P51 PILOT RANDOMISED CONTROLLED TRIAL OF A 7-WEEK DISEASE-SPECIFIC SELF-MANAGEMENT PROGRAMME FOR PATIENTS WITH COPD: BELLA (BETTER LIVING WITH LONG TERM AIRWAYS DISEASE STUDY)

S. J. C. Taylor, R. Sohanpal, S. A. Bremner, A. Devine, S. Eldridge, C. J. Griffiths. Barts and The London School of Medicine, Queen Mary, University of London, London, UK

Introduction Trials of self-management (SM) interventions for chronic obstructive pulmonary disease (COPD) have often had disappointing results. A recent Cochrane review suggested SM may reduce hospital admissions but concluded data are still insufficient to formulate recommendations.1

Objectives To conduct a pilot randomised controlled trial of a new disease-specific self-management programme for COPD.

Methods The intervention was based on the UK Expert Patients Programme (EPP) which is underpinned by the sociocognitive self-efficacy theory.2 It was distinct in three ways: (1) COPD relevant content; (2) sessions delivered by a trained lay tutor with COPD who “models” good SM; (3) involvement of a respiratory clinician (COPD patients have significant information needs). It involved seven weekly 2.5 h group sessions. Patients were recruited from primary care disease registers and randomised (2:1) to intervention or usual care. The St George Respiratory Questionnaire (SGRQ), Hospital Anxiety and Depression Scale (HADS), EQ-5D, exercise levels and self-efficacy (confidence) to manage COPD were collected at baseline, 2 and 6 months, as were all costs and healthcare resource use.

Results 224 (44%) patients replied to invitation letters and 116 (22%) were enrolled and randomised (78 intervention; 38 control). 46% were male, mean±SD age 69.5±9.8 years, mean forced expiratory volume in 1 s (FEV₁)% predicted 54%, 78% had had unscheduled COPD care in the previous 12 months. Groups were roughly similar at baseline. 35% of intervention patients did not attend any course sessions, 40% attended 5 or more sessions. The results at 6 months suggest that the intervention may increase exercise levels by a modest amount and increase health-related quality of life as measured by the EQ-5D (no overall effect on Total SGRQ score was detected) (table 1). Economic analyses suggested that, with a willingness to pay threshold of £10 000 per quality adjusted life year gained (QALY), the intervention would have a 70% probability of being cost effective.

Conclusions The intervention may be unappealing or inaccessible to many patients. Despite this, the pilot study suggests the intervention may improve quality of life and is likely to meet NICE criteria for a cost-effective intervention.

P52 RANDOMISED CONTROLLED TRIAL OF A SELF-MANAGEMENT PROGRAMME OF ACTIVITY, COPING AND EDUCATION (SPACE) FOR COPD

¹L. D. Apps, ²K. Wagg, ²L. Sewell, ²J. Williams, ¹S. J. Singh, ²S. J. Singh. ¹Coventry University, Coventry, UK, ²University Hospitals of Leicester, Leicester, UK

Self-management programmes in chronic obstructive pulmonary disease (COPD) have been explored with some positive results. However, the recent Cochrane Review (2007) concluded that, while there is some evidence for self-management education, further research was required to provide clear guidelines about its use. This study is a randomised controlled trial conducted in primary care to determine the effectiveness of a stand alone self-management manual for COPD (SPACE for COPD, A Self-management Programme of Activity, Coping & Education) compared with usual care.

Participants were recruited from primary care registers and randomised to usual care or self-management. The primary outcome measure was health status (Self-Reported Chronic Respiratory Questionnaire (CRQ-SR)) measured at baseline and 6 weeks. Exercise performance (Incremental Shuttle Walking Test (ISWT) and Endurance Shuttle Walk Test (ESWT)) was recorded as well as scores on the Hospital Anxiety and Depression Scale (HADS).

To date, 36 patients have completed measures at 6 weeks, 19 from usual care (mean (SD) age 71.21 (9.17) years; forced expiratory volume in 1 s (FEV₁) 1.45 (0.49) l; 12 men) and 17 from self-management (mean (SD) age 65.41 (10.16) years; FEV₁ 1.53 (0.62) l; 8 men). Paired t tests were performed and the results are shown in table 1 for all outcome measures. There were statistically significant improvements in the self-management group for CRQ-SR domain of dyspnoea with a mean change of 0.74. There were no significant changes in the standard care group in all CRQ-SR domains of dyspnoea, fatigue, emotion and mastery. Mean changes were 0.41, 0.16, 0.23 and 0.10, respectively. Statistically significant between-group differences were found for ISWT (p<0.01), ESWT (p<0.001), CRQ emotion domain and anxiety (p<0.05). In addition, the CRQ domain of emotion attained the minimal clinically important threshold of >0.5.

This shows that it is feasible to deliver a self-management package in primary care as a stand alone manual, with significant improvements demonstrated in dyspnoea, exercise performance and anxiety.