Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001196639
Ethics application status
Approved
Date submitted
16/10/2023
Date registered
20/11/2023
Date last updated
20/11/2023
Date data sharing statement initially provided
20/11/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of occupation-based groups on occupational performance and satisfaction in inpatient rehabilitation: A quasi-experimental pre-post design with non-equivalent control group.
Scientific title
Occupation-based groups in inpatient rehabilitation: effectiveness in improving occupational performance outcomes and barriers and enablers to successful implementation.
Secondary ID [1] 310793 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
stroke 331766 0
traumatic brain injury 331767 0
orthopedic 331768 0
general medical conditions 331769 0
general surgical conditions 331770 0
amputation (lower limb) 331771 0
deconditioning 331772 0
neurodegenerative conditions 331773 0
Condition category
Condition code
Musculoskeletal 328512 328512 0 0
Other muscular and skeletal disorders
Neurological 328513 328513 0 0
Other neurological disorders
Stroke 328612 328612 0 0
Ischaemic
Stroke 328613 328613 0 0
Haemorrhagic
Physical Medicine / Rehabilitation 328614 328614 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Occupation-based interventions delivered in a semi-supervised, group format for domestic-based daily activities (cooking, cleaning, laundry, and other domestic tasks).
Occupation-based interventions involve using engagement in part or whole of an intended occupation (daily activity) as a therapeutic agent of change. In the case of the intervention group, the occupation-based intervention will be delivered in a semi-supervised group format. Specific tasks practiced during groups will vary depending on patient goals but may include preparing breakfast, preparing lunch, emptying/stacking dishwasher, wiping bench tops, cleaning bathroom surfaces, vacuuming, sweeping, bed making, loading/unloading washing machines and dryers and hanging washing on indoor airers or outdoor clotheslines.

Groups are to be implemented in therapy kitchen, therapy laundry, outdoor clothesline, gym, and bathroom spaces on the relevant inpatient rehabilitation wards.

Groups are to be delivered by occupational therapists, allied health assistants and/or occupational therapy students.  

Group size varied between 2-4 participants.

Frequency and duration of the intervention group will vary per patient given the client-centred nature of this intervention. Patients continue to engage in the group treatment until they achieved their goals, reach a new baseline and/or are for discharge.
Intervention code [1] 327206 0
Rehabilitation
Comparator / control treatment
Occupation-based interventions delivered 1:1 for domestic-based daily activities.

Occupation-based interventions involve using engagement in whole or part of an intended occupation (daily activity) as a therapeutic agent of change.

Frequency and duration of the control group varied per patient given the client-centered nature of this intervention. Patients continued to engage in the control treatment until they achieved their goals, had reached a new baseline and/or were for discharge.
Control group
Active

Outcomes
Primary outcome [1] 336338 0
Canadian Occupational Performance Measure
Timepoint [1] 336338 0
Outcome measures will be administered before participation (pre treatment baseline) in any occupation-based interventions (either control or intervention treatment).

Outcome measures will be re-administered post participation in the control or intervention treatment and prior to hospital discharge.
Primary outcome [2] 336339 0
Goal Attainment Scale
Timepoint [2] 336339 0
Outcome measures will be administered before participation (pre treatment baseline) in any occupation-based interventions (either control or intervention treatment).

Outcome measures will be re-administered post participation in the control or intervention treatment and prior to hospital discharge.
Secondary outcome [1] 427892 0
Use of services (to assist with domestic based daily activities) on discharge
Timepoint [1] 427892 0
Use of services prior to hospital admission (baseline) and on discharge (post completion of the program) for control and intervention treatments.

Eligibility
Key inclusion criteria
INCLUSION
- Aged 18 years or above
- Medically stable
- Admitted to Stromlo, Namadgi or Majura inpatient rehabilitation wards for rehabilitation at the University of Canberra Hospital
- Adequate cognitive and communication abilities to enable full participation in the intervention in a semi-supervised format
- Discharge destination of home with domestic-based goals (1-5 goals)
- Written, informed consent to participate in the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
EXCLUSION
- < 1 domestic based goal identified
-Discharge destination to residential care facility
- Medically unstable
- Severe cognitive and/or communication deficits (<17/30 on the Mini Mental State Examination and <13/20 on the shortened Frenchay Aphasia Screening Test respectively).

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)
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
Quasi-experimental pre post design with non-equivalent control group. Study has two sequential time blocks. First time block will recruit and collect data on participants engaging in the control intervention. Second time block (after the first) will recruit and collect data on a new set of participants receiving the intervention program.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
17/07/2023
Date of last participant enrolment
Anticipated
Actual
10/11/2023
Date of last data collection
Anticipated
1/12/2023
Actual
Sample size
Target
60
Accrual to date
Final
21
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment hospital [1] 25737 0
The University of Canberra Hospital: Specialist Centre for Rehabilitation, Recovery and Research - Bruce
Recruitment postcode(s) [1] 41561 0
2617 - Bruce

Funding & Sponsors
Funding source category [1] 315030 0
Government body
Name [1] 315030 0
Department of Education- Research and Training Program (RTP) Scholarship
Country [1] 315030 0
Australia
Funding source category [2] 315031 0
Charities/Societies/Foundations
Name [2] 315031 0
Golden Key Society
Country [2] 315031 0
United States of America
Funding source category [3] 315032 0
Hospital
Name [3] 315032 0
University of Canberra Hospital
Country [3] 315032 0
Australia
Primary sponsor type
Hospital
Name
University of Canberra Hospital
Address
20 Guraguma Street Bruce ACT 2617
Country
Australia
Secondary sponsor category [1] 317052 0
University
Name [1] 317052 0
University of Canberra
Address [1] 317052 0
11 Kirinari Street Bruce ACT 2617
Country [1] 317052 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313993 0
ACT Health Human Research Ethics Committee
Ethics committee address [1] 313993 0
Ethics committee country [1] 313993 0
Australia
Date submitted for ethics approval [1] 313993 0
13/04/2023
Approval date [1] 313993 0
20/06/2023
Ethics approval number [1] 313993 0
2023/ETH00783

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

Contacts
Principal investigator
Name 130050 0
Ms Gemma Wall
Address 130050 0
University of Canberra Hospital 20 Guraguma Street Bruce ACT 2617
Country 130050 0
Australia
Phone 130050 0
+610493599138
Fax 130050 0
Email 130050 0
[email protected]
Contact person for public queries
Name 130051 0
Gemma Wall
Address 130051 0
University of Canberra Hospital 20 Guraguma Street Bruce ACT 2617
Country 130051 0
Australia
Phone 130051 0
+61 2 51240200
Fax 130051 0
Email 130051 0
[email protected]
Contact person for scientific queries
Name 130052 0
Gemma Wall
Address 130052 0
University of Canberra Hospital 20 Guraguma Street Bruce ACT 2617
Country 130052 0
Australia
Phone 130052 0
+61 2 51240200
Fax 130052 0
Email 130052 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
Ethics approval not granted for this.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20669Study protocol  [email protected] Publication TBA
20671Clinical study report  [email protected] Publication TBA
20672Ethical approval  [email protected]



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.