TeamCare PCN: Collaborative Care for Diabetes and Depression (TeamCare-PCN)

This study has been completed.
Sponsor:
Collaborators:
Alberta Health & Wellness
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Dr. Jeffrey Johnson, The Alliance for Canadian Health Outcomes Research in Diabetes
ClinicalTrials.gov Identifier:
NCT01328639
First received: March 30, 2011
Last updated: July 9, 2013
Last verified: July 2013
  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

Resource links provided by NLM:


Further study details as provided by The Alliance for Canadian Health Outcomes Research in Diabetes:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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)


Enrollment: 157
Study Start Date: November 2010
Study Completion Date: January 2013
Primary Completion Date: January 2013 (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:
  • TEAMcare
  • TeamCare

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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: NCT01328639

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
Sponsors and Collaborators
The Alliance for Canadian Health Outcomes Research in Diabetes
Alberta Health & Wellness
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Jeffrey A Johnson, PhD University of Alberta
Principal Investigator: Sumit Majumdar, MD University of Alberta
  More Information

Publications:
Jacobson N, Martell C, Dimidjian S. Behavioral activation treatment for depression: Returning to contextual roots. Clinical Psychology: Science and Practice 8:255, 2001.
Majumdar SR, Johnson JA, Bowker SL, Booth GL, Dolovich L, Ghali W, Harris SB, Hux JE, Holbrook A, Lee H, Toth EL, Yale J-F. A Canadian consensus for the standardized evaluation of quality improvement interventions in type 2 diabetes: Development of a Quality Indicator Set. Canadian Journal of Diabetes 29:220-229, 2005

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: July 9, 2013
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 August 28, 2014