BMJ Open BMJ Open: first published as 10.1136/bmjopen-2016-013682 on 31 March 2017. Downloaded from An interactive web-based Pulmonary Rehabilitation programme: A randomised controlled feasibility trial. ForJournal: peerBMJ Open review only Manuscript ID bmjopen-2016-013682 Article Type: Research Date Submitted by the Author: 16-Aug-2016 Complete List of Authors: Chaplin, Emma; University Hospitals of Leicester NHS Trust, Pulmonary Rehabilitation Hewitt, Stacey; Centre for Exercise and ehabilitation Science, Leicester Respiratory Biomedical Research Unit Apps, Lindsay; Centre for Exercise and ehabilitation Science, Leicester Respiratory Biomedical Research Unit Bankart, M. John; Keele University, Institute of Primary Care Pulikottil-Jacob, Ruth; Warwick Medical School , Warwick Evidence Boyce, Sally; Centre for Exercise and ehabilitation Science, Leicester Respiratory Biomedical Research Unit Morgan, Mike; University Hospitals of Leicester NHS Trust, Respiratory Medicine Williams, Johanna; Glenfield Hospital, University Hospitals of Leicester NHS Trust, Respirartory Medicine Singh, Sally; University Hospitals of Leicester NHS Trust, http://bmjopen.bmj.com/ Cardiac/Pulmonary Rehabilitation <b>Primary Subject Rehabilitation medicine Heading</b>: Secondary Subject Heading: Respiratory medicine SPACE for COPD, chronic obstructive pulmonary disease, Internet, Web- Keywords: based, pulmonary rehabilitation on September 23, 2021 by guest. Protected copyright. For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 1 of 28 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2016-013682 on 31 March 2017. Downloaded from 1 2 3 An interactive web-based Pulmonary Rehabilitation programme: A randomised controlled 4 feasibility trial. 5 6 Chaplin, Emma1, Hewitt, Stacey1, Apps, Lindsay1, Bankart, John2, Pulikottil-Jacob, Ruth3, 7 1 1 1 1,4 8 Boyce, Sally , Morgan, Mike , Williams, Johanna , Singh, Sally 1 9 Centre for Exercise and Rehabilitation Science, Leicester Respiratory Biomedical Research Unit, Department of 10 Respiratory Medicine, Glenfield Hospital, University Hospitals of Leicester, Leicester LE3 9QP UK 2 11 Department of Primary Care and Health Sciences, Keele University, Keele, UK 3 12 Health Sciences Research Institute, Medical School, University of Warwick, Coventry, UK 4 13 School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK 14 15 For peer review only 16 17 Corresponding Author: Emma Chaplin, BSc (Hons), Centre for Exercise and Rehabilitation 18 Science, NIHR Leicester Respiratory BRU, University Hospitals of Leicester NHS Trust, 19 Leicester, LE3 9QP, UK. +44116 2583181, [email protected] 20 21 Word Count: 22 23 24 Key words: SPACE for COPD; Internet; web-based; chronic obstructive pulmonary disease; 25 pulmonary rehabilitation 26 27 28 29 30 31 32 33 http://bmjopen.bmj.com/ 34 35 36 37 38 39 40 41 42 on September 23, 2021 by guest. Protected copyright. 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 2 of 28 BMJ Open: first published as 10.1136/bmjopen-2016-013682 on 31 March 2017. Downloaded from 1 2 3 Abstract: 4 5 Objectives: The aim of this study was to determine if an interactive web-based Pulmonary 6 7 Rehabilitation (PR) programme is a feasible alternative to conventional PR. 8 9 Design: Randomised controlled feasibility trial 10 11 Setting: Participants were recruited from PR assessments, primary care and community 12 rehabilitation programmes. Patients randomised to conventional rehabilitation commenced 13 14 the programme according to the standard care at their referred site on the next available 15 date. For peer review only 16 17 Participants: 103 patients were recruited to the study and randomised: 52 to conventional 18 rehabilitation [mean (±SD) age 66 (±8) years, MRC 3 (IQR2-4)]; 51 to the web arm [mean 19 20 (±SD) age 66 (±10) years, MRC 3 (IQR2-4)]. Participants had to be willing to participate in 21 either arm of the trial, have internet access and be web literate. 22 23 Interventions: Patients randomised to the web-based programme worked through the 24 website, exercising and recording their progress as well as reading the educational material 25 provided, on line. Conventional PR consisted of twice weekly, two hourly sessions (an hour 26 27 for exercise training and an hour for an education). 28 29 Outcome measures: Recruitment rates, eligibility and patient preference as well as data on 30 drop out and completion rates for both programmes were collected. Standard outcomes for 31 a PR assessment including measures of exercise capacity and quality of life questionnaires 32 33 were also evaluated. http://bmjopen.bmj.com/ 34 35 Results: A statistically significant improvement (p≤ 0.01) was observed within each group in 36 the ESWT (WEB: mean change 189 ± 211.1; PR classes: mean change 184.5 ± 247.4secs) and 37 CRQ-D (WEB: mean change 0.7 ± 1.2; PR classes: mean change 0.8 ± 1.0). However there 38 were no significant differences between the groups in any outcome. 39 40 41 Conclusion: An interactive web-based PR programme is feasible and acceptable when 42 compared to conventional PR. Future trials maybe around choice based PR programmes for on September 23, 2021 by guest. Protected copyright. 43 select patients enabling stratification of patient care. 44 45 Trial registration number ISRCTN03142263 46 47 48 49 Strengths and Limitations of this study 50 • The study concentrates on the feasibility of an interactive web-based Pulmonary 51 Rehabilitation programme (SPACE: Self-management Program of Activity, Coping 52 53 and Education for COPD®). It will provide data on recruitment, eligibility and 54 patient preference which will inform future trials around choice based 55 programmes for select patients. 56 • Much of the success depends on the eligibility of the patients, i.e. web literacy and 57 access to the internet. 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml Page 3 of 28 BMJ Open BMJ Open: first published as 10.1136/bmjopen-2016-013682 on 31 March 2017. Downloaded from 1 2 3 • The study will compare a variety of clinical outcomes between a web-based and a 4 conventional rehabilitation PR programme in order to test the various components 5 of the intervention. 6 7 8 9 10 Introduction 11 12 Chronic Obstructive Pulmonary Disease is the fourth leading cause of death in the United 13 14 15 Kingdom (UK)For and is characterised peer by a progressivereview deterioration only of debilitating symptoms 16 17 and increasingly frequent exacerbations. Pulmonary rehabilitation (PR) has been proven to 18 19 20 be effective in improving quality of life, psychological functioning and physical activity and 21 22 national guidelines recommend that PR should be offered and made available to all those 23 24 with COPD (1). The standard provision of PR is a supervised package of exercise and 25 26 27 education usually twice a week for a minimum of six weeks, which is either hospital or 28 29 community based, and supported by a home exercise programme (2). However the barriers 30 31 to uptake of a PR programme have previously been reported (3) which included transport, 32 33 http://bmjopen.bmj.com/ 34 the perceived benefits of PR, disruption to usual routine and the timings of programmes. 35 36 These factors play some contribution as to why programmes have poor attendance and 37 38 adherence resulting in many of the programmes reporting dropout rates as high as 50%. 39 40 41 42 Ongoing changes and challenges means that the NHS and the services it provides need to on September 23, 2021 by guest. Protected copyright. 43 44 adapt to take advantage of and capitalise on the opportunities that new technologies and 45 46 47 treatments can offer to patients (4). There is a growing evidence base for the use of the 48 49 internet in the management of many chronic conditions in areas as diverse as the 50 51 management of diabetes, Parkinson’s disease, depression, rheumatoid arthritis, asthma, 52 53 54 chronic pain and epilepsy (5-11). Computer-tailored interventions have been shown to 55 56 effectively improve health behaviours such as physical activity (12) and be cost effective 57 58 59 60 For peer review only - http://bmjopen.bmj.com/site/about/guidelines.xhtml BMJ Open Page 4 of 28 BMJ Open: first published as 10.1136/bmjopen-2016-013682 on 31 March 2017. Downloaded from 1 2 3 (13). The provision of a menu based and patient centred service is said to be essential to 4 5 improve uptake and completion rates within Cardiac Rehabilitation (CR) (14). However at 6 7 8 present there is no choice within Pulmonary Rehabilitation. A web-based PR programme has 9 10 the potential to be a novel and effective approach to increasing patient choice in the mode 11 12 of delivery and setting of rehabilitation (especially to those patients who decline the offer of 13 14 15 conventionalFor pulmonary peerrehabilitation) whilereview simultaneously increasingonly the capacity of PR. 16 17 18 We have previously developed and described ‘ACTIVATE YOUR HEART®’ (AYH)(15; 16) which 19 20 21 is an interactive web-based cardiac rehabilitation (CR) programme that has proved very 22 23 popular with patients. Brough et al (2014) reported a significant improvement in exercise 24 25 capacity and quality of life in patients that completed the web-based programme. Following 26 27 28 the success of AYH, we have developed a prototype website based on the educational 29 30 content of the ‘SPACE for COPD®’ self-management workbook. SPACE (Self-management 31 32 programme of Activity, Coping and Education) for COPD® (17) is a structured programme of 33 http://bmjopen.bmj.com/ 34 35 exercise, education and psychosocial support which has been developed by our institution 36 37 as a collaboration between experts, patients and carers and has been awarded a Crystal 38 39 40 Mark for Clarity by the Plain English Campaign (18).