Clinical trial NCT02082704: Interactive Spaced Education to Optimize Diabetes Care
Official title: Interactive Spaced Education to Optimize Diabetes Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: Diabetes
Education, Patient
Educational Technology
Lead sponsor: Boston VA Research Institute, Inc.
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2014-03-10
Enrollment: 456
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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:

-

Primary outcomes:
measure: HbA1c levels
timeFrame: Months 1-12
Secondary outcomes:
measure: Microalbumenuria levels [microalbumin-creatinine ratio].
timeFrame: Months 1-12
measure: Pill possession ratios of oral diabetes medications.
timeFrame: Months 1-12
measure: Treatment with angiotensin receptor blockers (ARB drugs) and angiotensin converting enzyme inhibitors (ACE inhibitors).
timeFrame: Months 1-12
measure: Pill possession ratios of angiotensin receptor blockers (ARB drugs) and angiotensin converting enzyme inhibitors (ACE inhibitors).
timeFrame: Months 1-12
measure: Weight / BMI
timeFrame: Months 1-12
measure: Low-density lipoprotein (LDL), high-density lipoprotein (HDL), total cholesterol & triglyceride levels,
timeFrame: Months 1-12
measure: Systolic and diastolic blood pressure.
timeFrame: Months 1-12
measure: Clinic visit frequency.
timeFrame: Months 1-12
measure: Initiation or alteration of insulin therapy
timeFrame: Months 1-12
measure: Changes in oral diabetes medication regimen.
timeFrame: Months 1-12
measure: Patient-perceived empowerment to manage their diabetes.
timeFrame: Months 1-12
measure: Baseline knowledge levels of patients assessed via their initial responses to SE game questions -- DSME SE game cohort only.
timeFrame: Months 1-6
measure: Analysis of SE game performance differences by patient-related variables (age, gender, geographic location, baseline HbA1c, etc.) -- DSME SE game cohort only.
timeFrame: Months 1-6
measure: Patient-perceived acceptability of SE game interventions.
timeFrame: Months 1-6
measure: Patient-perceived barriers and facilitators to the SE game intervention.
timeFrame: Months 1-6
measure: Patient's perceptions of the optimal parameters for the SE game intervention.
timeFrame: Months 1-6
Other outcomes:
Locations:
city: Boston
country: United States
facility: Veterans Affairs Boston Healthcare System
state: Massachusetts
Study officials:
affiliation: VA Boston Healthcare System
name: B. Price Kerfoot, MD EdM
role: PRINCIPAL_INVESTIGATOR
affiliation: VA Boston Healthcare System
name: Paul R. Conlin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.