DyspneaDyHPNCT03798158
Prevalence and Characterization of Persistent Dyspnea After Hospitalization
An observational study of Dyspnea and Pulmonary Disease, run by Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil at 1 site in France.
Trial summary
The investigators aim to make an overview of persistent dyspnea at the end of an hospitalization for a respiratory disease using an actual tool, the Multidisciplinary Dyspnea Profile questionnaire. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyspnea, Pulmonary Disease
- What is being tested?
- Multidisciplinary Dyspnea Profile questionnaire
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 11 Apr 2019to 30 Apr 2025
- 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: Every consecutive patient admitted to hospitalization for a respiratory cause having a significant dyspnea
Who may be able to join
- Age over 18 years old
- Able to respond the questionnaire
- Presenting at admission a dyspnea over 3/10 on numerical analogic scale
- Admitted for a respiratory cause
Who cannot join
- cognitive impairment
- aphasia
- no french-speaking person
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
ADOREPS
Paris, 75013
Capucine MORELOT, MD,PhD, 01 42 16 77 71 ext. 0033, capucine.morelot@aphp.fr
About this study
Official title: Prevalence and Characterization of Persistent Dyspnea After an Hospitalization for a Respiratory Disease
The investigators aim to make an overview of persistent dyspnea at the end of an hospitalization for a respiratory disease using an actual tool, the Multidisciplinary Dyspnea Profile questionnaire.
- Conditions
- Dyspnea, Pulmonary Disease
- Being tested
- Multidisciplinary Dyspnea Profile questionnaire
- Medical subject headings
- Dyspnea, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidisciplinary Dyspnea Profile questionnaireOther
Multidisciplinary Dyspnea Profile questionnaire at the beginning and the end of an hospitalization
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of persistent dyspnea in the end of an hospitalization for a a respiratory disease
Measured: An average of one week, until the end of the hospitalization
Secondary outcomes (2)
Characterization of persistent dyspnea using MDP
Measured: An average of one week, until the end of the hospitalization
Outcome of patients with persistent dyspnea after hospitalization
6 months mortality, incidence of rehospitalization
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2019
- Study start11 Apr 2019
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspneaStudies 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03798158
- Sponsor's protocol ID
- 2018-A02757-48
- Acronym
- DyHP
- Status last verified
- Jul 2021
- First submitted
- 21 Nov 2018
- Last updated
- 23 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Characterization of Persistent Dyspnea After an Hospitalization for a Respiratory Disease
- ClinicalTrials.gov ID
- NCT03798158
- Acronym / sponsor ID
- DyHP / 2018-A02757-48
- Conditions
- Dyspnea, Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le SommeilUniversity, hospital or other
- Study start
- 11 Apr 2019 (actual)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 9 Jan 2019 (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 investigators aim to make an overview of persistent dyspnea at the end of an hospitalization for a respiratory disease using an actual tool, the Multidisciplinary Dyspnea Profile questionnaire.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Every consecutive patient admitted to hospitalization for a respiratory cause having a significant dyspnea
Key inclusion criteria (4 listed)
- Age over 18 years old
- Able to respond the questionnaire
- Presenting at admission a dyspnea over 3/10 on numerical analogic scale
- Admitted for a respiratory cause
Key exclusion criteria (3 listed)
- cognitive impairment
- aphasia
- no french-speaking person
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 |
|---|---|---|
| Multidisciplinary Dyspnea Profile questionnaireMultidisciplinary Dyspnea Profile questionnaire at the beginning and the end of an hospitalization | Other | – |
Primary outcome
Prevalence of persistent dyspnea in the end of an hospitalization for a a respiratory disease
Time frame: An average of one week, until the end of the hospitalization
2 secondary outcomes
Characterization of persistent dyspnea using MDP
Time frame: An average of one week, until the end of the hospitalization
Outcome of patients with persistent dyspnea after hospitalization
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
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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.
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 Dyspnea and Pulmonary Disease, run by Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil at 1 site in France.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 23 Jul 2021. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of persistent dyspnea in the end of an hospitalization for a a respiratory disease (time frame: An average of one week, until the end of the hospitalization). 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 23 Jul 2021.