NCT03098303CompletedNot Applicable
Criteria Associated With Patient Willingness to Participate in Biomedical Research: a Prospective, Observational Study
University Hospital, Montpellier4 sites in 1 country1,000 target enrollmentStarted: December 23, 2014Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 1,000
- Locations
- 4
- Primary Endpoint
- Acceptation or refusal to participate in a biomedical research study
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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 Outcomes
- The PROTOACCEPT questionnaire(Day 0 (cross-sectional study))
Investigators
Study Sites (4)
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