CAMH - McMaster Collaborative Care Initiative For Mental Health Risk Factors In Dementia (CCI)
Primary Purpose
Depression, Anxiety, Mild Cognitive Impairment
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Sertraline
Venlafaxine
CBT/Psychological Therapy
Psychiatric Consultation
Lifestyle Intervention Resources
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Collaborative Care, Depression, Anxiety, Mild Cognitive Impairment, Integrated Care Pathway
Eligibility Criteria
Inclusion Criteria
- Female or male primary practice patients of participating physicians born in 1951, 1953 or 1955 (ICP) and 1950, 1952 or 1956 (TAU).
- Can read and understand English.
- Corrected visual ability that enables reading of newspaper headlines and corrected hearing capacity that is adequate to respond to a raised conversational voice.
- Willing and able to provide informed consent
Exclusion Criteria:
- Diagnosis of dementia.
- Substance abuse identified as an acute problem in the four weeks before being enrolled in the study (i.e. the day the patient signs the informed consent form).
- Those with delirium, or where we are unable to make a diagnosis of MCI, due to unstable comorbidities.
- Palliative-care patients.
Sites / Locations
- Centre for Addiction and Mental Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Enrolled Cases
Enrolled Controls
Arm Description
Integrated Care Pathway with different treatment interventions Interventions include: Sertraline, Venlafaxine, CBT/Psychological therapy, Psychiatric consultation, lifestyle intervention resources
No intervention: Treatment as usual (TAU) will be provided by the primary care practice staff
Outcomes
Primary Outcome Measures
Change in anxiety/depression/quality of life (QOL) scores among participants in the ICP and comparison groups
Comparison for the GAD-7/PHQ-9/QOL scores will be assessed using Group x Time ANOVAs repeated measure comparing scores at assessment times in the intervention and comparison groups.
Secondary Outcome Measures
Acceptability and perceived utility of the ICP
Qualitative data will be gathered from primary care teams to determine the acceptability and perceived utility data from brief team meetings and focus groups.
Feasibility of the ICP
Qualitative data for the feasibility indicators will be obtained from the information collected by the research coordinator from the primary care team during the recruitment, screening, and data collection phases of the study, as well as the chart review.
Adjustments made for the adoption of the ICP in primary care teams
Qualitative data about the adjustments made at each primary care practice to adopt the ICP will be gathered from brief meetings and focus groups.
Barriers to implementation of the ICP and the key elements to initiate, sustain and spread the ICP
Qualitative data on difficulties with implementing the ICP, as well as information on successfully initiating and supporting the ICP will be gathered from brief meetings and focus groups
Changes in the primary care providers' knowledge of, and ability to recognize and manage, depression, anxiety, and MCI in older adults.
Mean ratings on the Primary Care Team Questionnaire will be calculated at baseline and at the end of the study and compared using t-tests.
Time-to-treatment initiation among those in the ICP arm versus those in the comparison arm.
The length of time from identification of anxiety, depression or MCI and the start of the ICP intervention (i.e., time-to-treatment initiation) will be calculated in days for patients in the intervention group and comparison group. The average length of time-to-treatment initiation will be calculated for each group and these means will be compared using a t-test.
Specific Aim 3a: To assess the impact of the ICP on the rates of diagnoses/detection among older patients with anxiety, depression, or MCI compared to before ICP implementation.
During the recruitment phase of the study, charts of patients born in 1950, 1954 will be reviewed to identify diagnosis of depression, anxiety and/or MCI prior to the implementation of the ICP. The period of data collection for this chart review is calculated as one year prior to the time of the SIV for all sites.
Specific Aim 3b: To assess the impact of ICP on rates of diagnoses/detection among patients of the same age cohort as our target ICP population, but not in our study sample.
We will review contamination effects by reviewing the charts of clinic patients born in 1954 and 1958 to identify the diagnosis/detection of depression, anxiety and/or MCI in the 6 month period prior to the last study assessment for a given recruitment site.
