Ignite Creation Date:
2025-12-24 @ 2:03 PM
Ignite Modification Date:
2026-01-08 @ 8:25 AM
Study NCT ID:
NCT05547295
Status:
COMPLETED
Last Update Posted:
2025-07-30
First Post:
2022-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Impact of a Digital Tool MEDIASCREEN of Preventive Information for Patients on the Knowledge of the Risk of Pressure Sores Acquired During a Hospitalization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003668', 'term': 'Pressure Ulcer'}], 'ancestors': [{'id': 'D012883', 'term': 'Skin Ulcer'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-01-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-29', 'studyFirstSubmitDate': '2022-07-07', 'studyFirstSubmitQcDate': '2022-09-16', 'lastUpdatePostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the change on the knowledge of the risk of hospital-acquired pressure sores with a digital MEDIASCREEN information tool in comparison to the usual paper-based prevention materials', 'timeFrame': 'Change from baseline knowledge at 1 month', 'description': 'The comparison will be done with Skin-Management Needs Assessment Checklist score (SMNac). Minimum value =0, Maximum value = 100; higher score better outcome.'}], 'secondaryOutcomes': [{'measure': 'Evaluate patient satisfaction with the information delivered by the MEDIASCREEN digital tool', 'timeFrame': 'At 1 month', 'description': 'Measured by Visual Analogic scale from 0 to 100. Zero is represented : "Not at all satisfied" and 100 : "Completely satisfied".\n\nHigher scores better outcome.'}, {'measure': 'Assess the cognitive impact of the prevention information delivered by MEDIASCREEN tool, on self-esteem.', 'timeFrame': 'At the beginning and at 1 month', 'description': 'Measured of self-esteem with Rosenberg scale. Score range : 10-40. High scores indicate high self esteem.'}, {'measure': 'Assess the cognitive impact of the prevention information delivered by MEDIASCREEN tool, on sense of self-efficacy.', 'timeFrame': 'At the beginning and at 1 month', 'description': 'Measured of self-efficacy with scale to evaluate the feeling of personal effectiveness (MSES) Score range: 16-80. High scores indicate high feeling of personal effectiveness.'}, {'measure': 'Evaluate the psychological impact of information delivered from the tools', 'timeFrame': 'At 1 month', 'description': 'Measured by Visual Analogic scale from 0 to 100. Zero is represented : "No knowledge" and 100 : "Perfectly mastered subject".\n\nHigher scores better outcome.'}, {'measure': 'Evaluate the occurrence of pressure sores during hospitalization', 'timeFrame': 'At the beginning and at 1 month', 'description': 'Count of the apparition number of pressure sores.'}, {'measure': 'Evaluate the acquisition of knowledge by patients', 'timeFrame': 'At 1 month', 'description': 'Evaluate with questionnaire of knowledge, compose by 5 questions on three points each. The overall questionnaire will be on 15 points.\n\nHigher scores better outcome.'}, {'measure': 'Evaluate the user experience when using the digital tool MEDIASCREEN.', 'timeFrame': 'At 1 month', 'description': 'Measured by Questionnaire Attrakdiff for the user experience. The AttrakDiff questionnaire contains 28 question with 7 Likert-type scale from -3 to 3.'}, {'measure': 'Evaluate the observance when using the digital tool MEDIASCREEN.', 'timeFrame': 'At 1 month', 'description': 'Measured by the connexion data : number of connexion, duration of connexion, percentage of completion.'}, {'measure': 'Evaluate the acceptability of the digital information tool MEDIASCREEN digital information tool or the paper information brochure.', 'timeFrame': 'At the beggining and at 1 month', 'description': 'The acceptability will be assessed using a 13-item questionnaire based on the Unified Theory of Acceptance and Use of Technology (UTAUT) model. Each question is based on a Likert-type 5 point scale ranging from : 1=In total disagreement, 2= Somewhat disagree, 3= Neither agree nor disagree, 4= Somewhat agree, 5=In total agreement.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pressure Sore']}, 'descriptionModule': {'briefSummary': 'The study focuses on the impact of a digital MEDIASCREEN tool on the knowledge, technical know-how and behavioural skills in terms of pressure sores of patients. In addition, the cognitive impact of this type of tool will also be studied in our study population (self-esteem and feeling of personal effectiveness). The objective is to compare the impact of a digital MEDIASCREEN information tool with information tool compared to the usual paper-based prevention materials on knowledge of the risk of hospital-acquired pressure sores.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient in complete hospitalization in Physical Medicine and Rehabilitation\n* Patient affiliated to a social security system\n* Patient presenting a low to high risk of pressure ulcer inferior or equal to or equal to 16 on the Norton scale\n* Patient having signed his consent\n\nExclusion Criteria:\n\n* Difficulty understanding and is unable to give free and informed consent\n* Pregnant women\n* Person deprived of liberty by a judicial or administrative administrative decision\n* Major under legal protection by a judicial or administrative decision.\n* Person in an emergency situation unable to give their informed consent'}, 'identificationModule': {'nctId': 'NCT05547295', 'acronym': 'EDUCESCARRES', 'briefTitle': 'Evaluation of the Impact of a Digital Tool MEDIASCREEN of Preventive Information for Patients on the Knowledge of the Risk of Pressure Sores Acquired During a Hospitalization', 'organization': {'class': 'OTHER', 'fullName': 'Pôle Saint Hélier'}, 'officialTitle': 'Evaluation of the Impact of a Digital Tool MEDIASCREEN of Preventive Information for Patients on the Knowledge of the Risk of Pressure Sores Acquired During a Hospitalization, a Randomized Controlled Pilot Interventional Study in Single Blind', 'orgStudyIdInfo': {'id': '2022-A00520-43'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Paper Information', 'description': 'Patient will have classic paper information for prevention of pressure sores', 'interventionNames': ['Other: Paper prevention']}, {'type': 'EXPERIMENTAL', 'label': 'Numeric information from MEDIASCREEN', 'description': 'Patient will have information for prevention of pressure sores throught the digital tool MEDIASCREEN', 'interventionNames': ['Other: Numeric prevention']}], 'interventions': [{'name': 'Numeric prevention', 'type': 'OTHER', 'description': 'Numeric information for prevention of pressure sores thgrough digital tool MEDIASCREEN', 'armGroupLabels': ['Numeric information from MEDIASCREEN']}, {'name': 'Paper prevention', 'type': 'OTHER', 'description': 'Information for prevention of pressure sores in classic way with paper', 'armGroupLabels': ['Paper Information']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35000', 'city': 'Rennes', 'state': 'Brittany Region', 'country': 'France', 'facility': 'Pôle Saint-Hélier', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}], 'overallOfficials': [{'name': 'Aurélie Duruflé', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pôle Saint Hélier'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pôle Saint Hélier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}