NCT00935441

Effect of Case-Management Using Home Monitoring on Diabetes and Blood Pressure Outcomes

Effect of Nurse-Based, Protocol-Driven, Case-Management Utilizing Home Telemonitoring and Home HbA1c Measurement on Diabetes and Blood Pressure Outcomes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 460 (estimated)
• Sponsor: Minneapolis Veterans Affairs Medical Center · Federal
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
BEHAVIORAL	case management with telemonitoring	telephone contact with a case manager, home telemonitoring equipment for blood sugar and blood pressure, home HbA1c measurement
BEHAVIORAL	usual case management	telephone contact with a case manager

Timeline

• Start date: 2009-06-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2009-07-09
• Last updated: 2011-09-16

Locations

1 site across 1 country: United States