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

NCT ID: NCT02955719

Last Updated: 2021-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

145 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-30

Study Completion Date

2020-07-16

Brief Summary

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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

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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).

Conditions

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Depression Anxiety Mild Cognitive Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Enrolled Cases

Integrated Care Pathway with different treatment interventions

Interventions include:

Sertraline, Venlafaxine, CBT/Psychological therapy, Psychiatric consultation, lifestyle intervention resources

Group Type EXPERIMENTAL

Sertraline

Intervention Type DRUG

Venlafaxine

Intervention Type DRUG

CBT/Psychological Therapy

Intervention Type OTHER

Psychiatric Consultation

Intervention Type OTHER

Lifestyle Intervention Resources

Intervention Type OTHER

Enrolled Controls

No intervention: Treatment as usual (TAU) will be provided by the primary care practice staff

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Sertraline

Intervention Type DRUG

Venlafaxine

Intervention Type DRUG

CBT/Psychological Therapy

Intervention Type OTHER

Psychiatric Consultation

Intervention Type OTHER

Lifestyle Intervention Resources

Intervention Type OTHER

Other Intervention Names

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zoloft effexor

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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McMaster University

OTHER

Sponsor Role collaborator

Centre for Addiction and Mental Health

OTHER

Sponsor Role lead

Responsible Party

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Tarek Rajji

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tarek Rajji, MD

Role: PRINCIPAL_INVESTIGATOR

Center for Addiction and Mental Health

Locations

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Centre for Addiction and Mental Health

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type RESULT
PMID: 12053639 (View on PubMed)

Related Links

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http://www.camh.net/research

: 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

Other Identifiers

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019/2016

Identifier Type: -

Identifier Source: org_study_id

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