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

March 22, 2019 updated by: Instituto de Investigación Hospital Universitario La Paz

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
66

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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:

  1. Plan of action in an exacerbation.
  2. Education related to COPD.
  3. Information on pharmacological medication.
  4. Management of the exacerbation.
  5. Management of stress and / or anxiety.
  6. Nutritional recommendations.
  7. Physical exercise recommendations.
  8. 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Quality of life after 6 months of education
Time Frame: Six months
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
Time Frame: Six months
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
Time Frame: Six months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pulmonary function after 6 months of education
Time Frame: Six months
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
Time Frame: Six months
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
Time Frame: Six months
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
Time Frame: Six months
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
Time Frame: Six months
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
Time Frame: Six months
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
Time Frame: Six months
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
Time Frame: Six months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Instituto de Investigación Hospital Universitario La Paz

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2019

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2020

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 22, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings