Depression Clinical Trial
— CCIOfficial title:
CAMH - McMaster Collaborative Care Initiative For Mental Health Risk Factors In Dementia: Depression, Anxiety, and Mild Cognitive Impairment
NCT number | NCT02955719 |
Other study ID # | 019/2016 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | March 30, 2016 |
Est. completion date | July 16, 2020 |
Verified date | January 2021 |
Source | Centre for Addiction and Mental Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 145 |
Est. completion date | July 16, 2020 |
Est. primary completion date | July 16, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years to 65 Years |
Eligibility | Inclusion Criteria 1. Female or male primary practice patients of participating physicians born in 1951, 1953 or 1955 (ICP) and 1950, 1952 or 1956 (TAU). 2. Can read and understand English. 3. Corrected visual ability that enables reading of newspaper headlines and corrected hearing capacity that is adequate to respond to a raised conversational voice. 4. Willing and able to provide informed consent Exclusion Criteria: 1. Diagnosis of dementia. 2. 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). 3. Those with delirium, or where we are unable to make a diagnosis of MCI, due to unstable comorbidities. 4. Palliative-care patients. |
Country | Name | City | State |
---|---|---|---|
Canada | Centre for Addiction and Mental Health | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Centre for Addiction and Mental Health | McMaster University |
Canada,
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 Ca — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | From Baseline Screening to 24 month follow-up | |
Secondary | 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. | Baseline to 24 month follow-up | |
Secondary | 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. | Baseline to 24 month follow-up | |
Secondary | 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. | Baseline to 24 month follow-up | |
Secondary | 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 | Baseline to 24 month follow-up | |
Secondary | 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. | Baseline to 24 month follow-up | |
Secondary | 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. | Baseline to 24 month followup | |
Secondary | 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. | Calculate one year prior to the time of Site Initiation Visit for all recruiting sites. | |
Secondary | 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. | Calculate the 6 month period prior to the last study assessment for a given recruitment site. |
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