Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000658516
Ethics application status
Approved
Date submitted
30/04/2024
Date registered
22/05/2024
Date last updated
8/09/2024
Date data sharing statement initially provided
22/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
MOVE Together: Reduce falls.
Evaluating a program developed Together with people from culturally and linguistically diverse communities to support older people to MOVE better and Reduce Falls
Scientific title
Implementation of a co-designed program to increase tailored exercise to reduce falls in older people from culturally and linguistically diverse communities: a pilot feasibility trial.
Secondary ID [1] 312053 0
MRFF 2023755
Universal Trial Number (UTN)
Trial acronym
Linked study record
ACTRN12624000077561. This study (ACTRN12624000077561). co-designed the program being piloted as outlined in this record.

Health condition
Health condition(s) or problem(s) studied:
Older people at risk of falling 333643 0
Condition category
Condition code
Physical Medicine / Rehabilitation 330329 330329 0 0
Physiotherapy
Injuries and Accidents 330392 330392 0 0
Other injuries and accidents
Injuries and Accidents 330393 330393 0 0
Fractures
Musculoskeletal 330394 330394 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The MOVE Together: Reduce Falls program provides 10-12 individually tailored sessions, delivered by a physiotherapist, over 12-months to older people from culturally and linguistically diverse communities. The sessions will include:
- Prescription of an individually tailored exercise program, to be done with the participant in their home, with a focus on balance and functional exercises (e.g. Exercises which incorporate functional movements such as standing up from a chair).
- Behavior change strategies (e.g. goal setting and review, education, modelling of the behaviour, instruction, and social support) to support long term engagement.
Each physiotherapy session will run for 30-45min.
Sessions will generally take place in participants’ homes, either in-person via a home visit or via telehealth (video or phone call). Participants will also have the option to attend their sessions at a centre if this is their preference.
Information and education provided to participant via conversations that will be supported by infographics (pdf format) and animated videos regarding falls prevention and exercise in their preferred language. These resources have been codesigned with clinicians and older people from CALD communities specifically for this study.
Participants will also be asked to perform a regular home exercise program and offered the opportunity to take part in peer support sessions via zoom.

The following intervention elements will be tailored to the individual participant's need and personal preferences:
• Interpreters will be provided for physiotherapy sessions as needed
• Use, amount and mode of telehealth (telephone or videoconference) and support to use telehealth will be tailored to individual participants needs as guided by a physiotherapy telehealth suitability checklist.
• The home exercise program will be individually prescribed by the physiotherapist. Exercise type, dosage and intensity will be tailored to individual patient needs and preferences (e.g. health conditions, level of function, personal beliefs around exercise). Exercise type will consist of a combination of balance, strength and functional exercise. Examples include sit to stand, step ups, squats, single leg stance, dynamic balance tasks. Participants will be encouraged to exercise most days of the week (e.g 5 -7 days). Intensity will be at a level to provide sufficient challenge to improve balance and strength, while maintaining participant safety and considering other personal needs/ preferences (e.g. participant concerns around exercising). The program will support participants to achieve 3 hours exercise per week, however participants will start at a dosage appropriate for their current level of function. Exercises will be reviewed by the physiotherapist and progressed to ensure they continue to provide sufficient challenge. Note: The therapist can prescribe exercises for which videos and instructions are not already developed, in this situation they will provide individualised video/instruction as appropriate. Participants will have the option to record completion of the program in an exercise diary to track/ monitor progress if this is their preference. (Exercise diaries will be collected from all participants for a 2 week period at each assessment time point to monitor adherence).
• Mode of resources delivery used to support conversation topics and other information relevant to the study (e.g. via video, pdf, hard copy).
• The timing of 10-12 sessions over the 12-month period - however a suggested frequency is provided (including the first 5 sessions in the first 3 months (initially fortnightly); the second 5 sessions in the next 6 months (reducing frequency, monthly moving to bimonthly); two additional optional sessions can be used as ‘boosters’ to assist people reengage with the program if required (e.g. after an illness or absence) or address any other issues that arise.
• The order in which conversation topics are discussed with participants.
• The application of the 2 'Booster' sessions, these will be applied in discussion with the participants for the purpose of addressing individual issues impacting goal achievement.
• Attendance at optional monthly peer support sessions that will be conducted via zoom. Participants can choose to opt into these sessions.
• Behaviour change support will be tailored to respond to individualised barriers and enabler identified within physiotherapy sessions.
Intervention code [1] 328484 0
Behaviour
Intervention code [2] 328524 0
Treatment: Other
Comparator / control treatment
Participants will receive infographics and animated videos regarding falls prevention and exercise in their preferred language.
Participants will also be prescribed three to four exercises, selected by a physiotherapist which are suitable for their level of function and can be done safely on their own without further instruction. The physiotherapist will determine a suitable dosage which will vary depending on the exercise. Typically functional strengthening exercises will be performed 8 - 15 times, balance exercises for around 30 seconds to 1 min. Participants will be instructed to do these exercises most days of the week (e.g 5 days a week) and encouraged to do it for the duration of the study (i.e. 12 months).
Control group
Active

