Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618002057268
Ethics application status
Approved
Date submitted
31/05/2018
Date registered
21/12/2018
Date last updated
6/12/2019
Date data sharing statement initially provided
21/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The use of group based Occupational Therapy Breakfast Preparation Retraining to improve the independence in meal preparation tasks for people with brain injury.
Scientific title
Do increased opportunities to engage in breakfast preparation through a group intervention result in improved functional outcomes for people with brain injury.
Secondary ID [1] 295053 0
Nil Known
Universal Trial Number (UTN)
N/A
Trial acronym
The BITe Study
Linked study record
none

Health condition
Health condition(s) or problem(s) studied:
Acquired Brain Injury 308096 0
Condition category
Condition code
Physical Medicine / Rehabilitation 307141 307141 0 0
Occupational therapy
Injuries and Accidents 308653 308653 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A single site pilot randomised controlled trial will be conducted over 12- 18 months. Qualitative methods will be used to explore the satisfaction of breakfast group (intervention) to participants.
Twenty patients participating in an inpatient BIRU program will be assigned to receive a 5 day per week (Monday to Friday) breakfast preparation group based program (intervention) for 4 weeks facilitated by a minimum of one occupational therapist and one occupational therapy assistant. Group participants will receive retraining based on procedural learning principles and support provided according to a most to least hierarchy of prompts.

On day one of intervention, the treating therapist will provide orientation to the patient pertaining to the environmental set up and provide a list of meal options. The patient is able to select what they would like to prepare for breakfast each morning. The Therapist completes a functional assessment to determine their level of functioning and level of support required. The Therapist will generate a treatment plan using the hierarchy of prompts to then handover to staff involved for intervention to be implemented.

The intervention will be delivered via group facilitation with a maximum of 1:4 staff to patient ratio. As patients arrive to the group each day, the patients will be allocated to a staff member to provide the intervention and supervise the patient’s meal preparation. Patients will not be allocated prior to the group intervention as there will be variations with patient arrival time dependent on other influencing factors such as completion of self-care routines, medical procedures, and wake up times.

Patient progresses in the group with regular handover between group facilitator to adjust the intervention accordingly.

The intervention given is group/not group, both of which are characterised as 'good practice' Occupational Therapy (either individual or group). To ensure competency in the stage 1 task analysis (primary outcome measure), a two hour training session will be provided to therapists involved in the project who have not completed the Perceive Recall Plan Perform (PRPP) training. In addition, this training will also cover the hierarchy of prompts to ensure adherence of the intervention being delivered in line with the protocol. Therapists will also complete attendance checklists to monitor participant attendance in the study.
Intervention code [1] 301386 0
Rehabilitation
Comparator / control treatment
Control – participants will receive 1:1 simple meal preparation retraining. This will be in accordance with usual practice of clinician determined frequency (1-5 days per week).

Usual practice is not based upon specific guidelines. Researchers of the study will deliver the control in line with the protocol.

On day one of intervention using usual practice, the treating therapist will provide orientation to the patient pertaining to the environmental set up and provide a list of meal options. The patient is able to select what they would like to prepare for breakfast each session. The Therapist completes a functional assessment to determine their level of functioning and level of support required. The Therapist will generate a treatment plan using the hierarchy of prompts for intervention to be implemented over a 4 week period.
Control group
Active

Outcomes
Primary outcome [1] 306093 0
The primary outcome will be the amount of change in task mastery in simple meal preparation tasks as measured by the PRPP system of Task Analysis Stage 1 at baseline, 4 weeks and 12 weeks following the commencement of the intervention phase. This outcome will address the first research question by measuring change in task mastery of simple meal preparation tasks (breakfast).
Timepoint [1] 306093 0
Outcomes will be completed at baseline, 4 weeks and 12 weeks following the commencement of the intervention phase.
Secondary outcome [1] 347560 0
The Functional Autonomy Measurement System (SMAF) (Rai et al., 1996) will be measured at baseline, 4 weeks and 12 weeks following the commencement of the intervention phase. This outcome addresses the change in functional performance in meal preparation tasks.
Timepoint [1] 347560 0
The SMAF will be conducted at baseline, 4 weeks and 12 weeks following the commencement of the intervention phase.
Secondary outcome [2] 352421 0
Participants’ satisfaction with the breakfast group program will evaluated via 1 to 1 interview following the conclusion of the four week intervention. This outcome addresses participant’s perceptions of satisfaction of the group based intervention (treatment mode).
Timepoint [2] 352421 0
1:1 interview will occur following the conclusion of the four week intervention.
Secondary outcome [3] 352422 0
The number of breakfast preparation sessions offered to participants will be measured via file audit and therapy attendance sheets. This outcome addresses the opportunities and intensity of practice of meal preparation skills.
Timepoint [3] 352422 0
Therapy attendance sheets will be completed during the administration of the intervention. File audits will be conducted at the completion of the 4 week intervention/control.

