Diabetes Outcomes and Nurse Case Manager Study (DONCM)

January 26, 2016 updated by: Tom Elliott, BCDiabetes.Ca

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

140

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

    • British Columbia
      • Vancouver, British Columbia, Canada, V6R 1B6
        • BCDiabetes.Ca

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 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: nurse case management
nurse case management of diabetic variables
Active Comparator: standard diabetologist care
routine care by diabetologist & team

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
A1c
Time Frame: 6 months
changes in A1C between NCM vs. SC
6 months
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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood pressure
Time Frame: 6 months
changes in BP between NCM vs. SC. Blood pressure will be measured using an Omron Digital Blood Pressure Monitor HEM-907. Two upper arm readings are taken with the average of the two recorded.
6 months
BMI
Time Frame: 6 months
changes in BMI between NCM vs. SC. Height and weight will be measured using the Healthometer mechanical eye level upright standard physician scale with attached stadiometer. Body mass index (BMI) are calculated as weight in kilograms divided by height in meters squared.
6 months
Self-management behaviours
Time Frame: 6 months
changes in behaviour habits between NCM vs. SC. Self-management behaviours will be assessed using items from the Summary of Diabetes Self-Care Activities Measure-revised (SDSCA-R).This instrument measures self-care behaviors including diet, exercise, blood sugar testing and foot care. Participants are asked to report the number of days in the past week (range 0-7 days) in which he/she performed specific self-care practices. Greater number of days indicates better self-management.
6 months
Medication adherence
Time Frame: 6 months
changes in medication adherence between NCM vs. SC. Medication adherence will be assessed using the 4-item Moriskyscale that assesses beliefs and behaviors associated with taking medications.Responses are scored on a dichotomous scale: 0=no and 1=yes. A total score is calculated by adding up all items with lower scored indicating better adherence.
6 months
Patient motivation
Time Frame: 6 months
change in patient motivation between NCM vs. SC. motivation will be measured by the 13-item Patient Activation Measure which assesses participants' self-reported knowledge, skills, and confidence an individual has when managing his/her own health.
6 months
Diabetes-specific Social Support
Time Frame: 6 months
change in diabetes-specific social support between NCM vs. SC Diabetes-specific Social Support will be assessed with a 4-item scale developed by Tang et al. that measures amount of support and satisfaction with support from family, friends and the health care team.
6 months
Depressive Symptoms Severity
Time Frame: 6 months
change in depressive symptoms between NCM vs. SC Depressive Symptom Severity will be assessed using the 9-item PRIME-MD Patient Health Questionnaire (PHQ-9)
6 months

Collaborators and Investigators

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

Sponsor

Collaborators

Investigators

  • Principal Investigator: Tom Elliott, MBBS, University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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

August 1, 2012

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

August 2, 2012

First Submitted That Met QC Criteria

August 6, 2012

First Posted (Estimate)

August 7, 2012

Study Record Updates

Last Update Posted (Estimate)

January 27, 2016

Last Update Submitted That Met QC Criteria

January 26, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

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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