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Effect of Care Management on Diabetes Outcomes

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ClinicalTrials.gov Identifier: NCT00569556
Recruitment Status : Completed
First Posted : December 7, 2007
Last Update Posted : June 15, 2009
Sponsor:
Information provided by:
Minneapolis Veterans Affairs Medical Center

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Other: Case Management Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 550 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Care Management on Diabetes Outcomes
Study Start Date : September 2006
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Arm Intervention/treatment
No Intervention: Usual Care
Patients receive care through primary care provider
Other: Case Management
Phone contact by specially trained nurse case managers; lifestyle recommendations and medication changes as needed
Experimental: Case Management
Specially trained nurse case managers contact patients by telephone; monitor blood pressure, LDL, and HgbA1C;, and recommend lifestyle and medication changes as needed
Other: Case Management
Phone contact by specially trained nurse case managers; lifestyle recommendations and medication changes as needed



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Safety of the intervention (occurence of adverse events over the course of the trial) [ Time Frame: one year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00569556


Locations
United States, Minnesota
Minneapolis Veterans Affairs Medical Center
Minneapolis, Minnesota, United States, 55417
Sponsors and Collaborators
Minneapolis Veterans Affairs Medical Center
Investigators
Principal Investigator: Areef Ishani, MD, MS Minneapolis VAMC
Principal Investigator: Nacide Ercan-Fang, MD Minneapolis VAMC

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Areef Ishani, MD, MS, Minneapolis VAMC
ClinicalTrials.gov Identifier: NCT00569556     History of Changes
Other Study ID Numbers: 3823-A
VISN23
First Posted: December 7, 2007    Key Record Dates
Last Update Posted: June 15, 2009
Last Verified: June 2009

Keywords provided by Minneapolis Veterans Affairs Medical Center:
Diabetes Mellitus
Chronic Care Model
Case Management

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