Validity of a French Version of the Severe Asthma Questionnaire

NCT04520633 | Completed

• 2 other identifiers: APHP2008182020-AO1394-35
• Study Type: observational
• Target: 188
• Locations: 1 country
• Sites: 1

Brief Summary

"Severe asthma affects only 5% of asthmatics, but has a considerable impact on patients owing to the respiratory disability linked to asthma but also complications from oral corticosteroid (OCS) therapy. Biologics have recently been made available, and improve quality of life (QoL)severe asthma patients. Having a reproducible and reliable measuring tool of QoL for severe asthmatics would be useful for assessing the impact of the various interventions proposed. QoL questionnaires currently used in respiratory diseases are not specific to severe asthma. They are very focused on respiratory disability, but for example do not take into account the impact of treatments, especially oral steroids. The Severe Asthma Questionnaire (SAQ) is the very first tool specifically designed to assess the health related quality of life of severe asthma population. The development of its use goes through the validation of this questionnaire in its French translation available since September 2019. "

Conditions

Asthma

Keywords

severe asthma; quality of life questionnaire

Outcome Measures

Primary Outcomes (3)

• Factorial validity of french traduction of SAQ (Severe Asthma Questionnaire )

  Factorial validity (evidence that the instrument measures a single concept): principal component analysis of all items

  1 month

• Internal consistency of french traduction of SAQ

  Internal consistency (intercorrelation of items that contribute to a score): Item total correlation and Cronbach's alpha coefficient

  1 month

• Construct validity of french traduction of SAQ

  Construct validity (strength of correlation testing a priori hypotheses (discriminant and convergent validity) and degree to which the PRO instrument can distinguish among groups hypothesized a priori to be different (known groups validity)): Spearman correlation between SAQ and ACT\*, ACQ\*, miniAQLQ\*, SGRQ\*, SF36\*, EQ 5D 5L\*, EQ 5D VAS\*, OCS dose, Forced expiratory volume in 1s (FEV1)) * ACT: Asthma Control Test i * ACQ: Asthma Control Questionnaire * MiniAQLQ: Mini Asthma Quality of Life Questionnaire * SGRQ: Saint Georges Respiratory Questionnaire * SF36: 36-item Short-Form Health Survey * EQ 5D 5L: 5Level-EuroQualityoflife Instrument 5 Dimension * EQ 5D VAS: EuroQol Visual Analogue Scale

  1 month

Secondary Outcomes (4)

• Usability testing

  6 months

• Test-retest reliability

  6 months

• Ability to detect change

  6 months

• Minimal Clinically Important Difference (MCID)

  6 months

Study Arms (2)

control level stable

severe asthma for which the control level is stable (variation in ACT score \<3 between M0 and M6) contributing to the test-retest

biologic initiation

introduction or modification of biotherapy at M0

Other: biologic initiation

Interventions

biologic initiation OTHER

introduction or modification of biotherapy at M0

biologic initiation

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with severe asthma

You may qualify if:

• Adult patients
• Patients diagnosed with severe asthma as defined by the international consensus statement from European Respiratory Society and American Thoracic Society 2014: Asthma which requires treatment for GINA steps 4-5 asthma (high dose Inhaled Cortico Steroids \> 1000 micrograms and Long Action Beta Agonist or leukotriene or theophyllin modifier ) for the previous year
• \*or systemic CorticoSteroids for 50% of the previous year to prevent it from becoming ''uncontrolled'' or which remains ''uncontrolled'' despite this therapy
• Patient informed and not opposed to participating

You may not qualify if:

• Lung cancer, heart failure or Chronic Obstructive Pulmonary Disease, or other respiratory disease that may affect the evaluation of asthma
• Patient unable to read French
• Patient unwilling to take part in the research
• Patient under guardianship / curators
• Patient under AME

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Bichat-Claude Bernard University Hospital

Paris, 75018, France

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Camille Taillé, MD-PHD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: August 20, 2020
• Study Start: November 17, 2020
• Primary Completion: July 6, 2023
• Study Completion: July 6, 2023
• Last Updated: December 15, 2023

Record last verified: 2023-12

Locations

FR (1)