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

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.

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.

Study Overview

• Status: Completed
• Conditions: COPD
• Intervention / Treatment: Other: VQ11 validation

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

• Study Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80000
    • Clinique de l'Europe
  • Amiens, France, 80054
    • CHU Amiens Sud
  • Amiens, France, 80054
    • CHU Amiens Nord
  • Chauny, France, 02300
    • Centre Hospitalier de Chauny
  • Compiegne, France, 60200
    • Centre Hospitalier de Compiegne
  • Compiegne, France, 60200
    • Centre Médical
  • Creil, France, 60109
    • CH Creil
  • Denain, France, 59220
    • Centre Médical
  • Douai, France, 59507
    • CH de DOUAI
  • Le Havre, France, 76083
    • Hopital Jacques Monod
  • Le Havre, France, 76600
    • Centre Médical
  • Lille, France, 59037
    • CHRU de Lille
  • Reims, France, 51092
    • Hôpital Maison Blanche
  • Rouen, France, 76000
    • CHU de Rouen
  • Saint Quentin, France, 02321
    • Centre Hospitalier de St Quentin
  • Soissons, France, 02200
    • Zac Gouraud
  • Valenciennes, France, 59300
    • Résidence Saint Michel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: COPD arm; VQ11 validation: Stage II, III or IV COPD patients justifying a LABD will benefit from the studied VQ11 questionnaire	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	V1 (at baseline), V2 (3 months after V1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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	V1 (at baseline), V2 (3 months after V1)
Likert scales	To estimate the evolution of dyspnoea and the daily activity by Likert scale.	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.	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.	V2 (3 months after V1)
Bi-directional visual analogical scale regarding daily activity	To estimate the evolution of daily activity since the LABD initiation.	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.	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).	V1 (at baseline), V2 (3 months after V1)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Investigators: Principal Investigator: Charles DAYEN, MD, University Hospital of Amiens

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: June 29, 2012
• First Submitted That Met QC Criteria: July 26, 2012
• First Posted (Estimate): July 27, 2012

Study Record Updates

• Last Update Posted (Actual): August 10, 2018
• Last Update Submitted That Met QC Criteria: August 9, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: COPD; VQ11 questionnaire; LBD
• Other Study ID Numbers: PI2011_843_0006; 2011-A01653-38 (Other Identifier: ID-RCB)