Diabetes Health Enhancement Program to Improve Health of People With Diabetes

Diabetes Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

• NCT number: NCT00291590
• Study type: Interventional
• Source: VA Puget Sound Health Care System
• Status: Completed
• Phase: Phase 3
• Start date: July 2001
• Completion date: August 2003