Clinical trial NCT02007785: Study of the Effect of the Cognitive Orientation to Daily Occupational Performance (CO-OP) on Cognitive Impairment in Parkinson's Disease
Official title: Determining the Applicability of the Cognitive Orientation to Daily Occupational Performance (CO-OP) as a Meta-Cognitive Rehabilitation Strategy for Individuals With Parkinson's Disease-Related Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Cognitive Impairment
Keywords: Cognitive Orientation to daily Occupational Performance
CO-OP
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2013-12-11
Enrollment: 6
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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)

Primary outcomes:
measure: Change from Pre-Intervention Phase Baseline Pattern (2 week duration) on Canadian Occupational Performance Measure (COPM) score pattern at Intervention Phase (6 week duration), Post-Intervention Phase (2 week duration), and 3-Month Follow-up
timeFrame: Pre-Intervention Phase: Days 1, 3, 5, 9 and 11; Intervention Phase: Following treatment sessions 2, 4, 6, 8, and 10; Post-Intervention Phase: Days 1, 3, 5, 9, and 11; Follow-Up Phase: 3 months after completion of Post-Intervention Phase
measure: Change from Pre-Intervention Phase Baseline Pattern (2 week duration) on Parkinson Disease Questionnaire - 39 (PDQ-39) score pattern at Intervention Phase (6 week duration), Post-Intervention Phase (2 week duration), and 3-Month Follow-Up
timeFrame: Pre-Intervention Phase: Days 1, 3, 5, 9, and 11; Intervention Phase: Following treatment sessions 2, 4, 6, 8, and 10; Post-Intervention Phase: Days 1, 3, 5, 9, and 11; Follow-Up Phase: 3 months after completion of Post-Intervention Phase
measure: Change from Pre-Intervention Phase Baseline Pattern (2 week duration) on Zarit Burden Interview score pattern at Intervention Phase (6 week duration), Post-Intervention Phase (2 week duration), and 3-Month Follow-Up
timeFrame: Pre-Intervention Phase: Days 1, 3, 5, 9, and 11; Intervention Phase: Following treatment sessions 2, 4, 6, 8, and 10; Post-Intervention Phase: Days 1, 3, 5, 9, and 11; Follow-Up Phase: 3 months after completion of Post-Intervention Phase
measure: Change from Pre-Intervention Baseline Observations (2 week duration) on Direct Observation Record at Intervention Phase (6 week duration), Post-Intervention Phase (2 week duration), and 3-Month Follow-Up
timeFrame: Pre-Intervention Phase: Day 1; Intervention Phase: during all treatment sessions (1-12) as well as during an interview session between treatment sessions 6 and 7; Post-Intervention Phase: Day 1; Follow-Up Phase: Day 1
measure: Change from Pre-Intervention Baseline Observations (2 week duration) on Semi-Structured Interview at Intervention Phase (6 week duration), Post-Intervention Phase (2 week duration), and 3-Month Follow-Up
timeFrame: Pre-Intervention Phase: Day 1; Intervention Phase: between treatment sessions 6 and 7; Post-Intervention Phase: Day 1; Follow-Up Phase: Day 1
measure: Reflective Journal Log
timeFrame: From Day 1 of Baseline Phase until completion of Follow-Up Phase (up to 26 weeks in total)
Secondary outcomes:
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Deer Lodge Centre
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Catherine E Bryden Dueck, BMR (OT)
role: PRINCIPAL_INVESTIGATOR
References:
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