Ignite Creation Date:
2025-12-24 @ 7:03 PM
Ignite Modification Date:
2025-12-28 @ 5:50 PM
Study NCT ID:
NCT05176457
Status:
COMPLETED
Last Update Posted:
2024-01-31
First Post:
2021-10-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Communication Tool Evaluation on Intensive Care Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009633', 'term': 'Nonverbal Communication'}], 'ancestors': [{'id': 'D003142', 'term': 'Communication'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2022-06-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-29', 'studyFirstSubmitDate': '2021-10-21', 'studyFirstSubmitQcDate': '2022-01-03', 'lastUpdatePostDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Ease of Communication', 'timeFrame': "before PICT'REA introduction (Baseline)", 'description': 'The modified Ease of Communication Scale (ECS), comprising 8 questions of 1 to 5 points, for a maximum total of 40 points. The lower the score, the easiest the communication is.\n\nThis is regarding patients using traditional communication methods (slate, alphabet, lip reading, etc.)'}, {'measure': 'Ease of Communication', 'timeFrame': "after PICT'REA introduction (6 months)", 'description': 'The modified Ease of Communication Scale (ECS), comprising 8 questions of 1 to 5 points, for a maximum total of 40 points. The lower the score, the easiest the communication is.\n\nThis is regarding patients using the PICT REA application.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['intensive care', 'communication tool', 'invasive ventilation', 'speaking impairment', 'technology'], 'conditions': ['Communication, Nonverbal']}, 'descriptionModule': {'briefSummary': 'The present study evaluate the impact of a communication tool "PICT\'REA" on patients in reanimation units, equipped with ventilation systems, preventing them from speaking.\n\nThe app consists of simple pictograms allowing simple communication between patients and the reanimation care team.\n\nThe study will assess the quality of communication before and after the introduction of the communication tool in the reanimation unit.', 'detailedDescription': "Invasive mechanical ventilation is commonly used in intensive care, in sedated patients but also in perfectly conscious patients, and this on a daily basis.\n\nFor these patients, the resulting deprivation of oral expression is a major source of stress and discomfort. On the side of the caregivers, the difficulty of comprehension is a source of frustration on a daily basis.\n\nThus PICT'REA has been developped in order to help patients and caregivers to better understand each other during invasive ventilation.\n\nPICT'REA is a tool in the form of a mobile app with simple pictograms allowing simple communication (Yes/No/Pain chart...).\n\nThe study will analyze the quality of communication between patients and caregivers before and after the introduction of the application:\n\n* Before setting up the tool: control group\n\n * Over a period of 6 months\n * In the multi-purpose resuscitations of Cardio Vascular Surgery and Neurosurgery.\n* After setting up the tool:\n\n * Over a period of 6 months\n * In the same departments.\n\nThe analyses consists of various questionnaires :\n\n* the modified Ease of Communication Scale,\n* a Short questionnaire in 3 questions for caregivers,\n* IPREA questionnaire for patients,\n* Evaluation of the usability of the system by System Usability Scale questionnaire,\n* Evaluation of the attractiveness of the system by Attrackdiff questionnaire."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hospitalized in intensive care or intensive care\n* ventilated on a tracheostomy or an orotracheal intubation tube for\\> 24 hours\n* not too agitated or too sedated (RASS -1 to +2) for\\> 24 hours\n* Confusion Assessment Method (CAM) ICU negative\n* Speak or read French\n\nExclusion Criteria:\n\nInability to use the device:\n\n* Blind or visually impaired\n* Severe paresis of the upper limbs\n* No understanding of the tool.'}, 'identificationModule': {'nctId': 'NCT05176457', 'acronym': "PICT'REA", 'briefTitle': 'Communication Tool Evaluation on Intensive Care Patients.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': "A Communication Tool's Evaluation on Intensive Care Patients Equipped With Ventilation Systems.", 'orgStudyIdInfo': {'id': 'RC31/21/0427'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': "BEFORE PICT'REA introduction", 'description': 'Patients will have the usual communication tools (pen and paper, hands gestures...)'}, {'type': 'EXPERIMENTAL', 'label': "AFTER PICT'REA introduction", 'description': 'Patients will be given a tablet to communicate with the caregivers whenever needed', 'interventionNames': ["Other: communication tool PICT'REA"]}], 'interventions': [{'name': "communication tool PICT'REA", 'type': 'OTHER', 'description': 'The pictograms communication tool "PICT\'REA" will be available to patients with invasive ventilation systems preventing them from speaking', 'armGroupLabels': ["AFTER PICT'REA introduction"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'CHU Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Fanny VARDON-BOUNES, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}