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Criteria Associated With Patient Willingness to Participate in Biomedical Research (PROTOACCEPT)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03098303
Recruitment Status : Completed
First Posted : March 31, 2017
Last Update Posted : August 26, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief 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).

Condition or disease
Consulting in Pneumology Department, But Not for Oncology or Tobacology

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.

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Study Type : Observational
Actual Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Criteria Associated With Patient Willingness to Participate in Biomedical Research: a Prospective, Observational Study
Actual Study Start Date : December 23, 2014
Actual Primary Completion Date : December 13, 2016
Actual Study Completion Date : December 13, 2016



Primary Outcome Measures :
  1. 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?"


Secondary Outcome Measures :
  1. The PROTOACCEPT questionnaire [ Time Frame: Day 0 (cross-sectional study) ]
    The PROTOACCEPT questionnaire (see links below).



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:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • The patient was informed about the study.
  • The patient is scheduled for a consult in the pneumology department

Exclusion Criteria:

  • 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

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): NCT03098303


Locations
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France
Polyclinique Saint-Privat
Boujan-sur-Libron, France, 34760
Clinique de Marignane
Marignane, France, 13700
APHM - Hôpital Nord
Marseille, France, 13915
Centre Hospitalier Universitaire de Montpellier
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Study Director: Arnaud Bourdin, MD, PhD Montpellier University Hospitals
Additional Information:
Publications of Results:
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03098303    
Other Study ID Numbers: 9373
2014-A01201-46 ( Other Identifier: RCB number )
First Posted: March 31, 2017    Key Record Dates
Last Update Posted: August 26, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms