Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000077561
Ethics application status
Approved
Date submitted
26/04/2023
Date registered
30/01/2024
Date last updated
30/01/2024
Date data sharing statement initially provided
30/01/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Co-designing an exercise and fall prevention program for older people from culturally and lingistically diverse backgrounds
Scientific title
Co-designing and a preliminary exploration of the acceptability of an exercise and fall prevention program for older people from culturally and linguistically diverse backgrounds
Secondary ID [1] 308654 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls 328574 0
Condition category
Condition code
Injuries and Accidents 325588 325588 0 0
Other injuries and accidents
Musculoskeletal 325589 325589 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 325678 325678 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We are using an Integrated Knowledge Translation approach with 5 stages to develop an exercise program to increase sustained engagement with tailored exercise to reduce falls in older people (aged 65 years and older) from culturally and linguistically diverse (CALD) communities. The program will be co-designed with key stakeholders and will identify and address the enablers and barriers to exercise for falls prevention for older people from CALD communities. The intervention will be based on existing evidence and incorporates the following:
- individually tailored, progressive exercise including balance and functional training.
- targeted towards people living in the community.
- include behaviour change strategies to support long term engagement.
- deliverable via a combination of telehealth, individual in-home sessions, and community-based group sessions.
Stages 1, 3 and 5 are completed by the research team, which includes researchers, clinicians who work with older people from CALD communities (geriatricians, physiotherapists), representatives from organisations that work with people from CALD communities and older people from CALD communities.
Stages 2 and 4 involve recruitment of participants, who include older people from Italian, Arabic speaking and Chinese communities, care givers for people from these communities, health care workers & service providers for these communities and policy makers.
Stage 1: Research team designs specific of research, including specific question and approach. This involves 3 workshops conducted via zoom.
Stage 2: Five to seven workshops with approximately 50-70 older people/ caregivers, conducted in person. Led by an experienced facilitator and supported by Interpreters and bicultural workers.
Three to four workshops with health care workers/service providers/ policy makers. Conducted either via zoom or in person. Workshops will run for 2 to 2.5 hours.
Seeding questions for workshops were developed and informed by the Theoretical Domains Framework and designed to explore important domains that impact behaviour change.
Stage 3: The research team maps findings from Stage 2 to the taxonomy of behavior change techniques to identify solutions to incorporate into the intervention. The intervention will also be mapped to the TIDierR Checklist. This will be done over two to three workshops.
Stage 4a. The intervention prototype will be presented to participants for review and feedback over 2 to 4 workshops. Based on the feedback, the research team will determine what adaptations are required before being tested by participants
Stage 4b- Eight to ten older adults will be recruited to trial one to two individual (i.e. 1:1) sessions. The sessions will be delivered to each participant by one of two physiotherapists.
While the actual session length will be determined through the co-design process, we anticipate it will take 45 minutes to an hour.
Participants will complete a semi structured interview (30 – 45 minutes) or participate in a small focus group depending on their personal preference, to collect quantitative and qualitative data on components of implementability, including acceptability, fidelity and feasibility of the intervention. As we are only trialling one to two sessions, we will not be assessing adherence; this will be evaluated in subsequent trials
Stage 5: Stage 4 workshop summaries and interview feedback will be reviewed by the research team. A modified nominal group technique will be used to priorities and achieve consensus on the final design of the intervention
Intervention code [1] 325138 0
Prevention
Intervention code [2] 325139 0
Treatment: Other
Intervention code [3] 325140 0
Lifestyle
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333445 0
Preliminary evaluation of ‘implementabilty’ of the interventions a composite outcome: acceptability, fidelity and feasibility
- semi-structured interviews or focus groups (maximum of 4 participants) will be conducted, depending on the personal preferences of the participant, to identify adaptations/enhancements to the intervention. This will be conducted by a member of the research team using a question guide and audio recorded.
Timepoint [1] 333445 0
After completion of the final session
Secondary outcome [1] 417131 0
Evaluation of the experiences, cost and time required of the co-design process. Data will be collected via WE-ENACT surveys (workshop participants), records of research team hours and hourly rates and all costs associated with the project.
Timepoint [1] 417131 0
Experiences of the co-design process will be evaluated at the end of each workshop in Stages 2 and 4.
Evaluation of cost and time will be evaluated at the end of Stage 5. Records of cost and time will be kept throughout the project

