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Interactive Spaced Education to Optimize Diabetes Care

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ClinicalTrials.gov Identifier: NCT02082704
Recruitment Status : Completed
First Posted : March 10, 2014
Last Update Posted : July 12, 2017
Sponsor:
Collaborator:
Agency for Healthcare Research and Quality (AHRQ)
Information provided by (Responsible Party):
Boston VA Research Institute, Inc.

Brief Summary:
Investigators are conducting a randomized controlled trial to determine whether an online team-based spaced education (SE) game can improve HbA1c levels among these patients with diabetes (primary aim). Secondary aims include determining the impact of the game on patients' pill possession ratio (PPR) of oral DM meds and their microalbumin/creatinine (M/C) ratio, ACE PPR, and ARB PPR.

Condition or disease Intervention/treatment Phase
Diabetes Behavioral: SE Game on DSME Behavioral: SE Game on American History Not Applicable

Detailed Description:
Participants will be randomized to one of two cohorts: (1) the intervention cohort will participate in an online team-based game on diabetes self-management education (DSME) and will receive a paper documents on American history, and (2) the 'attention control' cohort will participate in an online team-based game on American history and will receive a paper documents on DSME. Each game would consist of 2 questions per week x 25 weeks = 50 questions total per arm. The questions are delivered via email by the Qstream platform to the participants. Upon clicking on a hyperlink in the email, participants select an answer that is downloaded to a server. They are then provided with the answer to and explanation of the question, along with additional educational materials. Using an adaptive methodology, the spacing and content of the game material will be individualized for each clinician based on their performance. Home-based testing of HbA1c and M/C ratio will be conducted by patients at enrollment, 6 months and 12 months. If successful, this SE game will improve diabetes management among VA patients and improve patient outcomes. Given the growing use of email and the Internet by patients, SE games could be easily expanded to a broad audience of VA patients with varying health problems across the country. With content tailored to meet specific needs, SE games can be utilized as tools to improve patients' clinical outcomes by bolstering their health management behaviors.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 456 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Interactive Spaced Education to Optimize Diabetes Care
Actual Study Start Date : June 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : November 2016

Arm Intervention/treatment
Experimental: SE Game on DSME
The intervention cohort will participate in an online team-based game on diabetes self-management education (DSME) and will receive a paper documents on American history,
Behavioral: SE Game on DSME
Investigators created an online educational game by incorporating game mechanics into an evidence-based form of online education, termed 'spaced education' (SE). Based upon two psychology research findings (the spacing and testing effects), SE has been shown in randomized trials to improves knowledge acquisition, boosts learning retention for up to two years, and durably improves clinical behavior.

Active Comparator: SE Game on American History
The 'attention control' cohort will participate in an online team-based game on American history and will receive a paper documents on DSME.
Behavioral: SE Game on American History
Investigators created an online educational game by incorporating game mechanics into an evidence-based form of online education, termed 'spaced education' (SE). Based upon two psychology research findings (the spacing and testing effects), SE has been shown in randomized trials to improves knowledge acquisition, boosts learning retention for up to two years, and durably improves clinical behavior.




Primary Outcome Measures :
  1. HbA1c levels [ Time Frame: Months 1-12 ]

Secondary Outcome Measures :
  1. Microalbumenuria levels [microalbumin-creatinine ratio]. [ Time Frame: Months 1-12 ]
  2. Pill possession ratios of oral diabetes medications. [ Time Frame: Months 1-12 ]
  3. Treatment with angiotensin receptor blockers (ARB drugs) and angiotensin converting enzyme inhibitors (ACE inhibitors). [ Time Frame: Months 1-12 ]
  4. Pill possession ratios of angiotensin receptor blockers (ARB drugs) and angiotensin converting enzyme inhibitors (ACE inhibitors). [ Time Frame: Months 1-12 ]
  5. Weight / BMI [ Time Frame: Months 1-12 ]
  6. Low-density lipoprotein (LDL), high-density lipoprotein (HDL), total cholesterol & triglyceride levels, [ Time Frame: Months 1-12 ]
  7. Systolic and diastolic blood pressure. [ Time Frame: Months 1-12 ]
  8. Clinic visit frequency. [ Time Frame: Months 1-12 ]
  9. Initiation or alteration of insulin therapy [ Time Frame: Months 1-12 ]
  10. Changes in oral diabetes medication regimen. [ Time Frame: Months 1-12 ]
  11. Patient-perceived empowerment to manage their diabetes. [ Time Frame: Months 1-12 ]
    Questionnaire

  12. Baseline knowledge levels of patients assessed via their initial responses to SE game questions -- DSME SE game cohort only. [ Time Frame: Months 1-6 ]
  13. Analysis of SE game performance differences by patient-related variables (age, gender, geographic location, baseline HbA1c, etc.) -- DSME SE game cohort only. [ Time Frame: Months 1-6 ]
  14. Patient-perceived acceptability of SE game interventions. [ Time Frame: Months 1-6 ]
    Questionnaire

  15. Patient-perceived barriers and facilitators to the SE game intervention. [ Time Frame: Months 1-6 ]
    Questionnaire

  16. Patient's perceptions of the optimal parameters for the SE game intervention. [ Time Frame: Months 1-6 ]
    Questionnaire



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:   No
Criteria

Inclusion Criteria:

  • Patients in the northeastern Veterans Affairs hospital system who are taking oral diabetes medications, have a PPR<80%, and have a HbA1c >7.5.

Exclusion Criteria:

-


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 ClinicalTrials.gov identifier (NCT number): NCT02082704


Locations
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United States, Massachusetts
Veterans Affairs Boston Healthcare System
Boston, Massachusetts, United States, 02130
Sponsors and Collaborators
Boston VA Research Institute, Inc.
Agency for Healthcare Research and Quality (AHRQ)
Investigators
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Principal Investigator: B. Price Kerfoot, MD EdM VA Boston Healthcare System
Principal Investigator: Paul R. Conlin, MD VA Boston Healthcare System
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Boston VA Research Institute, Inc.
ClinicalTrials.gov Identifier: NCT02082704    
Other Study ID Numbers: AHRQ 1R01HS019708-01A1
First Posted: March 10, 2014    Key Record Dates
Last Update Posted: July 12, 2017
Last Verified: July 2017
Keywords provided by Boston VA Research Institute, Inc.:
Diabetes
Education, Patient
Educational Technology
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases