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Does a Cognitive Orientation to daily Occupational Performance (CO-OP) treatment approach benefit adults with Parkinson’s Disease?

Exploring the impact of an occupation-based metacognitive strategy approach on the occupational performance, executive functioning and self-efficacy of adults with Parkinson’s Disease

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001483842
Enrollment
20
Registered
2021-11-01
Start date
2021-06-09
Completion date
2022-12-30
Last updated
2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

People with Parkinson’s disease (PD) experience cognitive dysfunction, limiting their occupational performance. Establishing an effective intervention to address the impact of cognition on daily life is a research priority. Interventions that comprehensively address cognitive and physical performance skills in people with PD have not previously been explored. The Cognitive Orientation to Daily Occupational Performance (CO-OP) treatment approach is effective for improving occupational performance, improving self-efficacy and participation in other adult populations. The proposed clinical trial will evaluate the efficacy of a CO-OP approach for people with PD. This study has four research questions: 1. Is the CO-OP approach feasible for people with PD? 2. Do people with PD benefit from CO-OP? 3. What CO-OP intervention intensity achieves optimum outcomes? 4. What do people with PD think and feel about the CO-OP approach? A parallel-group assessor blinded randomized controlled feasibility trial with long term follow-up will investigate the effectiveness of the CO-OP treatment approach for adults with PD. This will be the first study to evaluate the impact of CO-OP with people with Parkinson’s disease. This research aims to improve quality of life, confidence and reduce the impact of cognitive decline on the lives of people with PD. Significantly, this research will empower older people with PD to manage their symptoms and rate of progression. This research will lead to new, evidence-based services for older people with PD, based on their preferences and priorities and wide dissemination of findings to clinicians will increase access to new treatment options.

Interventions

Participants will be randomly assigned to either the CO-OP intervention or a waitlist control group with a blocked allocation, stratified by scores on Addenbrooke's Cognitive Evaluation, third edition (ACE-III), by a computer-generated randomization schedule. One-to-one CO-OP training will be carried out by a CO-OP certified occupational therapist in the participant’s home environment, as per the CO-OP intervention protocol. The intervention group will receive 20 hours of CO-OP intervention base

Participants will be randomly assigned to either the CO-OP intervention or a waitlist control group with a blocked allocation, stratified by scores on Addenbrooke's Cognitive Evaluation, third edition (ACE-III), by a computer-generated randomization schedule. One-to-one CO-OP training will be carried out by a CO-OP certified occupational therapist in the participant’s home environment, as per the CO-OP intervention protocol. The intervention group will receive 20 hours of CO-OP intervention based on the adapted intensive protocol for use with adults with traumatic Brain Injury (TBI),delivered over 10 weeks. Two one-hour appointments will be scheduled each week for the ten-week intervention period. Intervention will focus on the three top priority goals identified by the participant during completion of the Canadian Occupational Performance Measure (COPM) and sessions will follow the session plan outlined. The intervention protocol will be standardized to ensure consistency between participants and within intervention conditions. A client binder will be provided to each participant to keep in their homes over the duration of the intervention. The client binder contains study information, intervention schedule, goal tracking sheets, generalisation sheets and a daily activity log. Once the individualised goals have been established, baseline performance established and the global strategy taught, each session proceeds in generally the same format. Each session will involve working on the participant's goals through practice and using the global strategy 'Goal, Plan, Do, Check' to increase awareness of deficits in performance, develop skills in making plans to compensate for these deficits, and appraise performance. The therapist takes on a coaching role and uses guided discovery to help participants realise for themselves what is going wrong, instead of telling them, then encouraging then to try different options (such as hand position, gaze direction, using reminders) to improve performance. Each session can be divided into 3 sections: Introduction, where introductions/greetings occur and the client binder is provided (session1) or reviewed (subsequent sessions), the session content, which varies from session to session but follows the basis above with practicing goal activities and using the global strategy, and closure where the key session items are summarised, Goal-Plan-Do-Check is reviewed, participants rate their levels of effort and enjoyment and homework activities are outlined. Homework is carrying out plans developed to support goal activities, and checking whether they worked, and modifying the plan to make more effective if not. Session documentation will occur following each intervention session. The therapist field notes and CO-OP fidelity scales will be completed each session and will be used for feasibility aspects of the study and qualitative analysis.

Sponsors

The University of Queensland
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Inclusion criteria are a) aged 18 years and over; b) able to communicate in English; c) able to provide informed consent; d) living in the community, e) availability of technology with internet access and f) happy to receive intervention in their homes.

Exclusion criteria

Exclusion criteria are: a) pre-morbid or current major psychiatric or other neurological disorder; b) diagnosis of dementia c) significant sensory impairment (visual or hearing); or d) communication disorder; e) dependence on others for personal care; f) receiving concurrent allied health or cognitive intervention working on the same goals.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 10, 2026