Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

CAMH - McMaster Collaborative Care Initiative For Mental Health Risk Factors In Dementia (CCI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2017 by Tarek Rajji, Centre for Addiction and Mental Health
Sponsor:
Collaborator:
McMaster University
Information provided by (Responsible Party):
Tarek Rajji, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:
NCT02955719
First received: October 24, 2016
Last updated: March 30, 2017
Last verified: March 2017
  Purpose
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).

Condition Intervention
Depression
Anxiety
Mild Cognitive Impairment
Drug: Sertraline
Drug: Venlafaxine
Other: CBT/Psychological Therapy
Other: Psychiatric Consultation
Other: Lifestyle Intervention Resources

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: CAMH - McMaster Collaborative Care Initiative For Mental Health Risk Factors In Dementia: Depression, Anxiety, and Mild Cognitive Impairment

Resource links provided by NLM:


Further study details as provided by Tarek Rajji, Centre for Addiction and Mental Health:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Estimated Enrollment: 150
Study Start Date: April 2016
Estimated Study Completion Date: February 2021
Estimated Primary Completion Date: February 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
No Intervention: Enrolled Controls
No intervention: Treatment as usual (TAU) will be provided by the primary care practice staff

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 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).

  Eligibility

Ages Eligible for Study:   60 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Female or male primary practice patients of participating physicians born in 1951, 1952, 1955 or 1956.
  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02955719

Contacts
Contact: Tarek Rajji, MD 416-535-8501 ext 33661 tarek.rajji@camh.ca
Contact: Sara Jaffer, MA 416-535-8501 ext 39347 sara.jaffer@camh.ca

Locations
Canada, Ontario
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         
Sponsors and Collaborators
Centre for Addiction and Mental Health
McMaster University
Investigators
Principal Investigator: Tarek Rajji, MD Center for Addiction and Mental Health
  More Information

Additional Information:
Publications:
Responsible Party: Tarek Rajji, Dr., Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT02955719     History of Changes
Other Study ID Numbers: 019/2016
Study First Received: October 24, 2016
Last Updated: March 30, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Tarek Rajji, Centre for Addiction and Mental Health:
Collaborative Care
Depression
Anxiety
Mild Cognitive Impairment
Integrated Care Pathway

Additional relevant MeSH terms:
Depression
Depressive Disorder
Anxiety Disorders
Dementia
Cognition Disorders
Mild Cognitive Impairment
Behavioral Symptoms
Mood Disorders
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive 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

ClinicalTrials.gov processed this record on May 25, 2017