Diabetes Health Enhancement Program to Improve Health of People With Diabetes
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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 |
- Reduction in glycated hemoglobin levels
- Improvement in health status and diabetes self-care practices
| Estimated Enrollment: | 146 |
| Study Start Date: | July 2001 |
| Estimated Study Completion Date: | August 2003 |
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 |
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| United States, Washington | |
| Puget Sound Veterans Administration | |
| Seattle, Washington, United States, 98101 | |
| 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 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013