Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000349145
Ethics application status
Approved
Date submitted
19/02/2019
Date registered
6/03/2019
Date last updated
6/03/2019
Date data sharing statement initially provided
6/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Ironbark Study: Healthy Ageing for older Aboriginal people
Scientific title
Preventing Falls in Older Aboriginal People through exercise and yarning circles: Ironbark trial
Secondary ID [1] 295286 0
Nil Known
Universal Trial Number (UTN)
U1111-1228-1513
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls 308467 0
Health related quality of life 308469 0
Healthy ageing 308470 0
Physical activity 308471 0
Functional mobility 310112 0
Central obesity 310113 0
Mental health 310114 0
Social and emotional wellbeing 310187 0
Condition category
Condition code
Public Health 307466 307466 0 0
Other public health
Injuries and Accidents 308863 308863 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ironbark: Standing Strong program
A total of 60 community based sites will be recruited into this study.

The 30 sites allocated the Standing Strong program will be supported to deliver a weekly class that runs for around 1.5 hours including 30 – 45 minutes of exercises, and 30 – 45 minutes of facilitated discussions by a trained worker. The program will run for the year, with additional weekly home exercise recommended.

An Aboriginal site manager will recruit and support participants to participate in the class. A locally employed program facilitator (a trained exercise physiologist or equivalent) will facilitate the 30 - 45 minute strength and balance class. The program facilitator will be trained by the research team to use the Ironbark: Standing Strong and Tall manual, developed in the pilot project and specifically adapted for the present trial. The Manual includes exercises based on the Otago Exercise Program, as well as other games and activities to challenge balance and cognitive skills. Exercises, games and activities include one leg balances, step ups and leg raises. The program facilitator will also develop an individualised program for each participant to practice at home. All equipment needed in the weekly classes (resistance bands, balance beam, foam balance mats, balance disks) is provided as a component of the trial.

The intervention group will also participate in a weekly 30 - 45 minute discussion around falls prevention, based on the Stepping On Program and adapted for Aboriginal community by the Ironbark pilot project. All program facilitators will receive training on the program, the manual and handouts for participants.

Classes will be held weekly for 12 months, at a locally accessible location to be identified by the participating site.

All handouts have been designed for the study.
Intervention code [1] 301626 0
Prevention
Intervention code [2] 301627 0
Lifestyle
Intervention code [3] 301628 0
Behaviour
Comparator / control treatment
Ironbark: Healthy Community program
The 30 sites allocated to the Healthy Community program will be supported to deliver weekly discussions (yarning circles) and activities for participants, focusing on issues identified by the community. An Aboriginal site manager will coordinate the group and receive training on group facilitation. The Ironbark: Healthy Community program will be developed, or sites randomised into this stream can choose to deliver their own program. Yarning circles will be held weekly for 1.5 hours per week, and will not including a regular exercise or falls prevention program. The program will run for 12 months.
Control group
Active

Outcomes
Primary outcome [1] 306416 0
Self-reported rate of falls. Falls data will be collected weekly by site managers who will ask participants about self-reported falls, health, frequency of home exercise and sleep. Site managers will telephone non-attendees at least monthly and ask about falls in the previous weeks. A fall is defined as "an event which results in a person coming to rest inadvertently on the ground or floor or other lower level". If falls are reported, further questions will be asked about fall-related injury and medical attention received. Falls data will be used to calculate falls per person-year and the proportion of people who fall in the 12 months following program commencement.
Timepoint [1] 306416 0
Collected over 12 month time period following randomisation
Secondary outcome [1] 348497 0
Health related quality of life, using the EURO QoL
Timepoint [1] 348497 0
Baseline and 12 months following randomisation
Secondary outcome [2] 348498 0
Physical activity; measured by the Incidental Planned Exercise Questionnaire
Timepoint [2] 348498 0
Baseline and 12 months following randomisation
Secondary outcome [3] 348499 0
Functional mobility measured by Activities of Daily Living tool
Timepoint [3] 348499 0
Baseline and 12 months following randomisation
Secondary outcome [4] 348500 0
Central obesity measured through the World Health Organization waist circumference protocol
Timepoint [4] 348500 0
Baseline and 12 months following randomisation
Secondary outcome [5] 354942 0
Standing balance: Short Physical Performance Battery Assessment (SPPB)
Timepoint [5] 354942 0
Baseline and 12 months following randomisation
Secondary outcome [6] 354943 0
Sit to Stand: Short Physical Performance Battery Assessment (SPPB)
Timepoint [6] 354943 0
Baseline and 12 months following randomisation
Secondary outcome [7] 354944 0
Gait speed: Short Physical Performance Battery Assessment (SPPB)
Timepoint [7] 354944 0
Baseline and 12 months following randomisation
Secondary outcome [8] 354948 0
Mental health: Psychological Distress (Kessler Psychological Distress Scale (Kessler-5))
Timepoint [8] 354948 0
Baseline and 12 months following randomisation
Secondary outcome [9] 354949 0
Social and Emotional Wellbeing (GROWTH AND EMPOWERMENT TOOL, GEM)
Timepoint [9] 354949 0
12 months following randomisation

