Title: SPACE FOR COPD© delivered as a maintenance programme on Pulmonary Rehabilitation discharge: a randomised controlled trial evaluating the long-term effects on exercise tolerance and mental well-being.
Funder: Department of Health and Social Care

Abstract: Background: Chronic Obstructive Pulmonary Disease (COPD) is an umbrella term which describes airflow obstruction in the lungs, often caused by tobacco smoking. An estimated 1.2 million people have COPD6. Pulmonary Rehabilitation (PR) is recommended in national and international guidelines as a key intervention for managing the physiological and psychological consequences of COPD7,8. In the UK, rehabilitation is typically a six-week programme of exercise training and education, usually delivered in a hospital environment7. There is a strong body of evidence to show that PR improves health-related quality of life, exercise performance and disease knowledge, whilst also reducing anxiety, depression and symptoms9-12. Furthermore, it is the only known intervention to impact upon COPD hospital readmissions13. However, it seems that whilst PR is an effective intervention, the gains are not sustained beyond 12 months (systematic review level evidence14) and many patients require a repeat programme within 2 years15. Furthermore, qualitative work has identified feelings of 'abandonment' in patients who have completed PR2 and the desire for on-going support from health professionals and peers3,16. Aims: Does a self-management maintenance programme, delivered on Pulmonary Rehabilitation (PR) discharge, preserve the (anticipated) gains made in exercise tolerance and mental well-being, compared to usual care alone? The primary objective is to compare endurance walking distance at 12-months in those who have completed the maintenance programme compared to usual care. Research plan: The trial will be a prospective, randomised controlled trial with blinded quantitative outcomes. There will also be a nested qualitative study. Participants will be recruited from 2 acute hospital sites and assessed for eligibility on completion of a PR programme. Willing participants will be consented and randomised to receive either best usual care or the novel maintenance intervention for 12-months. Those randomised to usual care will receive standard advice at the end of their PR programme, including referral to a community exercise programme if available and/ or desired. Those randomised to the intervention will join a group of 5-10 other patients and be introduced to the SPACE FOR COPD maintenance programme by a trained health care professional. Patients will receive a SPACE FOR COPD manual to follow independently at home, with telephone support and be required to attend further group sessions over 12-months (4 group sessions in total). The aims of these groups are not to re-provide rehabilitation, but to discuss progress, address barriers and to increase motivation to maintain healthy lifestyle behaviours (e.g. exercise). Blinded outcomes will be measured at 6 and 12-months and include: exercise capacity, quality of life, mood, physical activity, symptoms and patient activation. Semi-structured, face-to-face interviews with patients and focus groups with staff will be conducted. We will explore patients' experiences of the maintenance programme, identifying barriers and facilitators to maintenance and to examine whether the sense of abandonment is lessened. For staff, the purpose of the focus groups is to discover the relative burden and benefits of this new intervention to their service. In addition, we will collect data on health resource use for health economic analysis. Benefits to patients and the NHS: We propose a structured and supportive maintenance package to lessen the feeling of 'abandonment' following rehabilitation. For patients, we anticipate that the benefits experienced in the initial PR programme (i.e. improved physical and mental well-being) will be sustained at 12-months. In addition, the peer support element of the maintenance programme will increase confidence and help motivate patients to continue healthy lifestyle behaviours e.g. exercise and exacerbation prevention. This has the potential to reduce the demand for repeat PR programmes and hospital readmissions; thus, saving the health service money.

Lay abstract: Chronic obstructive pulmonary disease describes a group of lung conditions that make it difficult to empty air out of the lungs because the airways are narrowed. Patients suffer from shortness of breath and tend to avoid activities which make them breathless, causing muscles to waste and weaken. An added problem is that patients often have repeated chest infections, some requiring hospital admission. This is detrimental for the patient and costly for the health service. Pulmonary Rehabilitation is a package of supervised exercise and education which is known to improve physical and mental well-being, as well as preventing hospital admissions in patients with COPD. However the benefits of rehabilitation do not last and patients talk about a feeling of abandonment at the end of the programme. The aim of this research is to test a new maintenance (on-going support) programme for patients with COPD. In this study, we will divide people into 2 groups at the end of rehabilitation. One group will receive best usual care including referral to a community exercise programme if wanted. The second group will receive best usual care plus the new maintenance programme. In this programme, patients will work through a booklet and attend group sessions for 12-months. All patients will do several tests over 12-months to measure physical and mental well-being. We will also interview patients and staff about their experiences and measure the costs of the programme. If successful, the new maintenance programme has the potential to preserve and enhance the benefits of rehabilitation for the patient. This may reduce hospital admissions, saving the health service money. This study was developed in response to patient feedback and with the support of patient representatives. The findings of the study will be announced at conferences, in publications and at patient groups.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: RESPIRATORY