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

Minneapolis Veterans Affairs Health Care System (VAHCS)

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Behavioral: case management with telemonitoring; Behavioral: usual case management

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00935441

4127-B

Details and patient eligibility

About

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.

Enrollment: 460 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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460 participants in 2 patient groups

Telemonitoring

Experimental group

Description:

Case management with home telemonitoring for blood sugar and blood pressure plus home HbA1c measurement

Treatment:

Behavioral: case management with telemonitoring

Usual case management

Active Comparator group

Description:

Case management

Treatment:

Behavioral: usual case management