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.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- COPD
- Sponsor
- Centre Hospitalier Universitaire, Amiens
- Enrollment
- 57
- Locations
- 15
- Primary Endpoint
- VQ11 score
- Status
- Completed
- Last Updated
- 5 months ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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).
Outcomes
Primary Outcomes
VQ11 score
Time Frame: 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 Outcomes
- RFE(V1 (at baseline), V2 (3 months after V1))
- VQ11 and visual analogical scale regarding daily activity(V1 (at baseline), V2 (3 months after V1))
- Likert scales(V2 (3 months after V1))
- Saint George's Respiratory Questionnaire(V1 (at baseline), V2 (3 months after V1))
- VQ11 sub-scores(V1 (at baseline), V2 (3 months after V1))
- Bi-directional visual analogical scale regarding dyspnoea(V2 (3 months after V1))
- Bi-directional visual analogical scale regarding daily activity(V2 (3 months after V1))
- VQ11 and visual analogical scales regarding dyspnoea(V1 (at baseline), V2 (3 months after V1))
- Dyspnoea evolution assessed by mMRC(V1 (at baseline), V2 (3 months after V1))