Criteria Associated With Patient Willingness to Participate in Biomedical Research

Criteria Associated With Patient Willingness to Participate in Biomedical Research: a Prospective, Observational Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03098303

Acronym

PROTOACCEPT

Enrollment

1000

Registered

2017-03-31

Start date

2014-12-23

Completion date

2016-12-13

Last updated

2020-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Consulting in Pneumology Department, But Not for Oncology or Tobacology

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
The PROTOACCEPT questionnaire	Day 0 (cross-sectional study)	The PROTOACCEPT questionnaire (see links below).

Countries

France

Outcome results