Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000894796
Ethics application status
Approved
Date submitted
1/07/2013
Date registered
12/08/2013
Date last updated
1/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
An Intervention to Increase Meaningful Occupation After Traumatic Brain Injury: The Participation, Engagement and Productive Alliance (PEPA) Program
Scientific title
Effectiveness of the Participation, Engagement and Productive Alliance (PEPA) Program to increase meaningful occupation after traumatic brain injury using single case experimental design methodology
Secondary ID [1] 282555 0
Nil known
Universal Trial Number (UTN)
Trial acronym
PEPA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Traumatic brain injury 289220 0
Condition category
Condition code
Neurological 289556 289556 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 289936 289936 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Individual intervention will be provided to participants. The intervention will target a minimum of three specific target behaviours related to the participant’s desired lifestyle changes, as selected by the participant during a goal-setting process. The target behaviours will be tailored to each individual participant and will therefore differ among participants. A participant-driven schedule of activity will be developed, initially drawing upon the Canadian Occupational Performance Measure and Goal Attainment Scaling. The intervention will be administered by a psychologist or occupational therapist. Participants will attend 1x 1 hour individual session per week plus 1 x 20-30 minute telephone intervention per week for 15 weeks intervention. Adherence to intervention will be monitored in several ways. Participant attendance at intervention sessions will be monitored weekly. Additionally at each session the therapist will be checking whether the participant has followed-up activities planned at the previous session. Furthermore the therapists providing the intervention will have weekly supervision meetings with the lead researcher to monitor the intervention is adhering to the study protocol.
Intervention code [1] 287220 0
Rehabilitation
Intervention code [2] 287221 0
Lifestyle
Comparator / control treatment
There will be an initial baseline phase, during which there is no intervention, and in which the target behaviours will be measured for each participant. The baseline phase will serve as the control condition. The basleline will be 5 weeks duration.
Control group
Active

Outcomes
Primary outcome [1] 289647 0
The specified target behaviours, which will vary for each participant. Target behaviours will vary widely hence the measurement of target behaviours will vary. Some anticipated examples are measurement of number of steps participant walks per day measured by a pedometer; or length of time spent in a specific activity per week measured by completion of an activity log; or number of social outings per week measured by completion of an activity log.
Timepoint [1] 289647 0
The frequency of measurement of target behaviours will vary depending on the target behaviour being addressed for the individual participant, but they will all be measured at most daily and at least weekly during baseline, intervention and a 1-week period post-intervention.
Primary outcome [2] 289648 0
Measure of goal achievement using the Goal Attainment Scaling (GAS)
Timepoint [2] 289648 0
Once during pre-intervention, once a week during intervention, and once 1 week post-intervention.
Primary outcome [3] 289649 0
Measure change in participant's quality of life using the Quality of Life After Brain Injury (QOLIBRI)
Timepoint [3] 289649 0
Pre-intervention, post-intervention, 2 and 6 month follow-up
Secondary outcome [1] 302941 0
Measure of change of leisure pursuits using the Nottingham Leisure Questionnaire (NLQ)
Timepoint [1] 302941 0
Pre-intervention, post-intervention, 2 and 6 month follow-up
Secondary outcome [2] 302942 0
Measure change in participant’s level of care and support needs using the Care and Needs Scale (CANS)
Timepoint [2] 302942 0
Pre-intervention, post-intervention, 2 and 6 month follow-up
Secondary outcome [3] 302943 0
Measure change in participant’s community integration using the Community Integration Measure (CIM)
Timepoint [3] 302943 0
Pre-intervention, post-intervention, 2 and 6 month follow-up
Secondary outcome [4] 302944 0
Measure change in participant’s self-esteem using the Coopersmith Self-Esteem Inventory (CSEI)
Timepoint [4] 302944 0
Pre-intervention, post-intervention, 2 and 6 month follow-up
Secondary outcome [5] 302945 0
Measure change in participant’s levels of depression, anxiety and stress using the Depression Anxiety Stress Scale (DASS)
Timepoint [5] 302945 0
Pre-intervention, post-intervention, 2 and 6 month follow-up
Secondary outcome [6] 302946 0
Measure change in participant's behavioural and executive function using the Frontal Systems Behavior Scale (FrSBe)
Timepoint [6] 302946 0
Pre-intervention, post-intervention
Secondary outcome [7] 302947 0
Measure change in participant’s life satisfaction using the Satisfaction With Life Scale (SWLS)
Timepoint [7] 302947 0
Pre-intervention, post-intervention, 2 and 6 month follow-up
Secondary outcome [8] 302948 0
Measure change in participant’s level of self-awareness of their deficits using the Self-Awareness of Deficits Interview (SADI)
Timepoint [8] 302948 0
Pre-intervention, post-intervention, 2 and 6 month follow-up
Secondary outcome [9] 302950 0
Measure change in participant's social networks using the Lubben Social Network Scale (LSNS)
Timepoint [9] 302950 0
Pre-intervention, post-intervention, 2 and 6 month follow-up
Secondary outcome [10] 302951 0
Measure any change in participant's daily activity pattern using an activity log
Timepoint [10] 302951 0
Baseline, during intervention, 1 week follow-up
Secondary outcome [11] 302952 0
Measure change in participant’s level of social support using the Social Support Survey (SSS)
Timepoint [11] 302952 0
Pre-intervention, post-intervention, 2 and 6 month follow-up
Secondary outcome [12] 302953 0
Measure change in participant’s psychosocial reintegration using the Sydney Psychosocial Reintegration Scale (SPRS)
Timepoint [12] 302953 0
Pre-intervention, post-intervention
Secondary outcome [13] 302954 0
Measure change in participant’s participation using the World Health Organisation Disability Assessment Scale (WHODAS)
Timepoint [13] 302954 0
Pre-intervention, post-intervention
Secondary outcome [14] 302955 0
Measure participant's readiness to change using the Readiness for Change Scale
Timepoint [14] 302955 0
Pre-intervention
Secondary outcome [15] 302956 0
Measure participant's level of commitment to working on goals using the Goal Commitment Questionnaire
Timepoint [15] 302956 0
Pre-intervention
Secondary outcome [16] 303000 0
Measure change in participant’s goal setting and rating of goals using the Canadian Occupational Performance Measure (COPM)
Timepoint [16] 303000 0
Once pre-intervention, once during the week post-intervention, and once each at 2 and 6 month follow-up

