Skip to main content
Top
Published in: Trials 1/2020

Open Access 01-12-2020 | Bronchiectasis | Research

Bronchiectasis Information and Education: a randomised, controlled feasibility trial

Authors: Katy L. M. Hester, Vicky Ryan, Julia Newton, Tim Rapley, Anthony De Soyza

Published in: Trials | Issue 1/2020

Login to get access

Abstract

Background

There has been comparatively little patient information about bronchiectasis, a chronic lung disease with rising prevalence. Patients want more information, which could improve their understanding and self-management. A novel information resource meeting identified needs has been co-developed in prior work. We sought to establish the feasibility of conducting a multi-centre randomised controlled trial to determine effect of the information resource on understanding, self-management and health outcomes.

Methods/design

We conducted an unblinded, single-centre, randomised controlled feasibility trial with two parallel groups (1:1 ratio), comparing a novel patient information resource with usual care in adults with bronchiectasis. Integrated qualitative methods allowed further evaluation of the intervention and trial process. The setting was two teaching hospitals in North East England. Participants randomised to the intervention group received the information resource (website and booklet) and instructions on its use. Feasibility outcome measures included willingness to enter the trial, in addition to recruitment and retention rates. Secondary outcome measures (resource use and satisfaction, quality of life, unscheduled healthcare presentations, exacerbation frequency, bronchiectasis knowledge and lung function) were recorded at baseline, 2 weeks and 12 weeks.

Results

Sixty-two participants were randomised (control group = 30; intervention group = 32). Thirty-eight (61%) were female, and the participants’ median age was 65 years (range 15–81). Median forced expiratory volume in 1 s percent predicted was 68% (range 10–120). Sixty-two of 124 (50%; 95% CI, 41–59%) of potentially eligible participants approached were recruited. Sixty (97%) of 62 participants completed the study (control group, 29 of 30 [97%]; 95% CI, 83–99%; 1 unrelated death; intervention group, 31 [97%] of 32; 95% CI, 84–99%; 1 withdrawal). In the intervention group, 27 (84%) of 32 reported using the information provided, and 25 (93%) of 27 of users found it useful, particularly the video content. Qualitative data analysis revealed acceptability of the trial and intervention. Web analytics recorded over 20,000 page views during the 16-month study period.

Conclusion

The successful recruitment process, high retention rate and study form completion rates indicate that it appears feasible to conduct a full trial based on this study design. Worldwide demand for online access to the information resource was high.

Trial registration

ISRCTN Registry, ISRCTN84229105. Registered on 25 July 2014.
Appendix
Available only for authorised users
Literature
1.
go back to reference Quint JK, et al. Changes in the incidence, prevalence and mortality of bronchiectasis in the UK from 2004-2013: a population based cohort study. Eur Respir J. 2016;47(1):186–93.PubMedCrossRef Quint JK, et al. Changes in the incidence, prevalence and mortality of bronchiectasis in the UK from 2004-2013: a population based cohort study. Eur Respir J. 2016;47(1):186–93.PubMedCrossRef
2.
go back to reference Ringshausen FC, et al. Bronchiectasis in Germany: a population-based estimation of disease prevalence. Eur Respir J. 2015;46:1805–7.PubMedCrossRef Ringshausen FC, et al. Bronchiectasis in Germany: a population-based estimation of disease prevalence. Eur Respir J. 2015;46:1805–7.PubMedCrossRef
4.
go back to reference Patel IS, et al. Bronchiectasis, exacerbation indices, and inflammation in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2004;170(4):400–7.PubMedCrossRef Patel IS, et al. Bronchiectasis, exacerbation indices, and inflammation in chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2004;170(4):400–7.PubMedCrossRef
5.
go back to reference O’Brien C, Guest PJ, Hill SL. Physiological and radiological characterisation of patients diagnosed with chronic obstructive pulmonary disease in primary care. Thorax. 2000;55:635–42.PubMedPubMedCentralCrossRef O’Brien C, Guest PJ, Hill SL. Physiological and radiological characterisation of patients diagnosed with chronic obstructive pulmonary disease in primary care. Thorax. 2000;55:635–42.PubMedPubMedCentralCrossRef
6.
go back to reference Kelly MG, Murphy S, Elborn JS. Bronchiectasis in secondary care: a comprehensive profile of a neglected disease. Eur J Intern Med. 2003;14(8):488–92.PubMedCrossRef Kelly MG, Murphy S, Elborn JS. Bronchiectasis in secondary care: a comprehensive profile of a neglected disease. Eur J Intern Med. 2003;14(8):488–92.PubMedCrossRef
7.
8.
go back to reference Wilson CB, et al. Validation of the St George’s Respiratory Questionnaire in bronchiectasis. Am J Respir Crit Care Med. 1997;156(2 Pt 1):536–41.PubMedCrossRef Wilson CB, et al. Validation of the St George’s Respiratory Questionnaire in bronchiectasis. Am J Respir Crit Care Med. 1997;156(2 Pt 1):536–41.PubMedCrossRef
9.
go back to reference O’Leary CJ, et al. Relationship between psychological well-being and lung health status in patients with bronchiectasis. Respir Med. 2002;96(9):686–92.PubMedCrossRef O’Leary CJ, et al. Relationship between psychological well-being and lung health status in patients with bronchiectasis. Respir Med. 2002;96(9):686–92.PubMedCrossRef
10.
go back to reference Hester KLM, et al. Fatigue in bronchiectasis. Q J Med. 2012;105(3):235–40.CrossRef Hester KLM, et al. Fatigue in bronchiectasis. Q J Med. 2012;105(3):235–40.CrossRef
11.
go back to reference Macfarlane JG, et al. Fatigue in bronchiectasis: its relationship to pseudomonas colonisation, dyspnoea and airflow obstruction [abstract]. Thorax. 2010;65:A60.CrossRef Macfarlane JG, et al. Fatigue in bronchiectasis: its relationship to pseudomonas colonisation, dyspnoea and airflow obstruction [abstract]. Thorax. 2010;65:A60.CrossRef
12.
go back to reference Pasteur MC, Bilton D, Hill AT. British Thoracic Society guideline for non-CF bronchiectasis. Thorax. 2010;65(Suppl 1):i1–58.PubMedCrossRef Pasteur MC, Bilton D, Hill AT. British Thoracic Society guideline for non-CF bronchiectasis. Thorax. 2010;65(Suppl 1):i1–58.PubMedCrossRef
14.
go back to reference Haworth CS, et al. Inhaled colistin in patients with bronchiectasis and chronic Pseudomonas infection. Am J Respir Crit Care Med. 2014;189(8):975–82.PubMedPubMedCentralCrossRef Haworth CS, et al. Inhaled colistin in patients with bronchiectasis and chronic Pseudomonas infection. Am J Respir Crit Care Med. 2014;189(8):975–82.PubMedPubMedCentralCrossRef
15.
go back to reference Hester KLM, et al. Patient information, education and self-management in bronchiectasis: facilitating improvements to optimise health outcomes. BMC Pulm Med. 2018;18:80.PubMedPubMedCentralCrossRef Hester KLM, et al. Patient information, education and self-management in bronchiectasis: facilitating improvements to optimise health outcomes. BMC Pulm Med. 2018;18:80.PubMedPubMedCentralCrossRef
17.
go back to reference George CF, Waters WE, Nicholas JA. Prescription information leaflets: a pilot study in general practice. Br Med J (Clin Res Ed). 1983;287(6400):1193–6.CrossRef George CF, Waters WE, Nicholas JA. Prescription information leaflets: a pilot study in general practice. Br Med J (Clin Res Ed). 1983;287(6400):1193–6.CrossRef
18.
go back to reference Audit Commission. What seems to be the matter: communication between hospital and patients. London: Her Majesty’s Stationery Office; 1993. Audit Commission. What seems to be the matter: communication between hospital and patients. London: Her Majesty’s Stationery Office; 1993.
19.
go back to reference Panagioti M, et al. Self-management support interventions to reduce health care utilisation without compromising outcomes: a systematic review and meta-analysis. BMC Health Serv Res. 2014;14:356.PubMedPubMedCentralCrossRef Panagioti M, et al. Self-management support interventions to reduce health care utilisation without compromising outcomes: a systematic review and meta-analysis. BMC Health Serv Res. 2014;14:356.PubMedPubMedCentralCrossRef
20.
go back to reference Hester KLM, McAlinden P, De Soyza A. Education and information for patients with bronchiectasis: what do patients want? [abstract]. Eur Respir J. 2011;38(Suppl 35):P3622. Hester KLM, McAlinden P, De Soyza A. Education and information for patients with bronchiectasis: what do patients want? [abstract]. Eur Respir J. 2011;38(Suppl 35):P3622.
21.
go back to reference Lavery K, et al. Self-management in bronchiectasis: the patients’ perspective. Eur Respir J. 2007;29(3):541–7.PubMedCrossRef Lavery K, et al. Self-management in bronchiectasis: the patients’ perspective. Eur Respir J. 2007;29(3):541–7.PubMedCrossRef
22.
go back to reference Hester KLM, De Soyza A, Rapley T. Information and education needs of patients with bronchiectasis: a qualitative investigation [abstract]. Thorax. 2012;67(Suppl 2):A141.CrossRef Hester KLM, De Soyza A, Rapley T. Information and education needs of patients with bronchiectasis: a qualitative investigation [abstract]. Thorax. 2012;67(Suppl 2):A141.CrossRef
23.
go back to reference Hester KLM. Information and education provision for patients with bronchiectasis: a qualitative study. PhD thesis. Newcastle upon Tyne: Newcastle University; 2012. Hester KLM. Information and education provision for patients with bronchiectasis: a qualitative study. PhD thesis. Newcastle upon Tyne: Newcastle University; 2012.
24.
go back to reference Hester KLM, et al. Living your life with bronchiectasis: an exploration of patients and carers information needs informing development of a novel information resource [abstract]. Thorax. 2015;70(Suppl 3):P201.CrossRef Hester KLM, et al. Living your life with bronchiectasis: an exploration of patients and carers information needs informing development of a novel information resource [abstract]. Thorax. 2015;70(Suppl 3):P201.CrossRef
25.
go back to reference Hester KLM, et al. Living your life with bronchiectasis: an exploration of patients’ and carers’ information needs. In: British Sociological Association Medical Sociology Group Annual Conference 2015. York: University of York; 2015. p. 106. Hester KLM, et al. Living your life with bronchiectasis: an exploration of patients’ and carers’ information needs. In: British Sociological Association Medical Sociology Group Annual Conference 2015. York: University of York; 2015. p. 106.
26.
go back to reference Hester KLM, et al. Information and education provision in bronchiectasis: co-development and evaluation of a novel patient-driven resource in a digital era. Eur Respir J. 2018;51:1702402.PubMedCrossRef Hester KLM, et al. Information and education provision in bronchiectasis: co-development and evaluation of a novel patient-driven resource in a digital era. Eur Respir J. 2018;51:1702402.PubMedCrossRef
27.
go back to reference Hester KLM, et al. Evaluation of a novel information resource for patients with bronchiectasis: study protocol for a randomised controlled trial. Trials. 2016;17:210.PubMedPubMedCentralCrossRef Hester KLM, et al. Evaluation of a novel information resource for patients with bronchiectasis: study protocol for a randomised controlled trial. Trials. 2016;17:210.PubMedPubMedCentralCrossRef
28.
go back to reference Spinou A, et al. The validity of health-related quality of life questionnaires in bronchiectasis: a systematic review and meta-analysis. BMJ. 2016;71:683–94. Spinou A, et al. The validity of health-related quality of life questionnaires in bronchiectasis: a systematic review and meta-analysis. BMJ. 2016;71:683–94.
29.
go back to reference Lancaster G, Dodd S, Williamson P. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004;10(2):307–12.CrossRefPubMed Lancaster G, Dodd S, Williamson P. Design and analysis of pilot studies: recommendations for good practice. J Eval Clin Pract. 2004;10(2):307–12.CrossRefPubMed
30.
go back to reference Wilson EB. Probable inference, the law of succession and statistical inference. J Am Stat Assoc. 1927;22:209–12.CrossRef Wilson EB. Probable inference, the law of succession and statistical inference. J Am Stat Assoc. 1927;22:209–12.CrossRef
32.
go back to reference Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol. 2006;3(2):77–101.CrossRef Braun V, Clarke V. Using thematic analysis in psychology. Qual Res Psychol. 2006;3(2):77–101.CrossRef
33.
go back to reference Grbich C. Qualitative research in health: an introduction. London: Sage; 1999. Grbich C. Qualitative research in health: an introduction. London: Sage; 1999.
35.
go back to reference Chalmers JD, et al. The Bronchiectasis Severity Index: an international derivation and validation study. Am J Respir Crit Care Med. 2014;189(5):576–85.PubMedPubMedCentralCrossRef Chalmers JD, et al. The Bronchiectasis Severity Index: an international derivation and validation study. Am J Respir Crit Care Med. 2014;189(5):576–85.PubMedPubMedCentralCrossRef
36.
go back to reference Nakash RA, et al. Maximising response to postal questionnaires - A systematic review of randomised trials in health research. BMC Med Res Methodol. 2006;6:5.PubMedPubMedCentralCrossRef Nakash RA, et al. Maximising response to postal questionnaires - A systematic review of randomised trials in health research. BMC Med Res Methodol. 2006;6:5.PubMedPubMedCentralCrossRef
38.
go back to reference Bugge C, et al. A process for Decision-making after Pilot and feasibility Trials (ADePT): development following a feasibility study of a complex intervention for pelvic organ prolapse. Trials. 2013;14:353.PubMedPubMedCentralCrossRef Bugge C, et al. A process for Decision-making after Pilot and feasibility Trials (ADePT): development following a feasibility study of a complex intervention for pelvic organ prolapse. Trials. 2013;14:353.PubMedPubMedCentralCrossRef
39.
go back to reference Bibby S, Milne R, Beasley R. Hospital admissions for non-cystic fibrosis bronchiectasis in New Zealand. N Z Med J. 2015;128(1421):30–8.PubMed Bibby S, Milne R, Beasley R. Hospital admissions for non-cystic fibrosis bronchiectasis in New Zealand. N Z Med J. 2015;128(1421):30–8.PubMed
40.
go back to reference Medical Research Council (MRC). A framework for the development and evaluation of RCTs for complex interventions to improve health. London: MRC; 2000. Medical Research Council (MRC). A framework for the development and evaluation of RCTs for complex interventions to improve health. London: MRC; 2000.
41.
42.
go back to reference Hill AT, et al. Pulmonary exacerbation in adults with bronchiectasis: a consensus definition for clinical research. Eur Respir J. 2017;49(6):1700051.PubMedCrossRef Hill AT, et al. Pulmonary exacerbation in adults with bronchiectasis: a consensus definition for clinical research. Eur Respir J. 2017;49(6):1700051.PubMedCrossRef
Metadata
Title
Bronchiectasis Information and Education: a randomised, controlled feasibility trial
Authors
Katy L. M. Hester
Vicky Ryan
Julia Newton
Tim Rapley
Anthony De Soyza
Publication date
01-12-2020
Publisher
BioMed Central
Keyword
Bronchiectasis
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-020-4134-5

Other articles of this Issue 1/2020

Trials 1/2020 Go to the issue