TeamCare PCN: Collaborative Care for Diabetes and Depression (TeamCare-PCN)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention |
|---|---|
|
Depression Depressive Symptoms Type 2 Diabetes |
Other: TeamCare Depression Intervention Other: Usual diabetes and depression care |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
| Official Title: | TeamCare PCN: Collaborative Care for Patients With Diabetes and Depression in Primary Care Networks |
- Change in Patient Health Questionnaire-9 items (PHQ-9) score [ Time Frame: Baseline, 3-month, 6-month, 9-month, 12-month ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Improvement is defined as 10% improvement over baseline
- Change in total cholesterol level [ Time Frame: baseline, 6-month, 12-month ] [ Designated as safety issue: No ]Improvement is defined as 10% improvement over baseline
- Change in Systolic blood pressure measurement [ Time Frame: baseline, 6-month, 12-month ] [ Designated as safety issue: No ]Improvement is defined as 10% improvement over baseline
- Change in self-reported Health Related Quality of Life [ Time Frame: Baseline, 6-month, 12-month ] [ Designated as safety issue: No ]Measured by SF-12-V2 and EQ-5D-5L
- Change in Diabetes-specific stress [ Time Frame: Baseline, 6-month, 12-month ] [ Designated as safety issue: No ]Measured by Problem Areas In Diabetes 5-level questionnaire (PAID-5)
- Change in Health behaviours [ Time Frame: Baseline, 6-month, 12-month ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Measured using the Summary of Diabetes Self Care Activities questionnaire (SDSCA)
- Change in Satisfaction with care [ Time Frame: Baseline, 12-month ] [ Designated as safety issue: No ]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)
| Estimated Enrollment: | 330 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Names:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Have family physician-identified type 2 diabetes
- 18 years of age or older
- Score >=10 on the PHQ-9
- Speak English and have adequate hearing to complete phone interviews
- Be willing and able to provide written informed consent to participate
Exclusion Criteria:
- Severe and/or terminal physical illness
- Serious and/or severe mental or psychiatric illness
- Pregnant or breastfeeding
- Live in long term care facility
- Already participating in other clinical trials
Contacts and Locations| Canada, Alberta | |
| St. Albert & Sturgeon PCN | |
| Edmonton, Alberta, Canada | |
| Leduc/Beaumont/ Devon PCN | |
| Edmonton, Alberta, Canada | |
| Camrose PCN | |
| Edmonton, Alberta, Canada | |
| Heartland PCN | |
| Fort Saskatchewan, Alberta, Canada | |
| Principal Investigator: | Jeffrey A Johnson, PhD | University of Alberta |
| Principal Investigator: | Sumit Majumdar, MD | University of Alberta |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dr. Jeffrey Johnson, Professor, The Alliance for Canadian Health Outcomes Research in Diabetes |
| ClinicalTrials.gov Identifier: | NCT01328639 History of Changes |
| Other Study ID Numbers: | Achord 1101-10 |
| Study First Received: | March 30, 2011 |
| Last Updated: | February 22, 2012 |
| Health Authority: | Canada: Health Research Ethics Board - University of Alberta, Edmonton, Alberta |
Keywords provided by The Alliance for Canadian Health Outcomes Research in Diabetes:
|
Collaborative care Diabetes management Depression management Primary care |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Diabetes Mellitus Diabetes Mellitus, Type 2 Behavioral Symptoms |
Mood Disorders Mental Disorders Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 21, 2013