Clinical Trials Directory

Trials / Completed

CompletedNCT02879929

Development and Validity of the DyNaChron Questionnaire for Chronic Nasal Dysfunction

Status
Completed
Phase
Study type
Observational
Enrollment
759 (actual)
Sponsor
Central Hospital, Nancy, France · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Nasal symptoms are the main elements that lead to a therapeutic decision and allow for evaluating treatment effects or natural evolution. Despite availability of several questionnaires with good measurement qualities, no systematic assessment takes into account the specific physical and psychosocial consequences of each of the six main nasal symptoms, independently of the disease. The study proposed to measure these symptoms with the use of a selfreport questionnaire and to test the validity of the questionnaire in a large representative sample of patients attending outpatient rhinologic clinics.

Detailed description

The study was conducted in two parts: (1) expert-based development and testing of the face validity of a questionnaire in French; and (2) validity testing, including construct validity by factor analysis, reproducibility by intraclass correlation coefficient (ICC) and Bland and Altman plots, and sensitivity to change by standardized response means, on a large sample of patients in a prospective multicenter study. DyNaChron, a questionnaire with 78 items divided into six domains and exploring both the physical and psychosocial repercussions of CND, was developed. In total, 759 patients completed the questionnaire at a first visit to a clinic, and 539 again 19.5 days later, on average.

Conditions

Timeline

Start date
2005-10-01
Primary completion
2006-12-01
Completion
2006-12-01
First posted
2016-08-26
Last updated
2017-08-16

Source: ClinicalTrials.gov record NCT02879929. Inclusion in this directory is not an endorsement.