Effect of Care Management on Diabetes Outcomes

Diabetes Mellitus Clinical Trial

Official title:

Effect of Care Management on Diabetes Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00569556
• Other study ID #: 3823-A
• Secondary ID: VISN23
• Status: Completed
• Phase: N/A
• First received: December 5, 2007
• Last updated: June 11, 2009
• Start date: September 2006
• Est. completion date: May 2009

Study information

• Verified date: June 2009
• Source: Minneapolis Veterans Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 550
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Other:
• Case Management
Phone contact by specially trained nurse case managers; lifestyle recommendations and medication changes as needed

Locations

Country	Name	City	State
United States	Minneapolis Veterans Affairs Medical Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Minneapolis Veterans Affairs Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		one year	No
Secondary	Safety of the intervention (occurence of adverse events over the course of the trial)		one year	Yes