Validation of the Turkish Version of the S3-NIV Questionnaire

ConditionsRespiratory Insufficiency Chronic Respiratory Failure

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorIstanbul Saglik Bilimleri University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Turkish Version of the S3-NIV Questionnaire
Other intervention
An 11-item self-administered questionnaire designed to evaluate the difficulties and compliance of patients using home non-invasive ventilation (NIV).

Treatment groups

120 Participants

are divided into 1 treatment group

Group A: Home NIV Patients1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

Baseline (Day 0)

Secondary outcomes

Test-Retest Reliability

Evaluated using the Intraclass Correlation Coefficient (ICC) between the first and second administrations of the questionnaire in a randomly selected subgroup.

Time frame

14 to 15 days after baseline

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Istanbul Saglik Bilimleri University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: