Viewing Study NCT00109369



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Study NCT ID: NCT00109369
Status: COMPLETED
Last Update Posted: 2011-02-01
First Post: 2005-04-27

Brief Title: Vermont Diabetes Information System
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization: National Institute of Diabetes and Digestive and Kidney Diseases NIDDK

Study Overview

Official Title: Vermont Diabetes Information System
Status: COMPLETED
Status Verified Date: 2011-01
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The Vermont Diabetes Information System VDIS is a registry-based decision support and reminder system based on the Chronic Care Model and targeted to primary care physicians and their patients with diabetes It will be evaluated by a randomized controlled study in 60 Primary Care practices in Vermont and nearby New York
Detailed Description: The long-term goal of the Vermont Diabetes Information System is to reduce morbidity and mortality from diabetes mellitus The project will implement and evaluate a state-wide system to support evidence-based disease management by primary care providers their practices and their patients in the community The primary study question is What is the effect of a Diabetes Information System including education feedback and decision support upon disease control measured by glycated hemoglobin Secondary questions address the effect of the system upon adherence to guideline recommendations blood pressure control patient satisfaction medication use and functional status We hypothesize that the information system will result in improvements in the process and outcomes of clinical care There are two specific aims

Aim 1 Implement the Diabetes Information System Objective 11 Develop a registry of patients with diabetes in primary care practices in Vermont Objective 12 Provide education and feedback to providers regarding their patients with diabetes Objective 13 Deliver decision support flow sheets alerts and reminders based on the registry and targeted at primary care providers and patients to prompt ideal management of diabetes

Aim 2 Assess the Diabetes Information System Objective 21 Assess disease control and guideline adherence by examining registry data in all subjects in a prospective two-year randomized controlled trial in 60 primary care practices Objective 22 Assess outcomes blood pressure control obesity functional status symptoms medication use and satisfaction by interview and examination in a sub-sample of patients from the controlled trial

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
K24DK068380 NIH None httpsreporternihgovquickSearchK24DK068380
R01DK061167 NIH None None