Clinical trial NCT00291590: Diabetes Health Enhancement Program to Improve Health of People With Diabetes
Official title: Phase 3 Randomized Controlled Trial of the Diabetes Health Enhancement Program for Medicaid and Dual Eligibles in South King County, Washington
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes
Keywords: diabetes
behavioral change
chronic care model
stage of change
Medicaid
Dual eligible
ethnic
self-care
Lead sponsor: VA Puget Sound Health Care System
Sponsor class: FED
Collaborators: name: Aventis Pharmaceuticals
First posted: 2006-02-14
Enrollment: 146
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: ECT

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.

Eligibility 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.

Primary outcomes:
measure: Reduction in glycated hemoglobin levels
Secondary outcomes:
measure: Improvement in health status and diabetes self-care practices
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Puget Sound Veterans Administration
state: Washington
Study officials:
affiliation: Puget Sound VA
name: Gayle E Reiber, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.