Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Effect of a Structured Comprehensive Intervention to Stimulate Self- Management and Improve Quality of Life in People With Chronic Obstructive Pulmonary Disease(COPD). A Randomised Clinical Trial.
This study evaluates the effect of of a structured self-management intervention plan in patients with chronic obstructive pulmonary disease in primary care setting.Half of the participants will receive the self-management plan while the other half will receive usual care.
Chronic Obstructive Pulmonary Disease (COPD) is a great magnitude public health problem with
an associated increased mortality and a high cost (consumption of health care resources and
loss of health related quality of life (HRQoL)). The comprehensive approach to this complex
disease, focusing self-care promotion, improves HRQoL and the patients‟ clinical status, as
shown by several studies, although further investigation is needed to confirm these results
in the field of Primary Care (PC) and to formulate clear recommendations on the more
effective type of intervention.
Hypothesis: In (moderate-severe) COPD patients, a structured self-management intervention
plan in the setting of primary care, is more effective than usual treatment on the main
outcomes associated with the disease: HRQoL, lung function, exacerbations and hospital
admissions, at 6, 12 and 24 months of follow-up.
Objectives: To evaluate the impact of a comprehensive intervention plan to promote self-care
and improve HRQoL in people with COPD in PC.
Methods: Multicenter randomized controlled trial, conducted at PC centers in Barcelona.
Determinations: Specific standardized and validated questionnaires, as the St George's
Respiratory for the HRQoL. Statistical analysis: Intention to treat analysis. Descriptive
statistics of the variables of the intervention and the control group to assess their
homogeneity at the beginning of the study. An analysis of variance (ANOVA) will be used to
assess differences among intervention groups.
Expected results: A significant improvement in HRQoL attributable to the intervention
performed in patients with COPD Applicability and Relevance: To implement the intervention
plan in clinical practice and to standardize its content.
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