Educational Efficacy Assessment of a Serious Game to Teach Insulin Therapy to Primary Care Physicians
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|ClinicalTrials.gov Identifier: NCT01759953|
Recruitment Status : Completed
First Posted : January 3, 2013
Last Update Posted : December 7, 2015
Background: Physicians´ lack of knowledge contributes to underuse of insulin and poor glycemic control in adults with diabetes mellitus (DM). Traditional continuing medical education have limited efficacy, so new approaches are required.
Objective: We report the design of a trial to assess the educational efficacy of InsuOnline©, a game for education of primary care physicians (PCPs) on initiation and adjustment of insulin for the treatment of DM, which was designed to be: a) educationally adequate; and b) self-motivating and attractive.
Methods: A multidisciplinary team, with endocrinologists, experts in medical education, and programmers, was assembled for design and development of InsuOnline©, a serious game which includes game elements and a well-defined, evidence-based curriculum of topics on insulin therapy. The first step of our study will be usability and playability tests, with PCPs and medical students, playing the game on a desktop. After that and further adjusts, we will perform an unblinded randomized controlled trial, with PCPs who work in the city of Londrina, to assess the educational validity of the game. A group of 64 PCPs will play InsuOnline© on the web, and the control group, of 64 PCPs, will underwent traditional teaching activities (lecture and group discussion). Knowledge on how to initiate and adjust insulin will be assessed by a web-based multiple-choice questionnaire, and attitudes regarding diabetes/insulin will be assessed by Diabetes Attitude Scale 3, at 3 time points: before, immediately after, and 6 months after the intervention. Subjects´ general impressions on the interventions will also be assessed by free-text questions. Software logs will be reviewed.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Knowledge, Attitudes, Practice||Other: Game Other: Traditional CME||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||170 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Controlled Trial to Assess the Educational Efficacy of a Serious Game for Teaching Insulin Therapy to Primary Care Physicians|
|Study Start Date :||July 2014|
|Actual Primary Completion Date :||December 2015|
|Actual Study Completion Date :||December 2015|
Active Comparator: InsuOnline game
Playing the InsuOnline game, on the web, in the player´s own time and rhythm, until its end, as already described previously.
InsuOnline game, on the web, in the player´s own time and rhythm
Active Comparator: Traditional CME
Traditional learning session as used for Continuing Medical Education, on insulin therapy, including a short lecture and a group discussion of the same clinical cases presented in the InsuOnline game
Other: Traditional CME
In-classroom traditional learning session about insulin therapy for diabetes, using a presential short lecture and a group discussion of the same clinical cases presented in the InsuOnline game
- Knowledge on insulin therapy for diabetes [ Time Frame: In up to one year ]Average number of correct answers to a standardized web-based questionnaire on use of insulin for treatment of diabetes
- Attitudes regarding diabetes/insulin [ Time Frame: In up to one year ]Average score on web-based Diabetes Attitude Score 3
- General impressions about the intervention [ Time Frame: In up to one year ]Comments from the participants about how they enjoyed the educational experience, assessed by a few web-based Likert-scale and free-text questions
- Usage data [ Time Frame: In up to one year ]Review of game usage data, collected from software-generated logs for each player: time spent on the game, number of logins, etc.
- Reasons for not finishing the game [ Time Frame: In up to one year ]Main reasons for not finishing the game, for the participants who do not play the InsuOnline game until its end.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01759953
|Hospital Universitário de Londrina|
|Londrina, PR, Brazil, 86038440|
|Principal Investigator:||Leandro A Diehl, M.D., MsC||Universidade Estadual de Londrina|
|Study Director:||Pedro A Gordan, M.D., PhD||Universidade Estadual de Londrina|
|Study Chair:||Izabel CM Coelho, M.D., PhD||Faculdades Pequeno Príncipe|