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Hypertension in PregnancyMoms@HomeNCT06835959

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

A study testing Moms@Home in people with Hypertension in Pregnancy and Chronic Hypertension, run by University of Massachusetts, Worcester at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years, women only
What is being tested?
Moms@Home
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
16 May 2025to 16 Nov 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lara Kovell, MD,MSc contact

(508) 856-2772

lara.kovell2@umassmed.edu

Abigail Arthur, MBChB, MPH contact

(508) 856-4394

abigail.arthur@umassmed.edu

United States1 site, 1 recruiting
  • UMass Memorial Medical Center - Memorial Campus

    Worcester, Massachusetts, 01655

    Abigail Arthur, MBChB, MPH

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Moms@Home, Enhanced Standard of Care
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
Medical subject headings
Hypertension, Pregnancy-Induced, Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Moms@HomeBehavioural

    Also called Peer Support Intervention

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

  • Enhanced Standard of CareBehavioural

    Also called Self-tracking Journal

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

Study groups in NCT06835959
Study groupRoleWhat they receive
Moms@Home armExperimentalParticipants 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.
Receives: Behavioral: Moms@Home
Enhanced Standard Care armActive comparatorParticipants randomized to Enhanced Standard Care (ESC) will receive a paper diary to self-report data including measurements from a digital blood pressure monitor.
Receives: Behavioral: Enhanced Standard of Care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Home Blood Pressure Monitoring Adherence

    Home blood pressure monitoring (HBPM) adherence is defined as performing HBPM measures ≥3 out of 7 days/week

    Measured: 8 weeks

  2. Feasibility of the Moms@Home intervention

    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.

    Measured: 8 weeks

  3. Acceptability

    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.

    Measured: 8 weeks

Secondary outcomes (8)
  1. Self-Efficacy

    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.

    Measured: Baseline, 4 weeks, 8 weeks

  2. Sustainability

    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.

    Measured: 8 weeks

  3. Blood Pressure (BP) measures

    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.

    Measured: Baseline, 4 weeks, 8 weeks

  4. Engagement with Moms@Home

    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.

    Measured: 4 weeks, 8 weeks

  5. Medication Adherence

    On a numeric scale, baseline and change in medication adherence will be assessed through a baseline, midpoint and post-intervention survey.

    Measured: Baseline, 4 weeks, 8 weeks

  6. Medication titration

    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.

    Measured: Baseline, 4 weeks, 8 weeks

  7. Goal attainment

    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.

    Measured: Baseline, 8 weeks

  8. Physical Activity

    On numeric scale, baseline and change in physical activity will be tracked by daily steps recorded by the FitBit.

    Measured: Baseline, 4 weeks, 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2025
  2. Study start16 May 2025
  3. Primary completion16 Jul 2027 (estimated)
  4. Study completion16 Nov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomized to receive either the Moms@Home intervention or ESC through permuted blocked randomization, in blocks of multiples of 2 such that half of the participants will use Moms@Home and the other half ESC.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06835959
Sponsor's protocol ID
00001895
Other IDs
K23HL163450
Acronym
Moms@Home
Status last verified
Jun 2026
First submitted
14 Feb 2025
Last updated
16 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • McManus DD, Trinquart L, Benjamin EJ, Manders ES, Fusco K, Jung LS, Spartano NL, Kheterpal V, Nowak C, Sardana M, Murabito JM. Design and Preliminary Findings From a New Electronic Cohort Embedded in the Framingham Heart Study. J Med Internet Res. 2019 Mar 1;21(3):e12143. doi: 10.2196/12143.

    PubMed 30821691
  • Hirshberg A, Sammel MD, Srinivas SK. Text message remote monitoring reduced racial disparities in postpartum blood pressure ascertainment. Am J Obstet Gynecol. 2019 Sep;221(3):283-285. doi: 10.1016/j.ajog.2019.05.011. Epub 2019 May 20. No abstract available.

    PubMed 31121137
  • Pealing LM, Tucker KL, Mackillop LH, Crawford C, Wilson H, Nickless A, Temple E, Chappell LC, McManus RJ; OPTIMUM-BP Investigators. A randomised controlled trial of blood pressure self-monitoring in the management of hypertensive pregnancy. OPTIMUM-BP: A feasibility trial. Pregnancy Hypertens. 2019 Oct;18:141-149. doi: 10.1016/j.preghy.2019.09.018. Epub 2019 Oct 13.

    PubMed 31618706
  • Dodson JA, Schoenthaler A, Fonceva A, Gutierrez Y, Shimbo D, Banco D, Maidman S, Olkhina E, Hanley K, Lee C, Levy NK, Adhikari S. Study design of BETTER-BP: Behavioral economics trial to enhance regulation of blood pressure. Int J Cardiol Cardiovasc Risk Prev. 2022 Oct 31;15:200156. doi: 10.1016/j.ijcrp.2022.200156. eCollection 2022 Dec.

    PubMed 36573193
  • Schoenthaler A, Cruz J, Payano L, Rosado M, Labbe K, Johnson C, Gonzalez J, Patxot M, Patel S, Leven E, Mann D. Investigation of a Mobile Health Texting Tool for Embedding Patient-Reported Data Into Diabetes Management (i-Matter): Development and Usability Study. JMIR Form Res. 2020 Aug 31;4(8):e18554. doi: 10.2196/18554.

    PubMed 32865505
  • Warren-Findlow J, Seymour RB, Brunner Huber LR. The association between self-efficacy and hypertension self-care activities among African American adults. J Community Health. 2012 Feb;37(1):15-24. doi: 10.1007/s10900-011-9410-6.

    PubMed 21547409
  • Aquino M, Munce S, Griffith J, Pakosh M, Munnery M, Seto E. Exploring the Use of Telemonitoring for Patients at High Risk for Hypertensive Disorders of Pregnancy in the Antepartum and Postpartum Periods: Scoping Review. JMIR Mhealth Uhealth. 2020 Apr 17;8(4):e15095. doi: 10.2196/15095.

    PubMed 32301744
  • Jakubowski BE, Hinton L, Khaira J, Roberts N, McManus RJ, Tucker KL. Is self-management a burden? What are the experiences of women self-managing chronic conditions during pregnancy? A systematic review. BMJ Open. 2022 Mar 18;12(3):e051962. doi: 10.1136/bmjopen-2021-051962.

    PubMed 35304393
  • Hirshberg A, Downes K, Srinivas S. Comparing standard office-based follow-up with text-based remote monitoring in the management of postpartum hypertension: a randomised clinical trial. BMJ Qual Saf. 2018 Nov;27(11):871-877. doi: 10.1136/bmjqs-2018-007837. Epub 2018 Apr 27.

    PubMed 29703800
  • Kovell LC, Denu M, Revoori R, Sadaniantz K, Staples B, Chiriboga G, Forrester SN, Lemon SC, Moore Simas TA, Person S, McManus DD, Mazor KM. Barriers and facilitators to home blood pressure monitoring in women with pregnancies complicated by hypertensive disorders: a qualitative study. J Hypertens. 2024 Nov 1;42(11):1994-2002. doi: 10.1097/HJH.0000000000003835. Epub 2024 Aug 9.

    PubMed 39248134

Questions about this trial

What is this clinical trial studying?

A study testing Moms@Home in people with Hypertension in Pregnancy and Chronic Hypertension, run by University of Massachusetts, Worcester at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lara Kovell, MD,MSc ((508) 856-2772, lara.kovell2@umassmed.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Home Blood Pressure Monitoring Adherence (time frame: 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06835959, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.

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