study.
Lara C Kovell, Mawulorm Denu, Ritika Revoori...
https://pubmed.ncbi.nlm.nih.gov/39248134