Development and Validation of the BVQ

Chronic Respiratory Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02894190
• Other study ID #: FDG_BVQ_01
• Status: Completed
• Start date: September 2016
• Est. completion date: March 31, 2020

Study information

• Verified date: January 2018
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: March 31, 2020
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Respiratory Disease
• Respiration Disorders
• Respiratory Tract Diseases

Locations

Country	Name	City	State
Italy	IRCCS Santa Maria Nascente, Fondazione Don Carlo Gnocchi	Milan

Sponsors (2)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus	Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Lopez-Campos JL, Jara-Palomares L, Muñoz X, Bustamante V, Barreiro E. Lights and shadows of non-invasive mechanical ventilation for chronic obstructive pulmonary disease (COPD) exacerbations. Ann Thorac Med. 2015 Apr-Jun;10(2):87-93. doi: 10.4103/1817-173 — View Citation

Ozyilmaz E, Ugurlu AO, Nava S. Timing of noninvasive ventilation failure: causes, risk factors, and potential remedies. BMC Pulm Med. 2014 Feb 13;14:19. doi: 10.1186/1471-2466-14-19. Review. — View Citation

van Boven JF, Chavannes NH, van der Molen T, Rutten-van Mölken MP, Postma MJ, Vegter S. Clinical and economic impact of non-adherence in COPD: a systematic review. Respir Med. 2014 Jan;108(1):103-13. doi: 10.1016/j.rmed.2013.08.044. Epub 2013 Sep 11. Revi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Feasibility and acceptability of the questionnaire (duration / missing data)		Baseline + After 3, 6 and 12 months following the recruitment
Secondary	Reliability over time of the questionnaire		Baseline + After 3, 6 and 12 months following the recruitment
Secondary	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