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How Participants Perceive Biomedical Research in Pulmonology (PROTOACCEPT2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03397056
Recruitment Status : Recruiting
First Posted : January 11, 2018
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:
The primary objective of this study is to determine how biomedical research is perceived by patients already participating in a pulmonology research project.

Condition or disease Intervention/treatment
Biomedical Research Other: Questionnaire

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.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: How Participants Perceive Biomedical Research in Pulmonology
Actual Study Start Date : March 7, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Group/Cohort Intervention/treatment
The study population

The target population corresponds to patients with a respiratory disease already included in a biomedical research protocol.

Intervention: Questionnaire

Other: Questionnaire
The Questionnaire is provided in the links at the end of the declaration.




Primary Outcome Measures :
  1. The PROTOACCEPT2 questionnaire. [ Time Frame: day 0 (transversal study) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The target population corresponds to patients with a respiratory disease already included in a biomedical research protocol.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03397056


Contacts
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Contact: Arnaud Bourdin, MD,PhD +33.4.67.33.61.26 a-bourdin@chu-montpellier.fr

Locations
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France
APHM - Hôpital Nord Recruiting
Marseille, France, 13915
Principal Investigator: Pascal Chanez, MD, PhD         
CHRU Montpellier - Hôpital Arnaud de Villeneuve Recruiting
Montpellier, France, 34295
Principal Investigator: Arnaud Bourdin, MD, PhD         
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Study Director: Arnaud Bourdin, MD, PhD University Hospitals of Montpellier

Additional Information:
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03397056    
Other Study ID Numbers: RECHMPL17_0447
First Posted: January 11, 2018    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

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.

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Analytic Code
Time Frame: Individual datasets will be made available at time of submission.
Access Criteria:

The conditions under which members of the public will be granted access to the uploaded files are:

  • The user does not work for a private insurance company;
  • The data will be used/examined in a not-for-profit manner;
  • The data will not be used in an attempt to identify a patient or group of patients;
  • The data will not be used in support of any kind of private insurance policy or health penalties;
  • The data will be used/examined for the advancement of science/teaching while respecting participant/patient privacy and rights;
  • The user will state why they wish to access the data.
URL: http://osf.io/pxnhc

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
Patient willingness
Participation