The MARVIN Chatbots to Provide Information for Different Health Conditions

NCT05789901 | Recruiting

• 1 other identifier: MP-37-2023-9333
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (5)

• Usability Metric for User eXperience (UMUX-Lite)

  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.

  Immediately, after 1-month of testing - objective 2

• Acceptability E-Scale (AES)

  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.

  Immediately after 1-month of testing - objective 2

• Change in Acceptability E-Scale (AES) over 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.

  Once every 3 months within 12 months

• Change in Intervention Appropriateness Measure (IAM) over 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.

  Once every 3 months within 12 months

• Change in Compatibility Subscale over 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.

  Once every 3 months within 12 months

Study Arms (4)

MARVIN: a Chatbot for HIV patients

OTHER

Co-construction of the chatbot, Usability study, Implementation, Evaluation of outcomes and Continuous improvements

Other: MARVIN

MARVIN: a Chatbot for Community Pharmacists

OTHER

Co-construction of the chatbots, Usability study, Implementation, Evaluation of outcomes and Continuous improvements

Other: MARVIN-Pharma

MARVINA: a Chatbot for Breast Cancer Patients

OTHER

Co-construction of the chatbots, Usability study, Implementation, Evaluation of outcomes and Continuous improvements

Other: MARVINA

MARVIN CHAMP: a Chatbot for Pediatric Infectious Conditions

OTHER

Co-construction of the chatbots, Usability study, Implementation, Evaluation of outcomes and Continuous improvements

Other: MARVIN-CHAMP

Interventions

MARVIN OTHER

Chatbot on Meta (Facebook) Messenger for HIV Patients

MARVIN: a Chatbot for HIV patients

MARVIN-Pharma OTHER

Chatbot on Meta (Facebook) Messenger for community pharmacists

MARVIN: a Chatbot for Community Pharmacists

MARVINA OTHER

Chatbot on Meta (Facebook) Messenger for breast cancer patients

MARVINA: a Chatbot for Breast Cancer Patients

MARVIN-CHAMP OTHER

CHatbot to Assist the Management of Pediatric patients with infectious conditions (CHAMP)

Also known as: CHatbot to Assist the Management of Pediatric patients with infectious conditions, CHAMP, CHAMPIONS

MARVIN CHAMP: a Chatbot for Pediatric Infectious Conditions

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Centre hospitalier de l'Université de Montréal (CHUM): collaborator

Study Sites (2)

Centre hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 3E4, Canada

RECRUITING

McGill University Health Centre (MUHC)

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

Related Publications (1)

• 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.

  PMID: 38349734 BACKGROUND

MeSH Terms

Conditions

HIV Infections; Breast Neoplasms

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Bertrand Lebouché, MD

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bertrand Lebouché, MD

CONTACT

514-843-2090; bertrand.lebouche@mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Scientist

Model Details: 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.

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: March 29, 2023
• Study Start: March 1, 2024
• Primary Completion (Estimated): December 31, 2033
• Study Completion (Estimated): December 31, 2034
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)