NCT03617614

Brief Summary

This study evaluates the effectiveness of a collaborative care model designed to treat frail seniors with both a mental (anxiety and/or depression) and a physical health condition impacting function with a comparison group that receives a psychiatric mood consult and a letter of recommendation but who are mainly cared for by their PCP.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2018

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 6, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

March 22, 2021

Status Verified

March 1, 2021

Enrollment Period

1.5 years

First QC Date

July 19, 2018

Last Update Submit

March 19, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in Patient Health Questionnaire (PHQ-9) from baseline to 12 months after discharge

    The Patient Health Questionnaire (PHQ-9) is a 9-item questionnaire that is used for screening, diagnosing, monitoring, and measuring the severity of depression. Each item can be answered on a 4 point scale running from 0= 'not at all' to 3= 'nearly every day'. The total score ranges from 0-27 where 0 is no depression and 27 is severe depression.

    Baseline to 12 months after discharge

Secondary Outcomes (4)

  • Change in Generalized Anxiety Disorder 7-item (GAD-7) from baseline to 12 months

    Baseline to 12 months after discharge

  • Change in World Health Organization Disability Assessment Schedule 2.0 (WHODAS) from baseline to 12 months

    Baseline to 12 months after discharge

  • Patient satisfaction with care

    12 months after discharge

  • Healthcare Utilization in the previous 3 months

    12 months after discharge

Study Arms (2)

Collaborative Care Model

Participants who received care from the Medical Psychiatry Alliance Seniors Outpatient Collaborative Care Program at Trillium Health Partners.

Behavioral: Collaborative Care Model

Mood Consult

Participants who received a one time mood consultation at the Centre for Addiction and Mental Health.

Behavioral: Mood Consultation

Interventions

Trained care managers (CM) work collaboratively with patients, caregivers, and primary care providers to provide education, care navigation and behavioral activation. The latter includes a stepped psychotherapy intervention called ENGAGE, that focuses on "reward exposure" engagement in meaningful, rewarding activities for patients. Patients (home) visits are delivered over a period of 6 to 16 weeks. Progress is assessed with standardized measures for depression (PHQ-9), anxiety (GAD-7) and functioning (WHO-DAS). Furthermore, patients are presented by the CM at Systematic Case Review meetings where an integrated team of medical, psychiatric and allied health professionals work collaboratively to review the patient's goals and treatment to formulate a care plan and recommendations.

Also known as: ENGAGE
Collaborative Care Model

A meeting with a psychiatrist to do assessment, provide education and make recommendations regarding the care of the patient for the Primary Care Provider.

Mood Consult

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Seniors discharged from the Medical Psychiatry Alliance Senior Outpatient Program or Seniors that received a one time mood consultation at CAMH

You may qualify if:

  • Depressive mood PHQ-9 \>9 or anxiety GAD-7 \>9
  • One or more chronic medical condition(s) impacting function
  • Had a one time mood consultation at CAMH or has been a patient in the Medical Psychiatry Alliance Senior Outpatient Program
  • Able to speak English

You may not qualify if:

  • Moderate to severe cognitive decline
  • Positive psychotic symptoms
  • Active suicidal ideation or attempt within the last year
  • Psychiatric admission within the last year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Trillium Health Partners

Mississauga, Ontario, L5B 1B8, Canada

Location

Centre for Addiction and Mental Health

Toronto, Ontario, M6J 1H4, Canada

Location

MeSH Terms

Conditions

Anxiety DisordersDepression

Interventions

engage 8200

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Officials

  • Judith Versloot, PhD

    Trillium Health Partners

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Lead (PhD)

Study Record Dates

First Submitted

July 19, 2018

First Posted

August 6, 2018

Study Start

July 1, 2018

Primary Completion

January 1, 2020

Study Completion

June 1, 2020

Last Updated

March 22, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

There is no plan to make individual participant data available to other researchers.

Locations