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Clinical Trials/NCT02082704
NCT02082704
Completed
N/A

Interactive Spaced Education to Optimize Diabetes Care

Boston VA Research Institute, Inc.1 site in 1 country456 target enrollmentJune 2014
ConditionsDiabetes

Overview

Phase
N/A
Intervention
Not specified
Conditions
Diabetes
Sponsor
Boston VA Research Institute, Inc.
Enrollment
456
Locations
1
Primary Endpoint
HbA1c levels
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2014
End Date
November 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

  • Not provided

Outcomes

Primary Outcomes

HbA1c levels

Time Frame: Months 1-12

Secondary Outcomes

  • Weight / BMI(Months 1-12)
  • Clinic visit frequency.(Months 1-12)
  • Changes in oral diabetes medication regimen.(Months 1-12)
  • Pill possession ratios of angiotensin receptor blockers (ARB drugs) and angiotensin converting enzyme inhibitors (ACE inhibitors).(Months 1-12)
  • Pill possession ratios of oral diabetes medications.(Months 1-12)
  • Systolic and diastolic blood pressure.(Months 1-12)
  • Patient-perceived barriers and facilitators to the SE game intervention.(Months 1-6)
  • Microalbumenuria levels [microalbumin-creatinine ratio].(Months 1-12)
  • Patient-perceived empowerment to manage their diabetes.(Months 1-12)
  • 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)
  • Patient's perceptions of the optimal parameters for the SE game intervention.(Months 1-6)

Study Sites (1)

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