Effect of Case-Management Using Home Monitoring on Diabetes and Blood Pressure Outcomes
Completed · Not applicable
Conditions studied: Diabetes Mellitus
In brief
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.
Key facts
- Study ID
- NCT00935441
- Run by
- Minneapolis Veterans Affairs Medical Center
- People needed
- 460
- Starts
- 2009-06-01
- Expected to finish
- 2011-09-01
- Last updated by the study team
- 2011-09-16
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Enrolled at Minneapolis VAMC,
- Type 1 or 2 Diabetes,
- HbA1c >8.5%,
- active land-line telephone connection
You may not qualify if…
- 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
Where it is running
- Minneapolis VAMC — Minneapolis, Minnesota, United States
Full record on ClinicalTrials.gov
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