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

June 12, 2026 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Massachusetts, Worcester

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 16, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 16, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 16, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 14, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 19, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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