How Participants Perceive Biomedical Research in Pulmonology

Completed

• Conditions: Biomedical Research
• Interventions: Other: Questionnaire

• Registration Number: NCT03397056
• Lead Sponsor: University Hospital, Montpellier

Brief Summary

The primary objective of this study is to determine how biomedical research is perceived by patients already participating in a pulmonology research project.

Detailed Description

Over time, clinical research has become a challenge both in terms of public health and in terms of scientific progress. Additionally, it has also become a financial challenge for institutions, especially in France where a significant part of their government funding is provided according to their ability to conduct quality clinical research. Pulmonology is a sector where clinical research is well established with strong incentives from several pharmaceutical companies and numerous academic research projects. Nevertheless, it is important to put the patient back at the centre of biomedical research.

A better knowledge of patient expectations, questions and misunderstandings would considerably improve treatment observance, clinical trial data quality, doctor-patient trust/relationship, and ultimately, the patient's health.

The primary objective of this study is to determine how biomedical research is perceived by patients already participating in a pulmonology research project.

The secondary objectives are to determine:

* how biomedical research is experienced / felt;

* if the information delivered to the patient (orally - information note) is clearly perceived.

Comparisons with PROTOACCEPT1 (osf.io/nsjjr) will also be performed.

Study Timeline

• Study First Submitted: 2018-01-05
• Study First Submitted QC: 2018-01-10
• Study First Posted: 2018-01-11
• Study Start: 2018-03-07
• Status Verified: 2019-03
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Last Update Submitted: 2020-03-09
• Last Update Posted: 2020-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• The patient presents with at least one of the following: (1) asthma, (2) chronic obstructive pulmonary disease, (3) bronchiectasis, (4) idiopathic pulmonary fibrosis, (5) pulmonary arterial hypertension, (6) sleep apnoea syndrome
• The patient is participating in a biomedical research protocol.

Exclusion Criteria

• Patient under 18 years of age
• Patient judged incapable of filling out the questionnaire for linguistic or other reasons.
• The patient has already participated in the present study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
The study population	Questionnaire	The target population corresponds to patients with a respiratory disease already included in a biomedical research protocol. Intervention: Questionnaire

Primary Outcome Measures

Name	Time	Method
The PROTOACCEPT2 questionnaire.	day 0 (transversal study)

Trial Locations

Locations (2)

CHRU Montpellier - Hôpital Arnaud de Villeneuve; 🇫🇷 Montpellier, France

APHM - Hôpital Nord; 🇫🇷 Marseille, France