- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01659294
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
Status
Completed
Conditions
Intervention / 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:
- referred by family physicians with inadequate glycemic control likely requiring exogenous insulin therapy
- 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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1-Elliott
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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