Effect of Care Management on Diabetes Outcomes

This study has been completed.
Sponsor:
Information provided by:
Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT00569556
First received: December 5, 2007
Last updated: June 11, 2009
Last verified: June 2009
  Purpose

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 Intervention
Diabetes Mellitus
Other: Case Management

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Care Management on Diabetes Outcomes

Resource links provided by NLM:


Further study details as provided by Minneapolis Veterans Affairs Medical Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety of the intervention (occurence of adverse events over the course of the trial) [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 550
Study Start Date: September 2006
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Minneapolis Veterans Affairs Medical Center

Additional 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
Study First Received: December 5, 2007
Last Updated: June 11, 2009
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on October 19, 2014