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  • Self-management intervention to reduce pulmonary exacerbations by supporting treatment adherence in adults with cystic fibrosis: a randomised controlled trial

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Cystic fibrosis
Original research
Self-management intervention to reduce pulmonary exacerbations by supporting treatment adherence in adults with cystic fibrosis: a randomised controlled trial
  1. Martin J Wildman1,2,
  2. Alicia O’Cathain2,
  3. Chin Maguire3,
  4. Madelynne A Arden4,
  5. Marlene Hutchings1,
  6. Judy Bradley5,
  7. Stephen J Walters2,
  8. Pauline Whelan6,
  9. John Ainsworth6,
  10. Iain Buchan6,7,
  11. Laura Mandefield2,
  12. Laura Sutton2,
  13. Paul Tappenden2,
  14. Rachel A Elliott8,
  15. Zhe Hui Hoo1,2,
  16. Sarah J Drabble2,
  17. Daniel Beever3
  18. CFHealthHub Study Team
    1. 1 Sheffield Adult Cystic Fibrosis Centre, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK
    2. 2 School of Health and Related Research, University of Sheffield, Sheffield, UK
    3. 3 Clinical Trials Research Unit, University of Sheffield, Sheffield, UK
    4. 4 Centre for Behavioural Science and Applied Psychology, Sheffield Hallam University, Sheffield, UK
    5. 5 Wellcome-Wolfson Institute for Experimental Medicine, School of Medicine Dentistry and Biomedical Sciences, Queen's University Belfast, Belfast, UK
    6. 6 Health eResearch Centre – Division of Imaging, Informatics and Data Sciences, Faculty of Biology, Medicine and Health, The University of Manchester School of Health Sciences, Manchester, UK
    7. 7 Department of Public Health and Policy, Institute of Population Health, University of Liverpool, Liverpool, UK
    8. 8 Division of Population Health, Health Services Research and Primary Care, Faculty of Biology, Medicine and Health, The University of Manchester School of Health Sciences, Manchester, UK
    1. Correspondence to Dr Martin J Wildman, Sheffield Adult Cystic Fibrosis Centre, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK; martin.wildman3{at}nhs.net

    Abstract

    Introduction Recurrent pulmonary exacerbations lead to progressive lung damage in cystic fibrosis (CF). Inhaled medications (mucoactive agents and antibiotics) help prevent exacerbations, but objectively measured adherence is low. We investigated whether a multi-component (complex) self-management intervention to support adherence would reduce exacerbation rates over 12 months.

    Methods Between October 2017 and May 2018, adults with CF (aged ≥16 years; 19 UK centres) were randomised to the intervention (data-logging nebulisers, a digital platform and behavioural change sessions with trained clinical interventionists) or usual care (data-logging nebulisers). Outcomes included pulmonary exacerbations (primary outcome), objectively measured adherence, body mass index (BMI), lung function (FEV1) and Cystic Fibrosis Questionnaire-Revised (CFQ-R). Analyses were by intent to treat over 12 months.

    Results Among intervention (n=304) and usual care (n=303) participants (51% female, median age 31 years), 88% completed 12-month follow-up. Mean exacerbation rate was 1.63/year with intervention and 1.77/year with usual care (adjusted ratio 0.96; 95% CI 0.83 to 1.12; p=0.64). Adjusted mean differences (95% CI) were in favour of the intervention versus usual care for objectively measured adherence (9.5% (8.6% to 10.4%)) and BMI (0.3 (0.1 to 0.6) kg/m2), with no difference for %FEV1 (1.4 (−0.2 to 3.0)). Seven CFQ-R subscales showed no between-group difference, but treatment burden reduced for the intervention (3.9 (1.2 to 6.7) points). No intervention-related serious adverse events occurred.

    Conclusions While pulmonary exacerbations and FEV1 did not show statistically significant differences, the intervention achieved higher objectively measured adherence versus usual care. The adherence difference might be inadequate to influence exacerbations, though higher BMI and lower perceived CF treatment burden were observed.

    • cystic fibrosis
    • psychology
    • nebuliser therapy

    Data availability statement

    Data are available on reasonable request. Requests for patient level data and statistical code should be made to the corresponding author and will be considered by members of the original trial management group, including the chief investigators and members of clinical trials research unit, who will release data on a case-by-case basis. Data will be shared following the principles for sharing patient level data as described by Tudur Smith C, et al BMC Medicine 2015;13:298 (https://doi.org/10.1186/s12916-015-0532-z). The data will not contain any direct identifiers, and we will minimise indirect identifiers and remove free-text data to minimise the risk of identification.

    https://creativecommons.org/licenses/by/4.0/

    This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

    https://doi.org/10.1136/thoraxjnl-2021-217594

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      Data availability statement

      Data are available on reasonable request. Requests for patient level data and statistical code should be made to the corresponding author and will be considered by members of the original trial management group, including the chief investigators and members of clinical trials research unit, who will release data on a case-by-case basis. Data will be shared following the principles for sharing patient level data as described by Tudur Smith C, et al BMC Medicine 2015;13:298 (https://doi.org/10.1186/s12916-015-0532-z). The data will not contain any direct identifiers, and we will minimise indirect identifiers and remove free-text data to minimise the risk of identification.

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      Footnotes

      • Collaborators CFHealthHub Study Team Members: H Cantrill, J Nicholl, S Michie, S Waterhouse, L Robinson, A Scott, S Antrobus, E Lumley, AN Biz, D Hind, C Orchard, E Nash, J Whitehouse, I Ketchall, J Rendall, H Rodgers, C Elston, S Bourke, W Flight, A McGowen, N Patel, D Watson, R Thomas, D Shiferaw, K Bateman, N Bell, N Withers, C Sheldon, M Pasteur, D Derry, D Waine, U Hill, J Myers, N Shafi, C Ohri, G Fitch, S Madge, S Elborn, K Miles, L Kent, V Mills, P Moran, G King, L Funnell, J Choyce, J Williams, C Evans, K Dack, J Trott, A Damani, S Raniwalla, D Tature, A Anderson, P Galey, L Warnock, J Faulkner, K Barbour, M Thomas, H Gledhill, K Donohue, H Seabridge, M Martin, K Lee, N Robson, C Weir, L Barlow and C Whitton.

      • Contributors MJW, AO'C, DH and MAA conceived and designed the study; CFHealthHub study team members collected data; SJW, LM and LS performed data analysis; MJW, AO'C, DH, MA and SJW performed data interpretation, and MJW drafted the manuscript. All authors reviewed and revised the manuscript and approved the final version. The corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted. MJW and SJW are the guarantors.

      • Funding This report presents independent research funded by the NIHR under its Grants for Applied Research Programme (RP-PG-1212-20015) and NHS England Commissioning for Quality and Innovation (IM2 Cystic Fibrosis Patient Adherence).

      • Disclaimer The views and opinions expressed are those of the authors and do not necessarily reflect those of the National Health Service, the NIHR, Medical Research Council, Central Commissioning Facility, the Programme Grants for Applied Research Programme or the Department of Health and Social Care.

      • Competing interests All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: no direct influence of any competing interest on the submitted work; support for MJW from Philips Respironics for early data transfer experience; support for the University of Manchester software team from PARI Pharma to create a medication reporting component within the CFHealthHub software; funding for MJW from Zambon; funding for IB from Microsoft Research; SJW is an NIHR Senior Investigator; IB became Chief Data Scientist (advisory) for AstraZeneca in September 2019; no other financial relationships that might have an interest in the submitted work in the previous three years; and no other relationships or activities that could appear to have influenced the submitted work.

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

      • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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