Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06254547
Other study ID # DL_Leaderboard_MS_01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 27, 2024
Est. completion date March 3, 2024

Study information

Verified date February 2024
Source Herlev Hospital
Contact Sigrid Kristensen, Bsc.med
Phone +4542434557
Email sigrid.ip.kristensen@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to examine the isolated effect of leaderboards (scoreboards) and daily training motivation on dermatology skill acquisition and training engagement within a gamified dermoscopy training platform. Research Questions: What is the effect of leaderboards and/or daily motivation on diagnostic accuracy? What is the effect of leaderboards and/or daily motivation on self-regulated learning: time spent training and case amount? What is the effect of leaderboards and/or daily motivation on training distribution? Method: 150 danish medical students will upon inclusion and end of trial answer a Multiple Choice Questionnaire (MCQ). Participants will be asked to download the gamified training platform onto their mobile devices. Within the app participants can access quizzes on a library of 10,000+ skin lesions combined with written educational modules on histopathological skin diagnosis. Participants receive instant feedback on quiz answered. Points are awarded for correct answers and removed for incorrect answers. Participants will be randomized to one of three groups; either receiving no communication from the principal investigator, receiving a daily motivational message, or receiving a once daily updated leaderboard ranking participant's scores. The intervention will last for seven days, followed by a 14-day washout period.


Description:

Subjects will be recruited through advertisements in online forums for medical students across all four Danish medical schools. Upon recruitment, subjects will be included via an on-boarding online meeting. They will be introduced to the study and the training platform, and will, if they choose to participate, complete a consent form, a questionnaire of baseline information (age, gender, university semester, dermatological experience) and a 12-case validated diagnostic pre-test. Participants will be randomized to study groups via sequential block randomization. The intervention will last for seven days. Depending on group randomization, participants will on day two through seven either receive a group daily message using an internet-based messaging service (see appendix) and view a daily updated leaderboard ranking, only receive the group daily message, or receive neither. Within the app, participants are able to train dermoscopy diagnosis through sessions of 10 cases. If participants correctly diagnose 8/10 cases, they will progress to the next session with new 10 cases of a higher difficulty, and so on. If participants do not reach a certain diagnostic accuracy, they will repeat their current level with 10 new cases until they are able to progress. There are a total of 6 session levels. Each case is assigned a difficulty level from one to four, calculated based on the percentage of times it has been answered correctly by previous users. In each session, participants are presented with 40% cases at their current level, 20% of an easier difficulty, 20% of a higher difficulty, and 20% cases of an unspecified difficulty. Participants will be awarded 2 points multiplied by case difficulty for each correct answer. 2 points, multiplied by case difficulty, will be taken away if participants assign a benign diagnosis to a malignant case, and 1 point, multiplied by case difficulty, if a malignant diagnosis is assigned to a benign case. Participants will receive 0 points if a case is correctly classified as benign or malignant, but the precise histological diagnosis is incorrectly guessed (For example guessing melanoma on a basal cell carcinoma case, or nevus on a case of dermatofibroma). Participants will be able to view points earned following each training session, as well as a cumulative total. After the seven-day interventional period, participants will start a 14-day washout period, in which participants can train freely, but no group will receive either daily messages or have access to the leaderboard. After the washout period, participants will be asked to complete a validated 12-case retention test, supervised by a member of the research group in a virtual meeting. As this project is an educational study comprising medical students, it does not fulfill the criteria described in the Danish Scientific Ethical Committees Act ยง 2, and does not require approval by the The Regional Ethical Committee of the Copenhagen Capital Region of Denmark. A waiver has been obtained by The Regional Ethical Committee of the Copenhagen Capital Region of Denmark (case nr. F-23075872) The research group considers this project ethically responsible.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date March 3, 2024
Est. primary completion date February 25, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Medical student at a Danish university Exclusion Criteria: - Have not completed a university-level course on histology - Have completed or are currently enrolled in a clinical university course in dermatology - Prior experience with the app Dermloop Learn or equivalent experience via. courses or by using other training platforms for skin diagnosis.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Daily updated ranking on leaderboard
The intervention will last for seven days. Participants will on day two through seven receive a group daily message using an internet-based messaging service and view a daily updated leaderboard ranking. Leaderboards will demonstrate participant's ranking in their respective group, participant's (anonymized) name, cumulative point total, total case amount, and current level. Participant ranking will be based on the cumulative point total. All groups will have continual access to their personal score. Participants will not receive further training encouragement to train in the app or interact with the research group beyond this, aside from technological aid.
Daily motivational message
The intervention will last for seven days. Participants will on day two through seven receive a group daily message using an internet-based messaging service encouraging training. Participants will not receive further training encouragement to train in the app or interact with the research group beyond this, aside from technological aid.