Eligibility
Key inclusion criteria
All patients admitted to a metropolitan brain injury rehabilitation unit (Liverpool) referred to occupational therapy and who fulfil the following criteria will be invited to participate:
• Admitted to Liverpool BIRU inpatient rehabilitation
• Diagnosis of acquired brain injury (ABI)
• Aged between 16 and 65 years
• Medically stable
• Able to follow single stage commands – verbal, visual and /or written
• Tolerating an oral diet
• Have an identified problem with meal preparation
• Have goals related to meal preparation
• Have the physical and cognitive capacity to engage in meal preparation
• Patient with an infection status of other multi-resistant organisms
Minimum age
16 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Patients that display behaviours that may place either themselves or others at risk.
• Unable to follow single stage commands – verbal, visual and /or written
• On PEG feeds
• Have not identified difficulties with meal preparation
• Do not have goals related to meal preparation
• Physically and cognitive are unable to engage in meal preparation
• Patients with an Infectious status of droplet precautions

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)
Forty participants will be randomly allocated to either group based breakfast preparation retraining intervention (experimental) or standard practice 1:1 simple meal preparation retraining (control group). All baseline outcomes will be assessed prior to randomisation by 1 of 4 occupational therapists. The allocation schedule will be computer generated and concealed in opaque consecutively numbered envelopes by a person not otherwise involved in the study. Inpatient Occupational therapists and therapy assistant/s will be trained to deliver the experimental and control interventions in a manner dictated by the trial protocol.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation schedule will be computer generated and concealed in opaque consecutively numbered envelopes by a person not otherwise involved in the study.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
n/a
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size
Based on annual admission numbers, it is expected that forty patients (n=40) admitted to the Liverpool Brain Injury Rehabilitation Unit will be referred to the occupational therapists for breakfast preparation intervention over a 12 month period. A sample size of 40 participants (i.e. 20 participants per group) has been deemed to be adequate for a pilot study where the aim is to demonstrate intervention efficacy (Hertzog, 2008).

Data analyses

Component A: Quantitative data analysis
Participant outcomes will be analysed and compared between baseline, post intervention and follow-up time periods using descriptive statistics including proportions, means/standard deviations, or median/interquartile range. Differences in categorical data/dichotomous measures including proportions will be analysed using McNemar’s test. Differences in continuous outcomes will be analysed using either paired t-tests (pre-post) and 95% confidence intervals, or Friedman’s test (using multiple time points).

Component B: Qualitative data analysis:
In accordance with grounded theory methods, the data analysis will be undertaken concurrently with the data collection (Thornberg & Charmaz, 2013). This analytic approach enables the data collected to inform the development of the theory which in turn guides subsequent data collection. Recordings of the interviews will be transcribed verbatim by the interviewer after each interview with each participant. NVivo software will be used to assist with data management and analysis. Copies of the transcribed interviews will be provided to participants for review if requested, to check the accuracy of the transcript as one form of member checking (Bryman, 2004).

The data will undergo a process of coding starting with initial coding. Initial coding will be completed using line-by-line analysis of transcripts (Thornberg & Charmaz, 2013). Initial coding will allow the researcher to compare data and remain open to exploring what they are interpreting (Thornberg & Charmaz, 2013) in relation to the participant’s experiences. This process will assist to further focus data collection. The constant comparative method will be used (Glaser & Strauss, 1967 as cited in Thornberg & Charmaz, 2013) to find similarities and differences within the data and to assist with the sorting and clustering of initial codes.

Following initial coding, focused coding of the data will be conducted. Focused coding involves using the most significant or frequent initial codes to sort and analyse large amounts of data (Thornberg & Charmaz, 2013). Focused codes will be used to capture and synthesise main themes that will then be raised as conceptual categories and further refined.

Finally, theoretical coding will be used to develop a theoretical explanation of the factors influencing participant satisfaction with the breakfast group program.

A number of strategies will be used to enhance the rigour of the analysis. Triangulation of investigators will be used for the checking of codes to ensure consistency of coding and categorisation (Krefting, 1991). Peer examination will be used to ensure the trustworthiness of the data collection and analysis (Krefting, 1991).

Memo writing will be used throughout the study by the researcher to record ideas about codes, the relationships between them and emerging categories (Thornberg & Charmaz, 2013).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/05/2021
Actual
Date of last participant enrolment
Anticipated
22/08/2022
Actual
Date of last data collection
Anticipated
20/11/2022
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 11050 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 22846 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 299636 0
Government body
Name [1] 299636 0
South Western Sydney Local Health District
Country [1] 299636 0
Australia
Primary sponsor type
Individual
Name
Miriam de Rooy, Principal Investigator and Senior Occupational Therapist
Address
Liverpool Brain Injury Rehabilitation Unit
Locked Bag 7103, Liverpool BC, NSW 1871
Country
Australia
Secondary sponsor category [1] 298973 0
None
Name [1] 298973 0
Address [1] 298973 0
Country [1] 298973 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300534 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 300534 0
Ethics committee country [1] 300534 0
Australia
Date submitted for ethics approval [1] 300534 0
01/06/2018
Approval date [1] 300534 0
08/10/2018
Ethics approval number [1] 300534 0
HE18/141

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

Contacts
Principal investigator
Name 83974 0
Mrs Miriam de rooy
Address 83974 0
Liverpool Brain Injury Rehabilitation Unit
Locked Bag 7103, Liverpool BC, NSW 1871
Country 83974 0
Australia
Phone 83974 0
+61 (02) 8738 5525
Fax 83974 0
+61 (02) 8738 5497
Email 83974 0
[email protected]
Contact person for public queries
Name 83975 0
Miriam de rooy
Address 83975 0
Liverpool Brain Injury Rehabilitation Unit
Locked Bag 7103, Liverpool BC, NSW 1871
Country 83975 0
Australia
Phone 83975 0
+61 (02) 8738 5525
Fax 83975 0
+61 (02) 8738 5497
Email 83975 0
[email protected]
Contact person for scientific queries
Name 83976 0
Miriam de rooy
Address 83976 0
Liverpool Brain Injury Rehabilitation Unit
Locked Bag 7103, Liverpool BC, NSW 1871
Country 83976 0
Australia
Phone 83976 0
+61 (02) 8738 5525
Fax 83976 0
+61 (02) 8738 5497
Email 83976 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
All data that is collected will be presented in a de-identified format as per the approved study protocol.


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.