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

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Behavioral: usual case management; Behavioral: case management with telemonitoring

• Registration Number: NCT00935441
• Lead Sponsor: Minneapolis Veterans Affairs Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-07-08
• Study First Submitted QC: 2009-07-08
• Study First Posted: 2009-07-09
• Status Verified: 2011-09
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Last Update Submitted: 2011-09-14
• Last Update Posted: 2011-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 460

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual case management	usual case management	Case management
Telemonitoring	case management with telemonitoring	Case management with home telemonitoring for blood sugar and blood pressure plus home HbA1c measurement

Primary Outcome Measures

Name	Time	Method
Glycemic control (HbA1c)	9 months after enrollment

Secondary Outcome Measures

Name	Time	Method
Systolic blood pressure control in patients with elevated blood pressure at baseline	9 months after enrollment

Trial Locations

Locations (1)

Minneapolis VAMC; 🇺🇸 Minneapolis, Minnesota, United States