Locations

Country Name City State
Denmark Herlev Hospital Herlev

Sponsors (1)

Lead Sponsor Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time spent training The participant's time spent with the platform, measured by the platform Three weeks
Primary Amount of cases The number of cases participants assign a diagnosis to, measured by the platform Three weeks
Primary Change in diagnostic accuracy Measured as a percentage of correctly diagnoses skin lesions in validated multiple choice questionnaire Three weeks
See also
  Status Clinical Trial Phase
Completed NCT04062032 - Metabolomic and Inflammatory Effects of Oral Aspirin (ASA) in Subjects at Risk for Melanoma Phase 2
Completed NCT03620019 - Denosumab + PD-1 in Subjects With Stage III/ IV Melanoma Phase 2
Active, not recruiting NCT03291002 - Study of Intratumoral CV8102 in cMEL, cSCC, hnSCC, and ACC Phase 1
Completed NCT04534309 - Behavioral Weight Loss Program for Cancer Survivors in Maryland N/A
Completed NCT00962845 - Hydroxychloroquine in Patients With Stage III or Stage IV Melanoma That Can Be Removed by Surgery Early Phase 1
Completed NCT00324623 - Cyclophosphamide and Fludarabine Followed by Cellular Adoptive Immunotherapy and Vaccine Therapy in Patients With Metastatic Melanoma Phase 1
Completed NCT00104845 - Vaccine Therapy in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Melanoma Phase 1
Completed NCT00096382 - Cyclophosphamide, Fludarabine, and Total-Body Irradiation Followed By Cellular Adoptive Immunotherapy, Autologous Stem Cell Transplantation, and Interleukin-2 in Treating Patients With Metastatic Melanoma Phase 2
Completed NCT00089193 - Vaccine Therapy With or Without Sargramostim in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Melanoma Phase 2
Completed NCT00072124 - Dacarbazine and/or Cisplatin Compared With Complete Metastasectomy in Treating Patients With Stage IV Melanoma Phase 3
Completed NCT00072085 - Immunization With gp100 Protein Vaccine in Treating Patients With Metastatic Melanoma Phase 2
Active, not recruiting NCT00039234 - Interleukin-2 With or Without Histamine Dihydrochloride in Treating Patients With Stage IV Melanoma Metastatic to the Liver Phase 3
Completed NCT00042783 - Vaccine Therapy in Treating Patients With Stage IV Melanoma Phase 2
Completed NCT00049010 - Diagnostic Study to Predict the Risk of Developing Metastatic Cancer in Patients With Stage I or Stage II Melanoma N/A
Completed NCT00006385 - Vaccine Therapy With or Without Biological Therapy in Treating Patients With Metastatic Melanoma Phase 2
Completed NCT00020358 - Vaccine Therapy in Treating Patients With Melanoma Phase 2
Completed NCT00006022 - Interleukin-2 Plus Bryostatin 1 in Treating Patients With Melanoma or Kidney Cancer Phase 1
Completed NCT00005610 - Study of Aerosolized Sargramostim in Treating Patients With Melanoma Metastatic to the Lung Phase 2
Recruiting NCT03767348 - Study of RP1 Monotherapy and RP1 in Combination With Nivolumab Phase 2
Withdrawn NCT00006126 - Peripheral Stem Cell Transplantation in Treating Patients With Melanoma or Small Cell Lung, Breast, Testicular, or Kidney Cancer That is Metastatic or That Cannot Be Treated With Surgery Phase 1