Clinical Trials Directory

Trials / Completed

CompletedNCT01865422

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
120 (actual)
Sponsor
Assistance Publique Hopitaux De Marseille · Academic / Other
Sex
All
Age
28 Days – 17 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
OTHERparent-proxy QoL chronic cough specific questionnaire (PC-QOL)

Timeline

Start date
2013-05-01
Primary completion
2014-05-01
Completion
2014-06-01
First posted
2013-05-30
Last updated
2014-09-01

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT01865422. Inclusion in this directory is not an endorsement.