Diabetes Mellitus Type 2 Clinical Trial
Official title:
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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