Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Randomized Controlled Trial to Assess the Educational Efficacy of a Serious Game for Teaching Insulin Therapy to Primary Care Physicians
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.
Status | Completed |
Enrollment | 170 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A and older |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
Brazil | Hospital Universitário de Londrina | Londrina | PR |
Lead Sponsor | Collaborator |
---|---|
Universidade Estadual de Londrina |
Brazil,
Akl EA, Sackett K, Pretorius R, Erdley S, Bhoopathi PS, Mustafa R, Schünemann HJ. Educational games for health professionals. Cochrane Database Syst Rev. 2008 Jan 23;(1):CD006411. doi: 10.1002/14651858.CD006411.pub2. Review. Update in: Cochrane Database Syst Rev. 2013;1:CD006411. — View Citation
American Diabetes Association. Standards of medical care in diabetes--2012. Diabetes Care. 2012 Jan;35 Suppl 1:S11-63. doi: 10.2337/dc12-s011. Review. — View Citation
Hayes 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. — View Citation
Inzucchi 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. Review. Erratum in: Diabetes Care. 2013 Feb;36(2):490. — View Citation
Lehmann ED. Interactive educational simulators in diabetes care. Med Inform (Lond). 1997 Jan-Mar;22(1):47-76. Review. — View Citation
Lerario 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. — View Citation
Mendes 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. — View Citation
Peyrot 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | General impressions about the intervention | Comments from the participants about how they enjoyed the educational experience, assessed by a few web-based Likert-scale and free-text questions | In up to one year | No |
Other | Usage data | Review of game usage data, collected from software-generated logs for each player: time spent on the game, number of logins, etc. | In up to one year | No |
Other | Reasons for not finishing the game | Main reasons for not finishing the game, for the participants who do not play the InsuOnline game until its end. | In up to one year | No |
Primary | 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 | No |
Secondary | Attitudes regarding diabetes/insulin | Average score on web-based Diabetes Attitude Score 3 | In up to one year | No |
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