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Open Access 01-12-2022 | Study protocol

Planning implementation and scale-up of physical activity interventions for people with walking difficulties: study protocol for the process evaluation of the ComeBACK trial

Authors: Siobhan Wong, Leanne Hassett, Harriet Koorts, Anne Grunseit, Allison Tong, Anne Tiedemann, Colin J. Greaves, Abby Haynes, Andrew Milat, Lisa A. Harvey, Nicholas F. Taylor, Rana S. Hinman, Marina De Barros Pinherio, Matthew Jennings, Daniel Treacy, Sandra O’Rourke, Courtney West, Elizabeth Ramsay, Catherine Kirkham, Claire Morris, Catherine Sherrington

Published in: Trials | Issue 1/2022

Abstract

Background

There is currently little evidence of planning for real-world implementation of physical activity interventions. We are undertaking the ComeBACK (Coaching and Exercise for Better Walking) study, a 3-arm hybrid Type 1 randomised controlled trial evaluating a health coaching intervention and a text messaging intervention. We used an implementation planning framework, the PRACTical planning for Implementation and Scale-up (PRACTIS), to guide the process evaluation for the trial. The aim of this paper is to describe the protocol for the process evaluation of the ComeBACK trial using the framework of the PRACTIS guide.

Methods

A mixed methods process evaluation protocol was developed informed by the Medical Research Council (MRC) guidance on process evaluations for complex interventions and the PRACTIS guide. Quantitative data, including participant questionnaires, health coach and administrative logbooks, and website and text message usage data, is being collected over the trial period. Semi-structured interviews and focus groups with trial participants, health coaches and health service stakeholders will explore expectations, factors influencing the delivery of the ComeBACK interventions and potential scalability within existing health services. These data will be mapped against the steps of the PRACTIS guide, with reporting at the level of the individual, provider, organisational and community/systems. Quantitative and qualitative data will elicit potential contextual barriers and facilitators to implementation and scale-up. Quantitative data will be reported descriptively, and qualitative data analysed thematically.

Discussion

This process evaluation integrates an evaluation of prospective implementation and scale-up. It is envisaged this will inform barriers and enablers to future delivery, implementation and scale-up of physical activity interventions. To our knowledge, this is the first paper to describe the application of PRACTIS to guide the process evaluation of physical activity interventions.

Trial registration

Australian and New Zealand Clinical Trials Registry (ANZCTR) Registration date: 10/12/2018.

Available only for authorised users

Bull FC, Al-Ansari SS, Biddle S, Borodulin K, Buman MP, Cardon G, et al. World Health Organization 2020 guidelines on physical activity and sedentary behaviour. Br J Sports Med. 2020;54(24):1451–62. https://doi.org/10.1136/bjsports-2020-102955.CrossRefPubMed

Guthold R, Stevens GA, Riley LM, Bull FC. Worldwide trends in insufficient physical activity from 2001 to 2016: a pooled analysis of 358 population-based surveys with 1·9 million participants. Lancet Glob Health. 2018;6(10):e1077–86. https://doi.org/10.1016/S2214-109X(18)30357-7.CrossRefPubMed

Hassett L, Shields N, Cole J, Owen K, Sherrington C. Comparisons of leisure-time physical activity participation by adults with and without a disability: results of an Australian cross-sectional national survey. BMJ Open Sport Exerc Med. 2021;7(1):e000991.CrossRefPubMedPubMedCentral

Hollis ND, Zhang QC, Cyrus AC, Courtney-Long E, Watson K, Carroll DD. Physical activity types among US adults with mobility disability, Behavioral Risk Factor Surveillance System, 2017. Disabil Health J. 2020;13(3):100888. https://doi.org/10.1016/j.dhjo.2020.100888.CrossRefPubMedPubMedCentral

Martin Ginis KA, Ma JK, Latimer-Cheung AE, Rimmer JH. A systematic review of review articles addressing factors related to physical activity participation among children and adults with physical disabilities. Health Psychol Rev. 2016;10(4):478–94. https://doi.org/10.1080/17437199.2016.1198240.CrossRefPubMed

Letts L, Martin Ginis KA, Faulkner G, Colquhoun H, Levac D, Gorczynski P. Preferred methods and messengers for delivering physical activity information to people with spinal cord injury: a focus group study. Rehabil Psychol. 2011;56(2):128–37. https://doi.org/10.1037/a0023624.CrossRefPubMed

