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Trial registered on ANZCTR


Registration number
ACTRN12623000969662
Ethics application status
Approved
Date submitted
14/08/2023
Date registered
6/09/2023
Date last updated
18/10/2023
Date data sharing statement initially provided
6/09/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility and acceptability of an Integrated Safe Mobilisation Program in Rehabilitation on Functional Mobility and Fall Risks in Older Adults with Cognitive Impairment and Decreased Mobility: A Pilot Study
Scientific title
Is it feasible to integrate a safe mobilisation program in inpatient rehabilitation settings to improve functional mobility and reduce the risk of falls in adults 65 years and over with cognitive impairment and decreased mobility?
Secondary ID [1] 310341 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cognitive impairment 331094 0
decreased functional mobility (gait, balance and transfers) 331095 0
falls 331096 0
Condition category
Condition code
Neurological 327882 327882 0 0
Dementias
Neurological 327883 327883 0 0
Neurodegenerative diseases
Injuries and Accidents 327884 327884 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: Integrated Safe Mobilisation Program.
The 2-week intervention program will be carried out by allied health staff (occupational therapists (OT) and physiotherapists) in an inpatient rehabilitation setting to train the participants and their family members/carers safe mobilisation strategies in addition to usual care.
The treating allied health staff will deliver the intervention (safe mobilisation strategy training), e.g. standing up from a chair and pausing for a few seconds before taking steps; walking with big steady steps, maintaining steady steps and rhythms when turning, and managing potential risks such as distractions and fatigue and forming safe mobilising behaviours. Following demonstration of the mobilisation tasks by the therapists, participants will be provided with verbal cues/instructions prior to each step when performing the tasks. The training will include basic training on functional mobility (all transfers such as sit to stand and bath and toilet transfers, balance and gait) and the techniques will be generalised into everyday activities.
The intervention will be delivered face to face, 5-10 sessions during the intervention period, with approximately 10 minutes each session. Participants’ carers/family members will be trained to provide prompts/cues of the safe mobilisation strategies during the intervention period in the rehab facility 2-4 sessions, approximately 10 minutes each session. An OT home visit may be conducted towards later part of the admission. Safe mobilisation strategies will be applied at participant's home and their carer/family member will practise providing prompts/cues during the visit,
Brochures and brief training video designed specifically for this study will be created and provided to participants' carers/family members and participating staff members.
The control group will be recruited first and usual care will be provided with additional study required outcome measures; recruitment of the intervention group will commence after control group is completed. The design of this recruitment sequence is taken into consideration of the ethical perspective from the therapists and fidelity of usual care for the control group (i.e. additional strategies not to be applied in usual care).
Intervention code [1] 326755 0
Rehabilitation
Intervention code [2] 326756 0
Prevention
Comparator / control treatment
The control group will receive usual care, which includes functional and gait training, fall prevention education, home assessment and hazard reduction, installation of equipment and modification as required.
Control group
Active

Outcomes
Primary outcome [1] 335729 0
Primary outcome is the feasibility and acceptability of the Integrated Safe Mobilisation Program measured by a purpose-designed questionnaire.
Timepoint [1] 335729 0
At the end of intervention (week 2), the purpose-designed questionnaire will be used to collect data on feedback on the program from the participants and their family members/carers.

Primary outcome [2] 335843 0
Primary outcome is the feasibility and acceptability of the Integrated Safe Mobilisation Program measured by feedback from focus group discussions.
On completion of the intervention program, a focus group will be run at the participating inpatient rehabilitation facility. The chief investigator will conduct the focus group, The allied health staff (approximately 6 people) who participated in the study and delivered the intervention will be invited to participate in the focus group discussion. The discussion will focus on the feasibility of intervention delivery, staff perception of the use of their time, easiness of training participants with the strategies, relevance of the program to their clinical role, and clarity of the training from the research team.
Timepoint [2] 335843 0
On completion of the intervention program (recruitment completion).
Primary outcome [3] 335844 0
Primary outcome is the feasibility and acceptability of the Integrated Safe Mobilisation Program measured by recruitment and retention rate.
Timepoint [3] 335844 0
Recruitment and retention rate will be assessed at baseline (week 0), end of intervention (week 2), and 3-month follow-up (week 12).
Secondary outcome [1] 425362 0
Functional mobility measured by Get Up & Go.
Timepoint [1] 425362 0
At baseline (week 0), end of intervention(week 2) and 3-month follow-up (week 12).
Secondary outcome [2] 426120 0
Functional mobility measured by 360 degree turn test.
Timepoint [2] 426120 0
At baseline (week 0), end of intervention (week 2) and 3-month follow up (week 12).
Secondary outcome [3] 426121 0
Functional mobility measured by Performance Oriented Mobility Assessment (POMA) (gait subscale).
Timepoint [3] 426121 0
At baseline (week 0), end of intervention (week 2) and 3-month follow up (week 12).
Secondary outcome [4] 426122 0
Functional mobility measured by Canadian Occupational Performance Measure (COPM) (Functional Mobility under Step 1A – Performance and Satisfaction).
Timepoint [4] 426122 0
At baseline (week 0), end of intervention (week 2) and 3-month follow up (week 12).
Secondary outcome [5] 426124 0
Functional mobility measured by Performance Assessment of Self-care Skills (PASS) (Mobility items – Bed mobility, Toilet mobility, Bathtub and shower mobility).
Timepoint [5] 426124 0
At baseline (week 0), end of intervention (week 2) and 3-month follow up (week 12).
Secondary outcome [6] 426130 0
Safety awareness measured by Safety Awareness Checklist (modified from Falls Behavioural Scale) to be completed by both the participants and their family members/carers (if applicable).
Timepoint [6] 426130 0
At baseline (week 0), end of intervention(week 2) and 3-month follow-up (week 12).
Secondary outcome [7] 426131 0
Purpose-designed scales to measure any perceived change and automaticity in safety of movement behaviours (transfers, turning, managing hazardous walking surface, distractions and fatigue) to be completed by both the participants and their family members/carers (if applicable). This will be assessed as a composit outcome.
Timepoint [7] 426131 0
At end of intervention (week 2) and 3-month follow-up (week 12).

Eligibility
Key inclusion criteria
• Community dwelling adults aged 65 years and over
• Admitted with a fall or sustained a fall within the previous 6 months
• Has a carer(s) who either usually live(s) with them or visit(s) at least three times per week when at home
• Receiving inpatient rehabilitation under a Geriatric Medicine Consultant Physician
• Able to mobilise with or without a walking aid independently, with supervision or assistance of 1 person at the time of admission into the rehab facility/when is ready for the intervention program to commence
• Some difficulty in functional mobility identified (transfers, gait and balance)
• Cognitive screening: MoCA (Montreal Cognitive Assessment) <26/30 or RUDAS (Rowland Universal Dementia Assessment Scale) <27/30 (for CALD participants whose English is insufficient for MoCA)
• Informed consent obtained from participants and their carers (if applicable)
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Unstable medical conditions
• No regular carer(s)
• Impaired ability to engage in intervention: inability to comprehend or follow simple task instructions, acute confusional state (e.g. delirium), active depression or other psychiatric disorders, severe behavioural disturbances
• Gait disorders with known neurological causes, e.g. Parkinson's Disease, cerebellar ataxia, hemiparetic gait, etc.
• Residents at Aged Care facilities who receive high level care
• Cognitively intact people, i.e. MoCA >=26/30 or RUDAS >=27/30 (for CALD participants whose English is insufficient for MoCA)

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
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
There will be two groups in the project - intervention group and control group. The control group will receive usual care, which includes functional and gait training, fall prevention education, home assessment and hazard reduction, installation of equipment and modification as required. In addition to usual care, the participants in the intervention group and their carers will receive training on safe mobilisation strategies.
The control group will be recruited first and usual care will be provided with completion of additional study required outcome measures; recruitment of the intervention group will commence after control group is completed. As the same allied health staff will be treating both the intervention and the control groups, the design of this recruitment sequence is taken into consideration of the ethical perspective from the therapists and fidelity of usual care for the control group (i.e. additional strategies not to be applied in usual care).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The SPSS statistical software package will be used to analyse all of the data. Statistical analyses will provide descriptive data about the participants who participate in this study (gender, age, cognitive screening scores, and so forth). Risk of falls will be assessed among participants using the validated tools - Get Up & Go, 360 Degree Turn Test, Performance Oriented Mobility Assessment (POMA) (gait subscale), Canadian Occupational Performance Measure (COPM) (functional mobility item), Performance Assessment of Self-care Skills (PASS) (mobility items) at baseline (week 0), end of intervention (week 2) and 3 months follow up (week 12). The results will be reported as the mean±SD. This will inform a future larger study which will be randomised with adequate power to investigate change.
Qualitative data will be analysed based on the purpose-designed questionnaire and focus group discussions. Reflexive thematic analysis will be undertaken to analyse the responses and perceptions from participating allied health staff.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/10/2023
Actual
Date of last participant enrolment
Anticipated
15/01/2025
Actual
Date of last data collection
Anticipated
15/04/2025
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 25368 0
Wolper Jewish Hospital - Woollahra
Recruitment postcode(s) [1] 41097 0
2025 - Woollahra

Funding & Sponsors
Funding source category [1] 314547 0
University
Name [1] 314547 0
The University of Sydney (Academic Start-up Funding Scheme)
Country [1] 314547 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Faculty of Medicine and Health
The University of Sydney
Susan Wakil Health Building
Western Avenue
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 316526 0
None
Name [1] 316526 0
None
Address [1] 316526 0
None
Country [1] 316526 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313586 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 313586 0
Ethics committee country [1] 313586 0
Australia
Date submitted for ethics approval [1] 313586 0
28/07/2023
Approval date [1] 313586 0
13/10/2023
Ethics approval number [1] 313586 0

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

Contacts
Principal investigator
Name 128650 0
Dr Weihong Zhang
Address 128650 0
Sydney School of Health Sciences Faculty of Medicine and Health The University of SydneyLevel 7, Susan Wakil Health Building (D18)Western AvenueCamperdown NSW 2006
Country 128650 0
Australia
Phone 128650 0
+61 2 93519438
Fax 128650 0
Email 128650 0
[email protected]
Contact person for public queries
Name 128651 0
Weihong Zhang
Address 128651 0
Sydney School of Health Sciences Faculty of Medicine and Health The University of SydneyLevel 7, Susan Wakil Health Building (D18)Western AvenueCamperdown NSW 2006
Country 128651 0
Australia
Phone 128651 0
+61 2 93519438
Fax 128651 0
Email 128651 0
[email protected]
Contact person for scientific queries
Name 128652 0
Weihong Zhang
Address 128652 0
Sydney School of Health Sciences Faculty of Medicine and Health The University of SydneyLevel 7, Susan Wakil Health Building (D18)Western AvenueCamperdown NSW 2006
Country 128652 0
Australia
Phone 128652 0
+61 2 93519438
Fax 128652 0
Email 128652 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


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.