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Clinical Trials/NCT00569556
NCT00569556
Completed
Not Applicable

Effect of Care Management on Diabetes Outcomes

Minneapolis Veterans Affairs Medical Center1 site in 1 country550 target enrollmentSeptember 2006

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus
Sponsor
Minneapolis Veterans Affairs Medical Center
Enrollment
550
Locations
1
Primary Endpoint
Combined outcome of BP<130/80 mmHG, HgbA1C<8%, and LDL<100mg/dl at 1 year; the primary analysis will compare the intervention to usual care with respect to the percentage of diabetic individuals achieving all three therapeutic goals
Status
Completed
Last Updated
16 years ago

Overview

Brief Summary

The purpose of the study is to determine if a nurse managed, protocol driven, disease management process for diabetes results in improved attainment of therapeutic goals for diabetes compared to usual care. It is hypothesized that implementation of the disease management process will improve the percentage of diabetic individuals attaining all three therapeutic targets (HgbA1C<8.0%, LDL<100mg/dl, and BP<130/80mmHG) by 10% compared to usual care.

Registry
clinicaltrials.gov
Start Date
September 2006
End Date
May 2009
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Minneapolis Veterans Affairs Medical Center

Eligibility Criteria

Inclusion Criteria

  • Enrolled at Minneapolis VAMC
  • Type 1 or 2 diabetes
  • Blood pressure at screening visit \> 140mmHg systolic or \> 90mmHg diastolic OR HgbA1C at screening visit \> 9.0% OR LDL at screening visit \> 100mg/dL

Exclusion Criteria

  • Primary care provider unwilling to have participant included in study
  • Life expectancy \< 1 year
  • Unable to give consent
  • Severe mental health condition
  • pregnant or planning on becoming pregnant

Outcomes

Primary Outcomes

Combined outcome of BP<130/80 mmHG, HgbA1C<8%, and LDL<100mg/dl at 1 year; the primary analysis will compare the intervention to usual care with respect to the percentage of diabetic individuals achieving all three therapeutic goals

Time Frame: one year

Secondary Outcomes

  • Safety of the intervention (occurence of adverse events over the course of the trial)(one year)

Study Sites (1)

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