Full Information
NCT ID
NCT02955719
First Posted
October 24, 2016
Last Updated
January 6, 2021
Sponsor
Centre for Addiction and Mental Health
Collaborators
McMaster University
1. Study Identification
Unique Protocol Identification Number
NCT02955719
Brief Title
CAMH - McMaster Collaborative Care Initiative For Mental Health Risk Factors In Dementia
Acronym
CCI
Official Title
CAMH - McMaster Collaborative Care Initiative For Mental Health Risk Factors In Dementia: Depression, Anxiety, and Mild Cognitive Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
March 30, 2016 (Actual)
Primary Completion Date
July 16, 2020 (Actual)
Study Completion Date
July 16, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health
Collaborators
McMaster University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Age remains the single most significant risk factor for developing dementia, particularly Alzheimer's dementia (AD). Given the rate at which Canada's population is aging, the quest to determine modifiable risk factors, whether by prevention, earlier detection, or an ability to slow the rate of decline, is a key priority in health care. Primary care is likely to play a pivotal role in this initiative. Collaborative mental health care between primary care providers and mental health clinicians has been demonstrated to be effective at the patient and system levels. Thus, the overall goal of this project is to assess impact and feasibility of implementing a collaborative care evidence-based Integrated Care Pathway (ICP) in addressing three potentially reversible risk factors at high risk for developing AD: anxiety, depression, or mild cognitive impairment (MCI).
Detailed Description
The investigators will enroll 150 participants overall (CAMH and McMaster). Seventy-five will be cases who will be enrolled into the ICP arm of the study and these will be patients born in the calendar year 1951, 1953 or 1955. The investigators will enroll an additional 75 controls that were born in the calendar year 1950, 1952 or 1956.
Patients of general practitioners being seen at primary healthcare clinics in the Greater Toronto Area and in Hamilton, who were born in the calendar year 1950, 1951, 1952, 1953, 1955, or 1956 will be consented and screened for anxiety, depression, and Mild Cognitive Impairment (MCI).
If patients born in 1951, 1953 and 1955 reach a threshold level of anxiety, depression, or MCI symptom burden and have a confirmed diagnosis, rather than receive treatment as usual, the participants will be enrolled into an Integrated Care Pathway (ICP), which offers evidence-informed treatment for the management of these syndromes in a routine, algorithmic fashion. All enrolled cases entered in the study will be provided with general interventions that address lifestyle and medical factors that both contribute to these syndromes and are thought to predispose patients to develop dementia. If the symptom burden is severe enough, based on standardized assessments, evidence-based psychopharmacology (a trial of sertraline and/or venlafaxine) will also be offered, with a standardized titration schedule. Collaboration will be built into the ICP - a psychiatrist will be present at the clinic and in contact with primary care providers to provide patient- and physician-level support, consultation, and episodes of care as necessary. Rates of anxiety, depression, and MCI diagnosis/detection, time to treatment initiation, and improvement in symptom burden will be assessed.
If patients born in 1950, 1952 and 1956 reach a threshold level of anxiety, depression, or MCI symptom burden, these individuals will form our comparison group and will receive treatment as usual (TAU).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Anxiety, Mild Cognitive Impairment
Keywords
Collaborative Care, Depression, Anxiety, Mild Cognitive Impairment, Integrated Care Pathway
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
145 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Enrolled Cases
Arm Type
Experimental
Arm Description
Integrated Care Pathway with different treatment interventions
Interventions include:
Sertraline, Venlafaxine, CBT/Psychological therapy, Psychiatric consultation, lifestyle intervention resources
Arm Title
Enrolled Controls
Arm Type
No Intervention
Arm Description
No intervention: Treatment as usual (TAU) will be provided by the primary care practice staff
Intervention Type
Drug
Intervention Name(s)
Sertraline
Other Intervention Name(s)
zoloft
Intervention Type
Drug
Intervention Name(s)
Venlafaxine
Other Intervention Name(s)
effexor
Intervention Type
Other
Intervention Name(s)
CBT/Psychological Therapy
Intervention Type
Other
Intervention Name(s)
Psychiatric Consultation
Intervention Type
Other
Intervention Name(s)
Lifestyle Intervention Resources
Primary Outcome Measure Information:
Title
Change in anxiety/depression/quality of life (QOL) scores among participants in the ICP and comparison groups
Description
Comparison for the GAD-7/PHQ-9/QOL scores will be assessed using Group x Time ANOVAs repeated measure comparing scores at assessment times in the intervention and comparison groups.
