Diabetes Health Enhancement Program to Improve Health of People With Diabetes

Phase 3

Completed

• Conditions: Diabetes

• Registration Number: NCT00291590
• Lead Sponsor: Robert Wood Johnson Foundation

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 Timeline

• Study Start: 2001-07
• Study Completion: 2003-08
• Status Verified: 2005-06
• Study First Submitted: 2006-02-13
• Study First Submitted QC: 2006-02-13
• Last Update Submitted: 2006-02-13
• Study First Posted: 2006-02-14
• Last Update Posted: 2006-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

Inclusion Criteria

• Insured under Medicaid (SSI) or dual enrolled under Medicaid and Medicare for at least one year
• Diagnosed type 1 or type 2 diabetes for at least 1 year (>1 inpatient or >2 outpatients visits with ICD-9 codes 250.00-250.9x, or prescriptions for insulin and/or oral hyperglycemic medications)
• Aged 40-85 years
• Geographically close to the Southeast Senior Center in South King County, Washington, and have a primary care provider (not HMO).

Exclusion Criteria

• Serious kidney disease (serum creatinine >2.5 or end-stage renal disease)
• Other serious illness that would preclude one-year study participation (dementia, terminal illness, organ transplantation)
• Pregnancy
• Inability to given informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Reduction in glycated hemoglobin levels

Secondary Outcome Measures

Name	Time	Method
Improvement in health status and diabetes self-care practices

Trial Locations

Locations (1)

Puget Sound Veterans Administration; 🇺🇸 Seattle, Washington, United States