Ignite Creation Date:
2025-12-25 @ 12:07 AM
Ignite Modification Date:
2025-12-25 @ 10:06 PM
Study NCT ID:
NCT06395558
Status:
RECRUITING
Last Update Posted:
2024-08-26
First Post:
2024-04-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
intErnet-based iNterventions FOR Cardiac arrEst suRvivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D006323', 'term': 'Heart Arrest'}, {'id': 'D012917', 'term': 'Social Adjustment'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The assessor will be unaware about the study arm allocation of the patient'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 137}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-23', 'studyFirstSubmitDate': '2024-04-24', 'studyFirstSubmitQcDate': '2024-04-30', 'lastUpdatePostDateStruct': {'date': '2024-08-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite outcome', 'timeFrame': '12 months', 'description': 'HADS (Hospital Anxiety and Depression Scale) score \\< 8 for depression or anxiety and TICS (Telephone Interview for Cognitive Status) \\> 31'}], 'secondaryOutcomes': [{'measure': 'HADS (Hospital Anxiety and Depression Scale) value', 'timeFrame': '12 months', 'description': 'Depression and anxiety symptoms'}, {'measure': 'TICS (Telephone Interview for Cognitive Status)', 'timeFrame': '12 months', 'description': 'Cognitive symptoms'}, {'measure': 'SF-12 (Short Form Health Survey 36)', 'timeFrame': '12 months', 'description': 'Health Related Quality of Life'}, {'measure': 'NRS (Neurobehavioural rating scale), PCRS (Patient Competency Rating Scale)', 'timeFrame': '12 months', 'description': 'Behavioural symptoms'}, {'measure': 'NRS (Neurobehavioural rating scale)', 'timeFrame': '12 months', 'description': 'Behavioural symptoms'}, {'measure': 'Pittsburgh Sleep Quality Index (PSQI)', 'timeFrame': '12 months', 'description': 'Sleep Quality'}, {'measure': 'Sexual Interest and Satisfaction Scale (SISS)', 'timeFrame': '12 months', 'description': 'Sexual Interest and Satisfaction'}, {'measure': 'Zarit Burden Inventory (ZBI)', 'timeFrame': '12 months', 'description': 'Caregiver Burden'}, {'measure': 'PCRS (Patient Competency Rating Scale)', 'timeFrame': '12 months', 'description': 'Behavioural symptoms'}, {'measure': 'HADS (Hospital Anxiety and Depression Scale) - Caregiver', 'timeFrame': '12 months', 'description': "Caregiver's depression and anxiety symptoms"}, {'measure': 'PSQI (Pittsburgh Sleep Quality Index) - Caregiver', 'timeFrame': '12 months', 'description': "Caregiver's sleep quality"}, {'measure': 'SF-12 (Short Form Health Survey 36) - Caregiver', 'timeFrame': '12 months', 'description': "Caregiver's Health Related Quality of Life"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cognitive Impairment', 'Depression, Anxiety', 'Cardiac Arrest', 'Quality of Life', 'Social Functioning', 'Sexual Dysfunction']}, 'referencesModule': {'references': [{'pmid': '39328897', 'type': 'DERIVED', 'citation': 'Gamberini L, Rucci P, Dolcini C, Masi M, Simoncini L, Tartaglione M, Del Giudice D, Domina R, Fagiolini A, Salucci P; Collaborators. ENFORCER, internet-based interventions for cardiac arrest survivors: A study protocol for a randomised, parallel-group, multicentre clinical trial. Resusc Plus. 2024 Sep 18;20:100772. doi: 10.1016/j.resplu.2024.100772. eCollection 2024 Dec.'}]}, 'descriptionModule': {'briefSummary': 'Anxiety, depression and cognitive impairment symptoms are common among cardiac arrest survivors. This randomized clinical trial will test whether an internet-based lifestyle intervention administered through a web app can foster anxiety and depression symptoms in patients who survived an out-of-hospital cardiac arrest and suffer from these symptoms'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hospital discharge after out-of-hospital cardiac arrest with Cerebral Performance Category 1 or 2\n* HADS anxiety or depression ≥ 8 and/or TICS ≤ 31\n* Informed consent for participation in the study\n* Native Italian speaker or adequate understanding of the Italian language\n* Adequate ability to use the web to guarantee access to the contents\n\nExclusion Criteria:\n\n* Previous cognitive dysfunction\n* Previous psychiatric disease\n* Previous episode of out-of-hospital cardiac arrest'}, 'identificationModule': {'nctId': 'NCT06395558', 'acronym': 'ENFORCER', 'briefTitle': 'intErnet-based iNterventions FOR Cardiac arrEst suRvivors', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Azienda Usl di Bologna'}, 'officialTitle': 'Internet-Based Interventions for Cardiac Arrest Survivors', 'orgStudyIdInfo': {'id': 'ENFORCER'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lifestyle intervention', 'interventionNames': ['Behavioral: Lifestyle intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'Lifestyle intervention', 'type': 'BEHAVIORAL', 'description': 'Multimodal web-based intervention programme on anxiety, depression and cognitive impairment consisting of knowledge development sessions and practical/gaming sessions focused on different domains: cognitive competence, socio-relational competence and emotions/affectivity, and physical activity-nutrition', 'armGroupLabels': ['Lifestyle intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40026', 'city': 'Imola', 'state': 'Bologna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Pamela Salucci, MD', 'role': 'CONTACT', 'email': 'pamela.salucci@montecatone.com'}], 'facility': 'Montecatone Rehabilitation Institute', 'geoPoint': {'lat': 44.35916, 'lon': 11.7132}}, {'zip': '40100', 'city': 'Bologna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Lorenzo Gamberini', 'role': 'CONTACT'}], 'facility': 'Azienda Unità Sanitaria Locale', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'centralContacts': [{'name': 'Lorenzo Gamberini, MD', 'role': 'CONTACT', 'email': 'gamberini6@ausl.bologna.it', 'phone': '3403550540', 'phoneExt': '+39'}, {'name': 'Pamela Salucci, MD', 'role': 'CONTACT', 'email': 'pamela.salucci@montecatone.com'}], 'overallOfficials': [{'name': 'Lorenzo Gamberini, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Azienda USL Bologna'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After study publication, indefinitely.', 'ipdSharing': 'YES', 'description': 'Fully anonymized patient data will be shared in an online repository', 'accessCriteria': 'No Access restrictions'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Usl di Bologna', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Montecatone Rehabilitation Institute S.p.A.', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}