Eligibility
Key inclusion criteria
Older adults from Italian, Arab speaking or Chinese (Mandarin or Cantonese speaking) communities who are at risk of falls, defined as:
- Having had a fall in the last 12 months; and/or
- Are worried about falling; and/or
- Are unsteady while walking or standing
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Unable to provide informed consent.
• Unable to actively and effectively participate in 1 – 2 sessions delivered by a physiotherapist, either in their home, via telehealth or in community-based group sessions.

Study design
Purpose of the study
Prevention
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
Qualitative data from semi-structured interviews with participants who tested the intervention will be analysed deductively using a theory-informed approach. Existing theoretical definitions and frameworks will be used for the two concepts – acceptability and fidelity. Acceptability – will be defined according to the Theoretical Framework of Acceptability which has seven constructs: affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness, and self-efficacy. Factors which moderate fidelity will be drawn from Carrol et al (2007) who propose consideration of factors such as: participant responsiveness, intervention complexity, strategies to facilitate implementation, quality of delivery, recruitment and context. Methodological considerations for managing and interpreting cross-cultural and cross-language data will be incorporated into the analytical approach.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
7/06/2023
Date of last participant enrolment
Anticipated
30/04/2024
Actual
Date of last data collection
Anticipated
31/05/2024
Actual
Sample size
Target
90
Accrual to date
69
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 23754 0
Royal Melbourne Hospital - Royal Park campus - Parkville
Recruitment hospital [2] 23755 0
Sunshine Hospital - St Albans
Recruitment hospital [3] 23793 0
Footscray Hospital - Footscray
Recruitment hospital [4] 23794 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [5] 23795 0
Williamstown Hospital - Williamstown
Recruitment hospital [6] 23796 0
The University of Melbourne - Parkville
Recruitment postcode(s) [1] 39199 0
3052 - Parkville
Recruitment postcode(s) [2] 39200 0
3021 - St Albans
Recruitment postcode(s) [3] 39242 0
3011 - Footscray
Recruitment postcode(s) [4] 39243 0
3016 - Williamstown
Recruitment postcode(s) [5] 39244 0
3011 - Seddon

Funding & Sponsors
Funding source category [1] 312888 0
Government body
Name [1] 312888 0
Australian Government Department of Health and Aged Care, Medical Research Future Fund (MRFF)
Country [1] 312888 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Parkville VIC 3010
Country
Australia
Secondary sponsor category [1] 314565 0
None
Name [1] 314565 0
Address [1] 314565 0
Country [1] 314565 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312165 0
Royal Melbourne Hospital Human Research Ethics Committee
Ethics committee address [1] 312165 0
Ethics committee country [1] 312165 0
Australia
Date submitted for ethics approval [1] 312165 0
29/11/2022
Approval date [1] 312165 0
02/03/2023
Ethics approval number [1] 312165 0
HREC/88727/MH-2022

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

Contacts
Principal investigator
Name 123702 0
A/Prof Catherine Said
Address 123702 0
Western Center for Health Research and Education (Sunshine Hosp), Furlong RdSt Albans VIC 3021
Country 123702 0
Australia
Phone 123702 0
+61 0409233362
Fax 123702 0
Email 123702 0
[email protected]
Contact person for public queries
Name 123703 0
Catherine Said
Address 123703 0
Western Center for Health Research and Education (Sunshine Hosp), Furlong RdSt Albans VIC 3021
Country 123703 0
Australia
Phone 123703 0
+61 0409233362
Fax 123703 0
Email 123703 0
[email protected]
Contact person for scientific queries
Name 123704 0
Catherine Said
Address 123704 0
Western Center for Health Research and Education (Sunshine Hosp), Furlong RdSt Albans VIC 3021
Country 123704 0
Australia
Phone 123704 0
+61 0409233362
Fax 123704 0
Email 123704 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
Participant data may contain identifying or sensitive information. This information will not be available to protect participant privacy.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17928Study protocol  [email protected] Directly from the Principal Investigator



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.