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OpenTrials
Completed

NCT Number: NCT02894190

Development and Validation of the BVQ

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

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Key information

Conditions

Chronic Respiratory Disease

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Santa Maria Nascente, Fondazione Don Carlo Gnocchi

Milan, 20148, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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

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

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

  2. Reliability over time of the questionnaire

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

  3. 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

Sponsors and collaborators

Lead sponsor

Fondazione Don Carlo Gnocchi ETS

Other

Collaborators

  • Catholic University of the Sacred Heart

Registry information

Official study title

Development and Validation of the Beliefs About Ventilation Questionnaire (BVQ)

Important dates

Study start
2016
Primary completion
2018
Study completion
2020
First posted
Sep 9, 2016
Registry last updated
Jul 26, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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