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Completed

NCT Number: NCT03098303

Criteria Associated With Patient Willingness to Participate in Biomedical Research

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Polyclinique Saint-Privat, Boujan-sur-Libron, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  1. The PROTOACCEPT questionnaire

    Time frame: Day 0 (cross-sectional study)

    The PROTOACCEPT questionnaire (see links below).

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: PROTOACCEPT

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 31, 2017
Registry last updated
Aug 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.