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Clinical Trials/NCT00935441
NCT00935441
Completed
Not Applicable

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

Minneapolis Veterans Affairs Medical Center1 site in 1 country460 target enrollmentJune 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes Mellitus
Sponsor
Minneapolis Veterans Affairs Medical Center
Enrollment
460
Locations
1
Primary Endpoint
Glycemic control (HbA1c)
Status
Completed
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2009
End Date
September 2011
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Minneapolis Veterans Affairs Medical Center
Responsible Party
Principal Investigator
Principal Investigator

Nacide Ercan-Fang

Principal Investigator

Minneapolis Veterans Affairs Medical Center

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

Outcomes

Primary Outcomes

Glycemic control (HbA1c)

Time Frame: 9 months after enrollment

Secondary Outcomes

  • Systolic blood pressure control in patients with elevated blood pressure at baseline(9 months after enrollment)

Study Sites (1)

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