Consulting in Pneumology Department, But Not for Oncology or TobacologyPROTOACCEPTNCT03098303
Criteria Associated With Patient Willingness to Participate in Biomedical Research
An observational study of Consulting in Pneumology Department, But Not for Oncology or Tobacology, run by University Hospital, Montpellier at 4 sites in France.
Trial summary
The primary objective of this study is to determine the variables associated with patient acceptation or refusal to participate in a clinical research protocol when seen in during a pneumology consultation (excluding oncology and tobaccology). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Consulting in Pneumology Department, But Not for Oncology or Tobacology
- How many people
- 1,000 participants
- Where
- 4 sitesFrance
- Study dates
- 23 Dec 2014to 13 Dec 2016
- 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: The target population corresponds to patients with respiratory disease. This study will be proposed to all patients consulting (excluding oncology and tobacco) in the associated departments.
Who may be able to join
- The patient was informed about the study.
- The patient is scheduled for a consult in the pneumology department
Who cannot join
- The patient is under judicial protection or is an adult under any kind of guardianship
- The patient expresses opposition to the study
- It is impossible to correctly inform the patient about the study
- The patient cannot fluently read French
- The patient is pregnant
- The patient is breastfeeding
- The patient has cancer
- The patient is consulting in tabaccology
Trial locations and contacts
4 sites in 1 country.
France4 sites
Polyclinique Saint-Privat
Boujan-sur-Libron, 34760
Clinique de Marignane
Marignane, 13700
APHM - Hôpital Nord
Marseille, 13915
Centre Hospitalier Universitaire de Montpellier
Montpellier, 34295
About this study
Official title: Criteria Associated With Patient Willingness to Participate in Biomedical Research: a Prospective, Observational Study
The primary objective of this study is to determine the variables associated with patient acceptation or refusal to participate in a clinical research protocol when seen in during a pneumology consultation (excluding oncology and tobaccology).
Read the detailed description
The secondary objectives of this study are:
- To compare patient acceptance rates for participation in a clinical research protocol before and after January 15, 2016.
- To determine the variables associated with accepting or refusing to participate in a clinical research protocol for patients seen during a pneumology consultation (excluding oncology and tobaccology) before January 15, 2016.
- To determine the variables associated with accepting or refusing to participate in a clinical research protocol for patients seen during a pneumology consultation (excluding oncology and tobaccology) after January 15, 2016.
- To describe the patient population seen during pneumology consultations.
- To determine the variables associated with accepting or refusing to participate in a clinical research protocol sponsored by a pharmaceutical laboratory.
- To determine the variables associated with accepting or refusing to participate in a clinical research protocol sponsored by an academic institution.
- Construct clusters (homogeneous groups) of patients seen during the pneumology consultations.
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptation or refusal to participate in a biomedical research study
Positive or negative response to the question "If a biomedical research protocole were proposed to you, would you accept to participate?"
Measured: Day 0 (cross-sectional study)
Secondary outcomes (1)
The PROTOACCEPT questionnaire
The PROTOACCEPT questionnaire (see links below).
Measured: Day 0 (cross-sectional study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study start23 Dec 2014
- Primary completion13 Dec 2016
- Study completion13 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Consulting in Pneumology Department, But Not for Oncology or TobacologyStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnaud Bourdin, MD, PhD, Study director, Montpellier University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03098303
- Sponsor's protocol ID
- 9373
- Other IDs
- 2014-A01201-46
- Acronym
- PROTOACCEPT
- Status last verified
- Aug 2020
- First submitted
- 27 Mar 2017
- Last updated
- 26 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pahus L, Suehs CM, Halimi L, Bourdin A, Chanez P, Jaffuel D, Marciano J, Gamez AS, Vachier I, Molinari N. Patient distrust in pharmaceutical companies: an explanation for women under-representation in respiratory clinical trials? BMC Med Ethics. 2020 Aug 13;21(1):72. doi: 10.1186/s12910-020-00509-y.
