Structured Comprehensive Intervention to Stimulate Self- Management and Improve Quality of Life in COPD Patients

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Status

Unknown

Conditions

Chronic Obstructive Pulmonary Disease

Treatments

Behavioral: COPD structured self-management plan.

Study type

Interventional

Funder types

Other

Identifiers

NCT03762330

P17/055

Details and patient eligibility

About

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.

Full description

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.

Enrollment

300 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with at least one visit at the primary care physician during the past year
Patients with a diagnosis of moderate (FEV1 50% - 80%) or severe (FEV1 30% - 50%) COPD
Patients treated with inhaled bronchodilators and accepting to participate in the study.

Exclusion criteria

Patients unable to come to the primary care centre
Patients with cognitive impairment and/or a severe mental condition.
Patients with a diagnosis of asthma, tuberculosis or other chronic respiratory disease.
Patients needing chronic oxygen therapy.
Patients with any terminal disease