Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001361190
Ethics application status
Approved
Date submitted
10/09/2019
Date registered
3/10/2019
Date last updated
22/10/2021
Date data sharing statement initially provided
3/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Implementing the Pathways and Resources for Engagement and Participation (PREP) program into an Australian context with young adults with complex disability (The PREP Project):
Scientific title
Feasibility of implementing Pathways and Resources for Engagement and Participation (PREP) in an Australian context with young adults with complex disability
Secondary ID [1] 299238 0
Nil known
Universal Trial Number (UTN)
U1111-1239-9827
Trial acronym
The PREP project
Linked study record

Health condition
Health condition(s) or problem(s) studied:
complex childhood-onset disability 314370 0
Condition category
Condition code
Neurological 312704 312704 0 0
Other neurological disorders
Musculoskeletal 312705 312705 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The PREP, designed by Dr Anaby and colleagues in Canada, is a 20-week client-centered intervention. PREP aims to improve individuals’ participation in activities of choice by modifying aspects of their environment, including physical, social, attitudinal and institutional elements. We will study the feasibility of implementing PREP in an Australian context, and evaluate participant outcomes using an interrupted time series design.

The PREP protocol involves five steps: (1) Make goals, after which is a 4 week period during which baseline measures are collected; (2) Map out a plan; (3) Make it happen (over a 12 week period); (4) Measure the process and outcomes (weekly, throughout the phases of the study including over a 4 week follow up period) and (5) Move forward to the next goal.

The intervention will be delivered by trained and supervised occupational therapy students, and begins with a meeting with the participant at their home or other community location of the participant’s preference. During the first 2-hour meeting, the young person will set three new participation goals or activities that they would like to engage in yet find difficult. The Canadian Occupational Performance Measure (COPM; Law et al.) will be used to identify participation issues from the young person’s perspective. This process will lead to pinpointing three specific community-based activities that are a priority for the young person to engage in (e.g., drawing, playing a musical instrument, joining a cooking club, participating in a sport).
Thereafter, is a 4-week period during which baseline measures are completed. Together with the young person, the interventionist will identify barriers within the environment for engaging in each activity and develop and implement a plan to remove these barriers and to build on supports so that young people can participate in activities of their choice. The 12-week intervention period includes 12 hours of therapy time; a 4-week intervention period is designated for each activity, and involves four therapy sessions, for a total of 12 sessions (4 sessions X 3 activities). Following the 12-week intervention, a further 4 weeks is allocated to follow up assessment. The baseline, intervention and 4-week follow-up periods span 20 weeks.
Using an interrupted time series design, data will be collected twice weekly throughout the 20 week period using the COPM Performance scale (rated 1-10) for each of the participants' individualised goals (3 goals per participant). In addition, COPM Satisfaction with Performance will be collected on five occasions: first assessment, at the end of 4 weeks, 8 weeks, 12 weeks, 16 weeks and 20 weeks.
Prior to testing the intervention as described, an additional PREP feasibility component will be implemented as follows:
First, applicability will be assessed by stakeholder review and revisions made if needed of the PREP materials. This is conducted in partnership with our research advisory partners. Then, perceptions of 3-4 young people with disability and their families/support network, and clinicians about the applicability, acceptability and feasibility of the revised PREP intervention will be assessed qualitatively through mock implementation of the revised PREP and individual and/or group interviews – all completed remotely. Mock implementation involves completing only the first 2 steps of the 5 involved in PREP. The stage adds a methodologically rigorous step enabling a stronger evaluation of the revised PREP prior to implementation as an intervention package in 2021. The Mock interviews will be undertaken using videoconferencing technology to be COVID-19 safe, and are anticipated to take 40-60 minutes. The Mock interviews will be delivered by the occupational therapy student under the supervision of a qualified therapist and audio-recorded for later analysis.
Intervention code [1] 315534 0
Rehabilitation
Comparator / control treatment
Participant as own control.
This interrupted time series design provides a 4 week baseline period, following enrollment and goal setting, during which baseline data for all three goals will be collected (twice weekly) to establish the control period. At week 4, intervention is provided for Goal 1, and data collection for Goals 2 and 3 continues without intervention, providing an additional level of control. At week 8, intervention is provided for Goal 2 (Goal 1 enters follow up phase) and Goal 3 remains in the non-intervention period. At week 12, intervention begins for Goal 3, and Goals 1 and 2 continue to be followed up post-intervention.
Control group
Active

