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

NCT ID: NCT00935441

Last Updated: 2011-09-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 460 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2011-09-30

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.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Telemonitoring

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

Group Type: EXPERIMENTAL

case management with telemonitoring

Intervention Type: BEHAVIORAL

telephone contact with a case manager, home telemonitoring equipment for blood sugar and blood pressure, home HbA1c measurement

Usual case management

Case management

Group Type: ACTIVE_COMPARATOR

usual case management

Intervention Type: BEHAVIORAL

telephone contact with a case manager

Interventions

case management with telemonitoring

telephone contact with a case manager, home telemonitoring equipment for blood sugar and blood pressure, home HbA1c measurement

Intervention Type: BEHAVIORAL

usual case management

telephone contact with a case manager

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Minneapolis Veterans Affairs Medical Center

FED

Sponsor Role: lead

Responsible Party

Nacide Ercan-Fang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Minneapolis VAMC

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

4127-B

Identifier Type: -

Identifier Source: org_study_id