Interactive Spaced Education to Optimize Diabetes Care

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Behavioral: SE Game on DSME; Behavioral: SE Game on American History

• Registration Number: NCT02082704
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2014-03-04
• Study First Submitted QC: 2014-03-06
• Study First Posted: 2014-03-10
• Study Start: 2014-06
• Primary Completion: 2015-08
• Study Completion: 2016-11
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-11
• Last Update Posted: 2017-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 456

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SE Game on DSME	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,
SE Game on American History	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.

Primary Outcome Measures

Name	Time	Method
HbA1c levels	Months 1-12

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Veterans Affairs Boston Healthcare System; 🇺🇸 Boston, Massachusetts, United States