Biomedical ResearchPROTOACCEPT2NCT03397056
How Participants Perceive Biomedical Research in Pulmonology
An observational study of Biomedical Research, run by University Hospital, Montpellier at 2 sites in France.
Trial summary
The primary objective of this study is to determine how biomedical research is perceived by patients already participating in a pulmonology research project. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biomedical Research
- What is being tested?
- Questionnaire
- How many people
- 500 participants
- Where
- 2 sitesFrance
- Study dates
- 7 Mar 2018to 31 Dec 2019
- 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 a respiratory disease already included in a biomedical research protocol.
Who may be able to join
- The patient presents with at least one of the following: (1) asthma, (2) chronic obstructive pulmonary disease, (3) bronchiectasis, (4) idiopathic pulmonary fibrosis, (5) pulmonary arterial hypertension, (6) sleep apnoea syndrome
- The patient is participating in a biomedical research protocol.
Who cannot join
- Patient under 18 years of age
- Patient judged incapable of filling out the questionnaire for linguistic or other reasons.
- The patient has already participated in the present study.
Trial locations and contacts
2 sites in 1 country.
France2 sites
APHM - Hôpital Nord
Marseille, 13915
CHRU Montpellier - Hôpital Arnaud de Villeneuve
Montpellier, 34295
About this study
The primary objective of this study is to determine how biomedical research is perceived by patients already participating in a pulmonology research project.
Read the detailed description
Over time, clinical research has become a challenge both in terms of public health and in terms of scientific progress. Additionally, it has also become a financial challenge for institutions, especially in France where a significant part of their government funding is provided according to their ability to conduct quality clinical research. Pulmonology is a sector where clinical research is well established with strong incentives from several pharmaceutical companies and numerous academic research projects. Nevertheless, it is important to put the patient back at the centre of biomedical research.
A better knowledge of patient expectations, questions and misunderstandings would considerably improve treatment observance, clinical trial data quality, doctor-patient trust/relationship, and ultimately, the patient's health.
The primary objective of this study is to determine how biomedical research is perceived by patients already participating in a pulmonology research project.
The secondary objectives are to determine:
- how biomedical research is experienced / felt;
- if the information delivered to the patient (orally - information note) is clearly perceived.
Comparisons with PROTOACCEPT1 (osf.io/nsjjr) will also be performed.
- Conditions
- Biomedical Research
- Being tested
- Questionnaire
- Keywords
- Patient willingness, Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireOther
The Questionnaire is provided in the links at the end of the declaration.
| Study group | Role | What they receive |
|---|---|---|
| The study population | The target population corresponds to patients with a respiratory disease already included in a biomedical research protocol.
Intervention: Questionnaire Receives: Other: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
The PROTOACCEPT2 questionnaire.
Measured: day 0 (transversal study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2018
- Study start7 Mar 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biomedical ResearchStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 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, University Hospitals of Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03397056
- Sponsor's protocol ID
- RECHMPL17_0447
- Acronym
- PROTOACCEPT2
- Status last verified
- Mar 2019
- First submitted
- 5 Jan 2018
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The general goal is to make the study data available to interested researchers as well as to provide proof of transparency for the study. Data (and an accompanying data dictionary) will be de-identified and potentially further cleaned or aggregated as the investigators deem necessary to protect participant anonymity. Data will be made available on a not-for-profit, free platform that allows access control: zenodo. A link on osf.io/pxnhc will point towards the zenodo upload.
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Participants Perceive Biomedical Research in Pulmonology
- ClinicalTrials.gov ID
- NCT03397056
- Acronym / sponsor ID
- PROTOACCEPT2 / RECHMPL17_0447
- Conditions
- Biomedical Research
- Keywords
- Patient willingness, Participation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 7 Mar 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 11 Jan 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 objective of this study is to determine how biomedical research is perceived by patients already participating in a pulmonology research project.
Detailed description
Over time, clinical research has become a challenge both in terms of public health and in terms of scientific progress. Additionally, it has also become a financial challenge for institutions, especially in France where a significant part of their government funding is provided according to their ability to conduct quality clinical research. Pulmonology is a sector where clinical research is well established with strong incentives from several pharmaceutical companies and numerous academic research projects. Nevertheless, it is important to put the patient back at the centre of biomedical research.
A better knowledge of patient expectations, questions and misunderstandings would considerably improve treatment observance, clinical trial data quality, doctor-patient trust/relationship, and ultimately, the patient's health.
The primary objective of this study is to determine how biomedical research is perceived by patients already participating in a pulmonology research project.
The secondary objectives are to determine:
- how biomedical research is experienced / felt;
- if the information delivered to the patient (orally - information note) is clearly perceived.
Comparisons with PROTOACCEPT1 (osf.io/nsjjr) will also be performed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The study population | – | Other: QuestionnaireThe target population corresponds to patients with a respiratory disease already included in a biomedical research protocol. Intervention: Questionnaire |
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 a respiratory disease already included in a biomedical research protocol.
Key inclusion criteria (2 listed)
- The patient presents with at least one of the following: (1) asthma, (2) chronic obstructive pulmonary disease, (3) bronchiectasis, (4) idiopathic pulmonary fibrosis, (5) pulmonary arterial hypertension, (6) sleep apnoea syndrome
- The patient is participating in a biomedical research protocol.
Key exclusion criteria (3 listed)
- Patient under 18 years of age
- Patient judged incapable of filling out the questionnaire for linguistic or other reasons.
- The patient has already participated in the present study.
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 |
|---|---|---|
| QuestionnaireThe Questionnaire is provided in the links at the end of the declaration. | Other | The study population |
Primary outcome
The PROTOACCEPT2 questionnaire.
Time frame: day 0 (transversal 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 10 Mar 2020.
- PROTOACCEPT2 on the Open Science Framework (access to questionnaire)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. The general goal is to make the study data available to interested researchers as well as to provide proof of transparency for the study. Data (and an accompanying data dictionary) will be de-identified and potentially further cleaned or aggregated as the investigators deem necessary to protect participant anonymity. Data will be made available on a not-for-profit, free platform that allows access control: zenodo. A link on osf.io/pxnhc will point towards the zenodo upload.
Related trials for Biomedical Research
RecruitingObservational study
Tissue Procurement for Biomedical Research
Normal Volunteers
RecruitingObservational study
Specimen and Data Collection in South Carolina Medicaid-Enrolled Patients With Type 2 Diabetes (T2D) and Metabolically Healthy Controls
Type 2 Diabetes, Healthy (Controls)
RecruitingObservational study
Biomedical Research Informatics Centre for Cardiovascular Sciences (The BRICCS Study)
Cardiovascular Diseases, Cardiovascular Risk Factor
Not yet recruitingObservational study
Evolution of Physical Frailty and Patient-Reported Outcome Measures in Kidney Transplant Candidates: A Mixed-Methods Longitudinal Study Protocol
Kidney Failure, Chronic, Frailty
RecruitingObservational study
Biomedical Signal Extraction From Symptom Descriptions: An Observational Registry Using the OpenGenome Platform
Signs and Symptoms, Fever
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
University Hospitals of Montpellier
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biomedical Research, run by University Hospital, Montpellier at 2 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 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: finished, as of the sponsor's last update on 10 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The PROTOACCEPT2 questionnaire. (time frame: day 0 (transversal study)). 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 10 Mar 2020.