How Participants Perceive Biomedical Research in Pulmonology

NCT ID: NCT03397056

Last Updated: 2020-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-07

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Biomedical Research

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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The study population

The target population corresponds to patients with a respiratory disease already included in a biomedical research protocol.

Intervention: Questionnaire

Questionnaire

Intervention Type OTHER

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

Interventions

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Questionnaire

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Arnaud Bourdin, MD, PhD

Role: STUDY_DIRECTOR

University Hospitals of Montpellier

Locations

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APHM - Hôpital Nord

Marseille, , France

Site Status

CHRU Montpellier - Hôpital Arnaud de Villeneuve

Montpellier, , France

Site Status

Countries

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France

Related Links

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http://osf.io/pxnhc

PROTOACCEPT2 on the Open Science Framework (access to questionnaire)

Other Identifiers

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RECHMPL17_0447

Identifier Type: -

Identifier Source: org_study_id

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