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Clinical Trials/NCT01440530
NCT01440530
Completed
N/A

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

Geisinger Clinic3 sites in 1 country170 target enrollmentFebruary 2010

Overview

Phase
N/A
Intervention
Not specified
Conditions
Diabetes Mellitus Type 2
Sponsor
Geisinger Clinic
Enrollment
170
Locations
3
Primary Endpoint
Diabetes Knowledge
Status
Completed
Last Updated
14 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
February 2010
End Date
November 2010
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Diabetes Mellitus Type 2
  • Geisinger Primary Care Provider
  • Access to a computer

Exclusion Criteria

  • Severe medical problems that limits travel to primary care
  • Diabetes Type 1
  • Cognitive Impairment
  • Taking anti-psychotic meds

Outcomes

Primary Outcomes

Diabetes Knowledge

Time Frame: 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.

Secondary Outcomes

  • Diabetes Self Care(6 months)

Study Sites (3)

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