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Development and Validity of the DyNaChron Questionnaire for Chronic Nasal Dysfunction (DyNaChron)

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ClinicalTrials.gov Identifier: NCT02879929
Recruitment Status : Completed
First Posted : August 26, 2016
Last Update Posted : August 16, 2017
Sponsor:
Information provided by (Responsible Party):
GUILLEMIN Francis, MD, Central Hospital, Nancy, France

Brief 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.

Condition or disease
Rhinitis Nasal Polyps

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.

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Study Type : Observational
Actual Enrollment : 759 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development and Validity of the DyNaChron Questionnaire for Chronic Nasal Dysfunction
Study Start Date : October 2005
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006



Primary Outcome Measures :
  1. Development of the DyNaChron questionnaire for chronic nasal dysfunction [ Time Frame: 6 months ]
    to develop a self-report questionnaire to assess nose and sinus functional symptoms together with their consequences for physical and psychosocial areas


Secondary Outcome Measures :
  1. Validation of the DyNaChron questionnaire for chronic nasal dysfunction [ Time Frame: 10 months ]
    to test the validity of the new instrument developped in a large representative sample of patients attending outpatient rhinology clinics



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients were consecutively recruited in 16 centers in rhinology outpatient clinics all over France.
Criteria

Inclusion Criteria:Patients had to

  • be older than 18 years
  • have nasal or sinus dysfunction for more than 3 months
  • be able to understand and read theFrench language.

Exclusion Criteria:

  • nasal or sinus tumor or Rendu-Osler disease,
  • patients were under immediate post-operative care

Publications of Results:
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Responsible Party: GUILLEMIN Francis, MD, PU-PH, Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT02879929    
Other Study ID Numbers: DyNaChron
First Posted: August 26, 2016    Key Record Dates
Last Update Posted: August 16, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by GUILLEMIN Francis, MD, Central Hospital, Nancy, France:
chronic nasal dysfunction
Quality of life
measurement
self-reporting questionnaire
development
validation
Additional relevant MeSH terms:
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Rhinitis
Nasal Polyps
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Polyps
Pathological Conditions, Anatomical