Outcomes
Primary outcome [1] 321346 0
The Canadian Occupational Performance Measure (Law et al.) is a valid, reliable and sensitive-to-change measure, and will be used to assess self-perceived 'Performance' of goals set using a 10 point rating scale.
Timepoint [1] 321346 0
Multiple: study uses interrupted time series methods with data collected twice weekly as follows:
Weeks 1-4: Baseline data collection period for all three goals
Weeks 5-8: Intervention provided for Goal 1; baseline data continues to be collected for Goals 2 &3;
Weeks 9-12: Intervention provided for Goal 2: follow up data collected for Goal 1, baseline data collection continues for Goal 3;
Weeks 13-16: Intervention provided for Goal 3, follow up data collected for Goals 1 & 2;
Weeks 17-20: Follow up data collected for all three goals.
Primary outcome [2] 321573 0
The Canadian Occupational Performance Measure (Law et al.) is a valid, reliable and sensitive-to-change measure, and will be used to assess self-perceived Satisfaction with Performance of goals set using a 10 point rating scale.
Timepoint [2] 321573 0
Multiple: study uses interrupted time series methods with data collected every 4 weeks as follows:.
Weeks 1: Baseline data collection period for all three goals
Weeks 4: Intervention provided for Goal 1; baseline data continues to be collected for Goals 2 &3;
Weeks 8: Intervention provided for Goal 2: follow up data collected for Goal 1, baseline data collection continues for Goal 3;
Weeks 12: Intervention provided for Goal 3, follow up data collected for Goals 1 & 2;
Weeks 16: Follow up data collected for all three goals at end of intervention period.
Weeks 20: Follow up data collected for all three goals.
Primary outcome [3] 321574 0
Measure of self-perceived level of involvement (defined as the experience of participation) in each goal activity using a 10 point visual analogue scale.
Timepoint [3] 321574 0
Multiple: study uses interrupted time series methods with data collected twice weekly as follows:
Weeks 1-4: Baseline data collection period for all three goals
Weeks 5-8: Intervention provided for Goal 1; baseline data continues to be collected for Goals 2 &3;
Weeks 9-12: Intervention provided for Goal 2: follow up data collected for Goal 1, baseline data collection continues for Goal 3;
Weeks 13-16: Intervention provided for Goal 3, follow up data collected for Goals 1 & 2;
Weeks 17-20: Follow up data collected for all three goals.
Secondary outcome [1] 374709 0
Implementation Feasibility: Capacity to recruit and complete PREP implementation in 2021 will be assessed as follows: a. Capacity to recruit: type and number of recruitment strategies, length of time to recruit and total number of participants recruited compared with numbers of those who contact researchers but decline (and the reasons when provided), will be collected. b. Number of participants who complete all elements will be assessed using an evaluation of missing COPM data at the end of the study period for each participant (ie after 20 weeks).
Timepoint [1] 374709 0
a. Recruitment data will be collated at the end of the recruitment period;
b. Missing data analysis will occur after each participant has completed the 20 week study period.
Secondary outcome [2] 374710 0
Implementation Acceptability of the PREP intervention to participants and other stakeholders will be assessed using interviews with participants and key service provider stakeholders at the completion of the 20-week program. Elements of interest will include repeated collection of COPM scores, optimal length of the intervention and of focusing on three goals within the timeframe.
Timepoint [2] 374710 0
Within 2 weeks of completion of the PREP intervention (ie weeks 21-22 post enrollment), participants and other key stakeholders (ie those providing the intervention) will be interviewed to consider the overall question of acceptability of PREP provided in this context.
Secondary outcome [3] 402180 0
Perceived acceptability of PREP will be assessed using data collected from (a) audio-recordings of mock PREP interviews and debrief; (b) interview and focus group data from young adults with complex impairment; and (c) brief survey data and audio recordings of interviews with other stakeholders.
Timepoint [3] 402180 0
Following implementation of PREP review and Mock PREP interviews and focus groups.
Secondary outcome [4] 402181 0
Perceived feasibility of PREP will be assessed using data collected from (a) audio-recordings of mock PREP interviews and debrief; (b) interview and focus group data from young adults with complex impairment; and (c) brief survey data and audio recordings of interviews with other stakeholders.
Timepoint [4] 402181 0
Following implementation of PREP review and Mock PREP interviews and focus groups.

