-
Randomized Controlled Trial Clinical Trial
[Effectiveness of a recuperative primary care intervention in patients with chronic obstructive pulmonary disease].
- J Molina París, C Molina París, P de Lucas Ramos, M A Lobo Alvarez, E Calvo Corbella, and G Lumbreras García.
- EAP Francia I, Fuenlabrada, Madrid, Spain. jmolinap@jazzfree.com
- Aten Primaria. 2005 Jun 15; 36 (1): 394439-44.
ObjectivesThe 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.DesignPragmatic cluster-randomised clinical trial.SettingClinics of 16 PC teams in various health areas of the Community of Madrid.Participants476 patients with light-moderate COPD, who sign their informed consent.VariablesQuality of life, number of crises, packages of medicines used to control the disease, unscheduled attendance, pulmonary function, dyspnoea and tolerance to exercise.MethodThe 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.DiscussionThis 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.
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