Melanoma (Skin)NCT06254547
Leaderboard Influence on Self-Regulated Training in a Gamified Dermoscopy Training App
A study testing Daily updated ranking on leaderboard and Daily motivational message in people with Melanoma (Skin) and Skin Cancer, run by Herlev Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Melanoma (Skin), Skin Cancer
- What is being tested?
- Daily updated ranking on leaderboard and Daily motivational message
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteDenmark
- Study dates
- 27 Jan 2024to 3 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Medical student at a Danish university
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Herlev Hospital
Herlev, 2730
Sigrid Kristensen, Bsc.med, 42434557, sigrid.ip.kristensen@gmail.com
About this study
Official title: Do Leaderboards Improve Self-regulated Training in a Gamified Dermoscopy Training App? A Randomized, Controlled Trial.
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:
Read more
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.
Read the detailed 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 § 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.
- Conditions
- Melanoma (Skin), Skin Cancer
- Being tested
- Daily updated ranking on leaderboard, Daily motivational message
- Keywords
- Education, Skin Cancer, Gamification, Leaderboard, Diagnostic Accuracy, Self-regulated learning
- Medical subject headings
- Melanoma, Skin Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily updated ranking on leaderboardOther
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 messageOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Motivational messages and leaderboard | Experimental | This group will receive daily reminders/motivational messages. They will be able to view their personal score and will be ranked on a daily updated leaderboard. Receives: Other: Daily updated ranking on leaderboard |
| Only motivational messages | Experimental | This group will receive daily reminders/motivational messages. They will be able to view their personal score, but they will not be ranked on a leaderboard. Receives: Other: Daily motivational message |
| Control | No intervention | This group will be able to view their personal score, but will not be ranked on a leaderboard or receive daily reminders/motivational messages. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time spent training
The participant's time spent with the platform, measured by the platform
Measured: Three weeks
Amount of cases
The number of cases participants assign a diagnosis to, measured by the platform
Measured: Three weeks
Change in diagnostic accuracy
Measured as a percentage of correctly diagnoses skin lesions in validated multiple choice questionnaire
Measured: Three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2024
- Study start27 Jan 2024
- Primary completion25 Feb 2024 (estimated)
- Study completion3 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma (Skin)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sigrid I. P. Kristensen, Herlev Hospital
- Investigators
- Martin Frendø, MD, PhD, Study director, Copenhagen Academy for Medical Education and Simulation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06254547
- Sponsor's protocol ID
- DL_Leaderboard_MS_01
- Status last verified
- Feb 2024
- First submitted
- 26 Jan 2024
- Last updated
- 12 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Leaderboards Improve Self-regulated Training in a Gamified Dermoscopy Training App? A Randomized, Controlled Trial.
- ClinicalTrials.gov ID
- NCT06254547
- Acronym / sponsor ID
- DL_Leaderboard_MS_01
- Conditions
- Melanoma (Skin), Skin Cancer
- Keywords
- Education, Skin Cancer, Gamification, Leaderboard, Diagnostic Accuracy, Self-regulated learning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- 27 Jan 2024 (actual)
- Primary completion
- 25 Feb 2024 (estimated)
- Study completion
- 3 Mar 2024 (estimated)
- First posted
- 12 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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 § 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Motivational messages and leaderboard | Experimental | Other: Daily updated ranking on leaderboardThis group will receive daily reminders/motivational messages. They will be able to view their personal score and will be ranked on a daily updated leaderboard. |
| Only motivational messages | Experimental | Other: Daily motivational messageThis group will receive daily reminders/motivational messages. They will be able to view their personal score, but they will not be ranked on a leaderboard. |
| Control | No intervention | –This group will be able to view their personal score, but will not be ranked on a leaderboard or receive daily reminders/motivational messages. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Medical student at a Danish university
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daily updated ranking on leaderboardThe 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. | Other | Motivational messages and leaderboard |
| Daily motivational messageThe 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. | Other | Only motivational messages |
Primary outcome
Time spent training
Time frame: Three weeks
The participant's time spent with the platform, measured by the platform
Amount of cases
Time frame: Three weeks
The number of cases participants assign a diagnosis to, measured by the platform
Change in diagnostic accuracy
Time frame: Three weeks
Measured as a percentage of correctly diagnoses skin lesions in validated multiple choice questionnaire
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Frendø, MD, PhD study director
Copenhagen Academy for Medical Education and Simulation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daily updated ranking on leaderboard and Daily motivational message in people with Melanoma (Skin) and Skin Cancer, run by Herlev Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sigrid Kristensen, Bsc.med (+4542434557, sigrid.ip.kristensen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time spent training (time frame: Three weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2024.