Diabetes Outcomes and Nurse Case Manager Study

Type 2 Diabetes Clinical Trial

— DONCM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01659294
• Other study ID #: 1-Elliott
• Status: Completed
• Phase: N/A
• First received: August 2, 2012
• Last updated: January 26, 2016
• Start date: August 2012
• Est. completion date: February 2015

Study information

• Verified date: January 2016
• Source: BCDiabetes.Ca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Behavioral:
• Nurse Case Management

• standard diabetologist care
routine care by diabetologist & team

Locations

Country	Name	City	State
Canada	Bcdiabetes.Ca	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
BCDiabetes.Ca	Sanofi

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A1c	changes in A1C between NCM vs. SC	6 months	No
Primary	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	No
Secondary	blood pressure	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	No
Secondary	BMI	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	No
Secondary	Self-management behaviours	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	No
Secondary	Medication adherence	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	No
Secondary	Patient motivation	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	No
Secondary	Diabetes-specific Social Support	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	No
Secondary	Depressive Symptoms Severity	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	No

External Links

•   Consent form
•   Protocol