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Protocol
Healthy ageing among older Aboriginal people: the Ironbark study protocol for a cluster randomised controlled trial
  1. Rebecca Ivers1,2,
  2. Julieann Coombes2,
  3. Catherine Sherrington3,
  4. Tamara Mackean2,4,
  5. Anne Tiedemann3,
  6. Anne-Marie Hill5,
  7. Lisa Keay2,6,
  8. Lindy Clemson7,
  9. Judy Simpson8,
  10. Courtney Ryder2,4,
  11. Rona Macniven1,9,
  12. Kathleen Clapham10
  13. On behalf of the Ironbark Study Collaborators
    1. 1 School of Population Health, University of New South Wales, Sydney, New South Wales, Australia
    2. 2 The George Institute for Global Health, University of New South Wales, Sydney, New South Wales, Australia
    3. 3 Institute for Musculoskeletal Health, School of Public Health, The University of Sydney and Sydney Local Health District, Sydney, Australia, Sydney, New South Wales, Australia
    4. 4 Southgate Institute for Health, Society, and Equity, Flinders University, Adelaide, South Australia, Australia
    5. 5 School of Physiotherapy and Exercise Science, Curtin University, Perth, Western Australia, Australia
    6. 6 School of Optometry and Vision Science, University of New South Wales, Sydney, New South Wales, Australia
    7. 7 Faculty of Health Sciences, The University of Sydney, Sydney, New South Wales, Australia
    8. 8 School of Public Health, The University of Sydney, Sydney, New South Wales, Australia
    9. 9 Poche Centre for Indigenous Health, The University of Sydney, Sydney, New South Wales, Australia
    10. 10 Ngarruwan Ngadju First Peoples Health and Wellbeing Research Centre, Australian Health Services Research Institute, The University of Wollongong, Wollongong, New South Wales, Australia
    1. Correspondence to Professor Rebecca Ivers, School of Population Health, The University of NSW, Sydney, NSW 2052, Australia; rebecca.ivers{at}unsw.edu.au

    Abstract

    Introduction Older Aboriginal people have a strong leadership role in their community including passing on knowledge and teachings around culture and connections to Country. Falls significantly affect older people and are a growing concern for older Aboriginal people and their families. Regular participation in balance and strength exercise has been shown to be efficacious in reducing falls. A pilot study developed in partnership with Aboriginal communities, the Ironbark: Standing Strong and Tall programme, demonstrated high community acceptability and feasibility, and gains in balance and strength in Aboriginal participants. This cluster randomised controlled trial will assess the effectiveness of the programme in reducing the rate of falls in older Aboriginal people.

    Methods We will examine the effectiveness and cost-effectiveness of the Ironbark group-based fall prevention programme compared with a group-based social programme, with Aboriginal people aged 45 years and older in three Australian states. The primary outcome is fall rates over 12 months, measured using weekly self-reported data. Secondary outcomes measured at baseline and after 12 months include quality of life, psychological distress, activities of daily living, physical activity, functional mobility and central obesity. Differences between study groups in the primary and secondary outcomes at 12 months will be estimated.

    Conclusion This is the first trial to investigate the effectiveness and cost-effectiveness of a fall prevention programme for Aboriginal peoples aged ≥45 years. The study has strong cultural and community governance, including Aboriginal investigators and staff, and is guided by a steering committee that includes representatives of Aboriginal community-controlled services.

    Trial registration number ACTRN12619000349145.

    • fall
    • program evaluation
    • older people
    • indigenous
    • clustered analyses
    • economic analysis

    https://doi.org/10.1136/injuryprev-2020-043915

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      Footnotes

      • Twitter @rebeccaivers, @kathleenclapham

      • Collaborators Ironbark study collaborators: The following are members of the Ironbark study collaborator group: Robert Cumming, Kate Hunter, Kris Rogers, Marion Kickett, Anne-Marie Eades, Stephen Jan, Kirsten Howard, Josephine Gwynn, Kim Delbaere, Aaron Simon, Roland Wilson, Tracey Ma, Adam Howie, Carolyn Lewis, Georgia Stewart, Sallie Cairnduff.

      • Contributors RI and RM led the writing of this paper. Study investigators (CS, AT, A-MH, KC, LC, LK, TM and CR) had overall responsibility for the conception of this study with scientific input, including expertise in the development of the statistical analysis (JS). JC contributed expertise to the study operational development and conception of this study. All authors contributed to the writing of this paper and approved the final draft.

      • Funding This work was supported by the Australian National Health and Medical Research Council grant number (NMHRC Project grant No. 1143085).

      • Competing interests None declared.

      • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

      • Patient consent for publication Not required.

      • Ethics approval Ethical approval has been obtained from the Aboriginal Health and Medical Research Council Ethics Committee (NSW) (140118), the Aboriginal Health Research Ethics Committee of South Australia (418790), the Western Australian Aboriginal Health Ethics Committee (962), the Southern Adelaide Clinical Human Research Ethics Committee (HREC/19/SAC/65) and Curtin University (HRE2020-0069) through the National Mutual Acceptance of ethical and scientific review for multicentre human research projects conducted in public health organisations. These ethics approvals have been noted by the University of New South Wales.

      • Provenance and peer review Not commissioned; externally peer reviewed.