NCT03397056

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 11, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

March 7, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

March 10, 2020

Status Verified

March 1, 2019

Enrollment Period

1.8 years

First QC Date

January 5, 2018

Last Update Submit

March 9, 2020

Conditions

Keywords

Patient willingnessParticipation

Outcome Measures

Primary Outcomes (1)

  • The PROTOACCEPT2 questionnaire.

    day 0 (transversal study)

Study Arms (1)

The study population

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

Other: Questionnaire

Interventions

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

The study population

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

APHM - Hôpital Nord

Marseille, 13915, France

Location

CHRU Montpellier - Hôpital Arnaud de Villeneuve

Montpellier, 34295, France

Location

Related Links

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Arnaud Bourdin, MD, PhD

    University Hospitals of Montpellier

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2018

First Posted

January 11, 2018

Study Start

March 7, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

March 10, 2020

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will share

The general goal is to make the study data available to interested researchers as well as to provide proof of transparency for the study. Data (and an accompanying data dictionary) will be de-identified and potentially further cleaned or aggregated as the investigators deem necessary to protect participant anonymity. Data will be made available on a not-for-profit, free platform that allows access control: zenodo. A link on osf.io/pxnhc will point towards the zenodo upload.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Individual datasets will be made available at time of submission.
Access Criteria
The conditions under which members of the public will be granted access to the uploaded files are: * The user does not work for a private insurance company; * The data will be used/examined in a not-for-profit manner; * The data will not be used in an attempt to identify a patient or group of patients; * The data will not be used in support of any kind of private insurance policy or health penalties; * The data will be used/examined for the advancement of science/teaching while respecting participant/patient privacy and rights; * The user will state why they wish to access the data.
More information

Locations