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Recruiting NCT05789901

The MARVIN Chatbots to Provide Information for Different Health Conditions

No phase Interventional HIV Infections Breast Cancer Pediatric Emergency Medicine

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MARVIN, MARVIN-Pharma, MARVINA, MARVIN-CHAMP.
Who it may be relevant to
Registry conditions: HIV Infections, Breast Cancer, Pediatric Emergency Medicine. Basic parameters: from 14 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

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

Primary outcome measures

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

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

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

Publications

  • 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

Identifiers

NCT: NCT05789901 · MP-37-2023-9333

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