Tailoring TM-HTN Intervention for Black Patients

Официальное название

Tailoring a Telemedicine Hypertension Management Intervention for Black Patients

Обзор

Current clinic-based hypertension (HTN) management models have several limitations, resulting in episodic care that does not adequately support patients' self-care skills, and fails to achieve blood pressure (BP) control.

Подробное описание

Telemedicine management of HTN (TM-HTN) can augment and overcome challenges by allowing more support for patients' HTN self-care skills, providing multiple home Blood Pressure values and overcoming failure to appropriately intensify treatment. TM-HTN consists of 1) home BP monitoring, 2) home BP based pharmacotherapy, and 3) telemedicine-based self-management support.

Вмешательства

• Поведенческое Telemedicine management of Hypertension
  TM-HTN intervention includes tailored and frequent self-management support, home blood pressure monitoring, pharmacotherapy, and as-needed assistance for health-related social needs provided by pharmacists, nurses, community health workers, and social workers. This will be compared with usual care
• Поведенческое Usual Care
  This includes usual clinic based HTN care using routinely available clinic resources (e.g., community health worker, social worker). Clinicians can offer self-management support (e.g., dietician referral) or recommend a home BP monitor. These activities mirror current primary care practice.

Первичные конечные точки

• Proportion of patients who are screened [Срок оценки: Month 6]
• Proportion of patients who are eligible [Срок оценки: Month 6]
• Proportion of patients who agree to participate [Срок оценки: Month 6]
• Proportion of patients who decline [Срок оценки: Month 6]
• Number of staff needed and time spent for intervention [Срок оценки: Month 6]
• Proportion of completed self-measurement of Blood Pressure at home [Срок оценки: Month 6]
• Proportion of completed self-management contacts. [Срок оценки: Month 6]

Вторичные конечные точки (7)

• Change in Blood Pressure [Срок оценки: Month 6]
• Medication adherence [Срок оценки: Month 6]
• Feasibility of Intervention Measure [FIM] [Срок оценки: Month 6]
• Acceptability of Intervention Measure [AIM] [Срок оценки: Month 6]
• Intervention Appropriateness Measure [IAM] [Срок оценки: Month 6]
• Patient Assessment of Chronic Illness Care [PACIC] [Срок оценки: Month 6]
• Organizational Readiness for Implementing Change [ORIC] [Срок оценки: Month 6]

Критерии участия

Критерии включения

• Subjects must be African American or Black
• experiencing socially disadvantage
• Patients with systolic Blood Pressure ≥140 mmHg on their last two clinic visits and baseline systolic BP >130 mmHg using the mean of two research BP values measured by trained staff
• Subjects must be on stable Blood Pressure medications for the preceding 6 weeks

Критерии исключения

• Unable to read or speak English
• diminished ability to measure home Blood Pressure
• chronic kidney disease ≥stage 4
• persistent/chronic atrial fibrillation
• severe hypertension >180/110 mmHg
• acute health changes in past 3 months increasing chance of Blood Pressure instability
• terminal illness

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 · 1 центр

• Wake Forest University Health Sciences — Winston-Salem

Идентификаторы

NCT: NCT06593119 · IRB00116281 · 11773

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