Diabetes
Conditions
Keywords
diabetes, behavioral change, chronic care model, stage of change, Medicaid, Dual eligible, ethnic, self-care
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.
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.
Interventions
BEHAVIORALDHEP
Sponsors
Aventis Pharmaceuticals
Robert Wood Johnson Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
ECT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in glycated hemoglobin levels | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in health status and diabetes self-care practices | — |
Countries
United States
Outcome results
None listed