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Completed

NCT Number: NCT00291590

Diabetes Health Enhancement Program to Improve Health of People With Diabetes

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Puget Sound Veterans Administration

Seattle, Washington, 98101, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

DHEP

Behavioral

Primary outcomes

  1. Reduction in glycated hemoglobin levels

Secondary outcomes

  1. Improvement in health status and diabetes self-care practices

Sponsors and collaborators

Lead sponsor

Robert Wood Johnson Foundation

Other

Collaborators

  • Aventis Pharmaceuticals

Registry information

Official study title

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

Important dates

Study start
2001
Study completion
2003
First posted
Feb 14, 2006
Registry last updated
Feb 14, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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