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

This study has been completed.
Sponsor:
Collaborator:
Dlife
Information provided by (Responsible Party):
Geisinger Clinic
ClinicalTrials.gov Identifier:
NCT01440530
First received: September 20, 2011
Last updated: September 23, 2011
Last verified: September 2011

September 20, 2011
September 23, 2011
February 2010
November 2010   (final data collection date for primary outcome measure)
Diabetes Knowledge [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01440530 on ClinicalTrials.gov Archive Site
Diabetes Self Care [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
Technology Intervention for Diabetes Engagement & Self-Care (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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Diabetes Mellitus Type 2
  • 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.
  • Experimental: Educational Intervention
    Intervention: Behavioral: Educational Intervention
  • Active Comparator: Control Group (usual care)
    Intervention: Other: Usual Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
170
November 2010
November 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01440530
2010-0173
No
Geisinger Clinic
Geisinger Clinic
Dlife
Principal Investigator: Margaret R Rukstalis, MD Geisinger Clinic
Geisinger Clinic
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP