Clinical trial NCT05789901: The MARVIN Chatbots to Provide Information for Different Health Conditions
Official title: A Master Research Protocol to Adapt and Evaluate an Artificial Intelligence Based Conversational Agent to Provide Information for Different Health Conditions: the MARVIN Chatbots
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: HIV Infections
Breast Cancer
Pediatric Emergency Medicine
Keywords: Chatbot
Intelligent Conversational Agent
Co-Construction
Adherence
Antiretroviral Therapy
mHealth
Implementation Science
Care
Breast Cancer
HIV
Self-Management
Adaptive Platform Trial Design
Telehealth
Digital Health
Artificial Intelligence
Pediatric Emergency Medicine
Patient and Stakeholder Engagement
Pediatric Infection
Large Language Models
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
Collaborators: name: Centre hospitalier de l'Université de Montréal (CHUM)
First posted: 2023-03-29
Enrollment: 400
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators adopt a platform trial design, which is defined as "a study designed to evaluate multiple interventions in the context of a single disease in a perpetual manner, with therapies allowed to enter or leave the platform on the basis of a decision algorithm.". Platform trials can also integrate elements of basket trial design, which aims to study a single intervention for different diseases. In the current case, with different healthcare settings and diseases or conditions under study, the investigators would have a mix of platform trial and basket trial designs for an adaptative platform trial design. Such will allow flexibility in handling multiple interventions adapted to different populations while retaining platform trial characteristics, such as early withdrawal of ineffective trial arms based on interim data (implementation outcomes) and introduction of new trial arms. Meanwhile, there is no initial fixed duration or sample size for each arm.
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Usability Metric for User eXperience (UMUX-Lite)
timeFrame: Immediately, after 1-month of testing - objective 2
measure: Acceptability E-Scale (AES)
timeFrame: Immediately after 1-month of testing - objective 2
measure: Change in Acceptability E-Scale (AES) over 12 months
timeFrame: Once every 3 months within 12 months
measure: Change in Intervention Appropriateness Measure (IAM) over 12 months
timeFrame: Once every 3 months within 12 months
measure: Change in Compatibility Subscale over 12 months
timeFrame: Once every 3 months within 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Centre hospitalier de l'Université de Montréal (CHUM)
state: Quebec
city: Montréal
country: Canada
facility: McGill University Health Centre (MUHC)
state: Quebec
Study officials:
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Bertrand Lebouché, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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 Trial (the MARVIN Chatbots Study). JMIR Res Protoc. 2024 Feb 13;13:e54668. doi: 10.2196/54668.