Diabetes Health Enhancement Program to Improve Health of People With Diabetes - Full Text View

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 III

MedlinePlus related topics:

Diabetes Medicaid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Educational/Counseling/Training, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Official Title:	Phase 3 Randomized Controlled Trial of the Diabetes Health Enhancement Program for Medicaid and Dual Eligibles in South King County, Washington

Further study details as provided by Puget Sound Veterans Administration 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

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:

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.

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

Keywords provided by Puget Sound Veterans Administration Health Care System:

diabetes

behavioral change

chronic care model

stage of change

Medicaid

Dual eligible

ethnic

self-care

Study placed in the following topic categories:

Metabolic Diseases

Diabetes Mellitus

Endocrine System Diseases

Endocrinopathy

Metabolic disorder

Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on September 05, 2008

Sponsors and Collaborators:	Robert Wood Johnson Foundation Aventis Pharmaceuticals
Information provided by:	Puget Sound Veterans Administration Health Care System
ClinicalTrials.gov Identifier:	NCT00291590