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NCT Number: NCT05789901

The MARVIN Chatbots to Provide Information for Different Health Conditions

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.

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Key information

Conditions

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

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre hospitalier de l'Université de Montréal (CHUM), Montreal, Quebec, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

MARVIN

Other

Chatbot on Meta (Facebook) Messenger for HIV Patients

MARVIN-Pharma

Other

Chatbot on Meta (Facebook) Messenger for community pharmacists

MARVINA

Other

Chatbot on Meta (Facebook) Messenger for breast cancer patients

MARVIN-CHAMP

Other

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

Other names: CHatbot to Assist the Management of Pediatric patients with infectious conditions, CHAMP, CHAMPIONS

Primary outcomes

  1. Usability Metric for User eXperience (UMUX-Lite)

    Time frame: 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.

  2. Acceptability E-Scale (AES)

    Time frame: 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.

  3. Change in Acceptability E-Scale (AES) over 12 months

    Time frame: 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.

  4. Change in Intervention Appropriateness Measure (IAM) over 12 months

    Time frame: 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.

  5. Change in Compatibility Subscale over 12 months

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bertrand Lebouché, MD

CONTACT

[email protected]

514-843-2090

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Centre hospitalier de l'Université de Montréal (CHUM)

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2033
Study completion
2034
First posted
Mar 29, 2023
Registry last updated
Mar 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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