Study of the Effect of the Cognitive Orientation to Daily Occupational Performance (CO-OP) on Cognitive Impairment in Parkinson's Disease

University of Manitoba

Status: Completed

Conditions: Cognitive Impairment; Parkinson's Disease

Treatments: Behavioral: CO-OP treatment protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT02007785

H2013:400

Details and patient eligibility

About

The purpose of the study will be to determine the effects of the Cognitive Orientation to daily Occupational Performance (CO-OP) as a treatment program for individuals with Parkinson's disease-related cognitive impairment. The potential effects of the CO-OP on successful engagement in meaningful activities will be examined from participants' and live-in caregivers' perspectives. Effects of the CO-OP on participant-perceived health-related quality of life and caregiver burden will also be evaluated.

Hypotheses:

1. Training with the CO-OP will have an effect or multiple effects on participation in meaningful activities and health-related quality of life for individuals with Parkinson's-related cognitive impairment.
2. Training with the CO-OP will have an effect or multiple effects on caregiver burden and health-related quality of life for caregivers of individuals with Parkinson's-related cognitive impairment.

Enrollment: 6 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for Participants with Parkinson's disease:

• Clinical diagnosis of Idiopathic Parkinson's Disease
• Presence of a live-in caregiver or significant other who is willing to participate in the study
• Montreal Cognitive Assessment (MoCA) score above 16/30 and below 26/30
• Schwab and England Activities of Daily Living Scale scores between 60% and 90%
• Hoehn and Yahr Scale scores between Stage 1 and Stage 3
• Self-reported difficulty completing routine functional activities that may be related to new cognitive changes since PD diagnosis

Exclusion Criteria for Participants with Parkinson's disease:

• Clinical diagnosis of atypical parkinsonism
• Clinical diagnosis of young-onset Parkinson's disease
• Co-morbidities associated with cognitive impairment
• Poorly controlled depression
• Clinical diagnosis of dementia
• Residence outside boundaries of the city of Winnipeg, Manitoba, Canada

Inclusion Criteria for Caregiver Participants:

• Live in the same residence as participant with Parkinson's
• Be willing to participate

Exclusion Criteria for Caregiver Participants:

• Scores at or below 16/30 on Montreal Cognitive Assessment (MoCA)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

CO-OP treatment protocol

Experimental group

Description:

Participants with Parkinson's disease will be participating in up to 12 one-on-one treatment sessions with 2 sessions per week, for up to 6 weeks. Each session will last 45-60 minutes. During these treatment sessions, each participant will be taught a problem-solving strategy that teaches individuals to monitor and adjust their own actions. Participants will be guided by the principal investigator to select 5 individual treatment goals to work on during treatment. Sessions will continue until all 5 treatment goals have been met or until 12 sessions have been completed, whichever occurs earlier. Initially, each participant's respective primary caregiver will be required to attend treatment sessions, so that the caregiver may be familiar with the treatment strategy in order to coach the participant with Parkinson's disease when you he or she uses the strategy at home.

Treatment:

Behavioral: CO-OP treatment protocol