Diabetes Outcomes and Nurse Case Manager Study
DONCM
Impact of Nurse Case Management on Diabetes-related Health Outcomes in a Specialty Care Setting: A Randomized Controlled Trial
1 other identifier
interventional
140
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable type-2-diabetes
Started Aug 2012
Typical duration for not_applicable type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 2, 2012
CompletedFirst Posted
Study publicly available on registry
August 7, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedJanuary 27, 2016
January 1, 2016
2.5 years
August 2, 2012
January 26, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
A1c
changes in A1C between NCM vs. SC
6 months
diabetes distress (DDS)
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 Outcomes (7)
blood pressure
6 months
BMI
6 months
Self-management behaviours
6 months
Medication adherence
6 months
Patient motivation
6 months
- +2 more secondary outcomes
Study Arms (2)
nurse case management
EXPERIMENTALnurse case management of diabetic variables
standard diabetologist care
ACTIVE COMPARATORstandard diabetologist care
Interventions
routine care by diabetologist \& team
Eligibility Criteria
You may qualify if:
- Type 2 diabetes
- A1c \> 8.0 or
- BP \> 140/90 or
- LDL cholesterol \> 2.0 (72 mg/dl)
You may not qualify if:
- inability to speak English or to be assisted by somebody fluent in English
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- BCDiabetes.Calead
- Sanoficollaborator
Study Sites (1)
Bcdiabetes.Ca
Vancouver, British Columbia, V6R 1B6, Canada
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tom Elliott, MBBS
University of British Columbia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PI
Study Record Dates
First Submitted
August 2, 2012
First Posted
August 7, 2012
Study Start
August 1, 2012
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
January 27, 2016
Record last verified: 2016-01