Diabetes Outcomes and Nurse Case Manager Study

NCT ID: NCT01659294

Last Updated: 2016-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2015-02-28

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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nurse case management

nurse case management of diabetic variables

Group Type EXPERIMENTAL

Nurse Case Management

Intervention Type BEHAVIORAL

standard diabetologist care

standard diabetologist care

Group Type ACTIVE_COMPARATOR

standard diabetologist care

Intervention Type BEHAVIORAL

routine care by diabetologist \& team

Interventions

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Nurse Case Management

Intervention Type BEHAVIORAL

standard diabetologist care

routine care by diabetologist \& team

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role collaborator

BCDiabetes.Ca

NETWORK

Sponsor Role lead

Responsible Party

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Tom Elliott

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tom Elliott, MBBS

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

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Bcdiabetes.Ca

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

Related Links

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Other Identifiers

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1-Elliott

Identifier Type: -

Identifier Source: org_study_id

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