Effect of Care Management on Diabetes Outcomes
2 other identifiers
interventional
550
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus
Started Sep 2006
Typical duration for not_applicable diabetes-mellitus
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
December 5, 2007
CompletedFirst Posted
Study publicly available on registry
December 7, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedJune 15, 2009
June 1, 2009
2.7 years
December 5, 2007
June 11, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
one year
Secondary Outcomes (1)
Safety of the intervention (occurence of adverse events over the course of the trial)
one year
Study Arms (2)
Usual Care
NO INTERVENTIONPatients receive care through primary care provider
Case Management
EXPERIMENTALSpecially trained nurse case managers contact patients by telephone; monitor blood pressure, LDL, and HgbA1C;, and recommend lifestyle and medication changes as needed
Interventions
Phone contact by specially trained nurse case managers; lifestyle recommendations and medication changes as needed
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Minneapolis Veterans Affairs Medical Center
Minneapolis, Minnesota, 55417, United States
Related Publications (1)
Ishani A, Greer N, Taylor BC, Kubes L, Cole P, Atwood M, Clothier B, Ercan-Fang N. Effect of nurse case management compared with usual care on controlling cardiovascular risk factors in patients with diabetes: a randomized controlled trial. Diabetes Care. 2011 Aug;34(8):1689-94. doi: 10.2337/dc10-2121. Epub 2011 Jun 2.
PMID: 21636796DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Areef Ishani, MD, MS
Minneapolis VAMC
- PRINCIPAL INVESTIGATOR
Nacide Ercan-Fang, MD
Minneapolis VAMC
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
Study Record Dates
First Submitted
December 5, 2007
First Posted
December 7, 2007
Study Start
September 1, 2006
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
June 15, 2009
Record last verified: 2009-06