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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00291590
• Other study ID #: DHEP001
• Status: Completed
• Phase: Phase 3
• First received: February 13, 2006
• Last updated: February 13, 2006
• Start date: July 2001
• Est. completion date: August 2003

Study information

• Verified date: June 2005
• Source: VA Puget Sound Health Care System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: August 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

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

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

Intervention

Behavioral:
• DHEP

Locations

Country	Name	City	State
United States	Puget Sound Veterans Administration	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Robert Wood Johnson Foundation	Aventis Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (1)

McFarland LV, Reiber GE, Norman JE. Recruitment of Medicaid and dual-enrolled Medicare beneficiaries with diabetes mellitus into a randomized controlled trial. Am J Manag Care. 2005 Jul;11(7):443-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in glycated hemoglobin levels
Secondary	Improvement in health status and diabetes self-care practices