RhinitisDyNaChronNCT02879929
Development and Validity of the DyNaChron Questionnaire for Chronic Nasal Dysfunction
An observational study of Rhinitis and Nasal Polyps, run by Central Hospital, Nancy, France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rhinitis, Nasal Polyps
- How many people
- 759 participants
- Where
- No sites listed yet
- Study dates
- Oct 2005to Dec 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients were consecutively recruited in 16 centers in rhinology outpatient clinics all over France.
Who may be able to join
- be older than 18 years
- have nasal or sinus dysfunction for more than 3 months
- be able to understand and read theFrench language.
Who cannot join
- nasal or sinus tumor or Rendu-Osler disease,
- patients were under immediate post-operative care
About this study
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.
Read the 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
- Rhinitis, Nasal Polyps
- Keywords
- chronic nasal dysfunction, Quality of life, measurement, self-reporting questionnaire, development, validation
- Medical subject headings
- Rhinitis, Nasal Polyps
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of the DyNaChron questionnaire for chronic nasal dysfunction
to develop a self-report questionnaire to assess nose and sinus functional symptoms together with their consequences for physical and psychosocial areas
Measured: 6 months
Secondary outcomes (1)
Validation of the DyNaChron questionnaire for chronic nasal dysfunction
to test the validity of the new instrument developped in a large representative sample of patients attending outpatient rhinology clinics
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study startOct 2005
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RhinitisStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 759 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GUILLEMIN Francis, MD, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02879929
- Sponsor's protocol ID
- DyNaChron
- Acronym
- DyNaChron
- Status last verified
- Aug 2017
- First submitted
- 19 Aug 2016
- Last updated
- 16 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kacha S, Guillemin F, Jankowski R. Development and validity of the DyNaChron questionnaire for chronic nasal dysfunction. Eur Arch Otorhinolaryngol. 2012 Jan;269(1):143-53. doi: 10.1007/s00405-011-1690-z. Epub 2011 Jul 8.
PubMed 21739093
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validity of the DyNaChron Questionnaire for Chronic Nasal Dysfunction
- ClinicalTrials.gov ID
- NCT02879929
- Acronym / sponsor ID
- DyNaChron / DyNaChron
- Conditions
- Rhinitis, Nasal Polyps
- Keywords
- chronic nasal dysfunction, Quality of life, measurement, self-reporting questionnaire, development, validation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 759 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 26 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were consecutively recruited in 16 centers in rhinology outpatient clinics all over France.
Key inclusion criteria (3 listed)
- be older than 18 years
- have nasal or sinus dysfunction for more than 3 months
- be able to understand and read theFrench language.
Key exclusion criteria (2 listed)
- nasal or sinus tumor or Rendu-Osler disease,
- patients were under immediate post-operative care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Validation of the DyNaChron questionnaire for chronic nasal dysfunction
Time frame: 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2017.
- Results publication: PubMed 21739093Kacha S, Guillemin F, Jankowski R. Development and validity of the DyNaChron questionnaire for chronic nasal dysfunction. Eur Arch Otorhinolaryngol. 2012 Jan;269(1):143-53. doi: 10.1007/s00405-011-1690-z. Epub 2011 Jul 8.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Rhinitis and Nasal Polyps, run by Central Hospital, Nancy, France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of the DyNaChron questionnaire for chronic nasal dysfunction (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02879929, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2017.