Development and Validation of the BVQ

July 25, 2022 updated by: Fondazione Don Carlo Gnocchi Onlus

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

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20148
        • IRCCS Santa Maria Nascente, Fondazione Don Carlo Gnocchi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

People with obstructive or restrictive respiratory diseases

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Baseline + After 3, 6 and 12 months following the recruitment

Secondary Outcome Measures

Outcome Measure
Time Frame
Feasibility and acceptability of the questionnaire (duration / missing data)
Time Frame: Baseline + After 3, 6 and 12 months following the recruitment
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
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
Baseline + After 3, 6 and 12 months following the recruitment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Don Carlo Gnocchi Onlus

Collaborators

Catholic University of the Sacred Heart

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

March 31, 2020

Study Registration Dates

First Submitted

September 5, 2016

First Submitted That Met QC Criteria

September 5, 2016

First Posted (Estimate)

September 9, 2016

Study Record Updates

Last Update Posted (Actual)

July 26, 2022

Last Update Submitted That Met QC Criteria

July 25, 2022

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDG_BVQ_01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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