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Идёт набор NCT06835959

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

Без фазы С лечением Hypertension in Pregnancy Chronic Hypertension Gestational Hypertension

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Moms@Home, Enhanced Standard of Care.
Кому может быть актуально
Состояния в реестре: Hypertension in Pregnancy, Chronic Hypertension, Gestational Hypertension. Базовые параметры: 18 лет — 50 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое Moms@Home
    Participants will use a storytelling mobile health app for daily home-based blood pressure monitoring and symptom/medication adherence tracking.
  • Поведенческое Enhanced Standard of Care
    Participants will use a paper journal daily to track home-based blood pressure values

Первичные конечные точки

  • Home Blood Pressure Monitoring Adherence [Срок оценки: 8 weeks]
  • Feasibility of the Moms@Home intervention [Срок оценки: 8 weeks]
  • Acceptability [Срок оценки: 8 weeks]
Вторичные конечные точки (8)
  • Self-Efficacy [Срок оценки: Baseline, 4 weeks, 8 weeks]
  • Sustainability [Срок оценки: 8 weeks]
  • Blood Pressure (BP) measures [Срок оценки: Baseline, 4 weeks, 8 weeks]
  • Engagement with Moms@Home [Срок оценки: 4 weeks, 8 weeks]
  • Medication Adherence [Срок оценки: Baseline, 4 weeks, 8 weeks]
  • Medication titration [Срок оценки: Baseline, 4 weeks, 8 weeks]
  • Goal attainment [Срок оценки: Baseline, 8 weeks]
  • Physical Activity [Срок оценки: Baseline, 4 weeks, 8 weeks]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • UMass Memorial Medical Center - Memorial Campus — Worcester

Публикации

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

Идентификаторы

NCT: NCT06835959 · 00001895 · K23HL163450

Первоисточники (государственные реестры)

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