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

NCT01865422 | Completed

• 2 other identifiers: 2012-A01548-352012-42
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Cough

Outcome Measures

Primary Outcomes (1)

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

  12 months

Study Arms (1)

chronic cough

EXPERIMENTAL

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

Interventions

parent-proxy QoL chronic cough specific questionnaire (PC-QOL) OTHER

chronic cough

Eligibility Criteria

• Age: 28 Days - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Location

MeSH Terms

Conditions

Chronic Cough

Condition Hierarchy (Ancestors)

Cough; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• LOIC MONDOLONI

  Assistance Publique Hopitaux De Marseille

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2013
• First Posted: May 30, 2013
• Study Start: May 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: June 1, 2014
• Last Updated: September 1, 2014

Record last verified: 2014-08

Locations

FR (1)