Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2026-03-01 @ 6:00 AM
Study NCT ID:
NCT04169958
Status:
UNKNOWN
Last Update Posted:
2019-11-20
First Post:
2018-12-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Suicide Risk Assessment by Digital Means
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013405', 'term': 'Suicide'}], 'ancestors': [{'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-17', 'studyFirstSubmitDate': '2018-12-22', 'studyFirstSubmitQcDate': '2019-11-17', 'lastUpdatePostDateStruct': {'date': '2019-11-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlations between collected digital data and suicidality rating score', 'timeFrame': '1.5 years', 'description': 'Correlations between collected digital data and suicidality rating score.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Suicide']}, 'descriptionModule': {'briefSummary': 'This study is an observational study, without intervention. Using a tablet application that developed for this study. In addition, sensors are used to examine the possibility of using the system to assess the risk of suicide. It should be noted that this is a pilot study, only for a wider study involving a larger number of patients.\n\nThe system developed for the benefit of this study is based on a smartphone application installed on a standard Smartphone device that will be found in the ED or by the examiner. The system collects data from five channels one by one (the information collected from each channel is collected separately).\n\nThe data recorded from the various channels is saved on the tablet device. Then, the information transferred to the database using a cable. A statistical analysis of the data from the various channels is carried out in order to assess suicidal behavior.\n\nAfter the statistical analysis, correlations will be examining between the results of the measurements and the results of the accepted questionnaires for the assessment of suicidality, which will be performed simultaneously.\n\nNote that the duration of participation is the duration of the measurements, ie a single session that lasts up to two hours The duration of the participants in the study is determined by the time of the measurements, ie a single session lasting up to two hours.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'We will recruit a total sample of N=50 in three stages:\n\n* Males and Females\n* 30 patients aged 12 - 18 years old (20% of the study sample) Participants will be recruited from the psychiatric ER (\\~50%), outpatient clinics (\\~20%), and inpatient wards (\\~30%) at the Sheba Medical Center, the largest hospital in Israel, serving a very large, demographically heterogenic and socioeconomically diverse population.\n* Psychiatric diagnosis: None, Affective Disorder, PTSD, ADHD, Personality Disorder, Anxiety Disorder, OCD.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Every patient who is examined in the psychiatric ward at the Sheba Medical Center\n* Proper ability to give informed consent\n\nExclusion Criteria:\n\n* A patient who is not independent and without an active therapist / guardian involved in the treatment'}, 'identificationModule': {'nctId': 'NCT04169958', 'briefTitle': 'Suicide Risk Assessment by Digital Means', 'organization': {'class': 'OTHER', 'fullName': 'The Chaim Sheba Medical Center'}, 'officialTitle': 'Suicide Risk Assessment by Digital Means', 'orgStudyIdInfo': {'id': 'SHEBA-18-5152-NG-CTIL'}}, 'armsInterventionsModule': {'interventions': [{'name': 'safe mood', 'type': 'OTHER', 'description': 'A tablet application that developed for this study. In addition, sensors are used to examine the possibility of using the system to assess the risk of suicide'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'NADAV GOLDENTAL, MD', 'role': 'CONTACT', 'email': 'nadav.gold@gmail.com', 'phone': '+972-503363498'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Chaim Sheba Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Nadav Goldental', 'investigatorAffiliation': 'The Chaim Sheba Medical Center'}}}}