- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT07934888
Combining an Effective Rule-based Chatbot With ChatGPT-supported Real-time Question-answer Functions to Promote Seasonal Influenza Vaccination Among Community-dwelling People Aged 65 Years and Above
Combining an Effective Rule-based Chatbot With ChatGPT-supported Real-time Question-answer Functions to Promote Seasonal Influenza Vaccination Among Community-dwelling People Aged 65 Years and Above: a Partially Blinded Randomized Controlled Trial
This study is a partially blinded (outcome assessors and data analysts) and parallel-group randomized controlled trial. Community-dwelling people aged ≥65 years who have not received the SIV for the approaching flu season will be randomized evenly (1:1) into either the intervention group or the control group. During the intervention period, the intervention group will have access to the hybrid combination of a rule-based chatbot (SIV-Chatbot) with the ChatGPT-supported real-time Question & Answer (QA) functions, while the control group will have access only to the SIV-Chatbot.
The SIV-Chatbot will deliver the same interventions for both groups. The number of intervention sessions (four) and timing (week 0, 2, 4 & 6) will also be the same. In the intervention group, the hybrid Chatbot will invite the participants to raise open-ended questions related to SIV using flexible methods (such as voice messages, typing with keyboards, or handwriting) at each session. The ChatGPT will answer these questions immediately in the format of text messages. The functions can be used repeatedly throughout the intervention period (weeks 0-6), and participants will be free to spend as much time as they want on such functions.
Telephone interviews will be conducted at baseline (T0), after completion of the intervention (T1), and six months after T1 (T2). The primary outcome will be the self-reported SIV uptake measured at T2. The research team will validate that outcome by requesting the participants upload an image of their SIV receipt, while hiding their personal identification, via the WhatsApp account used in this study.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Zixin Wang, PhD
- Номер телефона: +852 22528474
- Электронная почта: wangzx@cuhk.edu.hk
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- aged ≥65 years
- possession of a Hong Kong ID
- able to speak and comprehend Cantonese
- have a smartphone with internet access
- have either installed or are willing to install WhatsApp on their smartphone
- have not taken seasonal influenza vaccination for the approaching flu season
Exclusion Criteria:
- score ≤16 in the validated telephone version of the Cantonese Mini-Mental State Examination (T-CMMSE)
- either blindness or deafness
- with known contraindications to the SIV as indicated by the Hong Kong Centre for Health Protection (e.g., history of severe allergic reactions to any of the vaccine component or a previous dose of SIV and bleeding disorders)
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Исследования в области здравоохранения
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Intervention group
Have access to the hybrid combination of a rule-based chatbot (SIV-Chatbot) with the ChatGPT-supported real-time QA functions |
After assessing participants' stage of change (SOC) regarding SIV uptake, the rule-based component (SIV-Chatbot) will deliver online interventions tailored to their current SOC. There will be four intervention sessions at week 0, 2, 4 and 6. In addition, the hybrid Chatbot will invite the participants to raise open-ended questions related to SIV using flexible methods at each session. The ChatGPT will answer these questions immediately in the format of text messages. The functions can be used repeatedly throughout the intervention period (weeks 0-6), and participants will be free to spend as much time as they want on such functions. |
|
Активный компаратор: Control group
Have access only to a rule-based chatbot (SIV-Chatbot) |
After assessing participants' stage of change (SOC) regarding SIV uptake, the rule-based chatbot (SIV-Chatbot) will deliver online interventions tailored to their current SOC. There will be four intervention sessions at week 0, 2, 4 and 6. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Uptake of seasonal influenza vaccination
Временное ограничение: Six months after completion of the intervention
|
The primary outcome will be the self-reported seasonal influenza vaccination uptake measured at T2 (six months after completion of the intervention). The research team will validate that outcome by requesting the participants upload an image of their receipt. |
Six months after completion of the intervention
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Stage of change related to seasonal influenza vaccination uptake
Временное ограничение: T0 (baseline), T1 (after completion of intervention), and T2 (six months after completion of the intervention)
|
Participants' SOC will be measured at T0 (baseline), T1 (after completion of intervention), and T2 (six months after completion of the intervention) by using validated questions |
T0 (baseline), T1 (after completion of intervention), and T2 (six months after completion of the intervention)
|
|
Knowledge and attitudes related to seasonal influenza vaccination
Временное ограничение: T0 (baseline) and T2 (6 months after completion of the intervention)
|
Knowledge and attitudes will be measured at T0 (baseline) and T2 (6 months after completion of the intervention) by validated tools |
T0 (baseline) and T2 (6 months after completion of the intervention)
|
Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Другие идентификационные номера исследования
- GRF14611325
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
The data presented in this study are available from the corresponding author upon request. The data are not publicly available as they contain sensitive personal information.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .