Title: A feasibility study to inform the design of a randomised controlled trial (RCT) to evaluate an interactive internet (web) based Pulmonary Rehabilitation programme for patients with Chronic Obstructive Pulmonary Disease (COPD)
Funder: Department of Health (England)

Abstract: Background Pulmonary Rehabilitation (PR) is recognised as being an essential component in the management of COPD with proven efficacy in improving physical activity, psychological functioning and quality of life. National guidelines1 recommend that PR should be available to all those who may benefit however a survey by the British Lung foundation2 has found that fewer than 10% of people with COPD have access to such a service. We believe that the internet may provide an opportunity to increase the provision of PR and have developed a novel self management web based pulmonary rehabilitation programme (PRP). Our ultimate aim is to evaluate the clinical and cost effectiveness of the web based programme in a RCT but due to the technical features of this novel approach a feasibility study is needed to ensure that the study ‘can be done’. Study Aims and objectives The aim of this feasibility study is to provide data which will inform the subsequent design of a non-inferiority based RCT of web-based and conventional hospital based pulmonary rehabilitation. We aim to gather information regarding patient recruitment and drop out as well as conducting a pilot study which will evaluate a range of clinical and economic outcomes as well as garnering patient’s experiences of taking part in the study. Plan of investigation Eligible patients with COPD referred for PR at University Hospitals of Leicester (UHL) NHS Trust will be randomised into one of two groups: the intervention group who will take part in the web-based PRP and the conventional hospital rehabilitation group. Randomisation will be managed the Clinical Trials Unit at Leicester University. The study aims to recruit as many suitable patients as are referred to the PR service within the year long operational phase. Outcomes Patients will be assessed for PR prior to consent to the study. The primary outcome measure will be exercise capacity as measured by the incremental shuttle walking test (ISWT). Secondary outcome measures include health and psychological status and physical activity, as well as piloting a newly designed patient cost questionnaire for the proposed cost effectiveness analysis in the subsequent RCT. All patients will be assessed one week after completing their rehabilitation programme by an assessor who will be blind to treatment group allocation. There will also be a ‘nested’ qualitative study exploring patient’s experiences of the intervention. Potential benefits to patients and the NHS Benefits to patients in the eventual trial are likely to be increased choice in the delivery of services and increased provision as we hypothesize that providing web based rehabilitation may be more cost effective than conventional hospital based rehabilitation. The results of this feasibility study will ensure that the final design of the proposed RCT will be based on a realistic recruitment strategy and developed in line with the results of the qualitative research. The website has been developed as a collaboration between service users and experts in the field. We have sought to fully involve our service users in both the content and design of the website and study by conducting pre-protocol focus groups. Our team has previously designed and trialled ‘Activate your heart’ which is a web based cardiac rehabilitation programme which has proven popular with patients. We have found considerable enthusiasm for the concept of a web based approach to PR and many of our patients are very interested in maximising how technology can assist them in self-managing their condition. This approach could ultimately be replicated and rolled out regionally and nationally across the NHS, possibly as part of a ‘menu driven’ approach to providing services rather than ‘one size fits all’.


Research activity codes: 8.4 RESEARCH DESIGN AND METHODOLOGIES (HEALTH SERVICES)
Health categories: RESPIRATORY