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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
  Purpose

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.


Condition Intervention
Diabetes Mellitus Type 2
Behavioral: Educational Intervention
Other: Usual Care

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

Resource links provided by NLM:


Further study details as provided by Geisinger Clinic:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 170
Study Start Date: February 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Educational 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.
Active Comparator: Control Group (usual care) 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01440530

Locations
United States, Pennsylvania
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822
Geisinger Clinic - Gray's Woods
Port Matilda, Pennsylvania, United States, 16870
Geisinger Clinic - Kistler
Wilkes-Barre, Pennsylvania, United States, 18702
Sponsors and Collaborators
Geisinger Clinic
Dlife
Investigators
Principal Investigator: Margaret R Rukstalis, MD Geisinger Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Geisinger Clinic
ClinicalTrials.gov Identifier: NCT01440530     History of Changes
Other Study ID Numbers: 2010-0173
Study First Received: September 20, 2011
Last Updated: September 23, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Geisinger Clinic:
Diabetes Internet Education
Diabetes Education
Diabetes Self-Care
Diabetes Self-Management
Diabetes Behavior Intervention

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on November 24, 2014