French Linguistic and Metric Validations of Parent-proxy QOL Chronic Cough Specific Questionnaire (PC-QOL) (PC-QOL)
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|ClinicalTrials.gov Identifier: NCT01865422|
Recruitment Status : Completed
First Posted : May 30, 2013
Last Update Posted : September 1, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Cough||Other: parent-proxy QoL chronic cough specific questionnaire (PC-QOL)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||French Linguistic and Metric Validations of Parent-proxy QOL Chronic Cough Specific Questionnaire (PC-QOL)|
|Study Start Date :||May 2013|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||June 2014|
|Experimental: chronic cough||
Other: parent-proxy QoL chronic cough specific questionnaire (PC-QOL)
- parent-proxy QoL chronic cough specific questionnaire (PC-QOL) [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01865422
|Assistance Publique Hopitaux de Marseille|
|Marseille, France, 13354|
|Study Director:||LOIC MONDOLONI||Assistance Publique Hopitaux De Marseille|