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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SCREENING
Masking
NONE
Enrollment
57
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.
Clinique de l'Europe
Amiens, France
CHU Amiens Nord
Amiens, France
CHU Amiens Sud
Amiens, France
Centre Hospitalier de Chauny
Chauny, France
Centre Hospitalier de Compiègne
Compiègne, France
Centre Médical
Compiègne, France
CH Creil
Creil, France
Centre Médical
Denain, France
CH de DOUAI
Douai, France
Hopital Jacques MONOD
Le Havre, France
...and 7 more locations
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).
Time frame: V1 (at baseline), V2 (3 months after V1)
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.
Time frame: V1 (at baseline), V2 (3 months after V1)
RFE
Respiratory functional exploration (RFE) performed at rest (plethysmography) before and three months after LABD treatment initiation.
Time frame: 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
Time frame: V1 (at baseline), V2 (3 months after V1)
Likert scales
To estimate the evolution of dyspnoea and the daily activity by Likert scale.
Time frame: 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.
Time frame: 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.
Time frame: V2 (3 months after V1)
Bi-directional visual analogical scale regarding daily activity
To estimate the evolution of daily activity since the LABD initiation.
Time frame: 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.
Time frame: 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).
Time frame: V1 (at baseline), V2 (3 months after V1)
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