Clinical trial NCT03762330: Structured Comprehensive Intervention to Stimulate Self- Management and Improve Quality of Life in COPD Patients
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: quality of life
self-management,
structured plan
COPD
Lead sponsor: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
Sponsor class: OTHER
Collaborators: name: Institut Catala de Salut
First posted: 2018-12-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Quality of life St. George´s Respiratory Questionnaire (SGRQ)
timeFrame: Change from baseline at 6 ,12 and 24 months
Secondary outcomes:
measure: Intensity of symptoms related to COPD
timeFrame: Change from baseline at 6 ,12 and 24 months
measure: Dyspnea score severity
timeFrame: Change from baseline at 6 ,12 and 24 months
measure: Changes in the Body mass index, Obstruction, Dyspnea, Exacerbations Index (BODEx index )
timeFrame: Change from baseline at 6 ,12 and 24 months
measure: Number of COPD exacerbations
timeFrame: at 6 ,12 and 24 months from baseline
measure: Number of hospital admissions due to COPD exacerbation
timeFrame: at 6 ,12 and 24 months from baseline
measure: Changes in Anxiety and depression scales
timeFrame: Change from baseline at 6 ,12 and 24 months
measure: Changes in forced vital capacity (FVC)
timeFrame: Change from baseline at 6 ,12 and 24 months
measure: Changes in forced expiratory volume at the first second (FEV1)
timeFrame: Change from baseline at 6 ,12 and 24 months
measure: Results of the Test of Adherence to Inhalers (TAI test)
timeFrame: Change from baseline at 6 ,12 and 24 months
measure: Use of long-acting beta-adrenergic bronchodilator in monotherapy
timeFrame: At baseline and at 6 ,12 and 24 months
measure: Use of long-acting anticholinergic bronchodilator in monotherapy
timeFrame: At baseline and at 6 ,12 and 24 months
measure: Use of a double therapy of long-acting beta-adrenergic bronchodilator and long-acting anticholinergic bronchodilator
timeFrame: At baseline and at 6 ,12 and 24 months
measure: Use of a double therapy of long-acting beta-adrenergic bronchodilator and short-acting anticholinergic bronchodilator
timeFrame: At baseline and at 6 ,12 and 24 months
measure: Use of a triple therapy of long-acting beta-adrenergic bronchodilator and long-acting anticholinergic bronchodilator plus inhaled steroids
timeFrame: At baseline and at 6 ,12 and 24 months
measure: Use of a triple therapy of long-acting beta-adrenergic bronchodilator and short-acting anticholinergic bronchodilator plus inhaled steroids
timeFrame: At baseline and at 6 ,12 and 24 months
measure: Use of Roflumilast
timeFrame: At baseline and at 6 ,12 and 24 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: EAP Montcada i Reixac
Study officials:
affiliation: Servei Catala de la Salut
name: Maite Lopez Luque
role: PRINCIPAL_INVESTIGATOR
References: