Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-02 @ 1:06 AM
Study NCT ID:
NCT03397056
Status:
COMPLETED
Last Update Posted:
2020-03-10
First Post:
2018-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
How Participants Perceive Biomedical Research in Pulmonology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-09', 'studyFirstSubmitDate': '2018-01-05', 'studyFirstSubmitQcDate': '2018-01-10', 'lastUpdatePostDateStruct': {'date': '2020-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The PROTOACCEPT2 questionnaire.', 'timeFrame': 'day 0 (transversal study)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Patient willingness', 'Participation'], 'conditions': ['Biomedical Research']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://osf.io/pxnhc', 'label': 'PROTOACCEPT2 on the Open Science Framework (access to questionnaire)'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to determine how biomedical research is perceived by patients already participating in a pulmonology research project.', 'detailedDescription': "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.\n\nA 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.\n\nThe primary objective of this study is to determine how biomedical research is perceived by patients already participating in a pulmonology research project.\n\nThe secondary objectives are to determine:\n\n* how biomedical research is experienced / felt;\n* if the information delivered to the patient (orally - information note) is clearly perceived.\n\nComparisons with PROTOACCEPT1 (osf.io/nsjjr) will also be performed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The target population corresponds to patients with a respiratory disease already included in a biomedical research protocol.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n* The patient is participating in a biomedical research protocol.\n\nExclusion Criteria:\n\n* Patient under 18 years of age\n* Patient judged incapable of filling out the questionnaire for linguistic or other reasons.\n* The patient has already participated in the present study.'}, 'identificationModule': {'nctId': 'NCT03397056', 'acronym': 'PROTOACCEPT2', 'briefTitle': 'How Participants Perceive Biomedical Research in Pulmonology', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'How Participants Perceive Biomedical Research in Pulmonology', 'orgStudyIdInfo': {'id': 'RECHMPL17_0447'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'The study population', 'description': 'The target population corresponds to patients with a respiratory disease already included in a biomedical research protocol.\n\nIntervention: Questionnaire', 'interventionNames': ['Other: Questionnaire']}], 'interventions': [{'name': 'Questionnaire', 'type': 'OTHER', 'description': 'The Questionnaire is provided in the links at the end of the declaration.', 'armGroupLabels': ['The study population']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13915', 'city': 'Marseille', 'country': 'France', 'facility': 'APHM - Hôpital Nord', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'CHRU Montpellier - Hôpital Arnaud de Villeneuve', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Arnaud Bourdin, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospitals of Montpellier'}]}, 'ipdSharingStatementModule': {'url': 'http://osf.io/pxnhc', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'timeFrame': 'Individual datasets will be made available at time of submission.', 'ipdSharing': 'YES', 'description': '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.\n\nData will be made available on a not-for-profit, free platform that allows access control: zenodo.\n\nA link on osf.io/pxnhc will point towards the zenodo upload.', 'accessCriteria': 'The conditions under which members of the public will be granted access to the uploaded files are:\n\n* The user does not work for a private insurance company;\n* The data will be used/examined in a not-for-profit manner;\n* The data will not be used in an attempt to identify a patient or group of patients;\n* The data will not be used in support of any kind of private insurance policy or health penalties;\n* The data will be used/examined for the advancement of science/teaching while respecting participant/patient privacy and rights;\n* The user will state why they wish to access the data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}