West K, Purcell K, Haynes A, Taylor J, Hassett L. Sherrington C: “People associate us with movement so it’s an awesome opportunity”: perspectives from physiotherapists on promoting physical activity, exercise and sport. Int J Environ Res Public Health. 2021;18(6):2963. https://doi.org/10.3390/ijerph18062963.CrossRefPubMedPubMedCentral

Rutter HD, Savona NP, Glonti KM, Bibby JP, Cummins SP, Finegood DTP, et al. The need for a complex systems model of evidence for public health. Lancet (British edition). 2017;390(10112):2602–4. https://doi.org/10.1016/S0140-6736(17)31267-9.CrossRef

Reis RS, Salvo D, Ogilvie D, Lambert EV, Goenka S, Brownson RC. Scaling up physical activity interventions worldwide: stepping up to larger and smarter approaches to get people moving. Lancet. 2016;388(10051):1337–48. https://doi.org/10.1016/S0140-6736(16)30728-0.CrossRefPubMedPubMedCentral

10.

Lee K, Ding D, Grunseit A, Wolfenden L, Milat A Bauman A. Many Papers but Limited Policy Impact? A Bibliometric Review of Physical Activity Research, Translational Journal of the ACSM: Fall. 2021;6(Issue 4):e000167. https://doi.org/10.1249/TJX.0000000000000167.

11.

Milat AJ, Bauman AE, Redman S, Curac N. Public health research outputs from efficacy to dissemination: a bibliometric analysis. BMC Public Health. 2011;11(1):934. https://doi.org/10.1186/1471-2458-11-934.CrossRefPubMedPubMedCentral

12.

Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012;50(3):217–26. https://doi.org/10.1097/MLR.0b013e3182408812.CrossRefPubMedPubMedCentral

13.

Landes SJ, McBain SA, Curran GM. An introduction to effectiveness-implementation hybrid designs. Psychiatry Res. 2019;280:112513. https://doi.org/10.1016/j.psychres.2019.112513.CrossRefPubMedPubMedCentral

14.

Moore GF, Audrey S, Barker M, Bond L, Bonell C, Hardeman W, et al. Process evaluation of complex interventions: Medical Research Council guidance. BMJ : Br Med J. 2015;350. https://doi.org/10.1136/bmj.h1258.

15.

Koorts H, Eakin E, Estabrooks P, Timperio A, Salmon J, Bauman A. Implementation and scale up of population physical activity interventions for clinical and community settings: the PRACTIS guide. Int J Behav Nutr Phys Act. 2018;15(1):51. https://doi.org/10.1186/s12966-018-0678-0.CrossRefPubMedPubMedCentral

16.

Hassett L, Tiedemann A, Hinman RS, Crotty M, Hoffmann T, Harvey L, et al. Physical activity coaching for adults with mobility limitations: protocol for the ComeBACK pragmatic hybrid effectiveness-implementation type 1 randomised controlled trial. BMJ Open. 2020;10(11):e034696. https://doi.org/10.1136/bmjopen-2019-034696.CrossRefPubMedPubMedCentral

17.

Australia’s Physical Activity and Sedentary Behaviour Guidelines and the Australian 24-Hour Movement Guidelines. 2014. [https://www.health.gov.au/health-topics/physical-activity-and-exercise/physical-activity-and-exercise-guidelines-forall-australians?utm_source=health.gov.au&utm_medium=callout-autocustom&utm_campaign=digital_transformation].

18.

Michie S, van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci. 2011;6(1):42. https://doi.org/10.1186/1748-5908-6-42.CrossRefPubMedPubMedCentral

19.

Deci EL, Ryan RM. Self-determination theory: a macrotheory of human motivation, development, and health. Can Psychol/Psychol Can. 2008;49(3):182–5. https://doi.org/10.1037/a0012801.CrossRef

20.

Bandura A. Social foundations of thought and action: a social cognitive theory. Englewood Cliffs, N.J.: Prentice-Hall; 1986.

21.

Kanfer FH, Gaelick-Buys L. Self-management methods. In: Kanfer FH, Goldstein AP, editors. Helping people change: a textbook of methods edn. New York: Pergamon Press; 1991. p. 305–60.

22.