Outcomes
Primary outcome [1] 338088 0
Feasibility, guided by the framework of implementability proposed by Klaic et al (2022)
Timepoint [1] 338088 0
Surveys, based on Theoretical Framework of Acceptability Generic Questionnaire, and semi-structured interviews will be conducted at baseline, 6-months post baseline and 12-months post baseline (study conclusion).
The number of sessions delivered; mean attendance; attrition; and all protocol feasibility outcomes will be evaluated upon conclusion of the study.
Exercise related adverse events will also be monitored by the Data Safety Monitoring Board (DSMB). The DSMB will review and monitor all Serious Adverse Events throughout the trial. Adverse events will be formally evaluated for reporting at the conclusion of the study.”
Secondary outcome [1] 434468 0
Physical activity
Timepoint [1] 434468 0
Baseline, 6-months post baseline and 12-months post baseline (study conclusion).
Secondary outcome [2] 434469 0
Falls injuries.
Timepoint [2] 434469 0
Evaluated monthly for 12-months post baseline.
Secondary outcome [3] 434470 0
Quality of life
Timepoint [3] 434470 0
Baseline, 6-months post baseline and 12-months post baseline (study conclusion).
Secondary outcome [4] 434471 0
Physical function
Timepoint [4] 434471 0
Baseline, 6-months post baseline and 12-months post baseline (study conclusion).
Secondary outcome [5] 434472 0
Adverse events
Timepoint [5] 434472 0
12 months post baseline (at study conclusion).

Eligibility
Key inclusion criteria
• 65 years of age or over
• From Italian, Arabic speaking or Chinese communities.
• Deemed Intermediate or High risk of falls as per the Global Falls Guidelines
Algorithm.
• Living in the community (including living in a retirement village)
• Residing within 20 km of a Study Site.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Unable to walk 10 metres.
• Major cognitive impairment
• Unable to provide informed consent.
• Progressive neurological disorder (e.g. Parkinson’s Disease)
• Other medical issues which impacts ability to exercise.
• Currently doing three hours or more per week exercise,
• Currently doing regular (twice a week or more) balance and functional strength training.
• Currently attending a Falls and Balance Service, receiving Physiotherapy services for management of lower limb/ back conditions, or receiving Exercise Physiology Services. People attending these services will be eligible for inclusion once they have been discharged from these services providing they meet other criteria.
• Living in a residential care facility

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)
Central randomisation via REDCap
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block design stratified by community (Arabic speaking, Chinese or Italian) via REDCap.
Participants will have the option to enroll on their own or with a buddy. To ensure participants who enroll with their buddy are assigned to the same group, participants and ‘participant/ buddy’ dyads will each be considered as a cluster.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Quantitative feasibility data will be reported descriptively (i.e. proportions, means with 95% confidence intervals). The following criteria will determine whether the protocol is feasible and identify any modifications required prior to the definitive trial.
• Recruitment: > 5 participants per month. Rates at sites and strategies to support recruitment will be examined at monthly steering committee meetings, to inform recruitment plan for definitive trial.
• Retention: >70% of participants complete final assessments.
• Intervention session attendance: >70% of sessions attended.
• Safety: > 95% of intervention sessions delivered with no Serious Adverse Events determined by the independent adjudicator and Data Safety Monitoring Board as related or likely related to the intervention/trial.

Qualitative data from semi structured interviews will be analysed inductively and deductively using the Framework Method and applying an interpretivist paradigm.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
9/09/2024
Actual
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
60
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 316386 0
Government body
Name [1] 316386 0
Australian Government, Department of Health. National Health and Medical Research Council. Medical Research Future Fund Effective Therapies Grant
Country [1] 316386 0
Australia
Funding source category [2] 316390 0
Commercial sector/Industry
Name [2] 316390 0
Perpetual IMPACT Philanthropy Grant
Country [2] 316390 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Country
Australia
Secondary sponsor category [1] 318569 0
None
Name [1] 318569 0
Address [1] 318569 0
Country [1] 318569 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315192 0
The Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 315192 0
Ethics committee country [1] 315192 0
Australia
Date submitted for ethics approval [1] 315192 0
27/02/2024
Approval date [1] 315192 0
10/05/2024
Ethics approval number [1] 315192 0

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

Contacts
Principal investigator
Name 133946 0
Prof Catherine Said
Address 133946 0
WHCRE, Sunshine Hospital, 146 Furlong Rd St Albans VIC, 3021
Country 133946 0
Australia
Phone 133946 0
+61 478902963
Fax 133946 0
Email 133946 0
[email protected]
Contact person for public queries
Name 133947 0
Catherine Said
Address 133947 0
WHCRE, Sunshine Hospital, 146 Furlong Rd St Albans, VIC, 3021
Country 133947 0
Australia
Phone 133947 0
+61 478902963
Fax 133947 0
Email 133947 0
[email protected]
Contact person for scientific queries
Name 133948 0
Catherine Said
Address 133948 0
WHCRE, Sunshine Hospital, 146 Furlong Rd St Albans, VIC, 3021
Country 133948 0
Australia
Phone 133948 0
+61 478902963
Fax 133948 0
Email 133948 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?
Deidentified demographic (eg age, gender), clinical (eg history of falls) and outcome (eg IPAQ, falls,) data
When will data be available (start and end dates)?
Beginning 3 months post publication of the primary results, until 15 years
Available to whom?
Researchers who provide a methodologically sound proposal
Available for what types of analyses?
IPD meta analysis, related research
How or where can data be obtained?
Metadata will be available via Health Data Australia. Additional data can be obtained by contacting the Principal Investigator (Prof Catherine Said, [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.