Recruiting

Moms@Home

Sponsor:

University of Massachusetts, Worcester

Code:

NCT06835959

Conditions

Hypertension in Pregnancy

Chronic Hypertension

Gestational Hypertension

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

Interventions

Moms@Home

Enhanced Standard of Care

Study Details

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.

Conditions

Hypertension in Pregnancy

Chronic Hypertension

Gestational Hypertension

Study ID

NCT06835959

Start date

May 16, 2025

Status verified date

Jun, 2026

Completion date

Nov 16, 2027

Anticipated

Primary completion date

Jul 16, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 50

Healthy Volunteers: Not accepted

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

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

Interventions

Moms@Home

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

Enhanced Standard of Care

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

Primary outcome measure

  • Home Blood Pressure Monitoring Adherence [ Time Frame: 8 weeks ]
  • Feasibility of the Moms@Home intervention [ Time Frame: 8 weeks ]
  • Acceptability [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Lara Kovell, MD,MSc

(508) 856-2772lara.kovell2@umassmed.edu

Abigail Arthur, MBChB, MPH

(508) 856-4394abigail.arthur@umassmed.edu

Locations

UMass Memorial Medical Center - Memorial Campus

Recruiting

Worcester, Massachusetts, United States, 01655

More Information

Sponsor

University of Massachusetts, Worcester

Last update posted

Jun 16, 2026

Last verified

Jun, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Massachusetts, Worcester on 2026-06-16.