Educational Efficacy Assessment of a Serious Game to Teach Insulin Therapy to Primary Care Physicians
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Purpose
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 | Intervention |
|---|---|
|
Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Knowledge, Attitudes, Practice |
Other: Game Other: Traditional CME |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) |
| Official Title: | Randomized Controlled Trial to Assess the Educational Efficacy of a Serious Game for Teaching Insulin Therapy to Primary Care Physicians |
- Knowledge on insulin therapy for diabetes [ Time Frame: In up to one year ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Average score on web-based Diabetes Attitude Score 3
- General impressions about the intervention [ Time Frame: In up to one year ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Main reasons for not finishing the game, for the participants who do not play the InsuOnline game until its end.
| Estimated Enrollment: | 160 |
| Study Start Date: | June 2013 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
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Other: Game
InsuOnline game, on the web, in the player´s own time and rhythm
Other Names:
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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
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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
Other Names:
|
Show Detailed Description
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Primary care physicians working in Londrina or other cities from the state of Paraná, Brazil
Exclusion Criteria:
- Clinical Endocrinologists
- Diabetologists
- Refuse to participate in the study
Contacts and Locations| Contact: Leandro Diehl, M.D., MsC | +554399022581 | drgaucho@yahoo.com |
| Contact: Pedro Gordan, M.D., PhD | +554399293132 | gordan@sercomtel.com.br |
| Brazil | |
| Hospital Universitário de Londrina | Not yet recruiting |
| Londrina, PR, Brazil, 86038440 | |
| Contact: Leandro A Diehl, M.D., MsC +554399022581 drgaucho@yahoo.com | |
| Principal Investigator: Leandro A Diehl, M.D., MsC | |
| 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 |
More Information
Publications:
| Responsible Party: | Leandro Arthur Diehl, Assistant Professor, Universidade Estadual de Londrina |
| ClinicalTrials.gov Identifier: | NCT01759953 History of Changes |
| Other Study ID Numbers: | InsuOnline-01 |
| Study First Received: | December 21, 2012 |
| Last Updated: | December 31, 2012 |
| Health Authority: | Brazil: National Committee of Ethics in Research Brazil: Ministry of Health |
Keywords provided by Universidade Estadual de Londrina:
|
Diabetes Mellitus Insulin Video Games |
Medical Education Educational Technology Continuing Medical Education |
Additional relevant MeSH terms:
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Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Autoimmune Diseases Immune System Diseases Insulin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013