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Diabetes Outcomes and Nurse Case Manager Study (DONCM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01659294
Recruitment Status : Completed
First Posted : August 7, 2012
Last Update Posted : January 27, 2016
Information provided by (Responsible Party):
Tom Elliott, BCDiabetes.Ca

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Behavioral: Nurse Case Management Behavioral: standard diabetologist care Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : August 2012
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. A1c [ Time Frame: 6 months ]
    changes in A1C between NCM vs. SC

  2. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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. 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.

  7. 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)

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01659294

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Canada, British Columbia
Vancouver, British Columbia, Canada, V6R 1B6
Sponsors and Collaborators
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Principal Investigator: Tom Elliott, MBBS University of British Columbia

Additional Information:
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Responsible Party: Tom Elliott, PI, BCDiabetes.Ca Identifier: NCT01659294    
Other Study ID Numbers: 1-Elliott
First Posted: August 7, 2012    Key Record Dates
Last Update Posted: January 27, 2016
Last Verified: January 2016
Keywords provided by Tom Elliott, BCDiabetes.Ca:
Type 2 diabetes
case management
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases