Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001283369p
Ethics application status
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Not yet submitted
Date submitted
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25/09/2026
Date registered
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27/10/2026
Date last updated
Help: Date last updated
27/10/2026
Date data sharing statement initially provided
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27/10/2026
Type of registration
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Prospectively registered

Titles & IDs
Public title
The Cognitive Orientation to Daily Occupational Performance Approach (CO-OP) for daily activities and participation in people with Parkinson’s disease: a randomised controlled trial
Scientific title
Efficacy of the Cognitive Orientation to Daily Occupational Performance (CO-OP) Approach for goal attainment and satisfaction in people with Parkinson's disease: A randomised controlled trial
Additional trial identifiers [1] 318112 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Parkinson's disease 343152 0
Condition category
Condition code
Neurological 339239 339239 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Participants allocated to the intervention group will receive the Cognitive Orientation to Daily Occupational Performance (CO-OP) Approach delivered by occupational therapists trained and accredited in the CO-OP approach. The intervention consists of 10 face-to-face, individualised one-hour sessions delivered over 10 weeks in participants' homes. At baseline, participants identify personally meaningful occupational goals using the Canadian Occupational Performance Measure (COPM). Goals are further operationalised using Goal Attainment Scaling-Light (GAS-Light). Intervention sessions employ the CO-OP Goal-Plan-Do-Check framework and cognitive strategy training to improve performance and satisfaction in everyday goal related activities. Performance quality is monitored using the Performance Quality Rating Scale (PQRS). Outcome measures will be collected at baseline (T0), immediately post-intervention (T1; 10 weeks post-baseline), 3-month follow-up (T2; 3 months post-intervention), and 6-month follow-up (T3; 6 months post-intervention).

CO-OP is an occupation-based meta-cognitive approach that concentrates on facilitating metacognitive knowledge (awareness) and metacognitive self-regulation (goal setting, planning, initiation, execution, self-monitoring, and error management) to address multiple aspects of executive dysfunction. CO-OP integrates functional skills training (occupation-based) and metacognitive strategy training through client-centered goal setting and the use of a global metacognitive strategy of Goal-Plan-Do-Check. CO-OP is specifically designed with four intervention goals: skill acquisition, cognitive strategy use, generalization of learning beyond the treatment session, and transfer of learning to new tasks in everyday life. Remediation of specific cognitive impairments is not the goal of therapy, instead interventions are directed at client-centered functional activities. Throughout the therapeutic intervention people come to internalize the global strategy which enables new learning and problem-solving behaviors to emerge.

Standard CO-OP Intervention

Session 1 (begin CO-OP)

Introduction:

Introduce self.

Provide participant with client binder

Session Content:

Introduce the CO-OP global strategy (Goal-Plan-Do-Check).

Explain the use of the client binder and goal-tracking sheets. Explain that the participant should record goals, progress, and evidence for goal attainment in their own words.

Conduct Dynamic Performance Analysis (DPA) of the participant's selected goal, which was identified during the goal-setting appointment.

Guide the participant to make plans for the first goal. If time permits, plans for subsequent goals can be made.

Instruct the participant to complete plans for homework, or if time allows the client can complete plans as part of the therapy

Closure:

Summary of key session items by reviewing Goal-Plan-Do-Check and outlining the participants’ plans to be done before the next session

Rate levels of effort and enjoyment

The session will be documented by the occupational therapist.

Session 2 (Complete baseline performance analysis if not done earlier)

Session Content:

Ask the participant to describe the global strategy using their own words and ask whether they have any questions.

If the participant cannot describe the strategy, review its components.

Make plans for remaining goals.

Introducing generalization sheets.

Closure:

Summary of key session items by reviewing Goal-Plan-Do-Check and outlining the participants’ plans to be done before the next session

Rate levels of effort and enjoyment

The session will be documented by the occupational therapist.

Session 3 (Begin using the generalization and transfer package)

Session Content:

Ask the participant to describe the global strategy using their own words and ask whether they have any questions. If the participant cannot think of anything, ask "What is something you did today?" making questions more specific as necessary.

If the participant cannot describe the strategy, review its components.

Ask the participants how they have used the strategy since the last session (this question relates to the generalization and transfer exercise)

Review the generalization sheets if they are being used.

Ask the client which goal they would like to start with.

Check whether previous plans worked; use guided discovery to determine with the client why the plans worked or did not work and develop new plans.

Make plans for the goals being worked on, ensure that the plans are written down by the participant on the goal tracking sheets and ask the participant what the evidence will be for identifying whether the plans worked

Closure:

Generalization and transfer exercise: Ask the participants how else they will be using the global strategy before the next session. Remind the participant that you will ask how they used Goal-Plan-Do-Check for a goal other than the goals you are working on together at the next session

Summarize key session items by reminding the participant that they are encouraged to use Goal-Plan-Do-Check for another goal before the next session (generalization and transfer exercise), outlining the participant’s plans to be done before the next session, and reviewing with the participant the use of the generalization sheets (optional).

Rate levels of effort and enjoyment

The session will be documented by the occupational therapist.

Session 4-6 (learning to do CO-OP)

Session Content: These sessions continue as per Session 3, focusing on

Doing plans, checking plans, and working toward goal attainment

Generalizing Goal-Plan-Do-Check to goals outside therapy, and

Guiding the participant to learn self-analysis of their own performance (e.g. guiding participant to identify why plans did or did not work)

Sessions 7-9 (mastery and maintenance)

Session Content: These sessions continue as per the previous sessions. In later sessions, start preparing participant for the end of the intervention period. Continuing training in the use of Goal-Plan-Do-Check

Additions to session content

Celebrate any and all participant successes

Empathize with domain specific strategies that the participant has used successfully. Note whether any strategies have been used successfully in multiple situations.

Emphasize that participants can continue to use Goal-Plan-Do-Check and their domain specific strategies even once the intervention has finished

Guide them to develop a plan for continuing Goal-Plan-Do-Check

Ask them to practice this before session 9.

Session 10 (saying goodbye)

Final session content:

Ask the participant to describe the global strategy using their own words and ask whether they have any questions.

If the participant cannot describe the global strategy, review its components and have the participant use their chosen method of remembering Goal-Plan-Do-Check (e.g., sticky note, cue card)

Ask the participants how they have used the strategy since the last session and reflect on how they have incorporated the strategy into other goals, how much easier it is to use, and how it can be used to reach other goals or solve problems.

Video record post intervention performance of trained and untrained goals for assessment by blind assessor.

For each goal worked in therapy, ask participants how they have done it. Remind them where they started, ask them to describe how they are accomplishing the goal now, and provide feedback on what changed between the beginning and end of therapy from your perspective.

Redo the COPM

Make any final plans for goals or support required for continued use of Goal-Plan-Do-Check.

Closure:

Reinforce with the client how he or she plans to continue to use the global strategy

Celebrating progress and success

Emphasize independent global strategy use

Rate levels of effort and enjoyment

The session will be documented by the occupational therapist.
Intervention code [1] 334990 0
Rehabilitation
Intervention code [2] 334991 0
Treatment: Other
Description of the comparator or control
Participants allocated to the waitlist control (WLC) group will complete a 10-week non-intervention period. During this time, they will continue with their usual care, activities, and community Parkinson's programs, provided they do not receive targeted intervention for the specific goals established at baseline. At the conclusion of the 10-week waitlist period, participants will complete secondary baseline outcome assessments. They will then cross over to receive the CO-OP intervention, which comprises 10 individualised, one-hour sessions delivered weekly in their home environment by accredited CO-OP occupational therapists. For the WLC group, outcome measures will be administered at five time points: baseline (T0), post-waitlist/pre-intervention (T1), immediately post-intervention (T2), 3 months post-intervention (T3), and 6 months post-intervention (T4).
Control group
Active

Outcomes
Primary outcome [1] 346469 0
Occupational performance
Timepoint [1] 346469 0
CO-OP group: baseline (T0), immediately post-intervention (T1; 10 weeks post-baseline), 3-month follow-up (T2; 3 months post-intervention), and 6-month follow-up (T3; 6 months post-intervention). Waitlist control (WLC) group: baseline (T0), post-waitlist/pre-intervention (T1; 10 weeks post-baseline), immediately post-intervention (T2; 20 weeks post-baseline), 3-month follow-up (T3; 3 months post-intervention), and 6-month follow-up (T4; 6 months post-intervention).
Primary outcome [2] 346470 0
Occupational performance Satisfaction
Timepoint [2] 346470 0
CCO-OP group: baseline (T0), immediately post-intervention (T1; 10 weeks post-baseline), 3-month follow-up (T2; 3 months post-intervention), and 6-month follow-up (T3; 6 months post-intervention). Waitlist control (WLC) group: baseline (T0), post-waitlist/pre-intervention (T1; 10 weeks post-baseline), immediately post-intervention (T2; 20 weeks post-baseline), 3-month follow-up (T3; 3 months post-intervention), and 6-month follow-up (T4; 6 months post-intervention).
Primary outcome [3] 346471 0
Goal attainment
Timepoint [3] 346471 0
CO-OP group: baseline (T0), immediately post-intervention (T1; 10 weeks post-baseline), 3-month follow-up (T2; 3 months post-intervention), and 6-month follow-up (T3; 6 months post-intervention). Waitlist control (WLC) group: baseline (T0), post-waitlist/pre-intervention (T1; 10 weeks post-baseline), immediately post-intervention (T2; 20 weeks post-baseline), 3-month follow-up (T3; 3 months post-intervention), and 6-month follow-up (T4; 6 months post-intervention).
Secondary outcome [1] 465961 0
Performance quality (Primary Outcome)
Timepoint [1] 465961 0
CO-OP group: baseline (T0), immediately post-intervention (T1; 10 weeks post-baseline), 3-month follow-up (T2; 3 months post-intervention), and 6-month follow-up (T3; 6 months post-intervention). Waitlist control (WLC) group: baseline (T0), post-waitlist/pre-intervention (T1; 10 weeks post-baseline), immediately post-intervention (T2; 20 weeks post-baseline), 3-month follow-up (T3; 3 months post-intervention), and 6-month follow-up (T4; 6 months post-intervention).
Secondary outcome [2] 465962 0
Functional status
Timepoint [2] 465962 0
CO-OP group: baseline (T0), immediately post-intervention (T1; 10 weeks post-baseline), 3-month follow-up (T2; 3 months post-intervention), and 6-month follow-up (T3; 6 months post-intervention). Waitlist control (WLC) group: baseline (T0), post-waitlist/pre-intervention (T1; 10 weeks post-baseline), immediately post-intervention (T2; 20 weeks post-baseline), 3-month follow-up (T3; 3 months post-intervention), and 6-month follow-up (T4; 6 months post-intervention).
Secondary outcome [3] 465963 0
Health-related quality of life
Timepoint [3] 465963 0
CO-OP group: baseline (T0), immediately post-intervention (T1; 10 weeks post-baseline), 3-month follow-up (T2; 3 months post-intervention), and 6-month follow-up (T3; 6 months post-intervention). Waitlist control (WLC) group: baseline (T0), post-waitlist/pre-intervention (T1; 10 weeks post-baseline), immediately post-intervention (T2; 20 weeks post-baseline), 3-month follow-up (T3; 3 months post-intervention), and 6-month follow-up (T4; 6 months post-intervention).
Secondary outcome [4] 465964 0
Daily living self-efficacy
Timepoint [4] 465964 0
CO-OP group: baseline (T0), immediately post-intervention (T1; 10 weeks post-baseline), 3-month follow-up (T2; 3 months post-intervention), and 6-month follow-up (T3; 6 months post-intervention). Waitlist control (WLC) group: baseline (T0), post-waitlist/pre-intervention (T1; 10 weeks post-baseline), immediately post-intervention (T2; 20 weeks post-baseline), 3-month follow-up (T3; 3 months post-intervention), and 6-month follow-up (T4; 6 months post-intervention).
Secondary outcome [5] 465965 0
Metacognitive awareness
Timepoint [5] 465965 0
CO-OP group: baseline (T0), immediately post-intervention (T1; 10 weeks post-baseline), 3-month follow-up (T2; 3 months post-intervention), and 6-month follow-up (T3; 6 months post-intervention). Waitlist control (WLC) group: baseline (T0), post-waitlist/pre-intervention (T1; 10 weeks post-baseline), immediately post-intervention (T2; 20 weeks post-baseline), 3-month follow-up (T3; 3 months post-intervention), and 6-month follow-up (T4; 6 months post-intervention).
Secondary outcome [6] 468485 0
Psychosocial functioning
Timepoint [6] 468485 0
CO-OP group: baseline (T0), immediately post-intervention (T1; 10 weeks post-baseline), 3-month follow-up (T2; 3 months post-intervention), and 6-month follow-up (T3; 6 months post-intervention). Waitlist control (WLC) group: baseline (T0), post-waitlist/pre-intervention (T1; 10 weeks post-baseline), immediately post-intervention (T2; 20 weeks post-baseline), 3-month follow-up (T3; 3 months post-intervention), and 6-month follow-up (T4; 6 months post-intervention).
Secondary outcome [7] 468486 0
Self-regulation
Timepoint [7] 468486 0
CO-OP group: baseline (T0), immediately post-intervention (T1; 10 weeks post-baseline), 3-month follow-up (T2; 3 months post-intervention), and 6-month follow-up (T3; 6 months post-intervention). Waitlist control (WLC) group: baseline (T0), post-waitlist/pre-intervention (T1; 10 weeks post-baseline), immediately post-intervention (T2; 20 weeks post-baseline), 3-month follow-up (T3; 3 months post-intervention), and 6-month follow-up (T4; 6 months post-intervention).
Secondary outcome [8] 468930 0
Perceived cognitive function
Timepoint [8] 468930 0
CO-OP group: baseline (T0), immediately post-intervention (T1; 10 weeks post-baseline), 3-month follow-up (T2; 3 months post-intervention), and 6-month follow-up (T3; 6 months post-intervention). Waitlist control (WLC) group: baseline (T0), post-waitlist/pre-intervention (T1; 10 weeks post-baseline), immediately post-intervention (T2; 20 weeks post-baseline), 3-month follow-up (T3; 3 months post-intervention), and 6-month follow-up (T4; 6 months post-intervention).

Eligibility
Key inclusion criteria
Participants must be over 18 years old, diagnosed with PD (confirmed by neurologist report), able to communicate in English and provide informed consent. They should be living in the community, have experience using a computer or tablet with internet access, be willing to receive intervention in their homes, and meets cognitive eligibility requirements as determined by screening procedures.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Individuals with major psychiatric or other co-morbid neurological disorders, dementia, severe cognitive impairment, significant sensory or communication impairments preventing participation, full dependence in personal care, or ongoing similar interventions targeting the same goals will not be eligible.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed using an independently generated randomisation schedule that is inaccessible to the outcome assessors. Group allocation will be revealed only after completion of baseline assessments.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will follow a computer-generated blocked allocation schedule to ensure equal distribution between the intervention and waitlist control groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To account for potential attrition, we aim to recruit a total of 60 participants, 30 per group. This is based on a power analysis indicating that a minimum of 52 participants is needed to achieved power of .90 to detect a medium effect size at 'p equal to 0.01; f equal to 0.25' G*Power3. A conservative attrition rate of <15% lead to a target of 60, based on previous experience recruiting to neurorehabilitation clinical trials, which have demonstrated sufficient power to detect change within a small pilot sample.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2027
Actual
Date of last participant enrolment
Anticipated
30/06/2028
Actual
Date of last data collection
Anticipated
30/06/2029
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 322662 0
University
Name [1] 322662 0
University of the Sunshine Coast (In-Kind / Departmental Support)
Country [1] 322662 0
Australia
Funding source category [2] 323238 0
Government body
Name [2] 323238 0
Australian Government Department of Education-Research Training Program (RTP) Scholarship
Country [2] 323238 0
Australia
Primary sponsor type
University
Name
University of the Sunshine Coast (UniSC)
Address
Country
Australia
Secondary sponsor category [1] 325592 0
None
Name [1] 325592 0
Address [1] 325592 0
Country [1] 325592 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 321118 0
Human Research Ethics Committee of the University of the Sunshine Coast
Ethics committee address [1] 321118 0
Ethics committee country [1] 321118 0
Australia
Date submitted for ethics approval [1] 321118 0
31/10/2026
Approval date [1] 321118 0
Ethics approval number [1] 321118 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 152730 0
Dr Sarah Davies
Address 152730 0
University of the Sunshine Coast, 90 Sippy Downs Drive, Sippy Downs QLD 4556,
Country 152730 0
Australia
Phone 152730 0
+61 7 5409 8693
Fax 152730 0
Email 152730 0
[email protected]
Contact person for public queries
Name 152731 0
Sarah Davies
Address 152731 0
University of the Sunshine Coast, 90 Sippy Downs Drive, Sippy Downs QLD 4556,
Country 152731 0
Australia
Phone 152731 0
+61 7 5409 8693
Fax 152731 0
Email 152731 0
[email protected]
Contact person for scientific queries
Name 152732 0
Sarah Davies
Address 152732 0
University of the Sunshine Coast, 90 Sippy Downs Drive, Sippy Downs QLD 4556,
Country 152732 0
Australia
Phone 152732 0
+61 7 5409 8693
Fax 152732 0
Email 152732 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
What individual participant data might be shared?
• De-identified individual participant data:
• All outcomes data
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Studies testing whether findings can be repeated or confirmed
When can requests for individual participant data be made (start and end dates)?
From:
At the end of the study
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.