Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-06 @ 6:15 AM
Study NCT ID:
NCT07428005
Status:
RECRUITING
Last Update Posted:
2026-02-23
First Post:
2026-02-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development of an Italian Questionnaire for Splenectomized Patients Using a Delphi Consensus Method
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-17', 'studyFirstSubmitDate': '2026-02-17', 'studyFirstSubmitQcDate': '2026-02-17', 'lastUpdatePostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Development of a consensus-based questionnaire', 'timeFrame': 'At study completion (4 months)', 'description': 'Availability of a finalized Italian questionnaire developed through Delphi consensus to assess awareness and knowledge of infectious risk prevention strategies and vaccination attitudes in splenectomized individuals.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['splenectomy', 'asplenia', 'vaccination', 'infection prevention', 'delphi study', 'questionnaire development'], 'conditions': ['Splenectomy; Status', 'Asplenia', 'Splenectomized Patients']}, 'descriptionModule': {'briefSummary': 'This study aims to develop an Italian-language questionnaire assessing awareness, knowledge of infectious risk prevention strategies, and vaccination attitudes among splenectomized individuals. The questionnaire will be developed through a structured Delphi consensus process involving a multidisciplinary panel of healthcare professionals experienced in infection prevention and vaccination strategies. Two Delphi rounds will be conducted online to evaluate item relevance and clarity. Items reaching predefined consensus thresholds will be included in the final questionnaire. The resulting tool will support future studies assessing preventive care awareness and vaccination uptake among splenectomized patients.', 'detailedDescription': 'Individuals without a functioning spleen face a lifelong increased risk of severe infections, particularly from encapsulated bacteria. Preventive strategies include vaccination, antibiotic prophylaxis, and patient education. However, adherence to preventive measures remains suboptimal, partly due to limited awareness and knowledge among patients.\n\nThis study aims to develop a validated Italian-language questionnaire to assess awareness, knowledge of preventive strategies, and attitudes toward vaccination among splenectomized individuals.\n\nA modified Delphi consensus methodology will be used. A multidisciplinary panel of healthcare professionals involved in managing asplenic patients will be recruited. Following a preliminary literature scoping review, draft questionnaire items will be generated and submitted to two Delphi rounds conducted online.\n\nParticipants will rate each item for relevance and clarity using structured Likert scales. Items reaching predefined consensus thresholds will be retained and refined between rounds. The final questionnaire will consist only of items achieving expert consensus.\n\nThe study does not involve patients directly and poses minimal risk, as participation is voluntary and responses are anonymized.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of a multidisciplinary panel of healthcare professionals, including physicians, nurses, and healthcare assistants working at Fondazione Policlinico Universitario A. Gemelli IRCCS, with clinical or academic experience in vaccination and infection prevention, particularly in the management of patients with asplenia. Participants are selected to ensure representation from different specialties involved in the care of asplenic patients and will participate in a Delphi consensus process aimed at developing a questionnaire on infectious risk prevention awareness and vaccination attitudes.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthcare professionals working at Fondazione Policlinico Universitario A. Gemelli IRCCS\n* Professional experience in vaccination or infection prevention\n* Clinical involvement in care of patients with asplenia or related conditions\n* Italian native language proficiency\n* Provision of informed consent\n\nExclusion Criteria:\n\n* Participation in the expert panel is restricted to individuals who meet all predefined inclusion criteria. Failure to satisfy any inclusion criterion automatically results in exclusion from the study population'}, 'identificationModule': {'nctId': 'NCT07428005', 'briefTitle': 'Development of an Italian Questionnaire for Splenectomized Patients Using a Delphi Consensus Method', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Development of an Italian Questionnaire to Assess Awareness and Knowledge of Infectious Risk Prevention Strategies in Splenectomized Patients Using a Delphi Consensus Method', 'orgStudyIdInfo': {'id': '8121'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Delphi Consensus Process', 'type': 'OTHER', 'description': 'A structured Delphi consensus process involving a multidisciplinary panel of healthcare professionals aimed at developing and validating questionnaire items assessing awareness and knowledge of infectious risk prevention strategies and vaccination attitudes in splenectomized individuals. Participants evaluate questionnaire items across two online Delphi rounds, rating relevance and clarity. Items reaching predefined consensus thresholds are retained to produce the final questionnaire.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Rome', 'state': 'Lazio', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Patrizia Laurenti, Professor', 'role': 'CONTACT', 'email': 'patrizia.laurenti@policlinicogemelli.it', 'phone': '+390630155701'}, {'name': 'Patrizia Laurenti', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fondazione Policlinico Universitario A. Gemelli IRCCS', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'centralContacts': [{'name': 'LAURENTI PATRIZIA, PROFESSOR', 'role': 'CONTACT', 'email': 'patrizia.laurenti@policlinicogemelli.it', 'phone': '0630159333'}], 'overallOfficials': [{'name': 'LAURENTI PATRIZIA, PROFESSOR', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Laurenti Patrizia', 'investigatorAffiliation': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}}}}