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

C

Center for Addiction and Mental Health (CAMH)

Status

Completed

Conditions

Mild Cognitive Impairment
Depression
Anxiety

Treatments

Other: Lifestyle Intervention Resources
Other: Psychiatric Consultation
Drug: Venlafaxine
Other: CBT/Psychological Therapy
Drug: Sertraline

Study type

Interventional

Funder types

Other

Identifiers

NCT02955719
019/2016

Details and patient eligibility

About

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).

Full 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, 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).

Enrollment

145 patients

Sex

All

Ages

60 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

145 participants in 2 patient groups

Enrolled Cases
Experimental group
Description:
Integrated Care Pathway with different treatment interventions Interventions include: Sertraline, Venlafaxine, CBT/Psychological therapy, Psychiatric consultation, lifestyle intervention resources
Treatment:
Other: Lifestyle Intervention Resources
Drug: Sertraline
Drug: Venlafaxine
Other: CBT/Psychological Therapy
Other: Psychiatric Consultation
Enrolled Controls
No Intervention group
Description:
No intervention: Treatment as usual (TAU) will be provided by the primary care practice staff

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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