TEC4Home Blood Pressure Randomized Controlled Trial

Официальное название

Telehealth for Emergency-Community Continuity of Care Connectivity Via Home Telemonitoring for Blood Pressure Randomized Controlled Trial

Обзор

The goal of this clinical trial is to evaluate the effect of home blood pressure telemonitoring (HBPT) and case management (CM), relative to usual care, for improving blood pressure (BP) control among patients with high blood pressure discharged from the emergency department (ED). The main question it aims to answer is: Does telemonitoring with case management improve BP control, relative to usual care, for people with high blood pressure discharged from the ED? Secondary research questions will address: 1. How do these interventions (telemonitoring and case management) improve medication adherence? 2. Do these interventions reduce physician and ED visits? 3. Are these interventions safe? 4. How do these interventions influence patient experience? Participants in the intervention group will receive training and use of a home BP telemonitor with tele-transmission function for 12-months plus pharmacist case management to provide behavioral counseling, facilitate medication adherence, review telemonitored BP data, and adjust medications. The control group will receive usual care from their primary care physician and will receive the same home BP monitor and hypertension education.

Вмешательства

• Устройство Home Blood Pressure Telemonitoring (HBPT) + Case Management (CM)
  Home Blood Pressure Telemonitoring (HBPT) includes used of an app to collect and transmit blood pressure readings. Case Management (CM) includes pharmacists reviewing BP data and providing counselling to participants based on their BP values.

Первичные конечные точки

• Systolic blood pressure controlled [Срок оценки: 12-months]

Вторичные конечные точки (1)

• Impact of intervention on other blood pressure measures [Срок оценки: 6-months and 12-months]

Критерии участия

Критерии включения

• Adult patients aged ≥ 18 years of age
• Elevated triage BP AND increased average BP in three subsequent repeated measurements that are spaced at least 30 minutes after triage (systolic BP ≥ 160 mm Hg or diastolic BP ≥ 100 mm Hg)
• Own a smart phone
• Willing to measure and tele-transmit home BP readings

Критерии исключения

• Hypertensive emergencies with evidence of end-organ damage, stroke, or acute coronary syndrome
• Pregnant women
• Acute intoxication
• Acute surgical or trauma patients
• Psychiatrically unstable patients
• Advanced cognitive impairment
• Patient requiring admission to hospital
• Inability to use or care for home BP monitor correctly
• From nursing home
• Unstable housing
• Non-English speaking or no family members who can help translate

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06303206 · H23-00623

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