Eligibility
Key inclusion criteria
1. Sustained a severe TBI (duration of posttraumatic amnesia greater than one week)
2. Aged between 18 and 65 years
3. Between 1 and 15 years post trauma
4. Have received a comprehensive inpatient rehabilitation programme for the TBI
5. Living in the community in the Sydney metropolitan region
6. Independent in basic activities of daily living
7. Be able to travel independently by public transport
8. Have functional English to be able to participate in the therapy programme
9. Have sufficient neuropsychological skills (as documented in the neuropsychological and medical reports) to be able to participate in the therapy programme
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Current and major psychiatric disorder, including substance abuse as documented in medical records or determined by responses to the social and medical history form questionnaire
2. Participating in the competitive workforce
3. Pre-existing neurological disorder

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)
Participants will be referred to the study if the treating clinicians at the two hospital sites think that they are suitable for and would benefit from the study or if they are identified as being potentially eligible from a review of their medical record. A letter of invitation will be sent to the potential participant and the research staff will telephone him/her after two weeks, unless the person indicates that they do not want to be contacted.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
A single-case experimental design is used where the participant serves as his or her own control.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be analysed using a variety of techniques:
Target behaviours will be analysed using visual analysis of level, trend and variability, supported by quasi-statistical techniques (split-middle trend line and binomial test, percentage of non-overlapping data), along with modified time-series analysis where data permit. Goal attainment scaling will also be used.
This study is using a single case experimental design. The accepted current standard is that for direct intersubject replication at least 3 replications (original plus 3) are required. In this study we will be researching 10 participants which surpasses the standard. Refer to Gast, D.L. (2010). "Single subject research methodology in behavioural sciences". Routledge: New York.; Horner, R.H., Carr, E.C., Halle, J., McGee, G., Odom, S., & Wolery, M. (2005). "The use of single-subject research to identify evidence-based practice in special education". Exceptional Children, 71(2), 165-179; and Barlow, D.H., Nock, M.K, & Hersen, M. (2009). "Single case experimental designs: Strategies for studying behavior for change". 3rd ed. Boston: Pearson/Allyn and Bacon

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/08/2013
Actual
28/08/2013
Date of last participant enrolment
Anticipated
Actual
2/06/2015
Date of last data collection
Anticipated
Actual
16/06/2016
Sample size
Target
10
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 1047 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 1048 0
Royal Rehabilitation Hospital - Coorabel/Moorong - Ryde

