Structured Comprehensive Intervention to Stimulate Self- Management and Improve Quality of Life in COPD Patients
NCT ID: NCT03762330
Last Updated: 2020-07-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
300 participants
INTERVENTIONAL
2019-01-19
2021-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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COPD structured self-management plan
Participants will receive usual care for COPD and in addition, a structured self-management education plan.
COPD structured self-management plan.
Education plan , including knowledge of the disease, healthy life habits, correct use of inhalers, skills to control symptoms and strategies to face the disease and exacerbations
Usual care
COPD participants receiving only usual care
No interventions assigned to this group
Interventions
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COPD structured self-management plan.
Education plan , including knowledge of the disease, healthy life habits, correct use of inhalers, skills to control symptoms and strategies to face the disease and exacerbations
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Institut Catala de Salut
OTHER_GOV
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
OTHER
Responsible Party
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Principal Investigators
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Maite Lopez Luque
Role: PRINCIPAL_INVESTIGATOR
Servei Catala de la Salut
Locations
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EAP Montcada i Reixac
Barcelona, , Spain
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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P17/055
Identifier Type: -
Identifier Source: org_study_id
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