Diabetes Outcomes and Nurse Case Manager Study (DONCM)

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Tom Elliott, BCDiabetes.Ca
ClinicalTrials.gov Identifier:
NCT01659294
First received: August 2, 2012
Last updated: January 26, 2016
Last verified: January 2016
  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

Further study details as provided by BCDiabetes.Ca:

Primary Outcome Measures:
  • A1c [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    changes in A1C between NCM vs. SC

  • diabetes distress (DDS) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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:
  • blood pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • BMI [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • Self-management behaviours [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • Medication adherence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • Patient motivation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • Diabetes-specific Social Support [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • Depressive Symptoms Severity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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)


Enrollment: 140
Study Start Date: August 2012
Study Completion Date: February 2015
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
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:
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: January 26, 2016
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on August 24, 2016