NCT01651676

Estimation of the VQ11 Auto-questionnaire, to Follow Patients With Chronic Obstructive Pulmonary Disease

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Centre Hospitalier Universitaire, Amiens · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• COPD

Interventions

Type	Name	Description
OTHER	VQ11 validation	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.

Timeline

• Start date: 2013-02-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2012-07-27
• Last updated: 2025-11-19

Locations

17 sites across 1 country: France