Diabetes Mellitus
Conditions
Keywords
Diabetes mellitus, chronic care, case management, telemedicine
Brief summary
This is a randomized trial designed to determine if adoption of the chronic care model in conjunction with nurse case management, home telemonitoring, and home HbA1c monitoring can improve glycemic control compared to patients receiving usual case management. We hypothesize that nurse case management, with home telemonitoring of blood sugars and home HbA1c measurement will result in additional improvements in glycemic control compared to isolated nurse case management. Specifically, the telemonitoring group will have an HbA1c 0.5% lower compared to usual nurse case management. Secondary aims include an additional 5 mmHg improvement in systolic blood pressure (among patients with hypertension at the time of enrollment), improved patient satisfaction with treatment, improved medication adherence, reduced incidence of hypoglycemia, and reduced case manager time in the telemonitoring/home HbA1c group compared with usual caes management. The study will enroll 460 diabetic patients with HbA1c values greater than 8.5%, age 75 years or younger, who have a active land-line for telephone communication. Patients will be enrolled and actively case managed for 9 months.
Interventions
BEHAVIORALcase management with telemonitoring
telephone contact with a case manager, home telemonitoring equipment for blood sugar and blood pressure, home HbA1c measurement
BEHAVIORALusual case management
telephone contact with a case manager
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 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Enrolled at Minneapolis VAMC, * Type 1 or 2 Diabetes, * HbA1c \>8.5%, * active land-line telephone connection
Exclusion criteria
* Age \>75 years, * primary care provider unwilling to have patient enrolled, * active dialysis, * resident of assisted living facility, * research participant in previous diabetes case management study, * life expectancy \<1 year, * severe mental health condition, * active substance abuse, * pregnant or planning on becoming pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycemic control (HbA1c) | 9 months after enrollment |
Secondary
| Measure | Time frame |
|---|---|
| Systolic blood pressure control in patients with elevated blood pressure at baseline | 9 months after enrollment |
Countries
United States
Outcome results
None listed