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OpenTrials
Completed

NCT Number: NCT02082704

Interactive Spaced Education to Optimize Diabetes Care

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Veterans Affairs Boston Healthcare System

Boston, Massachusetts, 02130, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

SE Game on DSME

Behavioral

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.

SE Game on American History

Behavioral

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 outcomes

  1. HbA1c levels

    Time frame: Months 1-12

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Boston VA Research Institute, Inc.

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Mar 10, 2014
Registry last updated
Jul 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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