Eligibility
Key inclusion criteria
1. Young Adults aged 18-30 years who are interested and able to engage in the research and are able to formulate, communicate and rate their goals with their usual supports (e.g., communication aids/devices and support persons if needed). These individuals may have any of a variety of diagnoses, including, but not limited to, cerebral palsy.
2. Other stakeholders include interested family members or support persons of the young adult participants, and clinicians (predominantly the occupational therapists or student occupational therapists) working at St Vincent’s YACDS who engage in supporting the delivery of the PREP program and are interested to provide their perspectives about feasibility in qualitative interviews.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Youth who are recovering within the first year following a severe brain injury or an orthopaedic surgery will be excluded, as their functional capacities are less likely to be stable and any effects from PREP may not be fully attributable to PREP intervention.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Study design is (a) feasibility study of perceived acceptability and feasibility of PREP intervention in this context with 3-4 young adults with complex disability and relevant stakeholders; followed by (b) an interrupted time series, using a 20-week multi-baseline design across 3 goals replicated across 8 -10 youth.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This multiple methods study will involve both preparation and presentation of descriptive statistics to display the characteristics of the sample and the progress of participants through the PREP intervention to assess feasibility. To assess participant progress on each participation goal, a series of data points that represent the level of goal performance, generated by the COPM performance scale, will be plotted and analysed to detect change. 24 to 30 trajectories (three per participant) illustrating change in performance across all phases of the study (baseline, intervention, follow up), each based on 40 data points (20 weeks X twice per week) will be generated. This visual analysis of graphical data allows for a comparison of patterns of change, (e.g., level, variability, trend) between baseline and intervention data where an increase of at least 2-points on the COPM scale indicates a clinically significant change. Data gathered through interviews, surveys and focus groups will be analysed, using content analysis methods, to address issues of perceived (in 2020) and actual (in 2021) applicability and acceptability of the program to participants and key stakeholders.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/12/2019
Actual
12/08/2020
Date of last participant enrolment
Anticipated
24/02/2020
Actual
3/03/2021
Date of last data collection
Anticipated
31/07/2020
Actual
30/08/2021
Sample size
Target
14
Accrual to date
Final
9
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 14759 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment postcode(s) [1] 27991 0
3065 - Fitzroy
Recruitment postcode(s) [2] 35654 0
3058 - Coburg

Funding & Sponsors
Funding source category [1] 303778 0
Charities/Societies/Foundations
Name [1] 303778 0
Endeavour Foundation: Disability Research Fund
Country [1] 303778 0
Australia
Primary sponsor type
Individual
Name
Christine Imms
Address
University of Melbourne
Department of Paediatrics | MDHS
Level 3, West Building, Royal Children’s Hospital
50 Flemington Road, Parkville, Victoria 3052 Australia
Country
Australia
Secondary sponsor category [1] 303897 0
Individual
Name [1] 303897 0
Margaret Wallen
Address [1] 303897 0
Australian Catholic University
PO Box 968 North Sydney
NSW, 2059
Country [1] 303897 0
Australia
Other collaborator category [1] 280946 0
Individual
Name [1] 280946 0
Dana Anaby
Address [1] 280946 0
MAB-Mackay Rehabilitation Centre du CIUSSS du Centre-Ouest-de-l’Île-de-Montréal/CRIR
3500 Decarie Boulvard Rm. 411
Montreal, Quebec H4A 3J3
Country [1] 280946 0
Canada
Other collaborator category [2] 280947 0
Individual
Name [2] 280947 0
Emma Fredrickson
Address [2] 280947 0
Occupational Therapy Department
St Vincent's Hospital Melbourne
PO Box 2900 FITZROY, 3065
Victoria
Country [2] 280947 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304298 0
St Vincent's Hospital Melbourne, Human Research Ethics Committee
Ethics committee address [1] 304298 0
Ethics committee country [1] 304298 0
Australia
Date submitted for ethics approval [1] 304298 0
11/10/2019
Approval date [1] 304298 0
29/04/2020
Ethics approval number [1] 304298 0
2015/19
Ethics committee name [2] 304299 0
Australian Catholic University Human Research Ethics Committee
Ethics committee address [2] 304299 0
Ethics committee country [2] 304299 0
Australia
Date submitted for ethics approval [2] 304299 0
04/11/2019
Approval date [2] 304299 0
11/06/2020
Ethics approval number [2] 304299 0
2020-117R

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

Contacts
Principal investigator
Name 96442 0
Prof Christine Imms
Address 96442 0
Department of Paediatrics | MDHS
Level 3, West Building, Royal Children’s Hospital
50 Flemington Road, Parkville, Victoria 3052 Australia
Country 96442 0
Australia
Phone 96442 0
+61 393454953
Fax 96442 0
N/A
Email 96442 0
[email protected]
Contact person for public queries
Name 96443 0
Christine Imms
Address 96443 0
Department of Paediatrics | MDHS
Level 3, West Building, Royal Children’s Hospital
50 Flemington Road, Parkville, Victoria 3052 Australia
Country 96443 0
Australia
Phone 96443 0
+6193454953
Fax 96443 0
N/A
Email 96443 0
[email protected]
Contact person for scientific queries
Name 96444 0
Christine Imms
Address 96444 0
Department of Paediatrics | MDHS
Level 3, West Building, Royal Children’s Hospital
50 Flemington Road, Parkville, Victoria 3052 Australia
Country 96444 0
Australia
Phone 96444 0
+619345 4953
Fax 96444 0
N/A
Email 96444 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual trajectories of COPM outcomes will be available for each participant
When will data be available (start and end dates)?
Following publication, no end date.
Available to whom?
De-identified, raw individualised data for each participant trajectory will be disseminated publicly
Available for what types of analyses?
any analyses.
How or where can data be obtained?
From Principal investigator, via email: [email protected]


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.