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

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Supporting medication adherence for adults with cystic fibrosis : a randomised feasibility study. / Hind, Daniel; Drabble, Sarah J; Arden, Madelynne A; Mandefield, Laura; Waterhouse, Simon; Maguire, Chin; Cantrill, Hannah; Robinson, Louisa; Beever, Daniel; Scott, Alexander J; Keating, Sam; Hutchings, Marlene; Bradley, Judy; Nightingale, Julia; Allenby, Mark I; Dewar, Jane; Whelan, Pauline; Ainsworth, John; Walters, Stephen J; O'Cathain, Alicia; Wildman, Martin J.

In: BMC pulmonary medicine, Vol. 19, No. 1, 77, 11.04.2019, p. 77.

Research output: Contribution to journalArticle

Harvard

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, 77, pp. 77. https://doi.org/10.1186/s12890-019-0834-6

APA

Hind, D., Drabble, S. J., Arden, M. A., Mandefield, L., Waterhouse, S., Maguire, C., ... Wildman, M. J. (2019). Supporting medication adherence for adults with cystic fibrosis: a randomised feasibility study. BMC pulmonary medicine, 19(1), 77. [77]. https://doi.org/10.1186/s12890-019-0834-6

Vancouver

Hind D, Drabble SJ, Arden MA, Mandefield L, Waterhouse S, Maguire C et al. Supporting medication adherence for adults with cystic fibrosis: a randomised feasibility study. BMC pulmonary medicine. 2019 Apr 11;19(1):77. 77. https://doi.org/10.1186/s12890-019-0834-6

Author

Hind, Daniel ; Drabble, Sarah J ; Arden, Madelynne A ; Mandefield, Laura ; Waterhouse, Simon ; Maguire, Chin ; Cantrill, Hannah ; Robinson, Louisa ; Beever, Daniel ; Scott, Alexander J ; Keating, Sam ; Hutchings, Marlene ; Bradley, Judy ; Nightingale, Julia ; Allenby, Mark I ; Dewar, Jane ; Whelan, Pauline ; Ainsworth, John ; Walters, Stephen J ; O'Cathain, Alicia ; Wildman, Martin J. / Supporting medication adherence for adults with cystic fibrosis : a randomised feasibility study. In: BMC pulmonary medicine. 2019 ; Vol. 19, No. 1. pp. 77.

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@article{33fc759dba5a4209aceb3edac704f202,
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.",
keywords = "Adult, Attitude to Health, Cystic Fibrosis/drug therapy, Disease Progression, Feasibility Studies, Female, Humans, Male, Medication Adherence/psychology, Patient Education as Topic/methods, Pilot Projects, Quality of Life, Self-Management/methods, Stress, Psychological, Young Adult",
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}",
note = "{\circledC} The Author(s). 2019",
year = "2019",
month = "4",
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",
number = "1",

}

RIS (suitable for import to EndNote) - Download

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

N1 - © The Author(s). 2019

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.

KW - Adult

KW - Attitude to Health

KW - Cystic Fibrosis/drug therapy

KW - Disease Progression

KW - Feasibility Studies

KW - Female

KW - Humans

KW - Male

KW - Medication Adherence/psychology

KW - Patient Education as Topic/methods

KW - Pilot Projects

KW - Quality of Life

KW - Self-Management/methods

KW - Stress, Psychological

KW - Young Adult

UR - http://eprints.whiterose.ac.uk/143883/

UR - http://www.scopus.com/inward/record.url?scp=85064220913&partnerID=8YFLogxK

U2 - 10.1186/s12890-019-0834-6

DO - 10.1186/s12890-019-0834-6

M3 - Article

VL - 19

SP - 77

JO - BMC pulmonary medicine

JF - BMC pulmonary medicine

SN - 1471-2466

IS - 1

M1 - 77

ER -