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Physical activity coaching for adults with mobility limitations: protocol for the ComeBACK pragmatic hybrid effectiveness-implementation type 1 randomised controlled trial

journal contribution
posted on 02.12.2020, 20:28 by L Hassett, A Tiedemann, RS Hinman, M Crotty, T Hoffmann, L Harvey, Nicholas Taylor, C Greaves, D Treacy, M Jennings, A Milat, KL Bennell, K Howard, M Van Den Berg, M Pinheiro, S Wong, C Kirkham, E Ramsay, S O'Rourke, C Sherrington
© Introduction Mobility limitation is common and often results from neurological and musculoskeletal health conditions, ageing and/or physical inactivity. In consultation with consumers, clinicians and policymakers, we have developed two affordable and scalable intervention packages designed to enhance physical activity for adults with self-reported mobility limitations. Both are based on behaviour change theories and involve tailored advice from physiotherapists. Methods and analysis This pragmatic hybrid effectiveness-implementation type 1 randomised control trial (n=600) will be undertaken among adults with self-reported mobility limitations. It aims to estimate the effects on physical activity of: (1) an enhanced 6-month intervention package (one face-to-face physiotherapy assessment, tailored physical activity plan, physical activity phone coaching from a physiotherapist, informational/motivational resources and activity monitors) compared with a less intensive 6-month intervention package (single session of tailored phone advice from a physiotherapist, tailored physical activity plan, unidirectional text messages, informational/motivational resources); (2) the enhanced intervention package compared with no intervention (6-month waiting list control group); and (3) the less intensive intervention package compared with no intervention (waiting list control group). The primary outcome will be average steps per day, measured with the StepWatch Activity Monitor over a 1-week period, 6 months after randomisation. Secondary outcomes include other physical activity measures, measures of health and functioning, individualised mobility goal attainment, mental well-being, quality of life, rate of falls, health utilisation and intervention evaluation. The hybrid effectiveness-implementation design (type 1) will be used to enable the collection of secondary implementation outcomes at the same time as the primary effectiveness outcome. An economic analysis will estimate the cost-effectiveness and cost-utility of the interventions compared with no intervention and to each other. Ethics and dissemination Ethical approval has been obtained by Sydney Local Health District, Royal Prince Alfred Zone. Dissemination will be via publications, conferences, newsletters, talks and meetings with health managers. Trial registration number ACTRN12618001983291.

Funding

This work is supported by a project grant from the Australian National Health and Medical Research Council (APP 1145739). Authors LH, AT, RSH and CS receive salary funding from the Australian National Health and Medical Research Council Fellowship.

History

School

  • School of Allied Health

Publication Date

03/11/2020

Journal

BMJ Open

Volume

10

Issue

11

Article Number

e034696

Pagination

13p. (p. 1-13)

Publisher

BMJ Group

ISSN

2044-6055

Rights Statement

The Author reserves all moral rights over the deposited text and must be credited if any re-use occurs. Documents deposited in OPAL are the Open Access versions of outputs published elsewhere. Changes resulting from the publishing process may therefore not be reflected in this document. The final published version may be obtained via the publisher’s DOI. Please note that additional copyright and access restrictions may apply to the published version.

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