Supporting medication adherence for adults with cystic fibrosis: a randomised feasibility study

Daniel Hind; Sarah J Drabble; Madelynne A Arden; Laura Mandefield; Simon Waterhouse; Chin Maguire; Hannah Cantrill; Louisa Robinson; Daniel Beever; Alexander J Scott; Sam Keating; Marlene Hutchings; Judy Bradley; Julia Nightingale; Mark I Allenby; Jane Dewar; Pauline Whelan; John Ainsworth; Stephen J Walters; Alicia O'Cathain; Martin J Wildman

doi:10.1186/s12890-019-0834-6

Supporting medication adherence for adults with cystic fibrosis: a randomised feasibility study

Daniel Hind, Sarah J Drabble, Madelynne A Arden, Laura Mandefield, Simon Waterhouse, Chin Maguire, Hannah Cantrill, Louisa Robinson, Daniel Beever, Alexander J Scott, Sam Keating, Marlene Hutchings, Judy Bradley, Julia Nightingale, Mark I Allenby, Jane Dewar, Pauline Whelan, John Ainsworth, Stephen J Walters, Alicia O'CathainMartin J Wildman

School of Medicine, Dentistry and Biomedical Sciences

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

24 Citations (Scopus)

230 Downloads (Pure)

Abstract

BACKGROUND: Preventative medication reduces hospitalisations in people with cystic fibrosis (PWCF) but adherence is poor. We assessed the feasibility of a randomised controlled trial of a complex intervention, which combines display of real time adherence data and behaviour change techniques.

METHODS: Design: Pilot, open-label, parallel-group RCT with concurrent semi-structured interviews.

PARTICIPANTS: PWCF at two Cystic Fibrosis (CF) units. Eligible: aged 16 or older; on the CF registry. Ineligible: post-lung transplant or on the active list; unable to consent; using dry powder inhalers.

INTERVENTIONS: Central randomisation on a 1:1 allocation to: (1) intervention, linking nebuliser use with data recording and transfer capability to a software platform, and behavioural strategies to support self-management delivered by trained interventionists (n = 32); or, (2) control, typically face-to-face meetings every 3 months with CF team (n = 32).

OUTCOMES: RCT feasibility defined as: recruitment of ≥ 48 participants (75% of target) in four months (pilot primary outcome); valid exacerbation data available for ≥ 85% of those randomised (future RCT primary outcome); change in % medication adherence; FEV1 percent predicted (key secondaries in future RCT); and perceptions of trial procedures, in semi-structured interviews with intervention (n = 14) and control (n = 5) participants, interventionists (n = 3) and CF team members (n = 5).

RESULTS: The pilot trial recruited to target, randomising 33 to intervention and 31 to control in the four-month period, June-September 2016. At study completion (30th April 2017), 60 (94%; Intervention = 32, Control =28) participants contributed good quality exacerbation data (intervention: 35 exacerbations; control: 25 exacerbation). The mean change in adherence and baseline-adjusted FEV1 percent predicted were higher in the intervention arm by 10% (95% CI: -5.2 to 25.2) and 5% (95% CI -2 to 12%) respectively. Five serious adverse events occurred, none related to the intervention. The mean change in adherence was 10% (95% CI: -5.2 to 25.2), greater in the intervention arm. Interventionists delivered insufficient numbers of review sessions due to concentration on participant recruitment. This left interventionists insufficient time for key intervention procedures. A total of 10 key changes that were made to RCT procedures are summarised.

CONCLUSIONS: With improved research processes and lower monthly participant recruitment targets, a full-scale trial is feasible.

TRIAL REGISTRATION: ISRCTN13076797 . Prospectively registered on 07/06/2016.

Original language	English
Pages (from-to)	77
Journal	BMC Pulmonary Medicine
Volume	19
Issue number	1
DOIs	https://doi.org/10.1186/s12890-019-0834-6
Publication status	Published - 11 Apr 2019

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Supporting medication adherence for adults with cystic fibrosis: a randomised feasibility study
Copyright 2019 the authors. This is an open access article published under a Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution and reproduction in any medium, provided the author and source are cited
Final published version, 1.62 MBLicence: CC BY

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Hind, D., Drabble, S. J., Arden, M. A., Mandefield, L., Waterhouse, S., Maguire, C., Cantrill, H., Robinson, L., Beever, D., Scott, A. J., Keating, S., Hutchings, M., Bradley, J., Nightingale, J., Allenby, M. I., Dewar, J., Whelan, P., Ainsworth, J., Walters, S. J., ... Wildman, M. J. (2019). Supporting medication adherence for adults with cystic fibrosis: a randomised feasibility study. BMC Pulmonary Medicine, 19(1), 77. https://doi.org/10.1186/s12890-019-0834-6

