Interactive Spaced Education to Optimize Diabetes Care

Diabetes Clinical Trial

Official title:

Interactive Spaced Education to Optimize Diabetes Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02082704
• Other study ID #: AHRQ 1R01HS019708-01A1
• Status: Completed
• Phase: N/A
• First received: March 4, 2014
• Last updated: July 11, 2017
• Start date: June 2014
• Est. completion date: November 2016

Study information

• Verified date: July 2017
• Source: Boston VA Research Institute, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 456
• Est. completion date: November 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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:

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Veterans Affairs Boston Healthcare System	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Boston VA Research Institute, Inc.	Agency for Healthcare Research and Quality (AHRQ)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c levels		Months 1-12
Secondary	Microalbumenuria levels [microalbumin-creatinine ratio].		Months 1-12
Secondary	Pill possession ratios of oral diabetes medications.		Months 1-12
Secondary	Treatment with angiotensin receptor blockers (ARB drugs) and angiotensin converting enzyme inhibitors (ACE inhibitors).		Months 1-12
Secondary	Pill possession ratios of angiotensin receptor blockers (ARB drugs) and angiotensin converting enzyme inhibitors (ACE inhibitors).		Months 1-12
Secondary	Weight / BMI		Months 1-12
Secondary	Low-density lipoprotein (LDL), high-density lipoprotein (HDL), total cholesterol & triglyceride levels,		Months 1-12
Secondary	Systolic and diastolic blood pressure.		Months 1-12
Secondary	Clinic visit frequency.		Months 1-12
Secondary	Initiation or alteration of insulin therapy		Months 1-12
Secondary	Changes in oral diabetes medication regimen.		Months 1-12
Secondary	Patient-perceived empowerment to manage their diabetes.	Questionnaire	Months 1-12
Secondary	Baseline knowledge levels of patients assessed via their initial responses to SE game questions -- DSME SE game cohort only.		Months 1-6
Secondary	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
Secondary	Patient-perceived acceptability of SE game interventions.	Questionnaire	Months 1-6
Secondary	Patient-perceived barriers and facilitators to the SE game intervention.	Questionnaire	Months 1-6
Secondary	Patient's perceptions of the optimal parameters for the SE game intervention.	Questionnaire	Months 1-6