NCT05963802

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 4, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 27, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

February 6, 2024

Status Verified

February 1, 2024

Enrollment Period

3 months

First QC Date

July 4, 2023

Last Update Submit

February 5, 2024

Conditions

Keywords

Artificial intelligenceEducationHealth Science Students

Outcome Measures

Primary Outcomes (1)

  • System Usability Scale (SUS) scores are 0-100,The average SUS score is 68.

    Technology usability

    within 24 hours

Secondary Outcomes (1)

  • Student's perception of artificial intelligence, questionnaire reviwed by experts, No recognised gold standard measurement for outcome.

    within 24 hours

Study Arms (2)

Traditional Online tools Group

NO INTERVENTION

Group B will serve as the control group in this study. Participants in this group will receive instructions on how to complete the assignment using traditional online tools available on the internet, without the use of artificial intelligence. They will have a timeframe of six days to complete the assignment using these conventional tools. Similar to participants in Arm 1, they will also be required to fill out a survey on technology usability, providing feedback on their experience with the online tools.

Artificial Intelligence (ChatGPT) Group

EXPERIMENTAL

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

Other: Artificial Intelligence (ChatGPT) Group

Interventions

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.

Artificial Intelligence (ChatGPT) Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Health Science students
  • Must be registered for the course Chronic Health Conditions and Disability (HLTH 3503), Fall 2023.

You may not qualify if:

  • Unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carleton University

Ottawa, Canada

Location

Related Publications (5)

  • 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.

  • 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: 10.1038/s41598-021-97343-y.

  • 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: 10.1136/bmj.m3164.

  • 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.

  • Veras M, Dyer JO, Rooney M, Barros Silva PG, Rutherford D, Kairy D. Usability and Efficacy of Artificial Intelligence Chatbots (ChatGPT) for Health Sciences Students: Protocol for a Crossover Randomized Controlled Trial. JMIR Res Protoc. 2023 Nov 24;12:e51873. doi: 10.2196/51873.

MeSH Terms

Interventions

Artificial IntelligencePopulation Groups

Intervention Hierarchy (Ancestors)

AlgorithmsMathematical ConceptsDemographyPopulation Characteristics

Study Officials

  • Mirella Veras, PhD

    Carleton University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Participants will be informed about the interventions they will be assigned to, ensuring transparency in the study. However, the investigator responsible for the allocation will be blinded to the group assignment of each participant, maintaining the integrity of the study design. To collect the outcomes, an individual external to the research team will be involved. This approach helps minimize potential bias and ensures the data collection process remains independent and unbiased.
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: We employed a crossover 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 4, 2023

First Posted

July 27, 2023

Study Start

September 1, 2023

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

February 6, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations