Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001483842
Ethics application status
Approved
Date submitted
23/09/2021
Date registered
1/11/2021
Date last updated
14/01/2024
Date data sharing statement initially provided
1/11/2021
Date results information initially provided
14/01/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does a Cognitive Orientation to daily Occupational Performance (CO-OP) treatment approach benefit adults with Parkinson’s Disease?
Scientific title
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
Secondary ID [1] 305397 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's Disease 323755 0
Condition category
Condition code
Neurological 321278 321278 0 0
Parkinson's disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 321804 0
Rehabilitation
Intervention code [2] 321963 0
Treatment: Other
Comparator / control treatment
The wait-list control group will receive delayed training after a non-intervention period of 10 weeks. The wait-list control intervention will receive ten hours of CO-OP intervention delivered over ten weeks, in line with the standard CO-OP protocol. One, one-hour appointment will be scheduled each week for the ten-week intervention period.
Control group
Active

Outcomes
Primary outcome [1] 329054 0
Goal attainment as measured subjectively by the COPM. This is a goal setting interview form that allows participants to identify and rank their occupational performance problems, which are then converted into goals. The participants rate their satisfaction and performance for each goal activity before and after intervention, an improvement of 2 points is considered significant.
Timepoint [1] 329054 0
immediately Pre and Post-waitlist control (WLC), immediately post-CO-OP, Follow-up - 3 months after CO-OP completion.
Primary outcome [2] 329055 0
Perceived deficits questionnaire (PDQ) will be used to measure the perceived cognitive symptoms of participants
Timepoint [2] 329055 0
immediately Pre and Post-waitlist control (WLC), immediately post-CO-OP, Follow-up - 3 months after CO-OP completion.
Primary outcome [3] 329258 0
Goal Attainment - The goal attainment scale will be rated by a blinded assessor based on videotaped recordings or activities logs for goal activities to provide subjective assessment of whether occupational performance has improved
Timepoint [3] 329258 0
immediately Pre and Post-waitlist control (WLC), immediately post-CO-OP, Follow-up - 3 months after CO-OP completion.
Secondary outcome [1] 401291 0
Anxiety and depression and as measured by the HADS
Timepoint [1] 401291 0
post intervention- immediately following the 10 week intervention period
Secondary outcome [2] 401292 0
Self-efficacy as measured by the general self efficacy scale

Timepoint [2] 401292 0
immediately Pre and Post-waitlist control (WLC), immediately post-CO-OP, Follow-up - 3 months after CO-OP completion.
Secondary outcome [3] 401919 0
Fatigue as measured by the fatigue severity scale
Timepoint [3] 401919 0
immediately Pre and Post-waitlist control (WLC), immediately post-CO-OP, Follow-up - 3 months after CO-OP completion
Secondary outcome [4] 401920 0
Apathy as measured by the apathy scale
Timepoint [4] 401920 0
immediately Pre and Post-waitlist control (WLC), immediately post-CO-OP, Follow-up - 3 months after CO-OP completion.
Secondary outcome [5] 401921 0
Self-efficacy in activities of daily living as measured by the daily living self efficacy scale
Timepoint [5] 401921 0
immediately Pre and Post-waitlist control (WLC), immediately post-CO-OP, Follow-up - 3 months after CO-OP completion.
Secondary outcome [6] 401924 0
qualitative interview - 30 minute semi-structured one-on-one face to face interview with the primary investigator will be carried out.
Timepoint [6] 401924 0
immediately Pre and Post-waitlist control (WLC), immediately post-CO-OP, Follow-up - 3 months after CO-OP completion.
Secondary outcome [7] 416330 0
NART - national adult reading test
Telephone Montreal Cognitive Assessment (T-MoCA) are used at screening/baseline to screen for cognitive difficulties for exclusion and to describe the pre-morbid intelligence of the sample (demographic information)
Timepoint [7] 416330 0
baseline assessment used only to describe the study sample in terms in their pre-morbid intelligence quotient.
Secondary outcome [8] 416331 0
Parkinson's Disease Questionnaire - short form (PDQ-8) will measure health related quality of life,
Timepoint [8] 416331 0
immediately Pre and Post-waitlist control (WLC), immediately post-CO-OP, Follow-up - 3 months after CO-OP completion
Secondary outcome [9] 416332 0
Performance quality rating scale (PQRS) measures changes in performance
Timepoint [9] 416332 0
immediately Pre and Post-waitlist control (WLC), immediately post-CO-OP, Follow-up - 3 months after CO-OP completion
Secondary outcome [10] 416333 0
Schwab and England Scale (S&W) measure of disability.
Timepoint [10] 416333 0
immediately Pre and post wait list control, immediately post-CO-OP and at follow up - 3 month post CO-OP
Secondary outcome [11] 416334 0
Nottingham Extended Activities of Daily Living Scale (NEADL) will be used to measure disability level .
Timepoint [11] 416334 0
immediately Pre and Post wait list control (WLC), immediately post CO-OP and at follow up - 3 months post CO-OP

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

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)
blocked allocation, stratified by scores on ACE-III, by central randomisation by computer-generated randomization schedule.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
blocked allocation, stratified by scores on ACE-III, by central randomisation by computer-generated randomization schedule.
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
60 community-dwelling adults who have a confirmed diagnosis of PD (by neurologist report) will be recruited to participate in the RCT through convenience sampling, with 30 participants randomly assigned to each condition. A minimum of 50 participants are required to achieve power of .90 to detect a medium effect size at p = .01; f = .25
(G*Power3; Faul, Erdfelder, Lang, & Buchner, 2007), which allows for 25 participants per group. Additional participants i.e. 30 per group will be recruited to allow for potential attrition. This is a conservative rate of >15% based on previous experience recruiting to neurorehabilitation clinical trials, which have demonstrated sufficient power to detect change within a small pilot sample (Gullo, Aplin, Lim, & Bara, 2017; Gullo, Fleming, Bennett, & Shum, 2019; Shum, Fleming, Gill, Gullo, & Strong, 2011).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
9/06/2021
Date of last participant enrolment
Anticipated
30/12/2022
Actual
30/12/2022
Date of last data collection
Anticipated
30/06/2023
Actual
30/06/2023
Sample size
Target
60
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 35380 0
4000 - Brisbane

Funding & Sponsors
Funding source category [1] 309759 0
University
Name [1] 309759 0
The University of Queensland
Country [1] 309759 0
Australia
Funding source category [2] 309761 0
Charities/Societies/Foundations
Name [2] 309761 0
Parkinson's Queensland
Country [2] 309761 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
The University of Queensland
St Lucia
QLD
4072
Country
Australia
Secondary sponsor category [1] 310785 0
Charities/Societies/Foundations
Name [1] 310785 0
Parkinson's Queensland
Address [1] 310785 0
Suite 3, Level 2/2 Clunies Ross Ct, Eight Mile Plains QLD 4113
Country [1] 310785 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309517 0
University of Queensland Human Research Ethics Committee B
Ethics committee address [1] 309517 0
The University of Queensland
Brisbane QLD 4072 Australia
Ethics committee country [1] 309517 0
Australia
Date submitted for ethics approval [1] 309517 0
26/11/2020
Approval date [1] 309517 0
09/02/2021
Ethics approval number [1] 309517 0
2020/HE002650

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114426 0
Dr Hannah Gullo
Address 114426 0
School of Health and rehabilitation Sciences
The University of Queensland
St Lucia
QLD
4072
Country 114426 0
Australia
Phone 114426 0
+61 7 3365 3004
Fax 114426 0
Email 114426 0
[email protected]
Contact person for public queries
Name 114427 0
Mrs Sarah Davies
Address 114427 0
School of Health and rehabilitation Sciences
The University of Queensland
St Lucia
QLD
4072
Country 114427 0
Australia
Phone 114427 0
+61 7 3040 0846
Fax 114427 0
Email 114427 0
[email protected]
Contact person for scientific queries
Name 114428 0
Mrs Sarah Davies
Address 114428 0
School of Health and rehabilitation Sciences
The University of Queensland
St Lucia
QLD
4072
Country 114428 0
Australia
Phone 114428 0
+61 7 3365 3004
Fax 114428 0
Email 114428 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The consent form does not specifiy that IPD can be shared in this way


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.