NCT00291590

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P25-P50 for phase_3 diabetes

Timeline
Completed

Started Jul 2001

Typical duration for phase_3 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2001

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

February 13, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 14, 2006

Completed
Last Updated

February 14, 2006

Status Verified

June 1, 2005

First QC Date

February 13, 2006

Last Update Submit

February 13, 2006

Conditions

Diabetes

Keywords

diabetesbehavioral changechronic care modelstage of changeMedicaidDual eligibleethnicself-care

Outcome Measures

Primary Outcomes (1)

  • Reduction in glycated hemoglobin levels

Secondary Outcomes (1)

  • Improvement in health status and diabetes self-care practices

Interventions

DHEPBEHAVIORAL

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Puget Sound Veterans Administration

Seattle, Washington, 98101, United States

Location

Related Publications (1)

  • 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.

    PMID: 16044981BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

diclofenac hydroxyethylpyrrolidine

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Gayle E Reiber, PhD

    Puget Sound VA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
ECT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 13, 2006

First Posted

February 14, 2006

Study Start

July 1, 2001

Study Completion

August 1, 2003

Last Updated

February 14, 2006

Record last verified: 2005-06

Locations

US(1)