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Идёт набор NCT05789901

The MARVIN Chatbots to Provide Information for Different Health Conditions

Без фазы С лечением HIV Infections Breast Cancer Pediatric Emergency Medicine

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: MARVIN, MARVIN-Pharma, MARVINA, MARVIN-CHAMP.
Кому может быть актуально
Состояния в реестре: HIV Infections, Breast Cancer, Pediatric Emergency Medicine. Базовые параметры: от 14 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
Канада
Следующий шаг
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Официальное название

A Master Research Protocol to Adapt and Evaluate an Artificial Intelligence Based Conversational Agent to Provide Information for Different Health Conditions: the MARVIN Chatbots

Обзор

This research is a continuation of a usability study with the MARVIN chatbot. The investigators aim to adapt the MARVIN chatbot to open it to other health domains (e.g. breast cancer) and populations (e.g. pharmacists). Therefore, this protocol constitutes a master research protocol that will englobe different research projects with individual chatbots. The investigators adopt an adaptive platform trial design, which will allow flexibility in handling multiple interventions adapted to different populations while retaining the characteristics of a platform trial design allowing early withdrawal of ineffective trial arms based on interim data (implementation outcomes) and introduction of new trial arms.

Подробное описание

From 2020, the Principal Investigator's team has developed an innovative chatbot named Minimal AntiretRoViral INterference (MARVIN), for people with HIV. The primary objectives with this master protocol are to: 1) develop or adapt the MARVIN chatbots for different healthcare contexts through co-construction; 2) evaluate the global usability of individual chatbots in their respective use scenarios with a small sample of research participants; 3) evaluate the implementation and user outcomes (e.g., fidelity, appropriateness) of individual chatbots in their respective use scenarios with a larger sample of research participants. This includes also documentation of factors that inhibit or enhance the utilization of the chatbots and outcomes; and 4) establish and evaluate, through the previous objectives, different partnerships with research participants and research team members to co-construct chatbots that will respond to their needs and encourage continued use of the tool.

Вмешательства

  • Другое MARVIN
    Chatbot on Meta (Facebook) Messenger for HIV Patients
  • Другое MARVIN-Pharma
    Chatbot on Meta (Facebook) Messenger for community pharmacists
  • Другое MARVINA
    Chatbot on Meta (Facebook) Messenger for breast cancer patients
  • Другое MARVIN-CHAMP
    CHatbot to Assist the Management of Pediatric patients with infectious conditions (CHAMP)

Первичные конечные точки

  • Usability Metric for User eXperience (UMUX-Lite) [Срок оценки: Immediately, after 1-month of testing - objective 2]
  • Acceptability E-Scale (AES) [Срок оценки: Immediately after 1-month of testing - objective 2]
  • Change in Acceptability E-Scale (AES) over 12 months [Срок оценки: Once every 3 months within 12 months]
  • Change in Intervention Appropriateness Measure (IAM) over 12 months [Срок оценки: Once every 3 months within 12 months]
  • Change in Compatibility Subscale over 12 months [Срок оценки: Once every 3 months within 12 months]

Критерии участия

Inclusion Criteria for all objectives:

  • being 14 years or older;
  • being fluent in English and/or French;
  • being able to understand the requirements of study participation and provide informed consent during the duration of the study;
  • having access to a smartphone, tablet, or computer at home/at workplace;
  • having access to an internet connection at home or data plan on their device.

Inclusion Criteria Specific to objectives 2 and 3:

  • accept to use a Facebook Messenger-based Chatbot;
  • accept to use or create a personal Facebook account;
  • accept Facebook's privacy and data security policies.

Критерии исключения

  • not meeting the inclusion criteria
  • any reason, in the opinion of the investigator, which would make the candidate inappropriate for participation in an investigative study involving a chatbot (e.g., cognitive deficit)

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Канада · 2 центра
  • Centre hospitalier de l'Université de Montréal (CHUM) — Montreal
  • McGill University Health Centre (MUHC) — Montreal

Публикации

  • Ma Y, Achiche S, Pomey MP, Paquette J, Adjtoutah N, Vicente S, Engler K; MARVIN chatbots Patient Expert Committee; Laymouna M, Lessard D, Lemire B, Asselah J, Therrien R, Osmanlliu E, Zawati MH, Joly Y, Lebouche B. Adapting and Evaluating an AI-Based Chatbot Through Patient and Stakeholder Engagement to Provide Information for Different Health Conditions: Master Protocol for an Adaptive Platform T PMID 38349734

Идентификаторы

NCT: NCT05789901 · MP-37-2023-9333

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