NCT01759953

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 3, 2013

Completed
1.5 years until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

December 7, 2015

Status Verified

December 1, 2015

Enrollment Period

1.4 years

First QC Date

December 21, 2012

Last Update Submit

December 4, 2015

Conditions

Keywords

Diabetes MellitusInsulinVideo GamesMedical EducationEducational TechnologyContinuing Medical Education

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 COMPARATOR

Playing the InsuOnline game, on the web, in the player´s own time and rhythm, until its end, as already described previously.

Other: Game

Traditional CME

ACTIVE COMPARATOR

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

Interventions

GameOTHER

InsuOnline game, on the web, in the player´s own time and rhythm

Also known as: InsuOnline game, Serious game, Web-based game
InsuOnline game

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

Also known as: Classroom education, Onsite learning session, Lecture and clinical cases discussion
Traditional CME

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

Location

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: 22187469BACKGROUND
  • 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.

    PMID: 19655083BACKGROUND
  • 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.

    PMID: 18393965BACKGROUND
  • 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. doi: 10.2337/diacare.28.11.2673.

    PMID: 16249538BACKGROUND
  • Lehmann ED. Interactive educational simulators in diabetes care. Med Inform (Lond). 1997 Jan-Mar;22(1):47-76. doi: 10.3109/14639239709089834.

    PMID: 9183780BACKGROUND
  • 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. No abstract available.

    PMID: 22517736BACKGROUND
  • 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.

    PMID: 20529311BACKGROUND
  • Akl 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: 18254103BACKGROUND
  • Diehl 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.

  • Diehl 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.

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2BehaviorDiabetes MellitusInsulin Resistance

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesHyperinsulinism

Study Officials

  • Leandro A Diehl, M.D., MsC

    Universidade Estadual de Londrina

    PRINCIPAL INVESTIGATOR
  • Pedro A Gordan, M.D., PhD

    Universidade Estadual de Londrina

    STUDY DIRECTOR
  • Izabel CM Coelho, M.D., PhD

    Faculdades Pequeno Príncipe

    STUDY CHAIR

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

Locations