Funding & Sponsors
Funding source category [1] 287335 0
Government body
Name [1] 287335 0
Lifetime Care and Support Authority (NSW)
Country [1] 287335 0
Australia
Primary sponsor type
Individual
Name
Professor Robyn Tate
Address
John Walsh Centre for Rehabilitation Research
Kolling Institute
RNSH
Pacific Hwy
St Leonards
NSW 2065
Country
Australia
Secondary sponsor category [1] 286081 0
None
Name [1] 286081 0
Address [1] 286081 0
Country [1] 286081 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289308 0
Northern Sydney Coast Human Research Ethics Committee (EC00112)
Ethics committee address [1] 289308 0
Research Office
Kolling Building, Level 13
Royal North Shore Hospital
Pacific Hwy
St Leonards NSW 2065
Ethics committee country [1] 289308 0
Australia
Date submitted for ethics approval [1] 289308 0
Approval date [1] 289308 0
17/09/2012
Ethics approval number [1] 289308 0
EC00112
Ethics committee name [2] 289364 0
Royal Rehabilitation Centre Sydney Ethics Committee
Ethics committee address [2] 289364 0
PO Box 6
Ryde
NSW 1680
Ethics committee country [2] 289364 0
Australia
Date submitted for ethics approval [2] 289364 0
Approval date [2] 289364 0
25/01/2013
Ethics approval number [2] 289364 0
SSA/12/06
Ethics committee name [3] 289365 0
South Western Sydney Local Health District Ethics and Research Committee
Ethics committee address [3] 289365 0
Locked Bag 7279
Liverpool BC
NSW 1871
Ethics committee country [3] 289365 0
Australia
Date submitted for ethics approval [3] 289365 0
Approval date [3] 289365 0
12/02/2013
Ethics approval number [3] 289365 0
SSA/12/LPOOL/437

Summary
Brief summary
Participation in the workforce is often not possible for people who have sustained a severe traumatic brain injury (TBI). Furthermore, a large proportion of those who are unable to return to work also do not engage in any meaningful occupation in lieu of work. Such people generally have sustained major impairments of the cognitive functions essential to the development of meaningful occupational activities; specifically the ability to plan, initiate action, and to monitor and/or sustain activity. They often require structure and support if they are to develop a program of meaningful activities. This project specifically addresses the issue of diminished meaningful occupational activity for those who have sustained a TBI and are unable to return to work.
Using single case experimental design methodology this study will provide individual intervention specifically aimed at increasing the person’s engagement in meaningful activity.
Trial website
Trial related presentations / publications
1. Tate RL, Wakim D, Genders M. (2014). A systematic review of the efficacy of community-based, leisure/social activity programs for people with traumatic brain injury. Brain Impairment. 15(3), 157-176.
2. Tate RL (December, 2015). Increasing meaningful occupation after traumatic brain injury. Final report to the Lifetime Care and Support Authority of New South Wales.
3. Tate RL, Wakim D, Sigmundsdottir L, Longley W. (September, 2016). An intervention to increase meaningful occupation after traumatic brain injury. Paper presented at 39th annual meeting of the Australasian Society for the Study of Brain Impairment, Macau, China.
4. Tate RL, Wakim D, Sigmundsdottir L, Longley W. (July, 2016). Developing an intervention to increase meaningful occupation after traumatic brain injury. Paper presented at 13th annual meeting of the Special Interest Group in Neuropsychological Rehabilitation of the World Federation for NeuroRehabilitation. Glasgow, Scotland.
5. Tate RL. (April, 2016). Meaningful occupation after traumatic brain injury. Paper presented at Brain Sciences Symposium, University of New South Wales, Sydney.
6. Tate RL, Wakim D, Genders M. (July, 2015). Which interventions are effective in improving meaningful occupation after traumatic brain injury? A systematic review and recommendations for clinical practice. Paper presented at the ASSBI/INS conference, Sydney, Australia.
7. Tate RL. (July, 2015). No work and no play makes Jack’s life dull: what can we do? Paper presented at the John Walsh Centre for Rehabilitation Research Forum, Sydney, Australia.
8. Tate RL. (November, 2015). Using single-case experimental methodology in research and clinical practice. Paper presented at the Clinical Advisory Board Meeting of the Moving Ahead NHMRC Centre for Research Excellence, Sydney, Australia.
9. Tate RL. (November, 2014). Using single-case experimental methodology to conduct research: Project to increase meaningful occupation after traumatic brain injury. Paper presented at the Clinical Advisory Board Meeting of the Moving Ahead NHMRC Centre for Research Excellence, Sydney, Australia.
Public notes

Contacts
Principal investigator
Name 40270 0
Prof Robyn Tate
Address 40270 0
John Walsh Centre for Rehabilitation Research
Kolling Institute
RNSH
Pacific Hwy
St Leonards
NSW 2065
Country 40270 0
Australia
Phone 40270 0
+61 2 9926-4785
Fax 40270 0
Email 40270 0
[email protected]
Contact person for public queries
Name 40271 0
Prof Robyn Tate
Address 40271 0
John Walsh Centre for Rehabilitation Research
Kolling Institute
RNSH
Pacific Hwy
St Leonards
NSW 2065
Country 40271 0
Australia
Phone 40271 0
+61 2 9926-4785
Fax 40271 0
Email 40271 0
[email protected]
Contact person for scientific queries
Name 40272 0
Prof Robyn Tate
Address 40272 0
John Walsh Centre for Rehabilitation Research
Kolling Institute
RNSH
Pacific Hwy
St Leonards
NSW 2065
Country 40272 0
Australia
Phone 40272 0
+61 2 9926-4785
Fax 40272 0
Email 40272 0
[email protected]

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