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

CFHealthHub Study Team; Martin J. Wildman; Alicia O’Cathain; Chin Maguire; Madelynne A. Arden; Marlene Hutchings; Judy Bradley; Stephen J. Walters; Pauline Whelan; John Ainsworth; Iain Buchan; Laura Mandefield; Laura Sutton; Paul Tappenden; Rachel A. Elliott; Zhe Hui Hoo; Sarah J. Drabble; Daniel Beever; H. Cantrill; J. Nicholl; S. Michie; S. Waterhouse; L. Robinson; A. Scott; S. Antrobus; E. Lumley; A. N. 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; C. Evans; A. Anderson; Kath Donohue

doi:10.1136/thoraxjnl-2021-217594

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

CFHealthHub Study Team, Martin J. Wildman^*, Alicia O’Cathain, Chin Maguire, Madelynne A. Arden, Marlene Hutchings, Judy Bradley, Stephen J. Walters, Pauline Whelan, John Ainsworth, Iain Buchan, Laura Mandefield, Laura Sutton, Paul Tappenden, Rachel A. Elliott, Zhe Hui Hoo, Sarah J. Drabble, Daniel Beever, H. Cantrill, J. NichollS. Michie, S. Waterhouse, L. Robinson, A. Scott, S. Antrobus, E. Lumley, A. N. 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, C. Evans, A. Anderson, Kath Donohue

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

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.

Original language	English
Pages (from-to)	461-469
Number of pages	9
Journal	Thorax
Volume	77
Issue number	5
DOIs	https://doi.org/10.1136/thoraxjnl-2021-217594
Publication status	Published - May 2022

ASJC Scopus subject areas

Pulmonary and Respiratory Medicine

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1136/thoraxjnl-2021-217594

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CFHealthHub Study Team, Wildman, M. J., O’Cathain, A., Maguire, C., Arden, M. A., Hutchings, M., Bradley, J., Walters, S. J., Whelan, P., Ainsworth, J., Buchan, I., Mandefield, L., Sutton, L., Tappenden, P., Elliott, R. A., Hoo, Z. H., Drabble, S. J., Beever, D., Cantrill, H., ... Donohue, K. (2022). Self-management intervention to reduce pulmonary exacerbations by supporting treatment adherence in adults with cystic fibrosis: a randomised controlled trial. Thorax, 77(5), 461-469. https://doi.org/10.1136/thoraxjnl-2021-217594

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

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.",

author = "{CFHealthHub Study Team} and Wildman, {Martin J.} and Alicia O{\textquoteright}Cathain and Chin Maguire and Arden, {Madelynne A.} and Marlene Hutchings and Judy Bradley and Walters, {Stephen J.} and Pauline Whelan and John Ainsworth and Iain Buchan and Laura Mandefield and Laura Sutton and Paul Tappenden and Elliott, {Rachel A.} and Hoo, {Zhe Hui} and Drabble, {Sarah J.} and Daniel Beever and H. Cantrill and J. Nicholl and S. Michie and S. Waterhouse and L. Robinson and A. Scott and S. Antrobus and E. Lumley and Biz, {A. N.} and D. Hind and C. Orchard and E. Nash and J. Whitehouse and I. Ketchall and J. Rendall and H. Rodgers and C. Elston and S. Bourke and W. Flight and A. McGowen and N. Patel and D. Watson and R. Thomas and D. Shiferaw and K. Bateman and N. Bell and N. Withers and C. Sheldon and M. Pasteur and D. Derry and C. Evans and A. Anderson and Kath Donohue",

note = "Publisher Copyright: {\textcopyright} Author(s) (or their employer(s)) 2022.",

year = "2022",

month = may,

doi = "10.1136/thoraxjnl-2021-217594",

language = "English",

volume = "77",

pages = "461--469",

journal = "Thorax",

issn = "0040-6376",

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number = "5",

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CFHealthHub Study Team, Wildman, MJ, O’Cathain, A, Maguire, C, Arden, MA, Hutchings, M, Bradley, J, Walters, SJ, Whelan, P, Ainsworth, J, Buchan, I, Mandefield, L, Sutton, L, Tappenden, P, Elliott, RA, Hoo, ZH, Drabble, SJ, Beever, D, Cantrill, H, Nicholl, J, Michie, S, Waterhouse, S, Robinson, L, Scott, A, Antrobus, S, Lumley, E, Biz, AN, Hind, D, Orchard, C, Nash, E, Whitehouse, J, Ketchall, I, Rendall, J, Rodgers, H, Elston, C, Bourke, S, Flight, W, McGowen, A, Patel, N, Watson, D, Thomas, R, Shiferaw, D, Bateman, K, Bell, N, Withers, N, Sheldon, C, Pasteur, M, Derry, D, Evans, C, Anderson, A & Donohue, K 2022, 'Self-management intervention to reduce pulmonary exacerbations by supporting treatment adherence in adults with cystic fibrosis: a randomised controlled trial', Thorax, vol. 77, no. 5, pp. 461-469. https://doi.org/10.1136/thoraxjnl-2021-217594

TY - JOUR

T1 - Self-management intervention to reduce pulmonary exacerbations by supporting treatment adherence in adults with cystic fibrosis

T2 - a randomised controlled trial

AU - CFHealthHub Study Team

AU - Wildman, Martin J.

AU - O’Cathain, Alicia

AU - Maguire, Chin

AU - Arden, Madelynne A.

AU - Hutchings, Marlene

AU - Bradley, Judy

AU - Walters, Stephen J.

AU - Whelan, Pauline

AU - Ainsworth, John

AU - Buchan, Iain

AU - Mandefield, Laura

AU - Sutton, Laura

AU - Tappenden, Paul

AU - Elliott, Rachel A.

AU - Hoo, Zhe Hui

AU - Drabble, Sarah J.

AU - Beever, Daniel

AU - Cantrill, H.

AU - Nicholl, J.

AU - Michie, S.

AU - Waterhouse, S.

AU - Robinson, L.

AU - Scott, A.

AU - Antrobus, S.

AU - Lumley, E.

AU - Biz, A. N.

AU - Hind, D.

AU - Orchard, C.

AU - Nash, E.

AU - Whitehouse, J.

AU - Ketchall, I.

AU - Rendall, J.

AU - Rodgers, H.

AU - Elston, C.

AU - Bourke, S.

AU - Flight, W.

AU - McGowen, A.

AU - Patel, N.

AU - Watson, D.

AU - Thomas, R.

AU - Shiferaw, D.

AU - Bateman, K.

AU - Bell, N.

AU - Withers, N.

AU - Sheldon, C.

AU - Pasteur, M.

AU - Derry, D.

AU - Evans, C.

AU - Anderson, A.

AU - Donohue, Kath

PY - 2022/5

Y1 - 2022/5

N2 - 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.

AB - 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.

UR - http://www.scopus.com/inward/record.url?scp=85128488008&partnerID=8YFLogxK

U2 - 10.1136/thoraxjnl-2021-217594

DO - 10.1136/thoraxjnl-2021-217594

M3 - Article

C2 - 34556552

AN - SCOPUS:85128488008

SN - 0040-6376

VL - 77

SP - 461

EP - 469

JO - Thorax

JF - Thorax

IS - 5

ER -

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

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