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

June 3, 2025 updated by: Lara Kovell, University of Massachusetts, Worcester

Development of a Mobile Health Intervention to Improve Blood Pressure Management in Pregnancy (Moms@Home)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • Recruiting
        • UMass Memorial Medical Center - Memorial Campus
        • Contact:
          • Abigail Arthur, MBChB, MPH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: Moms@Home
Participants will use a storytelling mobile health app for daily home-based blood pressure monitoring and symptom/medication adherence tracking.
Other Names:
  • Peer Support Intervention
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.
Behavioral: Enhanced Standard of Care
Participants will use a paper journal daily to track home-based blood pressure values
Other Names:
  • Self-tracking Journal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Home Blood Pressure Monitoring Adherence
Time Frame: 8 weeks
Home blood pressure monitoring (HBPM) adherence is defined as performing HBPM measures ≥3 out of 7 days/week
8 weeks
Feasibility of the Moms@Home intervention
Time Frame: 8 weeks
Among the participants in the intervention group, the feasibility of the Moms@Home intervention will be assessed through a post-intervention survey using a 5-point Likert scale, with questions on the value and overall satisfaction with the mobile intervention app. On a numeric scale, number of screened and eligible participants and the number/reason(s) for declining participation or withdrawal will be tracked.
8 weeks
Acceptability
Time Frame: 8 weeks
Acceptability will be assessed using the System Usability Scale (SUS) and the perceived impact section of the End-user Mobile Application Rating Scale (uMARS). These are both validated measures of the usability/quality of mobile health apps. SUS is scored on a 0-100 scale, a higher score meaning better usability. The uMARS is scored on a 5-point Likert scale, with the total score calculated by averaging the scores across the items within the perceived impact subscale.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Self-Efficacy
Time Frame: Baseline, 4 weeks, 8 weeks
Change in self-efficacy will be determined through the Self-Efficacy to Manage Hypertension scale (Warren-Findlow, 2012). Each item of this scale is scored on a 1 to 10 scale, with the total score calculated by averaging the scores across the items. Higher mean scores indicate higher self-efficacy.
Baseline, 4 weeks, 8 weeks
Sustainability
Time Frame: 8 weeks
The sustainability of the Moms@Home intervention will be assessed through a post-intervention survey using a 5-point Likert scale, evaluating participants' perceptions of whether the Moms@Home storytelling mobile app could be continued beyond the study period.
8 weeks
Blood Pressure (BP) measures
Time Frame: Baseline, 4 weeks, 8 weeks
Home Blood Pressure Monitoring (HBPM) values will be assessed using blood pressure data collected from the Moms@Home app and paper BP diaries. Clinic blood pressure values will be obtained through a review of electronic health records.
Baseline, 4 weeks, 8 weeks
Engagement with Moms@Home
Time Frame: 4 weeks, 8 weeks
Among the participants in the intervention group, engagement with the Moms@Home intervention will be measured on a numeric scale by number of logins, time spent in the app, surveys completed, and storytelling videos watched.
4 weeks, 8 weeks
Medication Adherence
Time Frame: Baseline, 4 weeks, 8 weeks
On a numeric scale, baseline and change in medication adherence will be assessed through a baseline, midpoint and post-intervention survey.
Baseline, 4 weeks, 8 weeks
Medication titration
Time Frame: Baseline, 4 weeks, 8 weeks
Medication titration will be assessed based on any changes in the blood pressure medications participants are taking. These changes may include adjustments in dosage, discontinuation of medications, initiation of new medications, or switching between different medications. This data will be obtained from participants' electronic health records.
Baseline, 4 weeks, 8 weeks
Goal attainment
Time Frame: Baseline, 8 weeks
Attainment of personal goals related to home blood pressure monitoring set at the study baseline will be assessed with a post-intervention survey and reported as a percentage of goal achieved.
Baseline, 8 weeks
Physical Activity
Time Frame: Baseline, 4 weeks, 8 weeks
On numeric scale, baseline and change in physical activity will be tracked by daily steps recorded by the FitBit.
Baseline, 4 weeks, 8 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Focus group interviews
Time Frame: At least 3 months after randomization
The investigators will perform qualitative focus groups in a subpopulation of the Moms@Home study assignment to assess for ease of use, barriers and facilitators related to the intervention and long-term maintenance.
At least 3 months after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Massachusetts, Worcester

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Lara Kovell, MD,MSc, University of Massachusetts Medical School, Worcester

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 16, 2025

Primary Completion (Estimated)

July 16, 2027

Study Completion (Estimated)

November 16, 2027

Study Registration Dates

First Submitted

February 14, 2025

First Submitted That Met QC Criteria

February 14, 2025

First Posted (Actual)

February 19, 2025

Study Record Updates

Last Update Posted (Actual)

June 4, 2025

Last Update Submitted That Met QC Criteria

June 3, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00001895
  • K23HL163450 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The final dataset will consist of de-identified self-reported demographic and behavioral data from participants, along with home blood pressure monitoring (HBPM) data and physical activity data from the Moms@Home app and FitBit device. We will work with the NHLBI BioData Catalyst (BDC) to deposit the appropriate data. Otherwise, this final dataset will be kept on hand and distributed upon reasonable request after an appropriate data-use agreement has been put in place. All data will be de-identified prior to release.

IPD Sharing Time Frame

November 23rd, 2027 - November 23rd, 2028

IPD Sharing Access Criteria

The NHLBI Other investigators with appropriate data use agreements

IPD Sharing Supporting Information Type

  • ICF

Study Data/Documents

  1. Informed Consent Form
    Information identifier: Informed consent form

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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