Implementation Strategies for Self-Measured Blood Pressure Monitoring in Racially and Ethnically Diverse Populations

Обзор

This clinical trial aims to assess the impact of patient-focused and clinical-focused implementation strategies on blood pressure control. The investigators will assess the costs of these strategies and how effective they were at safely and equitably increasing home blood pressure monitoring.

Подробное описание

This study will focus on assessing implementation strategies to increase adoption of self-monitored blood pressure (SMBP) monitoring among low-income, culturally and linguistically diverse patients with hypertension in an urban safety net. The investigators propose a hybrid type 1 effectiveness-implementation trial of implementation strategies to increase use of SMBP monitoring with clinical support in an urban safety net system. 330 patients will be randomized to a low-intensity vs high-intensity implementation strategy for SMBP monitoring. The low-intensity strategy will replicate frequently used implementation efforts (provision of BP monitor with training on using a monitor) while the high-intensity strategy will address additional factors identified in prior work (e.g., digital literacy, social support). In six adult primary clinics, the investigators will concurrently provide a stepped-wedge clinic-level implementation strategy (clinical champions, electronic health record \[EHR\] tools) to increase provision of clinical support for SMBP data. To guide dissemination in other under-resourced settings, an economic evaluation will also be conducted.

Вмешательства

• Поведенческое BP monitor use training and app training
  Patients will be taught how to use a BP monitor, along with the accompanying mobile app to view their readings.
• Поведенческое Online patient portal enrollment and training
  Patients will receive training on how to use an online patient portal. If they are not yet enrolled in an online patient portal and would like to be, they will also be enrolled into one.
• Поведенческое SMS reminders to take blood pressure
  Patients will receive reminders via SMS to take their blood pressure.
• Поведенческое Education about self-management of hypertension
  One-time training with action planning, access to website with language concordant patient education, and educational text messages
• Поведенческое Educational text messages that encourage seeking support from a support person
  Educational text messages about behavioral changes that explicitly encourage seeking support from a support person
• Поведенческое Involvement of caregiver or support person
  Patients will be asked to involve a caregiver or support person for all activities above, including patient portal proxy access.
• Поведенческое Group classes
  Patients will be asked to attend in-person or online group education classes on hypertension management

Первичные конечные точки

• Change in clinic systolic BP [Срок оценки: Baseline, 12 months, 18 months]
• BP Control [Срок оценки: Monthly (-6 to 18 months)]

Вторичные конечные точки (7)

• BP Control [Срок оценки: Baseline, 12 months, 18 months]
• Home Systolic BP (SBP) [Срок оценки: Baseline, 12 months, 18 months]
• Patient Adoption [Срок оценки: 12 months]
• Clinic adoption [Срок оценки: Monthly (-6 to 18 months)]
• Reach [Срок оценки: 12 months]
• Costs [Срок оценки: During trial; 12 months]
• Patient Activation [Срок оценки: Baseline, 12 months]

Критерии участия

Критерии включения

• 18 years old/order
• Any sex or gender
• Any race or ethnicity
• Must be receiving primary care at any of the six enrolled clinics
• Have uncontrolled hypertension (BP >=140/90 mmHg at any two encounters in the previous 18 months, including the most recent encounter prior to enrollment)
• Can read and write English, Spanish, or Cantonese
• Be able to provide consent
• Must own a cell phone that receives SMS or text messages

Критерии исключения

• Those with conditions that might complicate remote BP monitoring:

• Pregnancy (and 12 months postpartum)
• Acute myocardial infarction or stroke in the last 12 months
• End-stage renal disease on dialysis
• Stage D heart failure
• Active treatment for cancer (except for nonmelanoma skin cancers)
• Pacemaker use
• Those with dementia, in hospice care, or with serious behavioral health conditions impeding participation

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

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Zuckerberg San Francisco General Hospital — San Francisco

Публикации

• Khoong EC, Kim HC, Li J, Larreynaga J, Luna I, Yang A, Kazi DS, Lyles CR, McCulloch C, Rahman SB, Sarkar U, Curtis N. Implementation Strategies for Self-Measured Blood Pressure Monitoring in Racially and Ethnically Diverse Populations (InSPIRED): A study protocol. Contemp Clin Trials. 2025 Nov;158:108101. doi: 10.1016/j.cct.2025.108101. Epub 2025 Oct 6. PMID 41057081

Идентификаторы

NCT: NCT06871462 · 24-42092 · R18HS029817

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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