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

NCT00935441 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 460

Last updated 2011-09-16

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Minneapolis Veterans Affairs Medical Center

    lead FED

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2011-09-30
Completion
2011-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00935441 on ClinicalTrials.gov