Lung DiseasesNCT03598569
Auto-evaluation of Dyspnea
An observational study of Lung Diseases, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
The primary aim of this study was to compare patients-rated evaluation and caregiver's assessment of dyspnea with the standard tools in pulmonology unit (Borg scale and visual analog scale) and the secondary aim was to performed an analysis depending on the diseases (lung cancer vs. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Diseases
- What is being tested?
- dyspnea
- How many people
- 271 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2013to Dec 2013
- 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 Any age
- Child, Adult, Older adult
Study population: all lung diseases
Who may be able to join
- age ≥18 and
- to have a diagnosis of acute or chronic respiratory disease
Who cannot join
- mental or cognitive disorders
- inability to understand the local language
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dyspnea Evaluated by a Qualified Examiner in Patients With Lung Diseases
The primary aim of this study was to compare patients-rated evaluation and caregiver's assessment of dyspnea with the standard tools in pulmonology unit (Borg scale and visual analog scale) and the secondary aim was to performed an analysis depending on the diseases (lung cancer vs. other lung diseases) and to verify the agreement between the evaluation between both visual analog scale and modified Borg scale.
- Conditions
- Lung Diseases
- Being tested
- dyspnea
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dyspneaOther
Also called evaluation
dyspnea assessment
| Study group | Role | What they receive |
|---|---|---|
| lung cancer | Not described Receives: Other: dyspnea | |
| other lung diseases | Not described Receives: Other: dyspnea |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analog scale
Measured: 3 seconds
borg scale
Measured: 3 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study startJun 2013
- Primary completionJul 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 271 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03598569
- Sponsor's protocol ID
- Autodyspnea
- Status last verified
- Jun 2018
- First submitted
- 15 Jul 2018
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dyspnea Evaluated by a Qualified Examiner in Patients With Lung Diseases
- ClinicalTrials.gov ID
- NCT03598569
- Acronym / sponsor ID
- Autodyspnea
- Conditions
- Lung Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 271 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Jun 2013 (actual)
- Primary completion
- Jul 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 26 Jul 2018 (actual)
- 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 primary aim of this study was to compare patients-rated evaluation and caregiver's assessment of dyspnea with the standard tools in pulmonology unit (Borg scale and visual analog scale) and the secondary aim was to performed an analysis depending on the diseases (lung cancer vs. other lung diseases) and to verify the agreement between the evaluation between both visual analog scale and modified Borg scale.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lung cancer | – | Other: dyspnea |
| other lung diseases | – | Other: dyspnea |
Who may qualify
- Age groups
- Child, Adult, Older adult
- Study population
- all lung diseases
Key inclusion criteria (2 listed)
- age ≥18 and
- to have a diagnosis of acute or chronic respiratory disease
Key exclusion criteria (2 listed)
- mental or cognitive disorders
- inability to understand the local language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dyspneaAlso: evaluationdyspnea assessment | Other | lung cancer, other lung diseases |
Primary outcome
visual analog scale
Time frame: 3 seconds
borg scale
Time frame: 3 seconds
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 2018.
- 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 Lung Diseases, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 2 inclusion and 2 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 2018. 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 Belgium. 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?
visual analog scale (time frame: 3 seconds). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2018.