Criteria Associated With Patient Willingness to Participa... | NCT03098303

Studies
Criteria Associated With Patient Willingness to Participate in Biomedical Research

NCT03098303

Sponsor

University Hospital, Montpellier

Status

Completed

Last Update Posted

Aug 26, 2020Actual

Enrollment

1,000Actual

Phase

Not provided

Conditions

Consulting in Pneumology Department, But Not for Oncology or Tobacology

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2014-A01201-46	Other Identifier	RCB number

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 23, 2014Actual

Primary Completion Date

Dec 13, 2016Actual

Completion Date

Dec 13, 2016Actual

First Submitted Date

Mar 27, 2017

First Submission Date that Met QC Criteria

Mar 27, 2017

First Posted Date

Mar 31, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 24, 2020

Last Update Posted Date

Aug 26, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Acceptation or refusal to participate in a biomedical research study	Positive or negative response to the question "If a biomedical research protocole were proposed to you, would you accept to participate?"	Day 0 (cross-sectional study)

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The target population corresponds to patients with respiratory disease. This study will be proposed to all patients consulting (excluding oncology and tobacco) in the associated departments.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Arnaud Bourdin, MD, PhD	Montpellier University Hospitals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Polyclinique Saint-Privat		Boujan-sur-Libron		34760	France
Clinique de Marignane

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32791969	Result	Pahus L, Suehs CM, Halimi L, Bourdin A, Chanez P, Jaffuel D, Marciano J, Gamez AS, Vachier I, Molinari N. Patient distrust in pharmaceutical companies: an explanation for women under-representation in respiratory clinical trials? BMC Med Ethics. 2020 Aug 13;21(1):72. doi: 10.1186/s12910-020-00509-y.
30922104	Result