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Идёт набор NCT07693699

Optimizing Sustainable Cuff Access and Training Pathways for Self-Measured Blood Pressure Monitoring in Primary Care

Без фазы С лечением 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: In-Clinic Cuff Delivery - Hands-on Training, In-Clinic Cuff Delivery - Written Instructions, Mail Order Cuff Delivery - Hands-on Training, Mail Order Cuff Delivery - Written Instructions.
Кому может быть актуально
Состояния в реестре: Hypertension. Базовые параметры: от 18 лет · Все.
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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Optimizing Sustainable Cuff Access and Training Pathways for Self-Measured Blood Pressure Monitoring in Primary Care: A Pragmatic Randomized Controlled Trial

Обзор

The goal of this study is to identify what cuff delivery and training strategies most effectively achieve successful delivery of a self-measured blood pressure (SMBP) intervention in routine care, among adult primary care patients with uncontrolled hypertension?

Подробное описание

The study team developed a clinical integration package as a multicomponent primary care-based approach to increase SMBP adoption through structured workflows, patient training, blood pressure logs, reminders/support, and clinical follow-up. Pilot work demonstrated that SMBP uptake can be significantly improved in underserved primary care settings. However, the pilot relied on research funds to purchase cuffs, which is not sustainable for health-system scale. A scalable model must identify practical pathways for patients to obtain standard validated blood pressure cuffs through routine care mechanisms, including vendor-supported, insurance-billed, consignment, or mail-order pathways, without depending on research-purchased devices.

In addition to cuff access, effective SMBP implementation also requires feasible approaches to patient training. Many patients do not receive standardized instruction on how to correctly measure and record home blood pressure readings, and intensive in-person training models may be difficult to sustain in routine primary care workflows. Health systems therefore need practical training strategies that balance effectiveness with scalability, ranging from brief hands-on education delivered during clinic visits to lower-touch written or self-guided educational materials.

Patients will be randomized to one of four arms:

1. Mail-order cuff delivery with hands-on training 2. Mail-order cuff delivery with written instructions 3. In-clinic cuff distribution with hands-on training 4. In-clinic cuff distribution with written instructions

All other intervention components will be standardized across study arms, including receipt of a blood pressure log, written instructions on when and how to obtain home blood pressure readings, and routine clinic processes for documenting or reviewing SMBP readings returned by patients. The design is intended to evaluate implementation pathways for SMBP delivery in routine care rather than to test the clinical efficacy of SMBP itself. This design is intended to evaluate operational implementation pathways for SMBP delivery in routine care rather than to test the clinical efficacy of SMBP itself.

Вмешательства

  • Поведенческое In-Clinic Cuff Delivery - Hands-on Training
    Complete vendor form; provide blood pressure log/instructions; demonstrate self-measured blood pressure using sample cuff; provide blood pressure cuff in clinic; submit vendor form as required; complete envelope checklist.
  • Поведенческое In-Clinic Cuff Delivery - Written Instructions
    Complete vendor form; provide blood pressure log/instructions; provide blood pressure cuff in clinic; submit vendor form as required; complete envelope checklist.
  • Поведенческое Mail Order Cuff Delivery - Hands-on Training
    Complete vendor form; provide blood pressure log/instructions; demonstrate self-measured blood pressure using sample cuff; submit vendor form for mail delivery; complete envelope checklist.
  • Поведенческое Mail Order Cuff Delivery - Written Instructions
    Complete vendor form; provide blood pressure log/instructions; submit vendor form for mail delivery; complete envelope checklist.

Первичные конечные точки

  • Rate of Blood Pressure Receipt [Срок оценки: up to day 14]
  • Rate of Training Completion [Срок оценки: up to day 14]
  • Rate of Cuff Order Completion [Срок оценки: up to day 14]
Вторичные конечные точки (6)
  • Time to Complete Intervention [Срок оценки: up to day 14]
  • Number of Participants Documenting at Least One Blood Pressure Reading [Срок оценки: up to day 21]
  • Time Between Cuff Receipt and First Documented Reading [Срок оценки: up to day 21]
  • Rate of Workflow Barriers [Срок оценки: up to day 14]
  • Rate of Fidelity [Срок оценки: up to day 14]
  • Rate of Differential Implementation Success [Срок оценки: up to day 14]

Критерии участия

Критерии включения

  • Age 18 years or older.
  • Diagnosed hypertension documented prior to the index clinic visit.
  • Scheduled for and attends an in-person visit with a participating clinician at a study clinic.
  • Elevated BP (blood pressure) documented in Epic during rooming or the clinic visit before study enrollment, defined as systolic BP >=140 mmHg or diastolic BP >=90 mmHg.

Критерии исключения

  • Visit is canceled, rescheduled, or the patient does not attend the visit.
  • Patient already has a usable home BP cuff provide through insurance within the past 5 years.
  • Patient declines assistance obtaining a BP cuff.
  • Patient declines submitting cuff order to insurance.
  • Patient unable to participate for operational reasons.

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
Поддерживающая терапия

Центры проведения

США · 6 центров
  • Advocate Medical Group Chicago (Southeast) — Chicago
  • Advocate Medical Group Chicago (Imani Village) — Chicago
  • Advocate Medical Group Beverly — Chicago
  • Advocate Medical Group Merrionette Park — Merrionette Park
  • Advocate Medical Group Oak Lawn (FP) — Oak Lawn
  • Advocate Medical Group Oak Lawn (IM) — Oak Lawn

Идентификаторы

NCT: NCT07693699 · IRB00151173

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