Clinical trial NCT01440530: Technology Intervention for Diabetes Engagement & Self-Care (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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus Type 2
Keywords: Diabetes Internet Education
Diabetes Education
Diabetes Self-Care
Diabetes Self-Management
Diabetes Behavior Intervention
Lead sponsor: Geisinger Clinic
Sponsor class: OTHER
Collaborators: name: Dlife
First posted: 2011-09-26
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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 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

Primary outcomes:
measure: Diabetes Knowledge
timeFrame: 6 months
Secondary outcomes:
measure: Diabetes Self Care
timeFrame: 6 months
Other outcomes:
Locations:
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
city: Port Matilda
country: United States
facility: Geisinger Clinic - Gray's Woods
state: Pennsylvania
city: Wilkes-Barre
country: United States
facility: Geisinger Clinic - Kistler
state: Pennsylvania
Study officials:
affiliation: Geisinger Clinic
name: Margaret R Rukstalis, MD
role: PRINCIPAL_INVESTIGATOR
References: