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

August 29, 2014 updated by: Assistance Publique Hopitaux De Marseille

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France, 13354
        • Assistance Publique Hopitaux de Marseille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 weeks to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: chronic cough
Other: parent-proxy QoL chronic cough specific questionnaire (PC-QOL)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
parent-proxy QoL chronic cough specific questionnaire (PC-QOL)
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique Hopitaux De Marseille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

May 27, 2013

First Submitted That Met QC Criteria

May 27, 2013

First Posted (Estimate)

May 30, 2013

Study Record Updates

Last Update Posted (Estimate)

September 1, 2014

Last Update Submitted That Met QC Criteria

August 29, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-A01548-35
  • 2012-42 (Other Identifier: AP HM)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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