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NCT Number: NCT06835959

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

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.

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Key information

Conditions

Hypertension in Pregnancy Cardiovascular Diseases Chronic Hypertension Female Urogenital Diseases and Pregnancy Complications Gestational Hypertension Hypertension Hypertension, Pregnancy-Induced Pregnancy Complications Urogenital Diseases Vascular Diseases

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UMass Memorial Medical Center - Memorial Campus

Worcester, Massachusetts, 01655, United States

Location status: Recruiting

Location contact

Abigail Arthur, MBChB, MPH

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Moms@Home

Behavioral

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

Enhanced Standard of Care

Behavioral

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

Other names: Self-tracking Journal

Primary outcomes

  1. 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

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Other outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Abigail Arthur, MBChB, MPH

CONTACT

[email protected]

(508) 856-4394

Lara Kovell, MD,MSc

CONTACT

[email protected]

(508) 856-2772

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Acronym: Moms@Home

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 19, 2025
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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