Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-02-28 @ 9:33 AM
Study NCT ID:
NCT04160234
Status:
UNKNOWN
Last Update Posted:
2021-02-10
First Post:
2019-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preoperative Risk Assessment in the Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-11-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2022-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-05', 'studyFirstSubmitDate': '2019-11-08', 'studyFirstSubmitQcDate': '2019-11-08', 'lastUpdatePostDateStruct': {'date': '2021-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Completion rate', 'timeFrame': '1 day', 'description': 'The completion rate of the total number of questions of the web-based questionnaires'}], 'secondaryOutcomes': [{'measure': "Frequency of patient's requests for help to the accompanying next of kin", 'timeFrame': '1 day', 'description': "The study team member, who is present during the study treatment, will assess the frequency of the patient's requests for help to the accompanying next of kin"}, {'measure': "Assessment of the kind of patient's requests for help to the accompanying next of kin", 'timeFrame': '1 day', 'description': "The study team member, who is present during the study treatment, will assess the kind of the patient's requests for help to the accompanying next of kin, divided into: technical request or request regarding the content of the web-based questions"}, {'measure': "Assessment of the kind of patient's requests for help to the study team member", 'timeFrame': '1 day', 'description': "The study team member, who is present during the study treatment, will assess the kind of the patient's requests for help to himself, divided into: technical request or request regarding the content of the web-based questions"}, {'measure': "Frequency of patient's requests for help to the study team member", 'timeFrame': '1 day', 'description': "The study team member, who is present during the study treatment, will assess the frequency of the patient's requests for help to him"}, {'measure': 'Elapsed time for questionnaire completion', 'timeFrame': '1 day', 'description': 'The survey software will automatically count the elapsed time for completion of the questionnaires. The time will start in the moment, when the patient accesses the website and it will end when he presses the finish button'}, {'measure': 'Ranking of unanswered questions', 'timeFrame': '1 day', 'description': 'We will analyse which questions where not answered by the most patients.'}, {'measure': 'Patient satisfaction', 'timeFrame': '1 day', 'description': 'Analysis of patient satisfaction about the web-based questionnaires. A paper-based satisfaction questionnaire is provided to the patient after the completion of the web-based survey. The satisfaction questionnaire will consist of a 5-point Likert scale. It will consist of the items: Strongly disagree; Disagree; Neither agree nor disagree; Agree; Strongly agree'}, {'measure': 'Frequency of technical problems', 'timeFrame': '1 day', 'description': 'The frequency of technical problems (i.e. internet connection, black screen etc.) will be assessed by the present study team member'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['elderly', 'surgery', 'preoperative risk'], 'conditions': ['Preoperative Risk Assessment']}, 'descriptionModule': {'briefSummary': 'PrepTAB aims to determine whether elderly patients are able to complete 4 preoperative risk assessment questionnaires within a web-based survey.', 'detailedDescription': 'Elderly patients are the most rapidly increasing group among surgical admissions. They are prone to a higher risk, because of predisposing risk factors. A comprehensive preoperative risk assessment is recommended by the European Society of Anaesthesiologists guideline, but time-consuming and usually not performed at present. A telemedical approach would enable an out-of hospital risk assessment before hospital admission and provide important information without the need for additional in-hospital resources. The feasibility of the completion of a web-based questionnaire by elderly patients, within a controlled in-hospital setting is required, as a base for a telemedical approach.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'A convenient sample of patients, meeting all inclusion and none exclusion criteria, will be enrolled in the study. The patients will be recruited from the anaesthesia ambulance in the University hospital RWTH Aachen, where they have an appointment with the anaesthetist before their planned surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Legally competent patients\n* Written informed consent\n* Age ≥ 65, male, female, diverse\n* Multimorbid patients (≥ 2 comorbidities (according to the Charlson Comorbidity Index)\n* Major elective surgery (such as total abdominal hysterectomy, endoscopic resection of prostate, lumbar discectomy, thyroidectomy, total joint replacement, lung operations, colon resection, radical neck dissection etc.)\n\nExclusion Criteria:\n\n* Blind or deaf patients\n* Patient/ Proxy not able to use electronic devices e.g. computer, tablet or smart phone\n* Non-fluency in local language\n* Alcohol and/ or drugs abuse\n* Ambulatory surgery\n* Repeated surgery, with previous participation\n* Patients with severe neurological or psychiatric disorder\n* Refusal of study participation by the patient'}, 'identificationModule': {'nctId': 'NCT04160234', 'acronym': 'PrepTAB', 'briefTitle': 'Preoperative Risk Assessment in the Elderly', 'organization': {'class': 'OTHER', 'fullName': 'RWTH Aachen University'}, 'officialTitle': 'Web-based Preoperative Risk Assessment in the Elderly: a Pilot-study', 'orgStudyIdInfo': {'id': 'EK 342/19'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Elderly patient', 'description': 'Preoperative elderly patients, who are planned for a surgical intervention', 'interventionNames': ['Other: web-based questionnaires']}], 'interventions': [{'name': 'web-based questionnaires', 'type': 'OTHER', 'description': 'Patients will be asked to complete web-based questionnaires on a tablet computer', 'armGroupLabels': ['Elderly patient']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52074', 'city': 'Aachen', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Ana Kowark, MD', 'role': 'CONTACT', 'email': 'anaesthesiologie@ukaachen.de', 'phone': '+4924180-88179'}, {'name': 'Sebastian Ziemann, MD', 'role': 'CONTACT', 'email': 'anaesthesiologie@ukaachen.de', 'phone': '+4924180-88179'}, {'name': 'Ana Kowark, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Mark Coburn, Prof.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sebastian Ziemann, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Anesthesiology, University Hospital Aachen', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}], 'centralContacts': [{'name': 'Ana Kowark, MD', 'role': 'CONTACT', 'email': 'akowark@ukaachen.de', 'phone': '+49241800'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RWTH Aachen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant', 'investigatorFullName': 'Ana Kowark', 'investigatorAffiliation': 'RWTH Aachen University'}}}}