CAMH - McMaster Collaborative Care Initiative For Mental Health Risk Factors In Dementia (CCI)
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|ClinicalTrials.gov Identifier: NCT02955719|
Recruitment Status : Recruiting
First Posted : November 4, 2016
Last Update Posted : April 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Depression Anxiety Mild Cognitive Impairment||Drug: Sertraline Drug: Venlafaxine Other: CBT/Psychological Therapy Other: Psychiatric Consultation Other: Lifestyle Intervention Resources||Not Applicable|
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 or 1955. The investigators will enroll an additional 75 controls that were born in the calendar year 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 1951, 1952, 1955, or 1956 will be consented and screened for anxiety, depression, and Mild Cognitive Impairment (MCI).
If patients born in 1951 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 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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||CAMH - McMaster Collaborative Care Initiative For Mental Health Risk Factors In Dementia: Depression, Anxiety, and Mild Cognitive Impairment|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||February 2021|
|Estimated Study Completion Date :||February 2021|
Experimental: Enrolled Cases
Integrated Care Pathway with different treatment interventions
Sertraline, Venlafaxine, CBT/Psychological therapy, Psychiatric consultation, lifestyle intervention resources
Other Name: zoloftDrug: Venlafaxine
Other Name: effexorOther: CBT/Psychological Therapy Other: Psychiatric Consultation Other: Lifestyle Intervention Resources
No Intervention: Enrolled Controls
No intervention: Treatment as usual (TAU) will be provided by the primary care practice staff
- Change in anxiety/depression/quality of life (QOL) scores among participants in the ICP and comparison groups [ Time Frame: From Baseline Screening to 36 month follow-up ]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.
- Acceptability and perceived utility of the ICP [ Time Frame: Baseline to 42 month follow-up ]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 [ Time Frame: Baseline to 42 month follow-up ]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 [ Time Frame: Baseline to 42 month follow-up ]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 [ Time Frame: Baseline to 42 month follow-up ]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. [ Time Frame: Baseline to 42 month follow-up ]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. [ Time Frame: Baseline to 36 month followup ]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.
- The change in rates of detection/diagnosis of anxiety, depression, or MCI - pre versus post ICP [ Time Frame: Six months pre-ICP vs the six month period post the initiation of the ICP ]Rates of diagnosis/detection prior to the introduction of the ICP will be gathered using the retrospective chart review of patients who turned 61 and 65 years in 2015 (born in 1950, 1954) over a 12-month period (August 2015-July 2017). This will be compared with rate of diagnosis in the study population.
- The change in rates of Depression, Anxiety and MCI diagnoses/detection among patients of the same age cohort as our target ICP population, in 2019 [ Time Frame: Baseline to six months of ICP vs Six months after completion of the ICP ]The rates of diagnosis/detection after completion of the study will be gathered using the retrospective chart review of patients who turn 61 and 65 years in 2019 (born in 1954, 1958) over a period of 12 months (August 2019-July 2020). This will be compared with the rates of diagnosis in the study population.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02955719
|Contact: Tarek Rajji, MD||416-535-8501 ext email@example.com|
|Contact: Sara Jaffer, MA||416-535-8501 ext firstname.lastname@example.org|
|Centre for Addiction and Mental Health||Recruiting|
|Toronto, Ontario, Canada, M6J 1H4|
|Contact: Tarek Rajji, MD 416-535-8501 ext 33661 Tarek.Rajji@camh.ca|
|Principal Investigator: Tarek Rajji, MD|
|Sub-Investigator: Sarah Colman, MD|
|Sub-Investigator: Pallavi Dham, MBBS|
|Principal Investigator:||Tarek Rajji, MD||Center for Addiction and Mental Health|