Chronic Respiratory Failure, Respiratory Insufficiency
Conditions
Keywords
Non-Invasive Ventilation, Validation, Questionnaire, Reliability, S3-NIV
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.
Interventions
OTHERTurkish Version of the S3-NIV Questionnaire
An 11-item self-administered questionnaire designed to evaluate the difficulties and compliance of patients using home non-invasive ventilation (NIV).
Sponsors
Istanbul Saglik Bilimleri University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Internal Consistency and Construct Validity of the Turkish S3-NIV | Baseline (Day 0) | Evaluated using Cronbach's alpha coefficient for internal consistency and Confirmatory/Exploratory Factor Analysis (CFA/EFA) to confirm the structural validity of the 11-item scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Test-Retest Reliability | 14 to 15 days after baseline | Evaluated using the Intraclass Correlation Coefficient (ICC) between the first and second administrations of the questionnaire in a randomly selected subgroup. |
Countries
Turkey (Türkiye)
Contacts
CONTACTDilek Unsal, PT PhD(c)
PRINCIPAL_INVESTIGATORIpek Ozmen, Prof.
Sureyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital
Outcome results
None listed