Reliability and Validity of the Turkish Version of the Severe Respiratory Insufficiency Questionnaire for Non-Invasive Ventilation (S3-NIV)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 120
- Locations
- 1
Study Overview
Brief Summary
This study aims to evaluate the psychometric properties, including reliability and validity, of the Turkish version of the Severe Respiratory Insufficiency Questionnaire for Non-Invasive Ventilation (S3-NIV). The S3-NIV is a specific tool designed to assess difficulties and compliance in patients receiving home non-invasive ventilation. A total of 120 stable patients using home NIV for at least 3 months will be enrolled across multiple centers.
Detailed Description
Following the official linguistic validation process authorized by the Mapi Research Trust, this multi-center observational study will assess the psychometric validity of the Turkish S3-NIV questionnaire. Patients will complete the 11-item S3-NIV questionnaire alongside a sociodemographic and clinical data form. To evaluate test-retest reliability, a randomly selected subgroup of patients (n=40) will re-complete the questionnaire 14 to 15 days after the initial administration. Internal consistency, construct validity (via factor analysis), and criterion validity (correlations with clinical parameters such as daily NIV usage hours and blood gas values) will be analyzed.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosed with chronic respiratory failure requiring home non-invasive ventilation (NIV).
- •Using a home NIV device for at least 3 months.
- •Being in a clinically stable phase (no exacerbation or hospitalization in the last 1 month).
- •Able to understand and answer the questionnaire.
- •Provided written informed consent.
Exclusion Criteria
- •Acute respiratory failure or clinical instability.
- •Severe cognitive impairment or psychiatric disorders preventing reliable communication.
- •Active malignancy or terminal illness with a short life expectancy.
- •Refusal to provide informed consent.
Investigators
Dilek Unsal
Physiotherapist, PhD (c)
Istanbul Saglik Bilimleri University