The MARVIN Chatbots to Provide Information for Different Health Conditions

Not Applicable

Recruiting

• Conditions: Breast Cancer; Pediatric Emergency Medicine; HIV Infections

• Registration Number: NCT05789901
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

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.

Study Timeline

• Study First Submitted: 2023-03-14
• Study First Submitted QC: 2023-03-27
• Study First Posted: 2023-03-29
• Status Verified: 2024-03
• Study Start: 2024-03-01
• Last Update Submitted: 2024-03-04
• Last Update Posted: 2024-03-06
• Primary Completion: 2033-12-31
• Study Completion: 2034-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Not provided

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Acceptability E-Scale (AES)	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)	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	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	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	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.

Trial Locations

Locations (2)

Centre hospitalier de l'Université de Montréal (CHUM); 🇨🇦 Montréal, Quebec, Canada

McGill University Health Centre (MUHC); 🇨🇦 Montréal, Quebec, Canada