ClinicalTrials.gov
ClinicalTrials.gov Menu

Diabetes Health Enhancement Program to Improve Health of People With Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00291590
Recruitment Status : Completed
First Posted : February 14, 2006
Last Update Posted : February 14, 2006
Sponsor:
Collaborator:
Aventis Pharmaceuticals
Information provided by:
VA Puget Sound Health Care System

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.


Condition or disease Intervention/treatment Phase
Diabetes Behavioral: DHEP Phase 3

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 Type : Interventional  (Clinical Trial)
Enrollment : 146 participants
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
Study Start Date : July 2001
Study Completion Date : August 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicaid
U.S. FDA Resources




Primary Outcome Measures :
  1. Reduction in glycated hemoglobin levels

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


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
ClinicalTrials.gov Identifier: NCT00291590     History of Changes
Other Study ID Numbers: DHEP001
First Posted: February 14, 2006    Key Record Dates
Last Update Posted: February 14, 2006
Last Verified: June 2005

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
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases