CAMH - McMaster Collaborative Care Initiative For Mental Health Risk Factors In Dementia (CCI)
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| ClinicalTrials.gov Identifier: NCT02955719 |
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Recruitment Status :
Completed
First Posted : November 4, 2016
Last Update Posted : January 7, 2021
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| 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, 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).
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 145 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | CAMH - McMaster Collaborative Care Initiative For Mental Health Risk Factors In Dementia: Depression, Anxiety, and Mild Cognitive Impairment |
| Actual Study Start Date : | March 30, 2016 |
| Actual Primary Completion Date : | July 16, 2020 |
| Actual Study Completion Date : | July 16, 2020 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Enrolled Cases
Integrated Care Pathway with different treatment interventions Interventions include: Sertraline, Venlafaxine, CBT/Psychological therapy, Psychiatric consultation, lifestyle intervention resources |
Drug: Sertraline
Other Name: zoloft Drug: Venlafaxine Other Name: effexor Other: CBT/Psychological Therapy Other: Psychiatric Consultation Other: Lifestyle Intervention Resources |
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No Intervention: Enrolled Controls
No intervention: Treatment as usual (TAU) will be provided by the primary care practice staff
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- Change in anxiety/depression/quality of life (QOL) scores among participants in the ICP and comparison groups [ Time Frame: From Baseline Screening to 24 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 24 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 24 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 24 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 24 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 24 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 24 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.
- 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. [ Time Frame: Calculate one year prior to the time of Site Initiation Visit for all recruiting sites. ]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. [ Time Frame: Calculate the 6 month period prior to the last study assessment for a given recruitment site. ]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.
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| Ages Eligible for Study: | 60 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
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
| Canada, Ontario | |
| Centre for Addiction and Mental Health | |
| Toronto, Ontario, Canada, M6J 1H4 | |
| Principal Investigator: | Tarek Rajji, MD | Center for Addiction and Mental Health |
Publications of Results:
| Responsible Party: | Tarek Rajji, Dr., Centre for Addiction and Mental Health |
| ClinicalTrials.gov Identifier: | NCT02955719 |
| Other Study ID Numbers: |
019/2016 |
| First Posted: | November 4, 2016 Key Record Dates |
| Last Update Posted: | January 7, 2021 |
| Last Verified: | January 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Collaborative Care Depression Anxiety Mild Cognitive Impairment Integrated Care Pathway |
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Dementia Depression Depressive Disorder Anxiety Disorders Cognitive Dysfunction Behavioral Symptoms Mood Disorders Mental Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurocognitive Disorders Cognition Disorders |
Sertraline Venlafaxine Hydrochloride Antidepressive Agents Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Serotonin Agents Physiological Effects of Drugs Serotonin and Noradrenaline Reuptake Inhibitors Antidepressive Agents, Second-Generation |