Community Support and Mobile Apps to Help Black Women Control High Blood Pressure After Pregnancy

Официальное название

Postpartum Remote Monitoring and Integration of Mobile Health With Engagement From Community Health Workers for Regulating Elevated Blood Pressure

Обзор

The goal of this randomized clinical trial is to evaluate the effectiveness of a collaborative care intervention, consisting of remote blood pressure monitoring and support from community health workers, in improving blood pressure control and reducing postpartum complications among Black women with hypertensive disorders of pregnancy (HDP). The primary objectives are to determine whether the intervention leads to improved blood pressure control at 12 months postpartum compared to standard care, and whether it reduces the incidence of serious maternal morbidity, including hospitalizations and cardiovascular events. Secondary objectives include examining whether patient activation and trust in the healthcare system mediate the relationship between the intervention and clinical outcomes. Participants will be enrolled at approximately 6 weeks postpartum and randomized to either the collaborative care intervention or standard postpartum care. All participants will self-monitor blood pressure using a provided device, receive guidance on hypertension management, and complete study assessments at multiple time points. Participants assigned to the intervention arm will additionally receive ongoing support from community health workers, including health education, care coordination, and assistance with healthcare navigation. Clinical outcomes and patient-reported measures will be assessed over a 12-month follow-up period.

Вмешательства

• Другое Collaborative care
  Bluetooth-enabled Remote Patient Monitoring (RPM) with algorithm-driven Community Health Worker (CHW) support. CHWs provide support (averaging 2.3 contacts/week) to facilitate medication titration and address social determinants of health. Treatment follows a standardized protocol using guideline-directed medical therapy targeting a blood pressure of \<130/80 mmHg.
• Другое Standard of Care (SOC)
  Traditional clinical management consisting of manual blood pressure monitoring and clinic-based medication titration. Treatment follows the same standardized protocol as the intervention arm, using guideline-directed medical therapy targeting a blood pressure of \<130/80 mmHg.

Первичные конечные точки

• Blood Pressure Control (BP <130/80 mmHg) [Срок оценки: Baseline (6 weeks) postpartum to 12 months postpartum]

Вторичные конечные точки (4)

• Patient Activation Measure (PAM-13) [Срок оценки: At Baseline (6 weeks) postpartum, 6 months postpartum and 12 months (1 year) postpartum]
• Morisky Medication Adherence Scale (MMAS-8) [Срок оценки: At Baseline (6 weeks) postpartum, 6 months postpartum, and 12 months (1 year) postpartum.]
• Trust in Physician Scale [Срок оценки: At Baseline (6 weeks) postpartum, 6 months postpartum, and 12 months (1 year) postpartum.]
• Severe Maternal Morbidity (SMM) Composite Rate [Срок оценки: Baseline (6weeks) postpartum to 12 months (1 year) postpartum]

Критерии участия

Критерии включения

• Black/ African American patients
• Age: 19 and 50 years of age
• Diagnosis: Hypertension Disorders of Pregnancy
• Enrolled in STAMPP-HTN for first 6 weeks postpartum

Критерии исключения

• Age: <19 years
• Significant Kidney or Liver disease that may limit antihypertensive medication adjustment

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

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Anderson LA, Dedrick RF. Development of the Trust in Physician scale: a measure to assess interpersonal trust in patient-physician relationships. Psychol Rep. 1990 Dec;67(3 Pt 2):1091-100. doi: 10.2466/pr0.1990.67.3f.1091. PMID 2084735
• Health IDoP. llinois Maternal Morbidity and Mortality Report: October 2023; 2023 [01082024]. Available from: https://dph.illinois.gov /content/dam/soi/en/web/idph/publications/idph/topics-and-services/life-stages-populations/ maternal-child-family-health-services/maternal-health/mmmr/maternal-morbidity-mortalityreport2023.pdf.
• AHA. Postpartum Systems of Care Recommendations. https://wwwheartorg/-/media/files /professional/quality-improvement/maternal-health/recommendationsformatted. 2024.
• Assistant Secretary for Public Affairs (ASPA) DoHaHSH. Strengthening Maternal Health. Available from: https://www.hhs.gov/healthcare/maternal-health/index.html.
• Roderick J. A. Little DBR. Statistical Analysis with Missing Data 2002.
• Patricia M. Grambsch TMT. Proportional Hazards Tests and Diagnostics Based on Weighted Residuals. Biometrika, Vol 81, No 3 (Aug, 1994), pp 515-526 (12 pages).
• Kaplan EL, & Meier, P. . Nonparametric Estimation from Incomplete Observations. Journal of the American Statistical Association. 1958.
• Cox DR. Regression Models and Life-Tables Journal of the Royal Statistical Society: Series B (Methodological), Volume 34, Issue 2.

Идентификаторы

NCT: NCT07606027 · 0312-26-EP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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