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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

Tracking Information
First Submitted Date March 27, 2017
First Posted Date March 31, 2017
Last Update Posted Date August 26, 2020
Actual Study Start Date December 23, 2014
Actual Primary Completion Date December 13, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 27, 2017)
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?"
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: March 27, 2017)
The PROTOACCEPT questionnaire [ Time Frame: Day 0 (cross-sectional study) ]
The PROTOACCEPT questionnaire (see links below).
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Criteria Associated With Patient Willingness to Participate in Biomedical Research
Official Title Criteria Associated With Patient Willingness to Participate in Biomedical Research: a Prospective, Observational Study
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).
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Consulting in Pneumology Department, But Not for Oncology or Tobacology
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 27, 2017)
1000
Original Actual Enrollment Same as current
Actual Study Completion Date December 13, 2016
Actual Primary Completion Date December 13, 2016   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03098303
Other Study ID Numbers 9373
2014-A01201-46 ( Other Identifier: RCB number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Montpellier
Study Sponsor University Hospital, Montpellier
Collaborators Not Provided
Investigators
Study Director: Arnaud Bourdin, MD, PhD Montpellier University Hospitals
PRS Account University Hospital, Montpellier
Verification Date August 2020