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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2012 by Universidade Estadual de Londrina
Sponsor:
Information provided by (Responsible Party):
Leandro Arthur Diehl, Universidade Estadual de Londrina
ClinicalTrials.gov Identifier:
NCT01759953
First received: December 21, 2012
Last updated: December 31, 2012
Last verified: December 2012
  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

Resource links provided by NLM:


Further study details as provided by Universidade Estadual de Londrina:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Other Outcome Measures:
  • 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.
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

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01759953

Contacts
Contact: Leandro Diehl, M.D., MsC +554399022581 drgaucho@yahoo.com
Contact: Pedro Gordan, M.D., PhD +554399293132 gordan@sercomtel.com.br

Locations
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         
Sponsors and Collaborators
Universidade Estadual de Londrina
Investigators
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:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014