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Набор скоро начнётся NCT07308613

Developing and Testing a Machine Learning Enabled Mindfulness Intervention for Reducing Loneliness Among Hong Kong Chinese Older Adults

Без фазы С лечением Loneliness

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: Mindfulness - Continue, Mindfulness - Enhance human coaching, Mindfulness - Booster, Active Control.
Кому может быть актуально
Состояния в реестре: Loneliness. Базовые параметры: от 65 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
Гонконг
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Developing and Testing a Machine Learning Enabled Mindfulness Intervention for Reducing Loneliness Among Hong Kong Chinese Older Adults: A Hybrid Experimental Design Study

Обзор

Develop and test an effective machine learning enabled application-based (app-based) mindfulness intervention for reducing loneliness of Hong Kong Chinese older adults.

Подробное описание

This study will utilize a hybrid Sequential Multiple Assignment Randomized Trial-Micro Randomized Trial (Hybrid SMART-MRT) to: 1) evaluate the effectiveness of a single-session intervention (SSI) of mindfulness on reducing loneliness; 2) identify the optimal first-line coaching approach after the SSI of mindfulness; 3) examine whether increasing the intensity of human coaching or adding a telephone-based human-delivered booster session will benefit participants who do not respond to the first-line coaching; 4) determine whether sending push notifications increases the engagement of our app-based coaching, by comparing its results with those of no push notification; 5) determine whether sending a recommended activity increases the engagement of our app-based coaching, by comparing its results with those of no recommended activity; and 6) determine whether sending a personalized motivational message increases the engagement of our app-based coaching, by comparing its results with those of a standard motivational message.

Вмешательства

  • Поведенческое Mindfulness - Continue
    Second-line of coaching (4 weeks): Continue with existing intervention plan
  • Поведенческое Mindfulness - Enhance human coaching
    Second-line of coaching (4 weeks): Increase intensity of human coaching
  • Поведенческое Mindfulness - Booster
    Second-line of coaching (4 weeks): Add a booster session
  • Поведенческое Active Control
    No rerandomization, no mindfulness, No MRT

Первичные конечные точки

  • Loneliness [Срок оценки: Baseline (T0), within 1 week after 1st-line of coaching (T1), within 1 week after 2nd-line of coaching (T2), 3 months after 2nd-line of coaching (T3), 6 months after 2nd-line of coaching (T4)]
Вторичные конечные точки (11)
  • Loneliness [Срок оценки: Baseline (T0), within 1 week after 1st-line of coaching (T1), within 1 week after 2nd-line of coaching (T2), 3 months after 2nd-line of coaching (T3), 6 months after 2nd-line of coaching (T4)]
  • Stress [Срок оценки: Baseline (T0), within 1 week after 1st-line of coaching (T1), within 1 week after 2nd-line of coaching (T2), 3 months after 2nd-line of coaching (T3), 6 months after 2nd-line of coaching (T4)]
  • Sleep Quality [Срок оценки: Baseline (T0), within 1 week after 1st-line of coaching (T1), within 1 week after 2nd-line of coaching (T2), 3 months after 2nd-line of coaching (T3), 6 months after 2nd-line of coaching (T4)]
  • Depression [Срок оценки: Baseline (T0), within 1 week after 1st-line of coaching (T1), within 1 week after 2nd-line of coaching (T2), 3 months after 2nd-line of coaching (T3), 6 months after 2nd-line of coaching (T4)]
  • Anxiety [Срок оценки: Baseline (T0), within 1 week after 1st-line of coaching (T1), within 1 week after 2nd-line of coaching (T2), 3 months after 2nd-line of coaching (T3), 6 months after 2nd-line of coaching (T4)]
  • Physical Health [Срок оценки: Baseline (T0), 6 months after 2nd-line of coaching (T4)]
  • Physical Health [Срок оценки: Baseline (T0), 6 months after 2nd-line of coaching (T4)]
  • Physical Symptoms [Срок оценки: Baseline (T0), 6 months after 2nd-line of coaching (T4)]
  • Chronic Illness [Срок оценки: Baseline (T0), 6 months after 2nd-line of coaching (T4)]
  • Multidimensional Scale of Perceived Social Support [Срок оценки: Baseline (T0), within 1 week after 1st-line of coaching (T1), within 1 week after 2nd-line of coaching (T2), 3 months after 2nd-line of coaching (T3), 6 months after 2nd-line of coaching (T4)]
  • Lubben Social Network Scale [Срок оценки: Baseline (T0), within 1 week after 1st-line of coaching (T1), within 1 week after 2nd-line of coaching (T2), 3 months after 2nd-line of coaching (T3), 6 months after 2nd-line of coaching (T4)]

Критерии участия

Критерии включения

  • Aged 65 or older
  • Possess a smartphone with an Android or iOS operating system
  • Communicable in Cantonese
  • Lonely (cut-off >/=6 on the three-item UCLA Loneliness Scale)

Критерии исключения

  • Cognitive impairment, psychiatric disorder, learning disability
  • Active suicide ideation
  • Engaged in psychotherapy and psychosocial interventions in the past year

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Факторный дизайн
Маскирование
Двойное слепое
Основная цель
Профилактика

Центры проведения

Гонконг · 1 центр
  • The Education University of Hong Kong — Гонконг

Идентификаторы

NCT: NCT07308613 · 2023-2024-0147

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