Diabetes Outcomes and Nurse Case Manager Study

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Behavioral: Nurse Case Management; Behavioral: standard diabetologist care

• Registration Number: NCT01659294
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-02
• Study First Submitted QC: 2012-08-06
• Study First Posted: 2012-08-07
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-26
• Last Update Posted: 2016-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nurse case management	Nurse Case Management	nurse case management of diabetic variables
standard diabetologist care	standard diabetologist care	standard diabetologist care

Primary Outcome Measures

Name	Time	Method
A1c	6 months	changes in A1C between NCM vs. SC
diabetes distress (DDS)	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

Name	Time	Method
Medication adherence	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.
blood pressure	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.
BMI	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.
Self-management behaviours	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.
Patient motivation	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.
Diabetes-specific Social Support	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.
Depressive Symptoms Severity	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)

Trial Locations

Locations (1)

Bcdiabetes.Ca; 🇨🇦 Vancouver, British Columbia, Canada