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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-A01653-38 | Other Identifier | ID-RCB |
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The purpose of this study is to estimate the capacity of the auto-questionnaire of quality of life, VQ11, to follow the evolution of patients with COPD (Chronic obstructive pulmonary disease) in stable state (without exacerbation in the previous 6 weeks) (3 months +/-15 days) during the implementation of a LABD (Long-acting bronchodilator) treatment.
The main objective is to compare the total Score of the VQ11 auto-questionnaire before and after LABD. A decrease of 5 points of the total score mimicking an improvement in the quality of life linked to health, specifically in the COPD.
Evaluation of the VQ11 auto-questionnaire of quality of life in pneumology investigation, during the implementation of a long-acting bronchodilator treatment of patients with COPD.
Two visits per patient are planned:
V1: After complete information and collection of the written consent, the pulmonologists ask the patients participating in the study to fill out the VQ11 questionnaire, 2 visual analogical scales concerning the dyspnoea and the physical activity, the short IPAQ version and the respiratory questionnaire of the Saint Georges hospital. RFE (respiratory functional exploration) is also realized during this medical exam.
V2 (3 months after the treatment setup, at day90 ± 15): the pulmonologists ask the patients participating in the study to fill out the VQ11 questionnaire, 2 visual analogical scales and Likert scales concerning the dyspnoea and the physical activity, the short IPAQ version and the respiratory questionnaire of the Saint Georges hospital. RFE (respiratory functional exploration) is also realized during this medical exam.
Inclusion period : 6 months; Study participation period / patient : 3 months; Complete study duration : 9 months
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COPD arm | Experimental | VQ11 validation: Stage II, III or IV COPD patients justifying a LABD will benefit from the studied VQ11 questionnaire |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VQ11 validation | Other | Two visits per patient are planned: V1 and V2. For each visit, the pulmonologists ask the patients participating in the study to fill out the VQ11 questionnaire, which will be correlated to the other parameters (Likert scale, IPAQ, RFE, SGRQ,...) LABD treatment consist in β 2 agonists or anticholinergic drug. |
| Measure | Description | Time Frame |
|---|---|---|
| VQ11 score | To compare changes of total Score of the VQ11 auto-questionnaire before and after LABD (decrease of 5 points of the total score mimicking an improvement in the quality of life linked to health, specifically in the COPD). | V1 (at baseline), V2 (3 months after V1) |
| Measure | Description | Time Frame |
|---|---|---|
| VQ11 and visual analogical scale regarding daily activity | To estimate the daily activity by a dedicated visual analogical scale. Variations between the two visits will be analysed in correlation to VQ11 changes. | V1 (at baseline), V2 (3 months after V1) |
| RFE |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles DAYEN, MD | University Hospital of Amiens | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique de l'Europe | Amiens | 80000 | France | |||
| CHU Amiens Nord |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | https://doi.org/10.1016/j.rmr.2015.10.647 Évaluation par auto-questionnaire de qualité de vie VQ11 de l'impact d'un traitement bronchodilatateur dans la BPCO en pratique pneumologique Revue des Maladies Respiratoires Volume 33, Supplement, January 2016, Page A34 |
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|
Respiratory functional exploration (RFE) performed at rest (plethysmography) before and three months after LABD treatment initiation. |
| V1 (at baseline), V2 (3 months after V1) |
| VQ11 sub-scores | To estimate the impact of an LABD treatment on patients with COPD before and three months after treatment initiation through the three sub-dimensions of the VQ11 questionnaire | V1 (at baseline), V2 (3 months after V1) |
| Likert scales | To estimate the evolution of dyspnoea and the daily activity by Likert scale. | V2 (3 months after V1) |
| VQ11 and visual analogical scales regarding dyspnoea | To estimate the dyspnoea by a dedicated visual analogical scale. Variations between the two visits will be analysed in correlation to VQ11 changes. | V1 (at baseline), V2 (3 months after V1) |
| Bi-directional visual analogical scale regarding dyspnoea | To estimate the evolution of dyspnoea since the LABD initiation. | V2 (3 months after V1) |
| Bi-directional visual analogical scale regarding daily activity | To estimate the evolution of daily activity since the LABD initiation. | V2 (3 months after V1) |
| Saint George's Respiratory Questionnaire | To estimate the impact of an LABD treatment on patients with COPD before and three months after treatment initiation using the SGRQ change between the two visits. | V1 (at baseline), V2 (3 months after V1) |
| Dyspnoea evolution assessed by mMRC | To estimate the impact of the LABD treatment on dyspnoea of patients with COPD before and three months after treatment initiation through the change of the Modified Medical Research Council dyspnoea scale (mMRC). | V1 (at baseline), V2 (3 months after V1) |
| Amiens |
| 80054 |
| France |
| CHU Amiens Sud | Amiens | 80054 | France |
| Centre Hospitalier de Chauny | Chauny | 02300 | France |
| Centre Hospitalier de Compiègne | Compiègne | 60200 | France |
| Centre Médical | Compiègne | 60200 | France |
| CH Creil | Creil | 60109 | France |
| Centre Médical | Denain | 59220 | France |
| CH de DOUAI | Douai | 59507 | France |
| Hopital Jacques MONOD | Le Havre | 76083 | France |
| Centre Médical | Le Havre | 76600 | France |
| CHRU de Lille | Lille | 59037 | France |
| Hopital Maison Blanche | Reims | 51092 | France |
| CHU de Rouen | Rouen | 76000 | France |
| Centre hospitalier de St Quentin | Saint-Quentin | 02321 | France |
| Zac Gouraud | Soissons | 02200 | France |
| Résidence Saint Michel | Valenciennes | 59300 | France |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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