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title = "Supporting medication adherence for adults with cystic fibrosis: a randomised feasibility study",

abstract = "BACKGROUND: Preventative medication reduces hospitalisations in people with cystic fibrosis (PWCF) but adherence is poor. We assessed the feasibility of a randomised controlled trial of a complex intervention, which combines display of real time adherence data and behaviour change techniques.METHODS: Design: Pilot, open-label, parallel-group RCT with concurrent semi-structured interviews.PARTICIPANTS: PWCF at two Cystic Fibrosis (CF) units. Eligible: aged 16 or older; on the CF registry. Ineligible: post-lung transplant or on the active list; unable to consent; using dry powder inhalers.INTERVENTIONS: Central randomisation on a 1:1 allocation to: (1) intervention, linking nebuliser use with data recording and transfer capability to a software platform, and behavioural strategies to support self-management delivered by trained interventionists (n = 32); or, (2) control, typically face-to-face meetings every 3 months with CF team (n = 32).OUTCOMES: RCT feasibility defined as: recruitment of ≥ 48 participants (75% of target) in four months (pilot primary outcome); valid exacerbation data available for ≥ 85% of those randomised (future RCT primary outcome); change in % medication adherence; FEV1 percent predicted (key secondaries in future RCT); and perceptions of trial procedures, in semi-structured interviews with intervention (n = 14) and control (n = 5) participants, interventionists (n = 3) and CF team members (n = 5).RESULTS: The pilot trial recruited to target, randomising 33 to intervention and 31 to control in the four-month period, June-September 2016. At study completion (30th April 2017), 60 (94%; Intervention = 32, Control =28) participants contributed good quality exacerbation data (intervention: 35 exacerbations; control: 25 exacerbation). The mean change in adherence and baseline-adjusted FEV1 percent predicted were higher in the intervention arm by 10% (95% CI: -5.2 to 25.2) and 5% (95% CI -2 to 12%) respectively. Five serious adverse events occurred, none related to the intervention. The mean change in adherence was 10% (95% CI: -5.2 to 25.2), greater in the intervention arm. Interventionists delivered insufficient numbers of review sessions due to concentration on participant recruitment. This left interventionists insufficient time for key intervention procedures. A total of 10 key changes that were made to RCT procedures are summarised.CONCLUSIONS: With improved research processes and lower monthly participant recruitment targets, a full-scale trial is feasible.TRIAL REGISTRATION: ISRCTN13076797 . Prospectively registered on 07/06/2016.",

author = "Daniel Hind and Drabble, {Sarah J} and Arden, {Madelynne A} and Laura Mandefield and Simon Waterhouse and Chin Maguire and Hannah Cantrill and Louisa Robinson and Daniel Beever and Scott, {Alexander J} and Sam Keating and Marlene Hutchings and Judy Bradley and Julia Nightingale and Allenby, {Mark I} and Jane Dewar and Pauline Whelan and John Ainsworth and Walters, {Stephen J} and Alicia O'Cathain and Wildman, {Martin J}",

year = "2019",

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day = "11",

doi = "10.1186/s12890-019-0834-6",

language = "English",

volume = "19",

pages = "77",

journal = "BMC Pulmonary Medicine",

issn = "1471-2466",

publisher = "BioMed Central Ltd.",

number = "1",

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Hind, D, Drabble, SJ, Arden, MA, Mandefield, L, Waterhouse, S, Maguire, C, Cantrill, H, Robinson, L, Beever, D, Scott, AJ, Keating, S, Hutchings, M, Bradley, J, Nightingale, J, Allenby, MI, Dewar, J, Whelan, P, Ainsworth, J, Walters, SJ, O'Cathain, A & Wildman, MJ 2019, 'Supporting medication adherence for adults with cystic fibrosis: a randomised feasibility study', BMC Pulmonary Medicine, vol. 19, no. 1, pp. 77. https://doi.org/10.1186/s12890-019-0834-6

TY - JOUR

T1 - Supporting medication adherence for adults with cystic fibrosis

T2 - a randomised feasibility study

AU - Hind, Daniel

AU - Drabble, Sarah J

AU - Arden, Madelynne A

AU - Mandefield, Laura

AU - Waterhouse, Simon

AU - Maguire, Chin

AU - Cantrill, Hannah

AU - Robinson, Louisa

AU - Beever, Daniel

AU - Scott, Alexander J

AU - Keating, Sam

AU - Hutchings, Marlene

AU - Bradley, Judy

AU - Nightingale, Julia

AU - Allenby, Mark I

AU - Dewar, Jane

AU - Whelan, Pauline

AU - Ainsworth, John

AU - Walters, Stephen J

AU - O'Cathain, Alicia

AU - Wildman, Martin J

PY - 2019/4/11

Y1 - 2019/4/11

N2 - BACKGROUND: Preventative medication reduces hospitalisations in people with cystic fibrosis (PWCF) but adherence is poor. We assessed the feasibility of a randomised controlled trial of a complex intervention, which combines display of real time adherence data and behaviour change techniques.METHODS: Design: Pilot, open-label, parallel-group RCT with concurrent semi-structured interviews.PARTICIPANTS: PWCF at two Cystic Fibrosis (CF) units. Eligible: aged 16 or older; on the CF registry. Ineligible: post-lung transplant or on the active list; unable to consent; using dry powder inhalers.INTERVENTIONS: Central randomisation on a 1:1 allocation to: (1) intervention, linking nebuliser use with data recording and transfer capability to a software platform, and behavioural strategies to support self-management delivered by trained interventionists (n = 32); or, (2) control, typically face-to-face meetings every 3 months with CF team (n = 32).OUTCOMES: RCT feasibility defined as: recruitment of ≥ 48 participants (75% of target) in four months (pilot primary outcome); valid exacerbation data available for ≥ 85% of those randomised (future RCT primary outcome); change in % medication adherence; FEV1 percent predicted (key secondaries in future RCT); and perceptions of trial procedures, in semi-structured interviews with intervention (n = 14) and control (n = 5) participants, interventionists (n = 3) and CF team members (n = 5).RESULTS: The pilot trial recruited to target, randomising 33 to intervention and 31 to control in the four-month period, June-September 2016. At study completion (30th April 2017), 60 (94%; Intervention = 32, Control =28) participants contributed good quality exacerbation data (intervention: 35 exacerbations; control: 25 exacerbation). The mean change in adherence and baseline-adjusted FEV1 percent predicted were higher in the intervention arm by 10% (95% CI: -5.2 to 25.2) and 5% (95% CI -2 to 12%) respectively. Five serious adverse events occurred, none related to the intervention. The mean change in adherence was 10% (95% CI: -5.2 to 25.2), greater in the intervention arm. Interventionists delivered insufficient numbers of review sessions due to concentration on participant recruitment. This left interventionists insufficient time for key intervention procedures. A total of 10 key changes that were made to RCT procedures are summarised.CONCLUSIONS: With improved research processes and lower monthly participant recruitment targets, a full-scale trial is feasible.TRIAL REGISTRATION: ISRCTN13076797 . Prospectively registered on 07/06/2016.

AB - BACKGROUND: Preventative medication reduces hospitalisations in people with cystic fibrosis (PWCF) but adherence is poor. We assessed the feasibility of a randomised controlled trial of a complex intervention, which combines display of real time adherence data and behaviour change techniques.METHODS: Design: Pilot, open-label, parallel-group RCT with concurrent semi-structured interviews.PARTICIPANTS: PWCF at two Cystic Fibrosis (CF) units. Eligible: aged 16 or older; on the CF registry. Ineligible: post-lung transplant or on the active list; unable to consent; using dry powder inhalers.INTERVENTIONS: Central randomisation on a 1:1 allocation to: (1) intervention, linking nebuliser use with data recording and transfer capability to a software platform, and behavioural strategies to support self-management delivered by trained interventionists (n = 32); or, (2) control, typically face-to-face meetings every 3 months with CF team (n = 32).OUTCOMES: RCT feasibility defined as: recruitment of ≥ 48 participants (75% of target) in four months (pilot primary outcome); valid exacerbation data available for ≥ 85% of those randomised (future RCT primary outcome); change in % medication adherence; FEV1 percent predicted (key secondaries in future RCT); and perceptions of trial procedures, in semi-structured interviews with intervention (n = 14) and control (n = 5) participants, interventionists (n = 3) and CF team members (n = 5).RESULTS: The pilot trial recruited to target, randomising 33 to intervention and 31 to control in the four-month period, June-September 2016. At study completion (30th April 2017), 60 (94%; Intervention = 32, Control =28) participants contributed good quality exacerbation data (intervention: 35 exacerbations; control: 25 exacerbation). The mean change in adherence and baseline-adjusted FEV1 percent predicted were higher in the intervention arm by 10% (95% CI: -5.2 to 25.2) and 5% (95% CI -2 to 12%) respectively. Five serious adverse events occurred, none related to the intervention. The mean change in adherence was 10% (95% CI: -5.2 to 25.2), greater in the intervention arm. Interventionists delivered insufficient numbers of review sessions due to concentration on participant recruitment. This left interventionists insufficient time for key intervention procedures. A total of 10 key changes that were made to RCT procedures are summarised.CONCLUSIONS: With improved research processes and lower monthly participant recruitment targets, a full-scale trial is feasible.TRIAL REGISTRATION: ISRCTN13076797 . Prospectively registered on 07/06/2016.

U2 - 10.1186/s12890-019-0834-6

DO - 10.1186/s12890-019-0834-6

M3 - Article

C2 - 30975206

SN - 1471-2466

VL - 19

SP - 77

JO - BMC Pulmonary Medicine

JF - BMC Pulmonary Medicine

IS - 1

ER -

Supporting medication adherence for adults with cystic fibrosis: a randomised feasibility study

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