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Trial Title:
The MARVIN Chatbots to Provide Information for Different Health Conditions
NCT ID:
NCT05789901
Condition:
HIV Infections
Breast Cancer
Pediatric Emergency Medicine
Conditions: Official terms:
Emergencies
Conditions: 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
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
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
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
MARVIN
Description:
Chatbot on Meta (Facebook) Messenger for HIV Patients
Arm group label:
MARVIN: a Chatbot for HIV patients
Intervention type:
Other
Intervention name:
MARVIN-Pharma
Description:
Chatbot on Meta (Facebook) Messenger for community pharmacists
Arm group label:
MARVIN: a Chatbot for Community Pharmacists
Intervention type:
Other
Intervention name:
MARVINA
Description:
Chatbot on Meta (Facebook) Messenger for breast cancer patients
Arm group label:
MARVINA: a Chatbot for Breast Cancer Patients
Intervention type:
Other
Intervention name:
MARVIN-CHAMP
Description:
CHatbot to Assist the Management of Pediatric patients with infectious conditions (CHAMP)
Arm group label:
MARVIN CHAMP: a Chatbot for Pediatric Infectious Conditions
Other name:
CHatbot to Assist the Management of Pediatric patients with infectious conditions
Other name:
CHAMP
Other name:
CHAMPIONS
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.
Criteria for 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)
Gender:
All
Minimum age:
14 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Centre hospitalier de l'Université de Montréal (CHUM)
Address:
City:
Montréal
Zip:
H2X 3E4
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Marie-Pacale Pomey, MD, PhD
Phone:
514 890 8000
Phone ext:
14302
Email:
marie-pascale.pomey@umontreal.ca
Facility:
Name:
McGill University Health Centre (MUHC)
Address:
City:
Montréal
Zip:
H4A 3J1
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Bertrand Lebouché, MD, PhD
Phone:
5148432090
Email:
bertrand.lecbouche@mcgill.ca
Investigator:
Last name:
Esli Osmanlliu, MDCM, MSc
Email:
Sub-Investigator
Start date:
March 1, 2024
Completion date:
December 31, 2034
Lead sponsor:
Agency:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Agency class:
Other
Collaborator:
Agency:
Centre hospitalier de l'Université de Montréal (CHUM)
Agency class:
Other
Source:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05789901
