Diabetes Health Enhancement Program to Improve Health of People With Diabetes

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Diabetes

Intervention / Treatment
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* Behavioral: DHEP


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Educational/Counseling/Training
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: DHEP|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in glycated hemoglobin levels |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in health status and diabetes self-care practices |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, behavioral change, chronic care model, stage of change, Medicaid, Dual eligible, ethnic, self-care