Estimation of the VQ11 Auto-questionnaire, to Follow Patients With Chronic Obstructive Pulmonary Disease
- Conditions
- COPD
- Interventions
- Other: VQ11 validation
- Registration Number
- NCT01651676
- Lead Sponsor
- Centre Hospitalier Universitaire, Amiens
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 57
- COPD patient with stage II, III ou IV justifying a LABD
- Patient in stable state (without exacerbation in the previous 6 weeks)
- Clinical criteria: dyspnoea stage I ou more (MMRC scale)
- Adult over 18 years old.
- Patients naïve from LABD treatment.
- Other associated pathology (bronchiectasia...)
- Heart disorder with a prevailing role in the dyspnoea
- Cardiac decompensation in the previous year
- Pregnancy and lactating
- Women in genital activity without efficient contraception method (IUD or estrogen-progestin pill)
- Lack of social insurance
- Patient non compliant to protocol, at the investigator's appreciation
- Simultaneous participation to other clinical trial.
- adult under judicial protection (tutor or curator).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description COPD arm VQ11 validation VQ11 validation: Stage II, III or IV COPD patients justifying a LABD will benefit from the studied VQ11 questionnaire
- Primary Outcome Measures
Name Time Method VQ11 score V1 (at baseline), V2 (3 months after V1) 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).
- Secondary Outcome Measures
Name Time Method RFE V1 (at baseline), V2 (3 months after V1) Respiratory functional exploration (RFE) performed at rest (plethysmography) before and three months after LABD treatment initiation.
VQ11 and visual analogical scale regarding daily activity V1 (at baseline), V2 (3 months after V1) To estimate the daily activity by a dedicated visual analogical scale. Variations between the two visits will be analysed in correlation to VQ11 changes.
Likert scales V2 (3 months after V1) To estimate the evolution of dyspnoea and the daily activity by Likert scale.
Saint George's Respiratory Questionnaire V1 (at baseline), V2 (3 months after V1) 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.
VQ11 sub-scores V1 (at baseline), V2 (3 months after V1) 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
Bi-directional visual analogical scale regarding dyspnoea V2 (3 months after V1) To estimate the evolution of dyspnoea since the LABD initiation.
Bi-directional visual analogical scale regarding daily activity V2 (3 months after V1) To estimate the evolution of daily activity since the LABD initiation.
VQ11 and visual analogical scales regarding dyspnoea V1 (at baseline), V2 (3 months after V1) To estimate the dyspnoea by a dedicated visual analogical scale. Variations between the two visits will be analysed in correlation to VQ11 changes.
Dyspnoea evolution assessed by mMRC V1 (at baseline), V2 (3 months after V1) 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).
Trial Locations
- Locations (15)
Clinique de l'Europe
🇫🇷Amiens, France
CHU Amiens Nord
🇫🇷Amiens, France
CHU Amiens Sud
🇫🇷Amiens, France
Centre Hospitalier de Chauny
🇫🇷Chauny, France
Centre Médical
🇫🇷Le Havre, France
CHRU de Lille
🇫🇷Lille, France
Hopital Jacques MONOD
🇫🇷Le Havre, France
Centre hospitalier de St Quentin
🇫🇷Saint Quentin, France
Hopital Maison Blanche
🇫🇷Reims, France
Zac Gouraud
🇫🇷Soissons, France
Résidence Saint Michel
🇫🇷Valenciennes, France
Centre Hospitalier de Compiègne
🇫🇷Compiegne, France
CH Creil
🇫🇷Creil, France
CH de DOUAI
🇫🇷Douai, France
CHU de Rouen
🇫🇷Rouen, France