Diabetes Health Enhancement Program to Improve Health of People With Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-07-31

Study Completion Date

2003-08-31

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.

Conditions

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Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

ECT

Blinding Strategy

NONE

Interventions

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DHEP

Intervention Type BEHAVIORAL

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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Gayle E Reiber, PhD

Role: PRINCIPAL_INVESTIGATOR

Puget Sound VA

Locations

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Puget Sound Veterans Administration

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND

PMID: 16044981 (View on PubMed)

Other Identifiers

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DHEP001

Identifier Type: -

Identifier Source: org_study_id