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Clinical Trials/NCT01659294
NCT01659294
Completed
Not Applicable

Impact of Nurse Case Management on Diabetes-related Health Outcomes in a Specialty Care Setting: A Randomized Controlled Trial

BCDiabetes.Ca1 site in 1 country140 target enrollmentAugust 2012
ConditionsType 2 Diabetes

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type 2 Diabetes
Sponsor
BCDiabetes.Ca
Enrollment
140
Locations
1
Primary Endpoint
A1c
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

This study will examine whether patients with diabetes who are either 1) newly discharged from hospital or 2) referred to an endocrinologist for management will have better diabetes outcomes when their care is managed primarily by a dedicated case manager (intervention) than by an endocrinologist (standard care) after 6 months of treatment.

Detailed Description

The study will be a randomized-control trial recruiting patients with type 2 diabetes in a specialty care setting from two sources: 1. referred by family physicians with inadequate glycemic control likely requiring exogenous insulin therapy 2. referred by medical staff at Vancouver General Hospital or St. Paul's Hospital during in-patient care \& about to be discharged (Appendix 1). Patients who meet the inclusion criteria will be randomly assigned into either the NCM group or SC group.

Registry
clinicaltrials.gov
Start Date
August 2012
End Date
February 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
BCDiabetes.Ca
Responsible Party
Principal Investigator
Principal Investigator

Tom Elliott

PI

BCDiabetes.Ca

Eligibility Criteria

Inclusion Criteria

  • Type 2 diabetes
  • A1c \> 8.0 or
  • BP \> 140/90 or
  • LDL cholesterol \> 2.0 (72 mg/dl)

Exclusion Criteria

  • inability to speak English or to be assisted by somebody fluent in English

Outcomes

Primary Outcomes

A1c

Time Frame: 6 months

changes in A1C between NCM vs. SC

diabetes distress (DDS)

Time Frame: 6 months

changes in diabetes distress between NCM vs. SC. Diabetes Distress (DDS) will be assessed using the 17-item Diabetes Distress Scale (DDS) developed by Polonsky and colleagues. The DDS measures emotional distress and functioning as it relates to living with diabetes. Responses are scored on a 6-point Likert scale (1=no problem to 6=serious problem). A total score is derived by taking the mean of all items. A score of \< 2 indicate low/no distress, 2 - 2.9 indicates moderate distress, and score of ≥ 3 indicates high distress.

Secondary Outcomes

  • Medication adherence(6 months)
  • blood pressure(6 months)
  • BMI(6 months)
  • Self-management behaviours(6 months)
  • Patient motivation(6 months)
  • Diabetes-specific Social Support(6 months)
  • Depressive Symptoms Severity(6 months)

Study Sites (1)

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