Chronic Respiratory DiseaseNCT02894190
Development and Validation of the BVQ
An observational study of Chronic Respiratory Disease, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
Trial summary
The main aim of this study is the development of the Beliefs about Ventilation Questionnaire (BVQ). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Respiratory Disease
- How many people
- 250 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2016to 31 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People with obstructive or restrictive respiratory diseases
Who may be able to join
- 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
Who cannot join
- Psychiatric Disorder
- Glasgow Coma Scale (CGS) <14
- Pure Obstructive Sleep Apnea Syndrome (OSAS)
- Tracheostomy with Invasive Ventilation (TIV) o Invasive Ventilation (IV)
Trial locations and contacts
1 site in 1 country.
Italy1 site
IRCCS Santa Maria Nascente, Fondazione Don Carlo Gnocchi
Milan, 20148
About this study
Official title: 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).
- Conditions
- Chronic Respiratory Disease
- Keywords
- Non Invasive Ventilation (NIV), Adherence, Beliefs, Development, Validation
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in adherence NIV in COPD patients at 3, 6 and 12 months as measured by the Beliefs of Ventilation Questionnaire (BVQ)
Measured: Baseline + After 3, 6 and 12 months following the recruitment
Secondary outcomes (3)
Feasibility and acceptability of the questionnaire (duration / missing data)
Measured: Baseline + After 3, 6 and 12 months following the recruitment
Reliability over time of the questionnaire
Measured: 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)
Measured: Baseline + After 3, 6 and 12 months following the recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2016 (estimated)
- Study startSep 2016
- Primary completion31 Dec 2018
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Respiratory DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETS
- Sponsor type
- University, hospital or other
- Collaborators
- Catholic University of the Sacred Heart
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02894190
- Sponsor's protocol ID
- FDG_BVQ_01
- Status last verified
- Jan 2018
- First submitted
- 5 Sep 2016
- Last updated
- 26 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Lopez-Campos JL, Jara-Palomares L, Munoz 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: 10.4103/1817-1737.151440.
PubMed 25829958Ozyilmaz 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.
PubMed 24520952van Boven JF, Chavannes NH, van der Molen T, Rutten-van Molken 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.
PubMed 24070566
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of the Beliefs About Ventilation Questionnaire (BVQ)
- ClinicalTrials.gov ID
- NCT02894190
- Acronym / sponsor ID
- FDG_BVQ_01
- Conditions
- Chronic Respiratory Disease
- Keywords
- Non Invasive Ventilation (NIV), Adherence, Beliefs, Development, Validation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
- Collaborators
- Catholic University of the Sacred Heart
- Study start
- Sep 2016
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 9 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main aim of this study is the development of the Beliefs about Ventilation Questionnaire (BVQ).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People with obstructive or restrictive respiratory diseases
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Psychiatric Disorder
- Glasgow Coma Scale (CGS) <14
- Pure Obstructive Sleep Apnea Syndrome (OSAS)
- Tracheostomy with Invasive Ventilation (TIV) o Invasive Ventilation (IV)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2022.
- Results publication: PubMed 25829958Lopez-Campos JL, Jara-Palomares L, Munoz 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: 10.4103/1817-1737.151440.
- Results publication: PubMed 24520952Ozyilmaz 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.
- Results publication: PubMed 24070566van Boven JF, Chavannes NH, van der Molen T, Rutten-van Molken 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Respiratory Disease, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02894190, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2022.