TeamCare PCN: Collaborative Care for Diabetes and Depression (TeamCare-PCN)
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|ClinicalTrials.gov Identifier: NCT01328639|
Recruitment Status : Completed
First Posted : April 5, 2011
Last Update Posted : July 11, 2013
Background & Objective: Type 2 diabetes is a complex disease characterized by multiple comorbidities. Depression is one of the most common comorbidities in individuals with diabetes with prevalence rates reaching 30%. Depression complicates diabetes treatment, portends worse outcomes and increases health care costs. One novel approach to managing diabetes with co-morbid depression is a collaborative primary care model involving a multidisciplinary health care team guiding patient-centered care. This model has been tested in the US and showed a significant reduction of depressive symptoms, improved diabetes care and patient-reported outcomes, and saved money. Our aim is to evaluate the implementation of this collaborative care model for type 2 diabetes and comorbid depression within the non-metro Primary Care Network (PCN) setting in Canada.
Intervention: The intervention involves three phases: (1) improving depressive symptoms, (2) improving blood sugar, blood pressure and cholesterol, and (3) improving lifestyle behaviours. The intervention is administered by a CM in collaboration with family physicians, psychiatrists, and internists.
Hypotheses: The TeamCare-PCN intervention will reduce depressive symptoms, achieve targets for cardio-metabolic measures and improve lifestyle behaviours. Furthermore, the investigators anticipate this intervention will be acceptable and implemented in a cost-effective manner in the PCN environment.
Methods: The investigators will employ a mixed-methods approach to our evaluation, using a controlled "on-off" trial design. Our primary analysis will be based on a multivariable scaled marginal model for the combined outcome of depressive symptoms and medical care. Secondary analyses will assess changes in lifestyle behaviours and patient-reported outcomes.
Significance: Our work will serve as a platform upon which an emerging model of primary care can incorporate an effective and cost-effective depression intervention into the management of individuals with type 2 diabetes, and as a framework for implementing and evaluating similar interventions in individuals with other chronic conditions.
|Condition or disease||Intervention/treatment||Phase|
|Depression Depressive Symptoms Type 2 Diabetes||Other: TeamCare Depression Intervention Other: Usual diabetes and depression care||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||157 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||TeamCare PCN: Collaborative Care for Patients With Diabetes and Depression in Primary Care Networks|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||January 2013|
|Actual Study Completion Date :||January 2013|
Active Comparator: Usual Care
Participants in this arm will be actively screened for depression and will receive the usual standard care for diabetes from their family physicians based on available clinical practice guidelines.
Other: Usual diabetes and depression care
Usual care of diabetes and depression involves providing care by the family physician based on usual standards of care and available clinical practice guidelines. Usual care does not involve additional active support from the Care Manager.
Experimental: TeamCare Depression Intervention
Participants in this arm will be actively screened for depression, and will receive care for depression and diabetes based on the collaborative teamcare model for the management of diabetes and co-morbid depression.
Other: TeamCare Depression Intervention
The TeamCare-PCN intervention involves a registered nurse Care Manager (CM), who coordinates collaborative team management for patients with diabetes and depression. The goal of the intervention is to reduce depressive symptoms, achieve targets for cardio-metabolic measures and improve lifestyle behaviours. The intervention includes three phases: (1) managing depression and improving depressive symptoms, (2) managing diabetes and controlling blood glucose, blood pressure and cholesterol, and (3) improving lifestyle behaviours such as healthy eating, physical activity and smoking cessation.
Other Name: TEAMcare
- Change in Patient Health Questionnaire-9 items (PHQ-9) score [ Time Frame: Baseline, 3-month, 6-month, 9-month, 12-month ]A remission of depression symptoms is indicated with a PHQ-9 score <10 for a period of three consecutive months.
- Change in HbA1c level [ Time Frame: baseline, 6-month, 12-month ]Improvement is defined as 10% improvement over baseline
- Change in total cholesterol level [ Time Frame: baseline, 6-month, 12-month ]Improvement is defined as 10% improvement over baseline
- Change in Systolic blood pressure measurement [ Time Frame: baseline, 6-month, 12-month ]Improvement is defined as 10% improvement over baseline
- Change in self-reported Health Related Quality of Life [ Time Frame: Baseline, 6-month, 12-month ]Measured by SF-12-V2 and EQ-5D-5L
- Change in Diabetes-specific stress [ Time Frame: Baseline, 6-month, 12-month ]Measured by Problem Areas In Diabetes 5-level questionnaire (PAID-5)
- Change in Health behaviours [ Time Frame: Baseline, 6-month, 12-month ]Includes assessment of smoking behaviours, alcohol consumption, substance use, and physical activity
- Change in Self-care management activities [ Time Frame: Baseline, 6-month, 12-month ]Measured using the Summary of Diabetes Self Care Activities questionnaire (SDSCA)
- Change in Satisfaction with care [ Time Frame: Baseline, 12-month ]Measured using the Consumer Assessment of Healthcare Providers and Systems questionnaire (CAHPS), Adult Primary Care 1.0, and the Patient Assessment of Chronic Illness Care questionnaire (PACIC)
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 ClinicalTrials.gov identifier (NCT number): NCT01328639
|Edmonton, Alberta, Canada|
|Leduc/Beaumont/ Devon PCN|
|Edmonton, Alberta, Canada|
|St. Albert & Sturgeon PCN|
|Edmonton, Alberta, Canada|
|Fort Saskatchewan, Alberta, Canada|
|Principal Investigator:||Jeffrey A Johnson, PhD||University of Alberta|
|Principal Investigator:||Sumit Majumdar, MD||University of Alberta|