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.

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Behavioral: SE Game on DSME; Behavioral: SE Game on American History

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 Type: Interventional
• Enrollment (Actual): 456
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02130
      • Veterans Affairs Boston Healthcare System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
HbA1c levels	Months 1-12

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Boston VA Research Institute, Inc.
• Collaborators: Agency for Healthcare Research and Quality (AHRQ)
• Investigators: Principal Investigator: B. Price Kerfoot, MD EdM, VA Boston Healthcare System; Principal Investigator: Paul R. Conlin, MD, VA Boston Healthcare System

Publications and helpful links

General Publications

• Kerfoot BP, Gagnon DR, McMahon GT, Orlander JD, Kurgansky KE, Conlin PR. A Team-Based Online Game Improves Blood Glucose Control in Veterans With Type 2 Diabetes: A Randomized Controlled Trial. Diabetes Care. 2017 Sep;40(9):1218-1225. doi: 10.2337/dc17-0310. Epub 2017 Aug 8.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2014
• Primary Completion (Actual): August 1, 2015
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: March 4, 2014
• First Submitted That Met QC Criteria: March 6, 2014
• First Posted (Estimate): March 10, 2014

Study Record Updates

• Last Update Posted (Actual): July 12, 2017
• Last Update Submitted That Met QC Criteria: July 11, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Diabetes; Education, Patient; Educational Technology
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: AHRQ 1R01HS019708-01A1