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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 57
- 试验地点
- 32
- 主要终点
- VQ11 score
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
COPD arm
VQ11 validation:
Stage II, III or IV COPD patients justifying a LABD will benefit from the studied VQ11 questionnaire
干预措施: VQ11 validation (Other)
结局指标
主要结局
VQ11 score
时间窗: 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).
次要结局
- 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))