Diabetes Mellitus
Conditions
Keywords
Diabetes Mellitus, Chronic Care Model, Case Management
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.
Interventions
OTHERCase Management
Phone contact by specially trained nurse case managers; lifestyle recommendations and medication changes as needed
Sponsors
Minneapolis Veterans Affairs Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Safety of the intervention (occurence of adverse events over the course of the trial) | one year |
Countries
United States
Outcome results
None listed