How much a recuperative primary care intervention affects the evolution of patients with chronic obstructive pulmonary disease

Abstract

Objectives. The main objective is to assess the effect of a respiratory rehabilitation programme on the quality of life of patients with COPD. Secondary aims are to determine whether the intervention, as against the habitual monitoring, improves tolerance to exercise and pulmonary function, and reduces dyspnoea, the number of crises and hospital admissions due to COPD and the medication used to control the disease. Design. Pragmatic cluster-randomised clinical trial. Setting. Clinics of 16 PC teams in various health areas of the Community of Madrid. Participants. 476 patients with light-moderate COPD, who sign their informed consent. Variables. Quality of life, number of crises, packages of medicines used to control the disease, unscheduled attendance, pulmonary function, dyspnoea and tolerance to exercise. Method. The consultations will be assigned to the control and intervention groups at random. At each clinic there will be a randomised selection from all patients with COPD and in a stable clinical condition. 238 patients are needed in each group, in order to detect a minimum difference of 4 points in quality of life, assuming a standard deviation of 16, 95% confidence level, 80% power and 20% losses. The effect between each factor and the variables evaluated through multivariate analysis will be calculated. Discussion. This research project aims to show that a basic recuperative intervention, which is feasible and primary care-based, can achieve improvements in the quality of life of patients with COPD.