Time Frame
From Baseline Screening to 24 month follow-up
Secondary Outcome Measure Information:
Title
Acceptability and perceived utility of the ICP
Description
Qualitative data will be gathered from primary care teams to determine the acceptability and perceived utility data from brief team meetings and focus groups.
Time Frame
Baseline to 24 month follow-up
Title
Feasibility of the ICP
Description
Qualitative data for the feasibility indicators will be obtained from the information collected by the research coordinator from the primary care team during the recruitment, screening, and data collection phases of the study, as well as the chart review.
Time Frame
Baseline to 24 month follow-up
Title
Adjustments made for the adoption of the ICP in primary care teams
Description
Qualitative data about the adjustments made at each primary care practice to adopt the ICP will be gathered from brief meetings and focus groups.
Time Frame
Baseline to 24 month follow-up
Title
Barriers to implementation of the ICP and the key elements to initiate, sustain and spread the ICP
Description
Qualitative data on difficulties with implementing the ICP, as well as information on successfully initiating and supporting the ICP will be gathered from brief meetings and focus groups
Time Frame
Baseline to 24 month follow-up
Title
Changes in the primary care providers' knowledge of, and ability to recognize and manage, depression, anxiety, and MCI in older adults.
Description
Mean ratings on the Primary Care Team Questionnaire will be calculated at baseline and at the end of the study and compared using t-tests.
Time Frame
Baseline to 24 month follow-up
Title
Time-to-treatment initiation among those in the ICP arm versus those in the comparison arm.
Description
The length of time from identification of anxiety, depression or MCI and the start of the ICP intervention (i.e., time-to-treatment initiation) will be calculated in days for patients in the intervention group and comparison group. The average length of time-to-treatment initiation will be calculated for each group and these means will be compared using a t-test.
Time Frame
Baseline to 24 month followup
Title
Specific Aim 3a: To assess the impact of the ICP on the rates of diagnoses/detection among older patients with anxiety, depression, or MCI compared to before ICP implementation.
Description
During the recruitment phase of the study, charts of patients born in 1950, 1954 will be reviewed to identify diagnosis of depression, anxiety and/or MCI prior to the implementation of the ICP. The period of data collection for this chart review is calculated as one year prior to the time of the SIV for all sites.
Time Frame
Calculate one year prior to the time of Site Initiation Visit for all recruiting sites.
Title
Specific Aim 3b: To assess the impact of ICP on rates of diagnoses/detection among patients of the same age cohort as our target ICP population, but not in our study sample.
Description
We will review contamination effects by reviewing the charts of clinic patients born in 1954 and 1958 to identify the diagnosis/detection of depression, anxiety and/or MCI in the 6 month period prior to the last study assessment for a given recruitment site.
Time Frame
Calculate the 6 month period prior to the last study assessment for a given recruitment site.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Female or male primary practice patients of participating physicians born in 1951, 1953 or 1955 (ICP) and 1950, 1952 or 1956 (TAU).
Can read and understand English.
Corrected visual ability that enables reading of newspaper headlines and corrected hearing capacity that is adequate to respond to a raised conversational voice.
Willing and able to provide informed consent
Exclusion Criteria:
Diagnosis of dementia.
Substance abuse identified as an acute problem in the four weeks before being enrolled in the study (i.e. the day the patient signs the informed consent form).
Those with delirium, or where we are unable to make a diagnosis of MCI, due to unstable comorbidities.
Palliative-care patients.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tarek Rajji, MD
Organizational Affiliation
Center for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6J 1H4
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
12053639
Citation
Kates N, Craven M; Collaborative Working Group of the College of Family Physicians of Canada, Canadian Psychiatric Association. Shared mental health care. Update from the Collaborative Working Group of the College of Family Physicians of Canada and the Canadian Psychiatric Association. Can Fam Physician. 2002 May;48:936. No abstract available.
Results Reference
result
Links:
URL
http://www.camh.net/research
Description
: Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addiction teaching hospital, fully affiliated with the University of Toronto, and a PAHO/WHO Collaborating Centre
Learn more about this trial
CAMH - McMaster Collaborative Care Initiative For Mental Health Risk Factors In Dementia
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