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
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
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014