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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02007785
Recruitment Status : Completed
First Posted : December 11, 2013
Last Update Posted : October 19, 2015
Sponsor:
Information provided by (Responsible Party):
Catherine Bryden Dueck, O.T. Reg. (MB), University of Manitoba

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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Cognitive Impairment Behavioral: CO-OP treatment protocol Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CO-OP treatment protocol
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.
Behavioral: CO-OP treatment protocol
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.
Other Name: Cognitive Orientation to daily Occupational Performance




Primary Outcome Measures :
  1. 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 [ Time Frame: 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 ]
    The COPM is a semi-structured interview focusing on client-centred problem identification that is founded on the Canadian guidelines for client-centred occupational therapy practice and requires approximately 30-40 minutes to administer. The COPM consists of three sections: self-care (basic and instrumental activities of daily living); productivity (education and work); and leisure (play, leisure, and social participation). The assessment begins with self-report of occupational performance issues. The identified occupational performance issues are then rated by the client according to importance on a 10-point Likert scale. The five issues identified as most important to the client are then rated again according to the client's self-determined performance level and satisfaction. Since the COPM is designed to be used as a measure of change, performance and satisfaction levels are scored again after a period of time, (usually during which an intervention has been administered).

  2. 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 [ Time Frame: 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 ]
    The PDQ-39 is the most widely used Parkinson's-specific measure of health-related quality of life. It is a self-administered questionnaire containing thirty nine questions that cover eight aspects of health-related quality of life: mobility (10 items), activities of daily living (6 items), emotional well-being (6 items), stigma (4 items), social support (3 items), cognition (4 items), communication (3 items), and bodily discomfort (3 items). Patients are asked to select the frequency of each problem item occurring over the past month on a 5-point scale (never / occasionally / sometimes / often / always or cannot do at all). The PDQ-39 requires approximately 10-20 minutes to administer.

  3. 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 [ Time Frame: 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 ]
    The Zarit Burden Interview (ZBI) is the most widely used measure of caregiver burden. It is a self-administered 22-item questionnaire designed to assess caregivers' perceptions of burden related to caring for an older person with dementia or a person with a disability. Questions on the interview address caregivers' physical health, as well as emotional, social, and financial wellbeing. Caregivers are asked to select the frequency of each problem item on a 5-point scale (never / rarely / sometimes / quite frequently / nearly always). The ZBI takes approximately 5-10 minutes to administer.

  4. 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 [ Time Frame: 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 ]
    Field notes consisting of direct observations of the behaviours of study participants and their caregivers / significant others and relevant contextual events and environmental features will be recorded with detailed descriptions in a log book. Observational data collected during the proposed study will provide rich,detailed information related to interactions between study participants and the physical and social environments in which the participants will work toward their CO-OP treatment goals, as well as detailed information related to the participants' performance on self-selected CO-OP treatment goals. Examples of observations that will be recorded include non-verbal body language, facial expression, and tone of voice of participants and caregivers, and detailed descriptions of physical environmental aspects that are relevant to the context of the study session.

  5. 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 [ Time Frame: Pre-Intervention Phase: Day 1; Intervention Phase: between treatment sessions 6 and 7; Post-Intervention Phase: Day 1; Follow-Up Phase: Day 1 ]
    Semi-structured interviews will resemble guided conversations using an interview guide consisting of open-ended questions. When appropriate, the interviewer will ask value neutral probing follow-up questions in order to elicit more information from the interviewee. Appropriate situations in which probing follow-up questions may be asked include when examples, explanations, and rationales for interviewees' responses are necessary to capture the participants' beliefs and views as thoroughly and accurately as possible. The interviewees' verbal statements will be recorded verbatim in an interview log book. Observations regarding body language and affect will also be recorded in the log book. Interviews will be audio recorded using two digital recorders (in case of failure of one recorder) in order to have as much data as possible available for analysis and to verify the accuracy of the data collected.

  6. Reflective Journal Log [ Time Frame: From Day 1 of Baseline Phase until completion of Follow-Up Phase (up to 26 weeks in total) ]
    A reflective journal log will be maintained as a deliberate, systematic self-examination process for the principal investigator. The principal investigator's thoughts, feelings, and reactions related to questions, quandaries, and complexities that arise as the study progresses will be recorded. Awareness of this data is important to identify and account for its potential to bias the processes of data collection and analysis, which may also influence emerging interpretations of study results.



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02007785


Locations
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Canada, Manitoba
Deer Lodge Centre
Winnipeg, Manitoba, Canada, R3J 0L3
Sponsors and Collaborators
University of Manitoba
Investigators
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Principal Investigator: Catherine E Bryden Dueck, BMR (OT) University of Manitoba
Publications:
DePoy, E., & Gitlin, L. (2005). Case Study Designs. In E. DePoy, & L. Gitlin, Introduction to Reserach: Understanding and Applying Multiple Strategies (3rd Ed.) (pp. 277-283). St. Louis, MO: Mosby.

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Responsible Party: Catherine Bryden Dueck, O.T. Reg. (MB), graduate student, University of Manitoba
ClinicalTrials.gov Identifier: NCT02007785    
Other Study ID Numbers: H2013:400
First Posted: December 11, 2013    Key Record Dates
Last Update Posted: October 19, 2015
Last Verified: October 2015
Keywords provided by Catherine Bryden Dueck, O.T. Reg. (MB), University of Manitoba:
Cognitive Orientation to daily Occupational Performance
CO-OP
Additional relevant MeSH terms:
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Parkinson Disease
Cognitive Dysfunction
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders