Technology Intervention for Diabetes Engagement & Self-Care (TIDES):Comparative Effectiveness Randomized Clinical Trial in Primary Care for Type 2 Diabetes to Improve Engagement, Knowledge, and Self-Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 6
- 主要终点
- Diabetes Knowledge
研究概览
简要总结
The purpose of this 3 site, 24-week, Comparative Effectiveness Randomized Clinical Trial in Primary Care is to compare usual care to an online, multi-media, digital intervention for Persons with Type 2 Diabetes to Improve Engagement, Knowledge, and Self-Care.
详细描述
Objective
Technology shows promise to enhance standard care of diabetes with cost-effective, online lifestyle interventions. Compared to Primary Care (PC) Diabetes System of Care (control), the investigators hypothesized Technology Intervention for Diabetes Engagement & Self-Care (TIDES) would significantly improve diabetes knowledge and self-care.
Methods: Following Institutional Review Board (IRB) approval, physician letters were sent to patients with type 2 diabetes, age >18 years with HgA1c >8% identified via Electronic Health Record (EHR) of an integrated US health system to invite participation in a 3-site, 24-week diabetes study. Of the 270 with >1 week email/web use invited to the shared medical visit (SMV) orientation, 166 subjects provided written informed consent. Diabetes knowledge and self-care assessments, vital signs, HgA1c, fasting glucose and lipids were collected at baseline, 3 and 6 months. Following randomization to TIDES (N=117) or usual care (N=49), TIDES group was oriented to the multimedia online intervention including a dosed sequence of learning via email, video, slide shows, food solutions, expert questions and answers,and quizzes.
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
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes Mellitus Type 2
- •Geisinger Primary Care Provider
- •Access to a computer
排除标准
- •Severe medical problems that limits travel to primary care
- •Diabetes Type 1
- •Cognitive Impairment
- •Taking anti-psychotic meds
结局指标
主要结局
Diabetes Knowledge
时间窗: 6 months
Change from Baseline Total Score on Diabetes Knowledge Questionnaire(DKQ)at 6 months.The DKQ is the shortened 24-item version of the Diabetes Knowledge Questionnaire was derived from an original 60-item instrument to reduce participant burden.Scores on the 60-item and 24-item versions are well correlated (r=0.85).Collins,G.S.,et al.,Modification and validation of the Revised Diabetes Knowledge Scale. Diabet Med, 2011. 28(3):p.306-10. Fitzgerald,J.T.,et al.,The reliability and validity of a brief diabetes knowledge test.Diabetes Care,1998.21(5):p.706-10.
次要结局
- Diabetes Self Care(6 months)