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临床试验/NCT02082704
NCT02082704已完成不适用

Interactive Spaced Education to Optimize Diabetes Care

Boston VA Research Institute, Inc.2 个研究点 分布在 1 个国家目标入组 456 人开始时间: 2014年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
456
试验地点
2
主要终点
HbA1c levels

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients in the northeastern Veterans Affairs hospital system who are taking oral diabetes medications, have a PPR<80%, and have a HbA1c >7.5.

排除标准

  • 未提供

研究组 & 干预措施

SE Game on American History

Active Comparator

The 'attention control' cohort will participate in an online team-based game on American history and will receive a paper documents on DSME.

干预措施: SE Game on American History (Behavioral)

SE Game on DSME

Experimental

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,

干预措施: SE Game on DSME (Behavioral)

结局指标

主要结局

HbA1c levels

时间窗: Months 1-12

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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