Criteria Associated With Patient Willingness to Participate in Biomedical Research

Completed

• Conditions: Consulting in Pneumology Department, But Not for Oncology or Tobacology

• Registration Number: NCT03098303
• Lead Sponsor: 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).

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 Timeline

• Study Start: 2014-12-23
• Primary Completion: 2016-12-13
• Study Completion: 2016-12-13
• Study First Submitted: 2017-03-27
• Study First Submitted QC: 2017-03-27
• Study First Posted: 2017-03-31
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-24
• Last Update Posted: 2020-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acceptation or refusal to participate in a biomedical research study	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

Name	Time	Method
The PROTOACCEPT questionnaire	Day 0 (cross-sectional study)	The PROTOACCEPT questionnaire (see links below).

Trial Locations

Locations (4)

Polyclinique Saint-Privat; 🇫🇷 Boujan-sur-Libron, France

Clinique de Marignane; 🇫🇷 Marignane, France

APHM - Hôpital Nord; 🇫🇷 Marseille, France

Centre Hospitalier Universitaire de Montpellier; 🇫🇷 Montpellier, France