COPDEDUEPOCNCT03889054
Effect of Education and Respiratory Rehabilitation on Quality of Life in COPD Patients
A study testing Education program in people with COPD, run by Instituto de Investigación Hospital Universitario La Paz.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Education program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2019to 1 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
Read the 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.
- Conditions
- COPD
- Being tested
- Education program
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education programBehavioural
Also called Behavioral management
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Current clinical management |
| Structured health education program | Active comparator | Patient will be referred to a specific consultation to carry out this intervention. Receives: Behavioral: Education program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Six months
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2019
- Study start1 Apr 2019 (estimated)
- Primary completion1 Apr 2020 (estimated)
- Study completion1 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized and parallel clinical trial of 66 patients (33 with health education associated with respiratory rehabilitation and 33 only with respiratory rehabilitation). There will be a follow-up of 6 months and 4 visits.
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03889054
- Sponsor's protocol ID
- PI-3534
- Acronym
- EDUEPOC
- Status last verified
- Mar 2019
- First submitted
- 22 Mar 2019
- Last updated
- 25 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03889054
- Acronym / sponsor ID
- EDUEPOC / PI-3534
- Conditions
- COPD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Instituto de Investigación Hospital Universitario La PazUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- 1 Apr 2019 (estimated)
- Primary completion
- 1 Apr 2020 (estimated)
- Study completion
- 1 May 2020 (estimated)
- First posted
- 25 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized and parallel clinical trial of 66 patients (33 with health education associated with respiratory rehabilitation and 33 only with respiratory rehabilitation). There will be a follow-up of 6 months and 4 visits.
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Current clinical management |
| Structured health education program | Active comparator | Behavioral: Education programPatient will be referred to a specific consultation to carry out this intervention. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Education programAlso: Behavioral managementThe 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. | Behavioural | Structured health education program |
Primary outcome
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.
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.
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.
8 secondary outcomes
Pulmonary function after 6 months of education
Time frame: 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
Adherence to inhaled treatment after 6 months of education
Time frame: Six months
Physical activity of patients after 6 months of education
Time frame: Six months
Physical activity of patients after 6 months of education
Time frame: Six months
Emotional state of patients after 6 months of education
Time frame: 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
Number of mild, moderate and severe exacerbations of patients after 6 months of education
Time frame: Six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Education program in people with COPD, run by Instituto de Investigación Hospital Universitario La Paz.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carlos Javier Carpio, Dr (+ 34 647267124, carlinjavier@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life after 6 months of education (time frame: Six months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2019.