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

Primary outcomes

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.