Pulmonary Arterial Hypertension (PAH)PAH-DBoQNCT03235401
The PAH Disability and Bothersomeness Questionnaire
An observational study of Pulmonary Arterial Hypertension (PAH), run by Association de Recherche en Physiopathologie Respiratoire at 1 site in France.
Trial summary
To develop a patient-reported questionnaire to investigate the impact of PAH (pulmonary arterial hypertension) on patients' daily lives in terms of bothersomeness and disability. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Arterial Hypertension (PAH)
- What is being tested?
- 37-items questionnaire
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jun 2017to Feb 2018
- 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
- Adult, Older adult
Study population: * 120 patients with idiopathic and heritable PAH (40 of which will be selected for a test-retest procedure) * Patients with PAH associated with other diseases will be excluded in order to clearly circumscribe the results to PAH
Who may be able to join
- patients with idiopathic and heritable PAH;
- patients over 18;
- male and female;
- NYHA Functional Class I, II, III \& IV;
- Written consent signed
- Patients with a good understanding of the French - language
- Patient affiliated with a social security scheme
Who cannot join
- Patients under 18 years of age
- Patients with other pathologies associated with PAH (Group 1)
- Patients with other forms of pulmonary hypertension (groups 2, 3, 4 and 5)
- Non-consenting patients
- Patients who do not have a good understanding of the French language
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre de Référence de l'Hypertension Pulmonaire Sévère, Service de Pneumologie et Soins Intensifs, Hôpital de Bicêtre,
Le Kremlin-Bicêtre, Val De Marne, 94270
Olivier SITBON, PHD, +33-(0)1 45 21 79 72, olivier.sitbon@u-psud.fr
Sophie ALAMI, PHD, 00 33 68 50 64 857, interlis.france@gmail.com
About this study
Official title: "Validation of a Questionnaire Assessing Disability and Bothersomeness in Pulmonary Arterial Hypertension (PAH): The PAH Disability and Bothersomeness Questionnaire"
To develop a patient-reported questionnaire to investigate the impact of PAH (pulmonary arterial hypertension) on patients' daily lives in terms of bothersomeness and disability.
Read the detailed description
A 3-steps study protocol was initiated in 2011 to develop a patient reported outcome measure (PROM) in PAH.The first two steps have been completed (qualitative study and Delphi consensus study) leading to the development of a provisional 37-items questionnaire. A reduction of items in this provisional questionnaire and the validation of the final questionnaire are the goals of the current study.
- Conditions
- Pulmonary Arterial Hypertension (PAH)
- Being tested
- 37-items questionnaire
- Keywords
- Questionnaire, Disability assessment, Bothersomeness, Pulmonary Arterial Hypertension, patient-reported outcome measure, New York Heart Association (NYHA) functional class
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
37-items questionnaireOther
Patient will answer the PAH-DBoQ questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary Arterial Hypertension patients | Not described Receives: Other: 37-items questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cronbach's alpha≥ 0.7
Internal consistency of the PAH Disability and Bothersomeness Questionnaire will be assessed with Cronhbach's alpha
Measured: at the end of the study (an average of 6 months)
Secondary outcomes (1)
Low rate of answers (≤95%)
low rate of answers will help reducing the number of questionnaire's items
Measured: at the end of the study (an average of 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2017
- Study start16 Jun 2017
- Primary completion16 Dec 2017 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial Hypertension (PAH)Studies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association de Recherche en Physiopathologie Respiratoire
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline, Soladis, Interlis
- Responsible party
- Sponsor
- Investigators
- Olivier SITBON, PHD, Principal investigator, Service de Pneumologie et Soins Intensifs, Hôpital de Bicêtre, Université Paris-Sud France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03235401
- Sponsor's protocol ID
- PAH-DBoQ
- Acronym
- PAH-DBoQ
- Status last verified
- Jul 2017
- First submitted
- 28 Jul 2017
- Last updated
- 1 Aug 2017
- 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 1 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Validation of a Questionnaire Assessing Disability and Bothersomeness in Pulmonary Arterial Hypertension (PAH): The PAH Disability and Bothersomeness Questionnaire"
- ClinicalTrials.gov ID
- NCT03235401
- Acronym / sponsor ID
- PAH-DBoQ / PAH-DBoQ
- Conditions
- Pulmonary Arterial Hypertension (PAH)
- Keywords
- Questionnaire, Disability assessment, Bothersomeness, Pulmonary Arterial Hypertension, patient-reported outcome measure, New York Heart Association (NYHA) functional class
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Association de Recherche en Physiopathologie RespiratoireUniversity, hospital or other
- Collaborators
- GlaxoSmithKline, Soladis, Interlis
- Study start
- 16 Jun 2017 (actual)
- Primary completion
- 16 Dec 2017 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 1 Aug 2017 (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.
To develop a patient-reported questionnaire to investigate the impact of PAH (pulmonary arterial hypertension) on patients' daily lives in terms of bothersomeness and disability.
Detailed description
A 3-steps study protocol was initiated in 2011 to develop a patient reported outcome measure (PROM) in PAH.The first two steps have been completed (qualitative study and Delphi consensus study) leading to the development of a provisional 37-items questionnaire. A reduction of items in this provisional questionnaire and the validation of the final questionnaire are the goals of the current study.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Arterial Hypertension patients | – | Other: 37-items questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- * 120 patients with idiopathic and heritable PAH (40 of which will be selected for a test-retest procedure) * Patients with PAH associated with other diseases will be excluded in order to clearly circumscribe the results to PAH
Key inclusion criteria (7 listed)
- patients with idiopathic and heritable PAH;
- patients over 18;
- male and female;
- NYHA Functional Class I, II, III \& IV;
- Written consent signed
Key exclusion criteria (5 listed)
- Patients under 18 years of age
- Patients with other pathologies associated with PAH (Group 1)
- Patients with other forms of pulmonary hypertension (groups 2, 3, 4 and 5)
- Non-consenting patients
- Patients who do not have a good understanding of the French 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 |
|---|---|---|
| 37-items questionnairePatient will answer the PAH-DBoQ questionnaire | Other | Pulmonary Arterial Hypertension patients |
Primary outcome
Cronbach's alpha≥ 0.7
Time frame: at the end of the study (an average of 6 months)
Internal consistency of the PAH Disability and Bothersomeness Questionnaire will be assessed with Cronhbach's alpha
1 secondary outcome
Low rate of answers (≤95%)
Time frame: at the end of the study (an average of 6 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2017.
- 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.
Olivier SITBON, PHD principal investigator
Service de Pneumologie et Soins Intensifs, Hôpital de Bicêtre, Université Paris-Sud France
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 Pulmonary Arterial Hypertension (PAH), run by Association de Recherche en Physiopathologie Respiratoire 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 7 inclusion and 5 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 1 Aug 2017. 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?
Contact Olivier SITBON, PHD (145217972 ext. +33, olivier.sitbon@u-psud.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cronbach's alpha≥ 0.7 (time frame: at the end of the study (an average of 6 months)). 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 1 Aug 2017; AzTrials last refreshed its copy on 4 Nov 2026.