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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Education program | Behavioral | 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:
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carlos Javier Carpio, Dr | Contact | + 34 647267124 | carlinjavier@hotmail.com |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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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.
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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 |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011314 | Preventive Health Services |