French Linguistic and Metric Validations of Parent-proxy QOL Chronic Cough Specific Questionnaire (PC-QOL)

Chronic Cough Clinical Trial

— PC-QOL  

Official title:

French Linguistic and Metric Validations of Parent-proxy QOL Chronic Cough Specific Questionnaire (PC-QOL)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01865422
• Other study ID #: 2012-A01548-35
• Secondary ID: 2012-42
• Status: Completed
• Phase: N/A
• First received: May 27, 2013
• Last updated: August 29, 2014
• Start date: May 2013
• Est. completion date: June 2014

Study information

• Verified date: August 2014
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial Summary

Cough is one of the most common reasons for consultation. Even if cough is a non-specific symptom, it can be the first sign of a chronic pathology. Several studies have demonstrated that chronic cough causes quality-of-life (QoL) impairment. Physicians' incapability to evaluate cough impact and patients' QoL has been documented. Therefore, a parent-proxy QoL chronic cough specific questionnaire (PC-QOL) has been developed and validated by Chang A. B.

Objective : The aim of the study is to validate the French version of the PC-QoL, a parent-proxy QoL chronic cough specific questionnaire.

Methods : Linguistic validation will be performed using backward/forward translation guidelines, and cognitive debriefing by 10 parents. Psychometric validation will be tested in 150 patients. Inclusion criteria are: patients with a diagnosis of chronic cough (> 4 weeks); 18 years of age or younger; all etiologies excepting cystic fibrosis. Informed consent from parents will be obtained. At enrollement, each parent will fulfill the PC-QOL questionnaire and two cough-related measures (visual analogue score, verbal category descriptive). Clinical data (medical history, physical examination) will be collected. Children QoL will be assessed using VSPA, Kidscreen and Qualin questionnaires. For assessing reproductibility and sensitivity to change, parents will be retested 7 and 21 days later. Content validity, construct's validity, external validity and instrument's reliability will be explored.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 17 Years

Eligibility

Inclusion Criteria:

Old under age 18

• Male or feminine

• Reached(Affected) by chronic cough ( more than 4 weeks), any confused(merged) étiologie

• Affiliated to a national insurance scheme

• Having given freely their written consent having been informed about the purpose, about the progress and about the incurred potential risks

Exclusion Criteria:

Patients of whom the parents(relatives) are incapable to understand(include) the purpose and the conditions of realization of the study, incapable to give their consent

• Patient whose membership(support) to the protocol is improbable according to the investigator

• Patient participant in another clinical trial or in period of exclusion from a previous clinical trial

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Chronic Cough
• Cough

Intervention

Other:
• parent-proxy QoL chronic cough specific questionnaire (PC-QOL)

Locations

Country	Name	City	State
France	Assistance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	parent-proxy QoL chronic cough specific questionnaire (PC-QOL)		12 months	No