- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01440530
Technology Intervention for Diabetes Engagement & Self-Care (TIDES) (TIDES)
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
-
Danville, Pennsylvania, United States, 17822
- Geisinger Medical Center
-
Port Matilda, Pennsylvania, United States, 16870
- Geisinger Clinic - Gray's Woods
-
Wilkes-Barre, Pennsylvania, United States, 18702
- Geisinger Clinic - Kistler
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Educational Intervention
|
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, slideshows, food solutions, expert questions and answers, and quizzes.
|
Active Comparator: Control Group (usual care)
|
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, slideshows, food solutions, expert questions and answers, and quizzes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Diabetes Self Care
Time Frame: 6 months
|
Change from Baseline on Partners in Health Scale(PIH)at 6 months.PIH is a validated instrument to measure self-management.
The 11 items cover capacity and motivation for behavior change scored on a 9-point scale,with zero as best response and 8 worst.Four factors explain ~80% of variance in PIH scores: knowledge,symptom management,coping and adherence.Petkov, J.,P.
Harvey,and M. Battersby, The internal consistency and construct validity of the partners in health scale:validation of a patient rated chronic condition self-management measure.
Qual Life Res, 2010.
19(7):p.1079-85.
|
6 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Margaret R Rukstalis, MD, Geisinger Clinic
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010-0173
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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