Eligibility
Key inclusion criteria
Participants must be Aboriginal or Torres Strait Islander people 45 years and older;
live in a private dwelling or retirement village; willing to attend weekly meetings. There are no gender restrictions.
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria are inability to leave the house without physical assistance from another person; a progressive neurological disease; or a medical condition precluding exercise.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Group allocation will be undertaken by a statistician not involved in recruitment, once all participants at a site have been recruited and baseline measurements have been completed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Groups will be randomly allocated using minimisation to ensure the intervention and control groups are well matched for remoteness of location (urban, regional or remote) and whether groups were pre-existing.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Due to the nature of the intervention, neither participants nor program facilitators can be formally blinded to allocation. However, both the control and intervention groups will be presented to participants as ‘healthy ageing’ groups and the focus of the weekly discussions will be on healthy ageing broadly. Weekly questions about falls will be accompanied by questions about general health, frequency of home exercise and service use.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
To account for correlation among individuals within clusters, all statistical models will use a generalised estimating equations (GEE) approach with an exchangeable correlation structure. The number of falls per person-year will be analysed using negative binomial regression models to estimate the difference in rates between the groups after one year (primary outcome). For the continuously-scored primary and secondary outcome measures, linear regression will be used to assess the effect of group allocation, with corresponding baseline scores as a covariate. Log-binomial regression, or a robust Poisson regression in case of convergence issues, will be used to compare groups on dichotomous outcome measures (proportion of fallers, proportion meetings physical activity cut-points). Secondary analyses will be conducted by a statistician using the SAS software package.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2019
Actual
Date of last participant enrolment
Anticipated
4/01/2021
Actual
Date of last data collection
Anticipated
3/01/2022
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,WA

Funding & Sponsors
Funding source category [1] 299880 0
Government body
Name [1] 299880 0
NHMRC
Country [1] 299880 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
The George Institute for Global Health
Address
1 King Street
Newtown NSW 2042
Country
Australia
Secondary sponsor category [1] 301816 0
University
Name [1] 301816 0
UNSW
Address [1] 301816 0
UNSW Sydney 2052 NSW
Country [1] 301816 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300749 0
Aboriginal Health & Medical Research Council of NSW
Ethics committee address [1] 300749 0
Level 3, 66 Wentworth Ave Surry Hills, NSW, 2010
Ethics committee country [1] 300749 0
Australia
Date submitted for ethics approval [1] 300749 0
16/04/2018
Approval date [1] 300749 0
08/08/2018
Ethics approval number [1] 300749 0
1401/18
Ethics committee name [2] 300792 0
Aboriginal Health Research Ethics Committee South Australia
Ethics committee address [2] 300792 0
220 Franklin Street,
Adelaide, SA 5000
Ethics committee country [2] 300792 0
Australia
Date submitted for ethics approval [2] 300792 0
18/10/2018
Approval date [2] 300792 0
19/11/2018
Ethics approval number [2] 300792 0
04-08-790
Ethics committee name [3] 300794 0
Western Australian Aboriginal Health Ethics Committee
Ethics committee address [3] 300794 0
450 Beaufort Street
Highgate Western Australia 6003
Ethics committee country [3] 300794 0
Australia
Date submitted for ethics approval [3] 300794 0
11/02/2019
Approval date [3] 300794 0
Ethics approval number [3] 300794 0
Ethics committee name [4] 302168 0
UNSW Human Research Ethics Committee
Ethics committee address [4] 302168 0
UNSW Research Ethics & Compliance Support
The University of New South Wales
Sydney NSW 2052 Australia
Ethics committee country [4] 302168 0
Australia
Date submitted for ethics approval [4] 302168 0
06/09/2018
Approval date [4] 302168 0
15/11/2018
Ethics approval number [4] 302168 0
1401/18

Summary
Brief summary
The Ironbark Study is evaluating the effectiveness of a fall prevention program for older Aboriginal people (45 years and older), compared to a weekly elders group. Both arms of the trial involve an ongoing program delivered weekly by a local person, in a community setting. The Ironbark – Standing Strong program is a weekly exercise and discussion program aimed at preventing falls, and the Ironbark – Healthy Community program is a weekly program that involves discussions and social activities. The study design is a cluster randomised control trial and the 60 participating services across NSW, SA and WA are randomly assigned to either program. Services are required to recruit 10 - 15 eligible Aboriginal people, have strong connections with their local Aboriginal community, and have culturally appropriate venue and staff to deliver the program. Services will be supported through training and resources to implement either program. At the end of the trial, the control groups will have the opportunity to deliver the intervention program for a 6 month period, including all resources and equipment needed. It is anticipated that this trial will inform national policy and program delivery around falls prevention and healthy ageing among older Aboriginal people.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 84686 0
Prof Rebecca Ivers
Address 84686 0
School of Public Health and Community Medicine
UNSW
Kensington
NSW 1466
Country 84686 0
Australia
Phone 84686 0
61 414 726 975
Fax 84686 0
Email 84686 0
rebecca.ivers@unsw.edu.au
Contact person for public queries
Name 84687 0
Ms Sallie Cairnduff
Address 84687 0
School of Public Health and Community Medicine
UNSW
Kensington
NSW 1466
Country 84687 0
Australia
Phone 84687 0
61 2 9385 9137
Fax 84687 0
Email 84687 0
s.cairnduff@unsw.edu.au
Contact person for scientific queries
Name 84688 0
Prof Rebecca Ivers
Address 84688 0
School of Public Health and Community Medicine
UNSW
Kensington
NSW 1466
Country 84688 0
Australia
Phone 84688 0
61 414 726 975
Fax 84688 0
Email 84688 0
rebecca.ivers@unsw.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The data will be de-identified.


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
SourceTitleYear of PublicationDOI
EmbaseHealthy ageing among older Aboriginal people: the Ironbark study protocol for a cluster randomised controlled trial.2020https://dx.doi.org/10.1136/injuryprev-2020-043915
N.B. These documents automatically identified may not have been verified by the study sponsor.