NCT05637749

Brief Summary

The goal of this study is to access the effect of facilitation on amount of psychological Flow generated in medical students playing a medical serious game. Students will be randomly assigned to play a serious game designed to revise diabetes management knowledge with and without a facilitator and the amount of Flow experienced compared. They will then be invited to partake in a focus group discussion to elicit insights into the mechanism of action governing facilitator-induced Flow

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 24, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 5, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2023

Completed
Last Updated

March 21, 2024

Status Verified

March 1, 2024

Enrollment Period

7 months

First QC Date

November 24, 2022

Last Update Submit

March 19, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Flow Short Scale (FSS) scores

    The FSS comprises 13 items on a 7-point Likert scale ranging from 1 ("not at all) to 7 ("very much"). It demonstrates good construct validity, psychometric properties, and a stable three-factor structure comprising fluency of performance, absorption by activity, and perceived importance or outcome importance of said activity.

    Immediately upon conclusion of the game activity

Study Arms (2)

Control

EXPERIMENTAL

Serious game intervention to be played as is, without facilitation.

Other: Medical serious game intervention (educational)

Intervention

ACTIVE COMPARATOR

Serious game intervention to be played with facilitator present in game environment.

Other: Medical serious game intervention (educational)

Interventions

Medical serious game designed to facilitate the rehearsal of diabetes management knowledge. Players are presented with a colony of individuals, all of whom have some form of diabetes, and are tasked to manage food, insulin, and medication intake throughout the day. The intervention may be played with a facilitator.

Intervention

Eligibility Criteria

Age19 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects enrolled in M1 through to M5 of the MBBS program under LKCMedicine.

You may not qualify if:

  • Students who have previously partaken in play testing of the intervention
  • Students not enrolled in the Bachelor of Medicine and Bachelor of Surgery (MBBS) program under LKCMedicine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lee Kong Chian School of Medicine

Singapore, 308232, Singapore

Location

Related Publications (1)

  • Tan JW, Tan G, Lian X, Chong DKS, Rajalingam P, Dalan R, Mogali SR. Impact of Facilitation on Cognitive Flow in a Novel Diabetes Management Rehearsal Game for Health Professions Education: Mixed Methods, Open-Label, Superiority Randomized Controlled Trial. JMIR Serious Games. 2024 Jul 17;12:e54703. doi: 10.2196/54703.

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Head of Anatomy

Study Record Dates

First Submitted

November 24, 2022

First Posted

December 5, 2022

Study Start

February 1, 2023

Primary Completion

September 6, 2023

Study Completion

September 6, 2023

Last Updated

March 21, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations