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Educational Efficacy Assessment of a Serious Game to Teach Insulin Therapy to Primary Care Physicians

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01759953
Recruitment Status : Completed
First Posted : January 3, 2013
Last Update Posted : December 7, 2015
Information provided by (Responsible Party):
Leandro Arthur Diehl, Universidade Estadual de Londrina

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin

Arm Intervention/treatment
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.
Other: Game
InsuOnline game, on the web, in the player´s own time and rhythm
Other Names:
  • InsuOnline game
  • Serious game
  • Web-based game

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
Other Names:
  • Classroom education
  • Onsite learning session
  • Lecture and clinical cases discussion

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. Attitudes regarding diabetes/insulin [ Time Frame: In up to one year ]
    Average score on web-based Diabetes Attitude Score 3

Other Outcome Measures:
  1. 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

  2. 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.

  3. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01759953

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Hospital Universitário de Londrina
Londrina, PR, Brazil, 86038440
Sponsors and Collaborators
Universidade Estadual de Londrina
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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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Leandro Arthur Diehl, Assistant Professor, Universidade Estadual de Londrina Identifier: NCT01759953    
Other Study ID Numbers: InsuOnline-01
First Posted: January 3, 2013    Key Record Dates
Last Update Posted: December 7, 2015
Last Verified: December 2015
Keywords provided by Leandro Arthur Diehl, Universidade Estadual de Londrina:
Diabetes Mellitus
Video Games
Medical Education
Educational Technology
Continuing Medical Education
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases