Development and Validation of the BVQ

N/ACompletedNCT02894190

Fondazione Don Carlo Gnocchi ETS250 enrolled

Overview

The main aim of this study is the development of the Beliefs about Ventilation Questionnaire (BVQ).

Study Type

OBSERVATIONAL

Enrollment

250

Conditions

Chronic Respiratory Disease

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age ≥ 18 years old * Indication to Non Invasive Ventilation (NIV), in three slots: \<4; \>4 e \<12; \<12 hours * Outpatients or Inpatients * Obstructive or restrictive reparatory disorder * Voluntary agreement to be involved in the Study Exclusion Criteria: * Psychiatric Disorder * Glasgow Coma Scale (CGS) \<14 * Pure Obstructive Sleep Apnea Syndrome (OSAS) * Tracheostomy with Invasive Ventilation (TIV) o Invasive Ventilation (IV)

Locations (1)

IRCCS Santa Maria Nascente, Fondazione Don Carlo Gnocchi

Milan, Italy

Outcomes

Primary Outcomes

Change from baseline in adherence NIV in COPD patients at 3, 6 and 12 months as measured by the Beliefs of Ventilation Questionnaire (BVQ)

Time frame: Baseline + After 3, 6 and 12 months following the recruitment

Secondary Outcomes

Feasibility and acceptability of the questionnaire (duration / missing data)

Time frame: Baseline + After 3, 6 and 12 months following the recruitment

Reliability over time of the questionnaire

Time frame: Baseline + After 3, 6 and 12 months following the recruitment

External construct validity (The World Health Organization Quality of Life (WHOQOL); hours of Non Invasive Ventilation (NIV) prescribed, effective and referred by patients)

Time frame: Baseline + After 3, 6 and 12 months following the recruitment

Data from ClinicalTrials.gov

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