Educational Efficacy Assessment of a Serious Game to Teach Insulin Therapy to Primary Care Physicians
Randomized Controlled Trial to Assess the Educational Efficacy of a Serious Game for Teaching Insulin Therapy to Primary Care Physicians
1 other identifier
interventional
170
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 21, 2012
CompletedFirst Posted
Study publicly available on registry
January 3, 2013
CompletedStudy Start
First participant enrolled
July 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedDecember 7, 2015
December 1, 2015
1.4 years
December 21, 2012
December 4, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Knowledge on insulin therapy for diabetes
Average number of correct answers to a standardized web-based questionnaire on use of insulin for treatment of diabetes
In up to one year
Secondary Outcomes (1)
Attitudes regarding diabetes/insulin
In up to one year
Other Outcomes (3)
General impressions about the intervention
In up to one year
Usage data
In up to one year
Reasons for not finishing the game
In up to one year
Study Arms (2)
InsuOnline game
ACTIVE COMPARATORPlaying the InsuOnline game, on the web, in the player´s own time and rhythm, until its end, as already described previously.
Traditional CME
ACTIVE COMPARATORTraditional 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
Interventions
InsuOnline game, on the web, in the player´s own time and rhythm
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
Eligibility Criteria
You may qualify if:
- Primary care physicians working in Londrina or other cities from the state of Paraná, Brazil
You may not qualify if:
- Clinical Endocrinologists
- Diabetologists
- Refuse to participate in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Universitário de Londrina
Londrina, Paraná, 86038440, Brazil
Related Publications (10)
American Diabetes Association. Standards of medical care in diabetes--2012. Diabetes Care. 2012 Jan;35 Suppl 1(Suppl 1):S11-63. doi: 10.2337/dc12-s011. No abstract available.
PMID: 22187469BACKGROUNDMendes AB, Fittipaldi JA, Neves RC, Chacra AR, Moreira ED Jr. Prevalence and correlates of inadequate glycaemic control: results from a nationwide survey in 6,671 adults with diabetes in Brazil. Acta Diabetol. 2010 Jun;47(2):137-45. doi: 10.1007/s00592-009-0138-z. Epub 2009 Aug 5.
PMID: 19655083BACKGROUNDHayes RP, Fitzgerald JT, Jacober SJ. Primary care physician beliefs about insulin initiation in patients with type 2 diabetes. Int J Clin Pract. 2008 Jun;62(6):860-8. doi: 10.1111/j.1742-1241.2008.01742.x. Epub 2008 Apr 3.
PMID: 18393965BACKGROUNDPeyrot M, Rubin RR, Lauritzen T, Skovlund SE, Snoek FJ, Matthews DR, Landgraf R, Kleinebreil L; International DAWN Advisory Panel. Resistance to insulin therapy among patients and providers: results of the cross-national Diabetes Attitudes, Wishes, and Needs (DAWN) study. Diabetes Care. 2005 Nov;28(11):2673-9. doi: 10.2337/diacare.28.11.2673.
PMID: 16249538BACKGROUNDLehmann ED. Interactive educational simulators in diabetes care. Med Inform (Lond). 1997 Jan-Mar;22(1):47-76. doi: 10.3109/14639239709089834.
PMID: 9183780BACKGROUNDInzucchi SE, Bergenstal RM, Buse JB, Diamant M, Ferrannini E, Nauck M, Peters AL, Tsapas A, Wender R, Matthews DR; American Diabetes Association (ADA); European Association for the Study of Diabetes (EASD). Management of hyperglycemia in type 2 diabetes: a patient-centered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2012 Jun;35(6):1364-79. doi: 10.2337/dc12-0413. Epub 2012 Apr 19. No abstract available.
PMID: 22517736BACKGROUNDLerario AC, Chacra AR, Pimazoni-Netto A, Malerbi D, Gross JL, Oliveira JE, Gomes MB, Santos RD, Fonseca RM, Betti R, Raduan R. Algorithm for the treatment of type 2 diabetes: a position statement of Brazilian Diabetes Society. Diabetol Metab Syndr. 2010 Jun 8;2(1):35. doi: 10.1186/1758-5996-2-35.
PMID: 20529311BACKGROUNDAkl EA, Sackett K, Pretorius R, Erdley S, Bhoopathi PS, Mustafa R, Schunemann HJ. Educational games for health professionals. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD006411. doi: 10.1002/14651858.CD006411.pub2.
PMID: 18254103BACKGROUNDDiehl LA, Souza RM, Gordan PA, Esteves RZ, Coelho IC. InsuOnline, an Electronic Game for Medical Education on Insulin Therapy: A Randomized Controlled Trial With Primary Care Physicians. J Med Internet Res. 2017 Mar 9;19(3):e72. doi: 10.2196/jmir.6944.
PMID: 28279950DERIVEDDiehl LA, Souza RM, Alves JB, Gordan PA, Esteves RZ, Jorge ML, Coelho IC. InsuOnline, a Serious Game to Teach Insulin Therapy to Primary Care Physicians: Design of the Game and a Randomized Controlled Trial for Educational Validation. JMIR Res Protoc. 2013 Jan 21;2(1):e5. doi: 10.2196/resprot.2431.
PMID: 23612462DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
December 21, 2012
First Posted
January 3, 2013
Study Start
July 1, 2014
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
December 7, 2015
Record last verified: 2015-12