Tiedemann A, Rissel C, Howard K, Tong A, Merom D, Smith S, et al. Health coaching and pedometers to enhance physical activity and prevent falls in community-dwelling people aged 60 years and over: study protocol for the Coaching for Healthy AGEing (CHAnGE) cluster randomised controlled trial. BMJ Open. 2016;6(5):e012277. https://doi.org/10.1136/bmjopen-2016-012277.CrossRefPubMedPubMedCentral

23.

Haynes A, Sherrington C, Wallbank G, Lester D, Tong A, Merom D, et al. “Someone’s got my back”: older people’s experience of the coaching for healthy ageing program for promoting physical activity and preventing falls. J Aging Phys Act. 2020;29(2):1–12. https://doi.org/10.1123/japa.2020-0116.CrossRef

24.

Hamilton C, McCluskey A, Hassett L, Killington M, Lovarini M. Patient and therapist experiences of using affordable feedback-based technology in rehabilitation: a qualitative study nested in a randomized controlled trial. Clin Rehabil. 2018;32(9):1258–70. https://doi.org/10.1177/0269215518771820.CrossRefPubMed

25.

Palinkas LA, Horwitz SM, Green CA, Wisdom JP, Duan N, Hoagwood K. Purposeful sampling for qualitative data collection and analysis in mixed method implementation research. Adm Policy Ment Health. 2015;42(5):533–44. https://doi.org/10.1007/s10488-013-0528-y.CrossRefPubMedPubMedCentral

26.

Saunders B, Sim J, Kingstone T, Baker S, Waterfield J, Bartlam B, et al. Saturation in qualitative research: exploring its conceptualization and operationalization. Qual Quant. 2018;52(4):1893–907. https://doi.org/10.1007/s11135-017-0574-8.CrossRefPubMed

27.

Kendzierski D, DeCarlo KJ. Physical activity enjoyment scale: Two validation studies. J Sport Exerc Physiol. 1991;13(1):50–64. https://doi.org/10.1123/jsep.13.1.50.CrossRef

28.

Horvath AO, Greenberg LS. Development and validation of the Working Alliance Inventory. J Couns Psychol. 1989;36(2):223–33. https://doi.org/10.1037/0022-0167.36.2.223.CrossRef

29.

Michie S, Ashford S, Sniehotta FF, Dombrowski SU, Bishop A, French DP. A refined taxonomy of behaviour change techniques to help people change their physical activity and healthy eating behaviours: the CALO-RE taxonomy. Psychol Health. 2011;26(11):1479–98. https://doi.org/10.1080/08870446.2010.540664.CrossRefPubMed

30.

Stirman SW, Gamarra J, Bartlett B, Calloway A, Gutner C. Empirical examinations of modifications and adaptations to evidence-based psychotherapies: methodologies, impact, and future directions. Clin Psychol (New York). 2017;24(4):396–420. https://doi.org/10.1111/cpsp.12218.CrossRef

31.

Wiltsey Stirman S, Baumann AA, Miller CJ. The FRAME: an expanded framework for reporting adaptations and modifications to evidence-based interventions. Implement Sci. 2019;14(1):58. https://doi.org/10.1186/s13012-019-0898-y.CrossRefPubMedPubMedCentral

32.

Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)—a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377–81. https://doi.org/10.1016/j.jbi.2008.08.010.CrossRefPubMed

33.

Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol. 2006;3(2):77–101. https://doi.org/10.1191/1478088706qp063oa.CrossRef

34.

Doyle L, Brady A-M, Byrne G. An overview of mixed methods research – revisited. J Res Nurs. 2016;21(8):623–35. https://doi.org/10.1177/1744987116674257.CrossRef

Title: Planning implementation and scale-up of physical activity interventions for people with walking difficulties: study protocol for the process evaluation of the ComeBACK trial
Authors: Siobhan Wong
Leanne Hassett
Harriet Koorts
Anne Grunseit
Allison Tong
Anne Tiedemann
Colin J. Greaves
Abby Haynes
Andrew Milat
Lisa A. Harvey
Nicholas F. Taylor
Rana S. Hinman
Marina De Barros Pinherio
Matthew Jennings
Daniel Treacy
Sandra O’Rourke
Courtney West
Elizabeth Ramsay
Catherine Kirkham
Claire Morris
Catherine Sherrington
Publication date: 01-12-2022
Publisher: BioMed Central
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-021-05990-3

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Planning implementation and scale-up of physical activity interventions for people with walking difficulties: study protocol for the process evaluation of the ComeBACK trial

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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