PubMed 32791969Molinari N, Suehs C, Vachier I, Pahus L, Halimi L, Gamez AS, Chanez P, Bourdin A. Adverse publicity of serious side effects to healthy volunteers has limited effect on willingness-to-participate in clinical trials. Clin Trials. 2019 Aug;16(4):440-442. doi: 10.1177/1740774519840268. Epub 2019 Mar 29. No abstract available.
PubMed 30922104
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Criteria Associated With Patient Willingness to Participate in Biomedical Research: a Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT03098303
- Acronym / sponsor ID
- PROTOACCEPT / 9373
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 23 Dec 2014 (actual)
- Primary completion
- 13 Dec 2016 (actual)
- Study completion
- 13 Dec 2016 (actual)
- First posted
- 31 Mar 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.
The primary objective of this study is to determine the variables associated with patient acceptation or refusal to participate in a clinical research protocol when seen in during a pneumology consultation (excluding oncology and tobaccology).
Detailed description
The secondary objectives of this study are:
- To compare patient acceptance rates for participation in a clinical research protocol before and after January 15, 2016.
- To determine the variables associated with accepting or refusing to participate in a clinical research protocol for patients seen during a pneumology consultation (excluding oncology and tobaccology) before January 15, 2016.
- To determine the variables associated with accepting or refusing to participate in a clinical research protocol for patients seen during a pneumology consultation (excluding oncology and tobaccology) after January 15, 2016.
- To describe the patient population seen during pneumology consultations.
- To determine the variables associated with accepting or refusing to participate in a clinical research protocol sponsored by a pharmaceutical laboratory.
- To determine the variables associated with accepting or refusing to participate in a clinical research protocol sponsored by an academic institution.
- Construct clusters (homogeneous groups) of patients seen during the pneumology consultations.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target population corresponds to patients with respiratory disease. This study will be proposed to all patients consulting (excluding oncology and tobacco) in the associated departments.
Key inclusion criteria (2 listed)
- The patient was informed about the study.
- The patient is scheduled for a consult in the pneumology department
Key exclusion criteria (8 listed)
- The patient is under judicial protection or is an adult under any kind of guardianship
- The patient expresses opposition to the study
- It is impossible to correctly inform the patient about the study
- The patient cannot fluently read French
- The patient is pregnant
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
Acceptation or refusal to participate in a biomedical research study
Time frame: Day 0 (cross-sectional study)
Positive or negative response to the question "If a biomedical research protocole were proposed to you, would you accept to participate?"
1 secondary outcome
The PROTOACCEPT questionnaire
Time frame: Day 0 (cross-sectional study)
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 Aug 2020.
- Results publication: PubMed 32791969Pahus L, Suehs CM, Halimi L, Bourdin A, Chanez P, Jaffuel D, Marciano J, Gamez AS, Vachier I, Molinari N. Patient distrust in pharmaceutical companies: an explanation for women under-representation in respiratory clinical trials? BMC Med Ethics. 2020 Aug 13;21(1):72. doi: 10.1186/s12910-020-00509-y.
- Results publication: PubMed 30922104Molinari N, Suehs C, Vachier I, Pahus L, Halimi L, Gamez AS, Chanez P, Bourdin A. Adverse publicity of serious side effects to healthy volunteers has limited effect on willingness-to-participate in clinical trials. Clin Trials. 2019 Aug;16(4):440-442. doi: 10.1177/1740774519840268. Epub 2019 Mar 29. No abstract available.
- The PROTOACCEPT patient questionnaireLink provided by the sponsor.
- PROTOACCEPT on the Open Science FrameworkLink provided by the sponsor.
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.
Arnaud Bourdin, MD, PhD study director
Montpellier University Hospitals
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Consulting in Pneumology Department, But Not for Oncology or Tobacology, run by University Hospital, Montpellier at 4 sites 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 2 inclusion and 8 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 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
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?
Acceptation or refusal to participate in a biomedical research study (time frame: Day 0 (cross-sectional study)). 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 NCT03098303, which also lists 2 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 Aug 2020.