Diabetes Outcomes and Nurse Case Manager Study (DONCM)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Tom Elliott, BCDiabetes.Ca
ClinicalTrials.gov Identifier:
NCT01659294
First received: August 2, 2012
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Type 2 Diabetes
Behavioral: Nurse Case Management
Behavioral: standard diabetologist care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Impact of Nurse Case Management on Diabetes-related Health Outcomes in a Specialty Care Setting: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by BCDiabetes.Ca:

Primary Outcome Measures:
  • A1c [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    achievement of A1c < 7.0

  • LDL cholesterol [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    target LDL <2.0 mmol/L (=76 mg/dl)

  • blood pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    < 140/90

  • weight [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    achieved weight, change in weight


Secondary Outcome Measures:
  • quality of life measures [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    changes in quality of life measures


Estimated Enrollment: 310
Study Start Date: August 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: nurse case management
nurse case management of diabetic variables
Behavioral: Nurse Case Management
Active Comparator: standard diabetologist care
standard diabetologist care
Behavioral: standard diabetologist care
routine care by diabetologist & team

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. Primary and secondary data, including A1C, fasting glucose, lipid profile, eGFR, blood pressure, BMI, self-report measures, adherence to annual eye exam/vaccination, emergency visits and hospital stays will be collected at baseline, 3-months (only for NCM group), and 6 months.

Study Population Number of Patients The literature suggests the probability of meeting targets on all three outcomes is about 10% in the control group and about 22% in the treatment group. In order to detect this increase in probability of success in all three groups with an 80% power and a 5% significance level, we require 146 patients per group. Since the analysis will include a factor for recruitment location as well as some other baseline covariates, we will recruit an additional 9 patients per group to cover lost power due to these nuisance parameters in the model. In total we will recruit 310 patients split equally between treatment and control.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01659294

Locations
Canada, British Columbia
Bcdiabetes.Ca
Vancouver, British Columbia, Canada, V6R 1B6
Sponsors and Collaborators
BCDiabetes.Ca
Sanofi
Investigators
Principal Investigator: Tom Elliott, MBBS University of British Columbia
  More Information

Additional Information:
No publications provided

Responsible Party: Tom Elliott, PI, BCDiabetes.Ca
ClinicalTrials.gov Identifier: NCT01659294     History of Changes
Other Study ID Numbers: 1-Elliott
Study First Received: August 2, 2012
Last Updated: July 15, 2014
Health Authority: Canada: Health Canada

Keywords provided by BCDiabetes.Ca:
Type 2 diabetes
outcomes
case management

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 16, 2014