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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Home NIV Patients | Patients with chronic respiratory failure who have been using home non-invasive ventilation (NIV) for at least 3 months and are in a clinically stable phase. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Turkish Version of the S3-NIV Questionnaire | Other | An 11-item self-administered questionnaire designed to evaluate the difficulties and compliance of patients using home non-invasive ventilation (NIV). |
| Measure | Description | Time Frame |
|---|---|---|
| Internal Consistency and Construct Validity of the Turkish S3-NIV | 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. | Baseline (Day 0) |
| Measure | Description | Time Frame |
|---|---|---|
| Test-Retest Reliability | Evaluated using the Intraclass Correlation Coefficient (ICC) between the first and second administrations of the questionnaire in a randomly selected subgroup. | 14 to 15 days after baseline |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with chronic respiratory failure who are followed up in the outpatient clinic and have been using a home non-invasive ventilation (NIV) device for at least 3 months.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dilek Unsal, PT PhD(c) | Contact | +90 530 4641198 | fztdlkunsal@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ipek Ozmen, Prof. | Sureyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sureyyapasa Chest Diseases and Thoracic Surgery Training and Research Hospital | Istanbul | 34854 | Turkey (Türkiye) |
A decision on sharing individual participant data (IPD) has not yet been made. Data sharing may be considered upon reasonable request to the principal investigator after the publication of the study results.
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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