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Идёт набор NCT06539845

Creating a New Health Promotion Module to Help the Indigenous People of Selangor Prepare for Disease X and Outbreaks

Без фазы С лечением Attitude to Health Behavior, Health Health Behavior Health-Related Behavior

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: Outbreak Preparedness Intervention for the Orang Asli, Educational Brochures for the Orang Asli.
Кому может быть актуально
Состояния в реестре: Attitude to Health, Behavior, Health, Health Behavior, Health-Related Behavior. Базовые параметры: 18 лет — 99 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
Малайзия
Следующий шаг
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Официальное название

Development and Effectiveness of a New Intervention on Household Preparedness for Disease X and Outbreaks Among Orang Asli in Selangor: A Cluster Randomized Trial

Обзор

The goal of this cluster randomized trial is to develop and test a new method for preparing indigenous (locally termed as Orang Asli) households in Selangor, a state in Malaysia, for outbreaks and Disease X, a potential unknown infectious threat. It aims to determine if the new method, a health education package comprised of workshops, simulation exercises, and card game play sessions, can enhance the readiness of these families for such outbreaks. The main questions it is looking to answer are: 1. Will the intervention package increase the level of preparedness for a Disease X and outbreaks among indigenous households in Selangor? 2. Will the intervention improve the awareness and attitudes of the indigenous people in Selangor towards outbreak preparedness? 3. Will it lead to more proactive preparedness actions by these households? To evaluate the effectiveness of the intervention package, researchers will compare outcomes between two groups: the intervention group receiving both the intervention package and educational brochures on communicable disease prevention, and the control group receiving only the brochures. Participants will: 1. Participate in the activities in the newly developed intervention package, which would include workshops, simulation exercises, and card game play sessions. 2. Answer surveys four times: before, immediately after, 1 month after and 2 months after the intervention, to measure any changes in their preparedness levels for an outbreak.

Вмешательства

  • Поведенческое Outbreak Preparedness Intervention for the Orang Asli
    The chosen villages will be given the intervention package, which includes a workshop, simulation exercises, and a card game, in addition to educational brochures on communicable disease prevention sourced from the Ministry of Health Malaysia "Info Sihat" website. This entire package will be delivered once, during the workshop, after they have answered the survey at T0.
  • Поведенческое Educational Brochures for the Orang Asli
    The chosen villages will be given educational brochures on communicable disease prevention sourced from the Ministry of Health Malaysia "Info Sihat" website. This will be given once during the first encounter with the participant, after they have answered the survey at T0.

Первичные конечные точки

  • Household Preparedness Score [Срок оценки: Before intervention (T0), immediately after the intervention (T1), 1-month follow-up (T2), and at a 2-months follow-up (T3)]
  • Household Preparedness Matrix [Срок оценки: Before intervention (T0), immediately after the intervention (T1), 1-month follow-up (T2), and at a 2-months follow-up (T3)]
Вторичные конечные точки (2)
  • Cognitive Preparedness score [Срок оценки: Before intervention (T0), immediately after the intervention (T1), 1-month follow-up (T2), and at a 2-months follow-up (T3)]
  • Preparedness Behaviour score [Срок оценки: Before intervention (T0), immediately after the intervention (T1), 1-month follow-up (T2), and at a 2-months follow-up (T3)]

Критерии участия

Критерии включения

  • Orang Asli ethnicity
  • Malaysian citizen
  • Age between 18 to 99 years old
  • The head of the household, or the person who contributes to, or influences health-related decisions for the household
  • Live in a household with at least three members
  • Able to converse in Malay

Критерии исключения

  • Having physical or cognitive disabilities (e.g., blindness, deafness, schizophrenia and dementia)
  • Having severe health conditions (e.g., respiratory and cardiovascular disease requiring oxygen support such as severe asthma/chronic obstructive pulmonary disease/heart failure and congenital heart diseases)
  • Residing temporarily (less than 2 years)
  • Intending to relocate to a different residence within the next 2 years

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Профилактика

Центры проведения

Малайзия · 2 центра
  • Pejabat JAKOA Daerah Gombak dan Petaling — Gombak
  • Pejabat JAKOA Daerah Gombak dan Petaling — Gombak

Идентификаторы

NCT: NCT06539845 · 24-01859-NQ7

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