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Идёт набор NCT06444308

Community Health Worker-led Hypertension Management

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: CommCare with Mobile Clinical Decision Support (CDS) Application, Remote Supervision by Physicians, CommCare Application without CDS.
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
Guatemala
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Assessing the Efficacy and Safety of Community Health Worker-led Hypertension Management Enabled by a Mobile Clinical Decision Support Application Compared to Physician Care: a Randomized, Controlled, Noninferiority Trial

Обзор

This study is to determine if hypertension management by community health workers (CHW) supported by a mobile health application and remote physician supervision is non-inferior to management by a physician for the primary outcome of improvement in systolic blood pressure. The target population is patients with hypertension in rural Guatemala. Study duration will be 12-24 months.

Подробное описание

The investigators have developed an innovative system of care utilizing CHWs equipped with a mobile application and supported and supervised remotely by physicians. This model of care is adapted from a CHW-led diabetes program enabled by a similar CDS application which the investigators implemented in the same communities in rural Guatemala where we will carry out this proposed study. This program safely led to significant improvements in glycemic control. The mobile application is built on the widely-used CommCare platform and provides clinical decision support (CDS) to CHWs based on protocols from the WHO and the International Society of Hypertension for antihypertensive medication initiation and titration, lifestyle counseling, and identification of patients requiring a higher level of care.

The Primary Objective is to determine if hypertension management by CHWs is non-inferior to care provided directly by a physician.

The Secondary Objective is to evaluate the safety, acceptability to patients, and cost of CHW-led care compared to care provided directly by a physician.

Вмешательства

  • Другое CommCare with Mobile Clinical Decision Support (CDS) Application
    For those assigned to the CHW arm, management will be assisted by CDS from the CommCare application.
  • Другое Remote Supervision by Physicians
    teleconsultation with a supervising physician
  • Другое CommCare Application without CDS
    The physician will have received training and orientation on the same clinical protocols followed by the CHWs, as well as access to reference materials for these protocols, but the version of the CommCare application used will not provide CDS, but will serve to record and review patient data only.

Первичные конечные точки

  • Change in Systolic Blood Pressure (SBP) [Срок оценки: Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months)]
Вторичные конечные точки (12)
  • Proportion of Participants with SBP less than 140mmHg [Срок оценки: Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months)]
  • Proportion of Participants with SBP less than their personalized goal [Срок оценки: Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months)]
  • Change in Diastolic Blood Pressure (DBP) [Срок оценки: Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months)]
  • Change in Hemoglobin A1c (HbA1c) [Срок оценки: Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months)]
  • Change in Diabetes Control [Срок оценки: Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months)]
  • Change in Weight [Срок оценки: Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months)]
  • Change in Total Cholesterol [Срок оценки: Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months)]
  • Change in LDL Cholesterol [Срок оценки: Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months)]
  • Change in HDL Cholesterol [Срок оценки: Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months)]
  • Change in Triglycerides [Срок оценки: Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months)]
  • Change in Creatinine [Срок оценки: Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months)]
  • Change in Estimated Glomerular Filtration Rate (eGFR) [Срок оценки: Baseline, 6 months, 12 months (all participants assessed to 6 months, but participants on study early may also be assessed at 12, 18 and 24 months)]

Критерии участия

Критерии включения

  • Adults age 18 or greater with diagnosis of hypertension AND blood pressure (BP) greater than or equal to 140/90 OR currently taking antihypertensive medication.
  • Ability to provide informed consent

Критерии исключения

  • Pregnancy
  • Severe comorbid condition(s) with life expectancy less than 1 year

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
Организация здравоохранения

Центры проведения

Guatemala · 1 центр
  • Community — San Lucas Tolimán

Идентификаторы

NCT: NCT06444308 · 2024-0566 · A532050 · Protocol Version 1/12/26 · 4R33TW011891-03

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