Effect of Education and Respiratory Rehabilitation on Quality of Life in COPD Patients (EDUEPOC)

Effect of a Joint Program of Health Education and Respiratory Rehabilitation on the Health-related Quality of Life of Patients With Chronic Obstructive Pulmonary Disease and History of Exacerbation

In patients with COPD and a history of recent exacerbation, to compare the quality of life after completing a joint program of health education and respiratory rehabilitation with those patients who only receive respiratory rehabilitation. To compare lung function, the distance traveled in the 6-minute walk test and in the test of the shuttle between both groups. Also, to compare between both groups adherence to inhaled treatment, physical activity, and emotional condition. Finally, to compare the number of visits to emergencies and hospitalizations, and on the other hand, the number of mild, moderate and severe exacerbations between both groups

Study Overview

• Status: Unknown
• Conditions: COPD
• Intervention / Treatment: Behavioral: Education program

Detailed Description

In this trial we selected COPD patients with a history of recent exacerbation to be submitted to a respiratory rehabilitation program with or without a individualized program of health education. We try to demonstrate a better improvement in the quality of life after completing a joint program of health education and respiratory rehabilitation in this patients than those one who only receive respiratory rehabilitation. We also want to demonstrate an improvement in lung function, the distance travelled in the 6-minute walk test and in the test of the shuttle, the adherence to inhaled treatment, the physical activity, the emotional condition, the number of visits to emergencies and hospitalizations and the number of mild, moderate and severe exacerbations between both groups.

• Study Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carlos Javier Carpio, Dr; Phone Number: + 34 647267124; Email: carlinjavier@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age over 30 years.
• COPD diagnosis according to GesEPOC criteria (FEV 1 / FVC greater 0.7).
• Smoker or ex-smoker with a cumulative consumption of more than 10 packages per year.
• Exacerbation of COPD diagnosed in the last 15 days.

Exclusion Criteria:

• Impossibility of obtaining informed consent.
• Osteoarticular, neuromuscular or cognitive limitation.
• Diagnosis of active neoplastic disease, except epidermoid carcinoma of skin.
• Patient with limitation or difficulty to go to the rehabilitation unit to complete the training program.
• Participation in another study / trial in the previous 6 months.
• Have participated in a respiratory rehabilitation program the previous year (12 previous months).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control; Current clinical management
ACTIVE_COMPARATOR: Structured health education program; Patient will be referred to a specific consultation to carry out this intervention.	Behavioral: Education program; The education sessions will be given in 3 opportunities (15-30, 45 and at 90 days from diagnosis of the exacerbation) and it will be individualized. The program will include measures of self-care and self-management recommended in patients with COPD: Plan of action in an exacerbation.; Education related to COPD.; Information on pharmacological medication.; Management of the exacerbation.; Management of stress and / or anxiety.; Nutritional recommendations.; Physical exercise recommendations.; Healthy lifestyle recommendations. The first session will last 90 minutes and will be explain according to the contents of the manual "Controlling COPD". A presentation designed for this purpose will be displayed and this manual will be provided to patients to carry out their reading at home. The second and third sessions will last 15 minutes and the purpose will be to resolve doubts.; Other Names: Behavioral management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life after 6 months of education	To compare the quality of life related to health measured by the Saint George respiratory questionnaire after 6 months between patients who received health education and those who did not receive it.	Six months
Quality of life after 6 months of education	To compare health relate quality of life measured by the EuroQoL questionnaire, after 6 months between patients who received health education and those who did not receive it.	Six months
Quality of life after 6 months of education	To compare health relate quality of life measured by COPD Assessment Test (CAT) after 6 months between patients who received health education and those who did not receive it.	Six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulmonary function after 6 months of education	To compare pulmonary function measured by spirometry after 6 months between patients who received health education and those who did not receive it.	Six months
Distance traveled in the 6-minute walk test and in the shuttle walking test after 6 months of education	To compare the distance traveled in the 6-minute walk test and in the shuttle walking test after 6 months between patients who received health education and those who did not receive it.	Six months
Adherence to inhaled treatment after 6 months of education	To compare adherence to inhaled treatment after 6 months between patients who received health education and those who did not receive it.	Six months
Physical activity of patients after 6 months of education	To compare the physical activity of patients measured by International Physical Activity Questionnaire (IPAQ) after 6 months between patients who received health education and those who did not receive it.	Six months
Physical activity of patients after 6 months of education	To compare the physical activity of patients measured by an accelerometer after 6 months between patients who received health education and those who did not receive it.	Six months
Emotional state of patients after 6 months of education	To compare the emotional state of patients measured by Hospital Anxiety and Depression Scale (HADS) after 6 months between patients who received health education and those who did not receive it.	Six months
Number of visits to the emergency department, number of hospital admissions and days of hospital admission of patients after 6 months of education	To compare the number of visits to the emergency department, the number of hospital admissions and the days of hospital admission after 6 months between patients who received health education and those who did not receive it.	Six months
Number of mild, moderate and severe exacerbations of patients after 6 months of education	To compare the number of mild, moderate and severe exacerbations after 6 months between patients who received health education and those who did not receive it.	Six months

Collaborators and Investigators

• Sponsor: Instituto de Investigación Hospital Universitario La Paz
• Collaborators: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): April 1, 2019
• Primary Completion (ANTICIPATED): April 1, 2020
• Study Completion (ANTICIPATED): May 1, 2020

Study Registration Dates

• First Submitted: March 22, 2019
• First Submitted That Met QC Criteria: March 22, 2019
• First Posted (ACTUAL): March 25, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 25, 2019
• Last Update Submitted That Met QC Criteria: March 22, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: PI-3534

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No