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Diabetes Health Enhancement Program to Improve Health of People With Diabetes

This study has been completed.
Aventis Pharmaceuticals
Information provided by:
VA Puget Sound Health Care System Identifier:
First received: February 13, 2006
Last updated: NA
Last verified: June 2005
History: No changes posted

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.

Condition Intervention Phase
Diabetes Behavioral: DHEP Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Educational/Counseling/Training
Official Title: Phase 3 Randomized Controlled Trial of the Diabetes Health Enhancement Program for Medicaid and Dual Eligibles in South King County, Washington

Resource links provided by NLM:

Further study details as provided by VA Puget Sound Health Care System:

Primary Outcome Measures:
  • Reduction in glycated hemoglobin levels

Secondary Outcome Measures:
  • Improvement in health status and diabetes self-care practices

Estimated Enrollment: 146
Study Start Date: July 2001
Estimated Study Completion Date: August 2003
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.


Ages Eligible for Study:   40 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00291590

United States, Washington
Puget Sound Veterans Administration
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Robert Wood Johnson Foundation
Aventis Pharmaceuticals
Principal Investigator: Gayle E Reiber, PhD Puget Sound VA
  More Information

Publications: Identifier: NCT00291590     History of Changes
Other Study ID Numbers: DHEP001
Study First Received: February 13, 2006
Last Updated: February 13, 2006

Keywords provided by VA Puget Sound Health Care System:
behavioral change
chronic care model
stage of change
Dual eligible

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases processed this record on August 18, 2017