Viewing Study NCT00291590



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Study NCT ID: NCT00291590
Status: COMPLETED
Last Update Posted: 2006-02-14
First Post: 2006-02-13

Brief Title: Diabetes Health Enhancement Program to Improve Health of People With Diabetes
Sponsor: Robert Wood Johnson Foundation
Organization: VA Puget Sound Health Care System

Study Overview

Official Title: Phase 3 Randomized Controlled Trial of the Diabetes Health Enhancement Program for Medicaid and Dual Eligibles in South King County Washington
Status: COMPLETED
Status Verified Date: 2005-06
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: Management of chronic diseases such as diabetes relies upon the health care providers and the patients self-care Self management programs for diabetes that target self-empowerment tools have been found to be effective in some studies but have not typically included individuals on Medicaid

Our goal for this trial was to observe if patients participating in such a program could decrease glycated hemoglobin levels improve health status and improve self-care practices
Detailed Description: Design Setting and Population A Phase 3 one year prospective trial randomized to intervention or control usual care with Medicaid or dual-Medicare beneficiaries with diabetes aged 40-85 years old residing in South King County Washington

Intervention A targeted multi-component self-management program incorporating a stage-of-change approach to overcome barriers and facilitate life-style behavior changes to achieve patient-driven health action plans for nutrition or exercise goals

Main Outcome Measures Glycemic control HbA1c physical and mental health self-care practices

Recruitment Status Completed participants are no longer being recruited data analysis is complete

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