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

NCT02955719 | Completed

• 1 other identifier: 019/2016
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Depression; Anxiety; Mild Cognitive Impairment

Keywords

Collaborative Care; Depression; Anxiety; Mild Cognitive Impairment; Integrated Care Pathway

Outcome Measures

Primary Outcomes (1)

• Change in anxiety/depression/quality of life (QOL) scores among participants in the ICP and comparison groups

  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.

  From Baseline Screening to 24 month follow-up

Secondary Outcomes (8)

• Acceptability and perceived utility of the ICP

  Baseline to 24 month follow-up

• Feasibility of the ICP

  Baseline to 24 month follow-up

• Adjustments made for the adoption of the ICP in primary care teams

  Baseline to 24 month follow-up

• Barriers to implementation of the ICP and the key elements to initiate, sustain and spread the ICP

  Baseline to 24 month follow-up

• Changes in the primary care providers' knowledge of, and ability to recognize and manage, depression, anxiety, and MCI in older adults.

  Baseline to 24 month follow-up

Study Arms (2)

Enrolled Cases

EXPERIMENTAL

Integrated Care Pathway with different treatment interventions Interventions include: Sertraline, Venlafaxine, CBT/Psychological therapy, Psychiatric consultation, lifestyle intervention resources

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

Enrolled Controls

NO INTERVENTION

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

Interventions

Sertraline DRUG

Also known as: zoloft

Enrolled Cases

Venlafaxine DRUG

Also known as: effexor

Enrolled Cases

CBT/Psychological Therapy OTHER

Enrolled Cases

Psychiatric Consultation OTHER

Enrolled Cases

Lifestyle Intervention Resources OTHER

Enrolled Cases

Eligibility Criteria

• Age: 60 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead
• McMaster University: collaborator

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M6J 1H4, Canada

Location

Related Publications (1)

• 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.

  PMID: 12053639 RESULT

Related Links

• : 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

MeSH Terms

Conditions

Depression; Anxiety Disorders; Cognitive Dysfunction

Interventions

Sertraline; Venlafaxine Hydrochloride

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Cognition Disorders; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Phenethylamines; Ethylamines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Lipids

Study Officials

• Tarek Rajji, MD

  Center for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: October 24, 2016
• First Posted: November 4, 2016
• Study Start: March 30, 2016
• Primary Completion: July 16, 2020
• Study Completion: July 16, 2020
• Last Updated: January 7, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)