How Participants Perceive Biomedical Research in Pulmonology

Biomedical Research Clinical Trial

— PROTOACCEPT2  

Official title:

How Participants Perceive Biomedical Research in Pulmonology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03397056
• Other study ID #: RECHMPL17_0447
• Status: Completed
• Start date: March 7, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2019
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Biomedical Research

Intervention

Other:
• Questionnaire
The Questionnaire is provided in the links at the end of the declaration.

Locations

Country	Name	City	State
France	APHM - Hôpital Nord	Marseille
France	CHRU Montpellier - Hôpital Arnaud de Villeneuve	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The PROTOACCEPT2 questionnaire.		day 0 (transversal study)

External Links

•   PROTOACCEPT2 on the Open Science Framework (access to questionnaire)