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

NCT06835959 | Recruiting

• 2 other identifiers: 00001895K23HL163450
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (3)

• Home Blood Pressure Monitoring Adherence

  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

  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

  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 Outcomes (8)

• Self-Efficacy

  Baseline, 4 weeks, 8 weeks

• Sustainability

  8 weeks

• Blood Pressure (BP) measures

  Baseline, 4 weeks, 8 weeks

• Engagement with Moms@Home

  4 weeks, 8 weeks

• Medication Adherence

  Baseline, 4 weeks, 8 weeks

Other Outcomes (1)

• Focus group interviews

  At least 3 months after randomization

Study Arms (2)

Moms@Home arm

EXPERIMENTAL

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

Enhanced Standard Care arm

ACTIVE COMPARATOR

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

Interventions

Moms@Home BEHAVIORAL

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

Also known as: Peer Support Intervention

Moms@Home arm

Enhanced Standard of Care BEHAVIORAL

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

Also known as: Self-tracking Journal

Enhanced Standard Care arm

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

UMass Memorial Medical Center - Memorial Campus

Worcester, Massachusetts, 01655, United States

RECRUITING

Related Publications (10)

• 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.

  PMID: 30821691 BACKGROUND

• 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.

  PMID: 31121137 BACKGROUND

• 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.

  PMID: 31618706 BACKGROUND

• 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.

  PMID: 36573193 BACKGROUND

• 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.

  PMID: 32865505 BACKGROUND

• 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.

  PMID: 21547409 BACKGROUND

• 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.

  PMID: 32301744 BACKGROUND

• 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.

  PMID: 35304393 BACKGROUND

• 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.

  PMID: 29703800 BACKGROUND

• 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.

  PMID: 39248134 BACKGROUND

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced; Hypertension

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Lara Kovell, MD,MSc

  University of Massachusetts Medical School, Worcester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lara Kovell, MD,MSc

CONTACT

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

Abigail Arthur, MBChB, MPH

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blinded to the randomization assignments. Both investigators and participants will be aware of the randomization assignments to facilitate the implementation of the interventions.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: February 19, 2025
• Study Start: May 16, 2025
• Primary Completion (Estimated): July 16, 2027
• Study Completion (Estimated): November 16, 2027
• Last Updated: June 4, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: November 23rd, 2027 - November 23rd, 2028
• Access Criteria: The NHLBI Other investigators with appropriate data use agreements

Locations

US (1)