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Proactive Diabetes Case Management
This study has been completed.
First Received: March 14, 2001   Last Updated: January 30, 2009   History of Changes
Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00013208
  Purpose

Despite a growing array of therapeutic options and efficacious treatment strategies to prevent or delay some of the most severe complications of type 2 diabetes, there continue to be many individuals with outcomes that are far from optimal. Interventions to improve diabetes care by educating providers and patients have been disappointing. In the past several years, case management has been widely advocated as a cost-effective approach to coordinate diabetes care and improve outcomes, although there is little rigorous evidence demonstrating the benefits of this type of intervention.


Condition Intervention
Diabetes Mellitus
Behavioral: Case Management

MedlinePlus related topics: Diabetes
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title: Proactive Diabetes Case Management

Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment: 260
Study Completion Date: August 2002
Arms Assigned Interventions
1 Behavioral: Case Management

Detailed Description:

Background:

Despite a growing array of therapeutic options and efficacious treatment strategies to prevent or delay some of the most severe complications of type 2 diabetes, there continue to be many individuals with outcomes that are far from optimal. Interventions to improve diabetes care by educating providers and patients have been disappointing. In the past several years, case management has been widely advocated as a cost-effective approach to coordinate diabetes care and improve outcomes, although there is little rigorous evidence demonstrating the benefits of this type of intervention.

Objectives:

This study had the following specific aims: 1) to evaluate the effect of a targeted, proactive case management intervention for high risk veterans with type 2 diabetes on: a) glycemic control, b) intermediate cardiovascular outcomes, c) satisfaction, d) adherence to specific care standards, and e) short-term resource utilization; and 2) using Monte Carlo simulation models, to estimate the expected impact of changes in key processes of care and intermediate outcomes on end-stage outcomes.

Methods:

This study was conducted as a prospective randomized controlled trial. Participating veterans with diabetes (N = 246) receiving care at two VAMCs were randomly assigned, stratified by site and baseline hemoglobin A1c (A1c), to the intervention or control group. The intervention consisted of two nurse practitioners who actively monitored and coordinated patient care, guided by approved treatment algorithms. Data for the study were collected through a baseline and exit examination, a baseline and exit survey, and the VA medical information system. The primary outcome measure was the change in glycemic control, as measured by A1c. Secondary outcomes included serum LDL, blood pressure, satisfaction, and resource utilization. The data were analyzed using univariate and bi-variate (t-test, Wilcoxon rank-sum, chi-square) methods as well as multivariable regression.

Status:

Completed Manuscripts

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients were eligible to participate in the study if their most current hemoglobin A1c (HbA1c) was >=8.5 (reported within the last year); they had at least 1 prescription for an oral hypoglycemic agent, insulin, or monitoring supplies filled in the last year; and, they had an outpatient visit scheduled with a general internist, nurse practitioner, or physician assistant between May, 1999 and January, 2000.

Patients were not eligible for the study if the patient (or another member of the household when applicable) indicated that they: (1) were under 18 years of age; (2) had never been diagnosed with diabetes; (3) had been diagnosed with Type 1 diabetes or had been diagnosed before age 30; (4) did not have a telephone; (5) did not speak English; (6) were not competent for interview; (7) did not receive their primary diabetes care within the VA system; (8) were currently receiving treatment for cancer (other than non-melanoma); (9) had been diagnosed with kidney failure, congestive heart failure (and were short of breath at rest), liver disease, or blindness; (10) changed residences during certain months of the year; (11) planned to move in the near future; or their HbA1c obtained at baseline was < 7.5%.

Exclusion Criteria:

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00013208

Locations
United States, Michigan
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, United States, 48113-0170
Sponsors and Collaborators
Investigators
Principal Investigator: Sarah L. Krein, PhD RN VA Ann Arbor Healthcare System
  More Information

Publications:
Responsible Party: Department of Veterans Affairs ( Krein, Sarah - Principal Investigator )
Study ID Numbers: IIR 97-077
Study First Received: March 14, 2001
Last Updated: January 30, 2009
ClinicalTrials.gov Identifier: NCT00013208     History of Changes
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder

Additional relevant MeSH terms:
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on May 06, 2009