Overview

This trial is active, not recruiting.

Condition diabetes
Treatments se game on dsme, se game on american history
Sponsor Boston VA Research Institute, Inc.
Collaborator Agency for Healthcare Research and Quality (AHRQ)
Start date June 2014
End date August 2015
Trial size 500 participants
Trial identifier NCT02082704, AHRQ 1R01HS019708-01A1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Arm
(Experimental)
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,
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)
The 'attention control' cohort will participate in an online team-based game on American history and will receive a paper documents on DSME.
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 Outcomes

Measure
HbA1c levels
time frame: Months 1-12

Secondary Outcomes

Measure
Microalbumenuria levels [microalbumin-creatinine ratio].
time frame: Months 1-12
Pill possession ratios of oral diabetes medications.
time frame: Months 1-12
Treatment with angiotensin receptor blockers (ARB drugs) and angiotensin converting enzyme inhibitors (ACE inhibitors).
time frame: Months 1-12
Pill possession ratios of angiotensin receptor blockers (ARB drugs) and angiotensin converting enzyme inhibitors (ACE inhibitors).
time frame: Months 1-12
Weight / BMI
time frame: Months 1-12
Low-density lipoprotein (LDL), high-density lipoprotein (HDL), total cholesterol & triglyceride levels,
time frame: Months 1-12
Systolic and diastolic blood pressure.
time frame: Months 1-12
Clinic visit frequency.
time frame: Months 1-12
Initiation or alteration of insulin therapy
time frame: Months 1-12
Changes in oral diabetes medication regimen.
time frame: Months 1-12
Patient-perceived empowerment to manage their diabetes.
time frame: Months 1-12
Baseline knowledge levels of patients assessed via their initial responses to SE game questions -- DSME SE game cohort only.
time frame: Months 1-6
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
Patient-perceived acceptability of SE game interventions.
time frame: Months 1-6
Patient-perceived barriers and facilitators to the SE game intervention.
time frame: Months 1-6
Patient's perceptions of the optimal parameters for the SE game intervention.
time frame: Months 1-6

Eligibility Criteria

Male or female participants of any age.

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:

Additional Information

Official title Interactive Spaced Education to Optimize Diabetes Care
Principal investigator B. Price Kerfoot, MD EdM
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Boston VA Research Institute, Inc..