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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05963802
Other study ID # AIHSS01
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2023
Est. completion date December 1, 2023

Study information

Verified date February 2024
Source Carleton University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Crossover Randomized Control trial, in which subjects are randomly assigned to one of two groups: one (ChatGPT) receiving the intervention that is being tested, and the control group receiving usual online resources.


Description:

A two-stage randomization strategy will be adopted. The allocation of participants into event groups A and B will be determined through computer-generated randomization in an allocation ratio: 1:1. To address ethical concerns regarding power dynamics between professors and students; the investigators have opted to involve an individual who is independent of the research team. This decision aims to minimize any potential bias or influence that could arise from direct professor involvement in the intervention. This approach helps ensure that the study is conducted fairly and unbiasedly, fostering a research environment that prioritizes equal opportunities for all participants. Both groups will simultaneously work on an assignment (A and B). The investigators employed a cross-over design to ensure equity in the learning experience for all students. This involved assigning students either the ChatGPD (A) or the regular online tools (B) for accessing resources and assisting them with their assignments. During the initial phase of the intervention, participants in group A will utilize ChatGPT to complete their assignments, while participants in Group B will serve as the control group. In the subsequent period, the interventions will switch between the two groups. To assess the participants' technology usability, both groups will complete pre-and post-questionnaires. Additionally, participants will be requested to fill out a post-intervention questionnaire to evaluate their perceptions of the assistance methods. After a period of a wash-out of 13 days/week, participants who were previously allocated to Group A will be allocated to Group B and the same with participants previously allocated to Group B will be to Group A. This crossover randomized control trial will include 50 health sciences students who are registered to the course Chronic Health Conditions and Disability ( HLTH 3503), Carleton University. During the first part of the intervention, A group will use ChatGPT to complete their assignment, while B participants will act as a control group. In the second week, the interventions will cross over. Both groups' participants will complete a pre-and post-questionnaire to assess their knowledge. Participants will also complete a post-intervention questionnaire to evaluate their perceptions. The System Usability Scale (SUS) will be administered at the end of the interventions and when participants cross over to the other assistance tool. This allows for the assessment of outcomes and comparisons within and between the two intervention arms. By collecting data at multiple points in the study, the investigators can evaluate the effects of each intervention and any potential carryover effects during the crossover period. Additionally, it provides an opportunity to measure changes in outcomes within individual participants as they switch from one intervention to another. The questionnaire about socioeconomic, literacy questions, Benefits of AI and risks and negative experiences associated with AI usage.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date December 1, 2023
Est. primary completion date December 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Health Science students - Must be registered for the course Chronic Health Conditions and Disability (HLTH 3503), Fall 2023. Exclusion Criteria: • Unable to provide informed consent

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Artificial Intelligence (ChatGPT) Group
Participants in Group A will be assigned to utilize ChatGPT as their tool to complete assignments. They will be given a period of six days to utilize artificial intelligence through ChatGPT for assignment completion. Along with the assignment instructions, participants will receive an ethical guideline and specific guidelines on how to effectively utilize ChatGPT. Once the intervention period is concluded, participants will be given a 24-hour window to complete a survey that assesses the usability of the technology. The survey aims to gather valuable feedback on the participants' experience and perception of using ChatGPT for their assignments. In addition, participants in Arm 1 will also be asked to fill out a survey regarding their perception of using artificial intelligence (AI) as an assistance tool to complete their assignments. This survey aims to gather insights into their thoughts, opinions, and attitudes towards utilizing AI in the learning process.

Locations

Country Name City State
Canada Carleton University Ottawa

Sponsors (2)

Lead Sponsor Collaborator
Carleton University Université de Montréal

Country where clinical trial is conducted

Canada, 

References & Publications (4)

Dwan K, Li T, Altman DG, Elbourne D. CONSORT 2010 statement: extension to randomised crossover trials. BMJ. 2019 Jul 31;366:l4378. doi: 10.1136/bmj.l4378. — View Citation

Liu X, Rivera SC, Moher D, Calvert MJ, Denniston AK; SPIRIT-AI and CONSORT-AI Working Group. Reporting guidelines for clinical trial reports for interventions involving artificial intelligence: the CONSORT-AI Extension. BMJ. 2020 Sep 9;370:m3164. doi: 10. — View Citation

Luna A, Casertano L, Timmerberg J, O'Neil M, Machowsky J, Leu CS, Lin J, Fang Z, Douglas W, Agrawal S. Artificial intelligence application versus physical therapist for squat evaluation: a randomized controlled trial. Sci Rep. 2021 Sep 13;11(1):18109. doi — View Citation

Zhou L, Bao J, Setiawan IMA, Saptono A, Parmanto B. The mHealth App Usability Questionnaire (MAUQ): Development and Validation Study. JMIR Mhealth Uhealth. 2019 Apr 11;7(4):e11500. doi: 10.2196/11500. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary System Usability Scale (SUS) scores are 0-100,The average SUS score is 68. Technology usability within 24 hours
Secondary Student's perception of artificial intelligence, questionnaire reviwed by experts, No recognised gold standard measurement for outcome. Student's perception about the use of artificial intelligence within 24 hours
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