Technology Intervention for Diabetes Engagement & Self-Care (TIDES)

Diabetes Mellitus Type 2 Clinical Trial

— TIDES  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01440530
• Other study ID #: 2010-0173
• Status: Completed
• Phase: N/A
• First received: September 20, 2011
• Last updated: September 23, 2011
• Start date: February 2010
• Est. completion date: November 2010

Study information

• Verified date: September 2011
• Source: Geisinger Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus Type 2
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• 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.

Other:
• 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.

Locations

Country	Name	City	State
United States	Geisinger Medical Center	Danville	Pennsylvania
United States	Geisinger Clinic - Gray's Woods	Port Matilda	Pennsylvania
United States	Geisinger Clinic - Kistler	Wilkes-Barre	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Geisinger Clinic	Dlife

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diabetes Knowledge	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	No
Secondary	Diabetes Self Care	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	No

External Links

•   Geisinger Health System