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

September 14, 2011 updated by: Nacide Ercan-Fang, Minneapolis Veterans Affairs Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

460

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55417
        • Minneapolis VAMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telemonitoring
Case management with home telemonitoring for blood sugar and blood pressure plus home HbA1c measurement
Behavioral: case management with telemonitoring
telephone contact with a case manager, home telemonitoring equipment for blood sugar and blood pressure, home HbA1c measurement
Active Comparator: Usual case management
Case management
Behavioral: usual case management
telephone contact with a case manager

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Glycemic control (HbA1c)
Time Frame: 9 months after enrollment
9 months after enrollment

Secondary Outcome Measures

Outcome Measure
Time Frame
Systolic blood pressure control in patients with elevated blood pressure at baseline
Time Frame: 9 months after enrollment
9 months after enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minneapolis Veterans Affairs Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

July 8, 2009

First Submitted That Met QC Criteria

July 8, 2009

First Posted (Estimate)

July 9, 2009

Study Record Updates

Last Update Posted (Estimate)

September 16, 2011

Last Update Submitted That Met QC Criteria

September 14, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4127-B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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