Diabetes Health Enhancement Program to Improve Health of People With Diabetes

This study has been completed.
Sponsor:
Collaborator:
Aventis Pharmaceuticals
Information provided by:
VA Puget Sound Health Care System
ClinicalTrials.gov Identifier:
NCT00291590
First received: February 13, 2006
Last updated: NA
Last verified: June 2005
History: No changes posted
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00291590

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

Publications:
ClinicalTrials.gov Identifier: NCT00291590     History of Changes
Other Study ID Numbers: DHEP001
Study First Received: February 13, 2006
Last Updated: February 13, 2006
Health Authority: United States: Federal Government

Keywords provided by VA Puget Sound Health Care System:
diabetes
behavioral change
chronic care model
stage of change
Medicaid
Dual eligible
ethnic
self-care

Additional relevant MeSH terms:
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 22, 2014