TeamCare PCN: Collaborative Care for Diabetes and Depression

NCT01328639 | Completed

• 1 other identifier: Achord 1101-10
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Depression; Depressive Symptoms; Type 2 Diabetes

Keywords

Collaborative care; Diabetes management; Depression management; Primary care

Outcome Measures

Primary Outcomes (1)

• Change in Patient Health Questionnaire-9 items (PHQ-9) score

  A remission of depression symptoms is indicated with a PHQ-9 score \<10 for a period of three consecutive months.

  Baseline, 3-month, 6-month, 9-month, 12-month

Secondary Outcomes (8)

• Change in HbA1c level

  baseline, 6-month, 12-month

• Change in total cholesterol level

  baseline, 6-month, 12-month

• Change in Systolic blood pressure measurement

  baseline, 6-month, 12-month

• Change in self-reported Health Related Quality of Life

  Baseline, 6-month, 12-month

• Change in Diabetes-specific stress

  Baseline, 6-month, 12-month

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

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

TeamCare Depression Intervention

EXPERIMENTAL

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

Interventions

TeamCare Depression Intervention OTHER

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.

Also known as: TEAMcare

TeamCare Depression Intervention

Usual diabetes and depression care OTHER

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.

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have family physician-identified type 2 diabetes
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Alliance for Canadian Health Outcomes Research in Diabetes: lead
• Alberta Health & Wellness: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (4)

Camrose PCN

Edmonton, Alberta, Canada

Location

Leduc/Beaumont/ Devon PCN

Edmonton, Alberta, Canada

Location

St. Albert & Sturgeon PCN

Edmonton, Alberta, Canada

Location

Heartland PCN

Ft Saskatchewan, Alberta, Canada

Location

Related Publications (25)

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  BACKGROUND

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• Johnson JA, Lier DA, Soprovich A, Al Sayah F, Qiu W, Majumdar SR. Cost-Effectiveness Evaluation of Collaborative Care for Diabetes and Depression in Primary Care. Am J Prev Med. 2016 Jul;51(1):e13-20. doi: 10.1016/j.amepre.2016.01.010.

  PMID: 26947212 DERIVED

• Mathe N, Johnson ST, Wozniak LA, Majumdar SR, Johnson JA. Alternation as a form of allocation for quality improvement studies in primary healthcare settings: the on-off study design. Trials. 2015 Aug 25;16:375. doi: 10.1186/s13063-015-0904-x.

  PMID: 26303892 DERIVED

• Johnson JA, Al Sayah F, Wozniak L, Rees S, Soprovich A, Qiu W, Chik CL, Chue P, Florence P, Jacquier J, Lysak P, Opgenorth A, Katon W, Majumdar SR. Collaborative care versus screening and follow-up for patients with diabetes and depressive symptoms: results of a primary care-based comparative effectiveness trial. Diabetes Care. 2014 Dec;37(12):3220-6. doi: 10.2337/dc14-1308. Epub 2014 Oct 14.

  PMID: 25315205 DERIVED

• Johnson JA, Al Sayah F, Wozniak L, Rees S, Soprovich A, Chik CL, Chue P, Florence P, Jacquier J, Lysak P, Opgenorth A, Katon WJ, Majumdar SR. Controlled trial of a collaborative primary care team model for patients with diabetes and depression: rationale and design for a comprehensive evaluation. BMC Health Serv Res. 2012 Aug 16;12:258. doi: 10.1186/1472-6963-12-258.

  PMID: 22897901 DERIVED

MeSH Terms

Conditions

Depression; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Jeffrey A Johnson, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Sumit Majumdar, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 30, 2011
• First Posted: April 5, 2011
• Study Start: November 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: July 11, 2013

Record last verified: 2013-07

Locations

CA (4)