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Development and Validation of the BVQ

Completed
Conditions
Chronic Respiratory Disease
Registration Number
NCT02894190
Lead Sponsor
Fondazione Don Carlo Gnocchi Onlus
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
250
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)

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Change from baseline in adherence NIV in COPD patients at 3, 6 and 12 months as measured by the Beliefs of Ventilation Questionnaire (BVQ)Baseline + After 3, 6 and 12 months following the recruitment
Secondary Outcome Measures
NameTimeMethod
External construct validity (The World Health Organization Quality of Life (WHOQOL); hours of Non Invasive Ventilation (NIV) prescribed, effective and referred by patients)Baseline + After 3, 6 and 12 months following the recruitment
Reliability over time of the questionnaireBaseline + After 3, 6 and 12 months following the recruitment
Feasibility and acceptability of the questionnaire (duration / missing data)Baseline + After 3, 6 and 12 months following the recruitment

Trial Locations

Locations (1)

IRCCS Santa Maria Nascente, Fondazione Don Carlo Gnocchi

🇮🇹

Milan, Italy

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