A Master Research Protocol to Adapt and Evaluate an Artificial Intelligence Based Conversational Agent to Provide Information for Different Health Conditions: the MARVIN Chatbots
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 4
- 主要终点
- Acceptability E-Scale (AES)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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)
研究组 & 干预措施
MARVIN: a Chatbot for HIV patients
Co-construction of the chatbot, Usability study, Implementation, Evaluation of outcomes and Continuous improvements
干预措施: MARVIN (Other)
MARVIN: a Chatbot for Community Pharmacists
Co-construction of the chatbots, Usability study, Implementation, Evaluation of outcomes and Continuous improvements
干预措施: MARVIN-Pharma (Other)
MARVINA: a Chatbot for Breast Cancer Patients
Co-construction of the chatbots, Usability study, Implementation, Evaluation of outcomes and Continuous improvements
干预措施: MARVINA (Other)
MARVIN CHAMP: a Chatbot for Pediatric Infectious Conditions
Co-construction of the chatbots, Usability study, Implementation, Evaluation of outcomes and Continuous improvements
干预措施: MARVIN-CHAMP (Other)
结局指标
主要结局
Acceptability E-Scale (AES)
时间窗: Immediately after 1-month of testing - objective 2
The AES contains 6 items rated with different 5-point Likert scales (e.g., 1=very difficult to 5=very easy). It is a validated measure of acceptability and usability of computer-based interventions for health populations. Scores range from 0 to 30, and according to the literature, scores above 24 are considered high acceptability.
Usability Metric for User eXperience (UMUX-Lite)
时间窗: Immediately, after 1-month of testing - objective 2
The UMUX-Lite is a 2-item questionnaire, answered on a 7-point Likert scale (1 = strongly disagree to 5 = strongly agree), that was deemed appropriate for evaluating medical technology. The items ask whether the chatbot meets the user's needs and the user's perceived ease of use. Scores range from 0 to 100, with more than 68 being considered high usability according to the literature.
Change in Acceptability E-Scale (AES) over 12 months
时间窗: Once every 3 months within 12 months
The AES contains 6 items rated with different 5-point Likert scales (e.g., 1=very difficult to 5=very easy). It is a validated measure of acceptability and usability of computer-based interventions for health populations. Scores range from 0 to 30, and according to the literature, scores above 24 are considered high acceptability.
Change in Intervention Appropriateness Measure (IAM) over 12 months
时间窗: Once every 3 months within 12 months
Appropriateness relates to the relevance or compatibility of the innovation to address a particular issue or problem. The compatibility of an information technology innovation is the extent of which it is considered consistent with users' values, needs, and past experiences. The Compatibility Subscale is a validated tool that contains three items and evaluates on 7-points Likert scales (1 = extremely disagree to 7 = extremely agree) how an IT innovation "fits" with the user's work style. A modified version could be used by healthcare professionals, such as pharmacists.
Change in Compatibility Subscale over 12 months
时间窗: Once every 3 months within 12 months
Appropriateness relates to the relevance or compatibility of the innovation to address a particular issue or problem. The compatibility of an information technology innovation is the extent of which it is considered consistent with users' values, needs, and past experiences. A validated tool that could be used by patients is the Intervention Appropriateness Measure (IAM). It also contains 4 items scored on a five-point Likert scale (1=strongly disagree to 5=strongly agree) of agreement evaluating how the innovation is suitable for users.
次要结局
未报告次要终点
研究者
Dr. Bertrand Lebouche
Clinical Scientist
McGill University Health Centre/Research Institute of the McGill University Health Centre