Ignite Creation Date:
2025-12-25 @ 4:15 AM
Ignite Modification Date:
2026-02-25 @ 7:23 PM
Study NCT ID:
NCT03320720
Status:
UNKNOWN
Last Update Posted:
2017-10-25
First Post:
2017-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Home Treatment for Acute Psychiatric Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 700}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-11', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2020-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-10-24', 'studyFirstSubmitDate': '2017-10-19', 'studyFirstSubmitQcDate': '2017-10-24', 'lastUpdatePostDateStruct': {'date': '2017-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inpatient days', 'timeFrame': '2 years follow-up', 'description': 'Number of inpatient days per patient'}], 'secondaryOutcomes': [{'measure': 'Total days in treatment', 'timeFrame': '2 years follow-up', 'description': 'Total days in Treatment per patient = inpatient and home treatment'}, {'measure': 'Treatment costs', 'timeFrame': '2 years follow-up', 'description': 'Calculated direct treatment costs'}, {'measure': 'Rehospitalization rate', 'timeFrame': '2 years follow-up', 'description': 'Number of rehospitalizations per patient and duration until rehospitalization'}, {'measure': 'Adverse events', 'timeFrame': '2 years follow-up', 'description': 'e.g. suicide or attempted suicide'}, {'measure': 'Global Assessment of Functioning Scale (GAF)', 'timeFrame': '2 years follow-up', 'description': 'Scale measures social, occupational and psychological functioning and ranges from 0 to 100 (higher values mean better outcome).'}, {'measure': 'Health of the Nation Outcome Scale (HoNOS)', 'timeFrame': '2 years follow-up', 'description': 'Scale measures the severity of symptoms and ranges from 0 to 48 (higher values mean worse outcome).'}, {'measure': 'Clinical Global Impression Scale (CGI)', 'timeFrame': '2 years follow-up', 'description': 'Scale measures the severity of symptoms, global improvement and therapeutic response and ranges from 0 to 7 (higher values mean worse outcome).'}, {'measure': "Patients' satisfaction", 'timeFrame': '2 years follow-up', 'description': "Patients' satisfaction assessed by the official questionnaire of the national association of the quality development in hospitals (ANQ)"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mental Disorder']}, 'descriptionModule': {'briefSummary': "The study's goal is to evaluate whether home treatment is an effective and efficient alternative to inpatient care for people with acute mental illness. Patients who meet the study's inclusion criteria are randomly assigned to either the condition home treatment or inpatient care (treatment-as-usual), during one year. Following two years, the two treatment modalities will be analyzed in terms of inpatient days, cost effectiveness, rehospitalization rate, severity of symptoms and sociodemographics.", 'detailedDescription': "The study's goal is to evaluate whether home treatment is an effective and efficient alternative to inpatient care for people with acute mental illness. Therefore, psychiatric patients in need of hospitalization who meet the study's inclusion criteria are randomly assigned to either the condition home treatment or inpatient care (treatment-as-usual) during one year. Home treatment patients are visited by a mobile and multiprofessional care team at their homes. Additionally, patients without a health insurance for home treatment and patients who are directly assigned to home treatment are included in separate study groups. Following two years, it will be checked whether home treatment leads to a reduction of inpatient days as a primary outcome. Further outcomes such as cost effectiveness, rehospitalization rate, severity of symptoms and sociodemographics will be also analyzed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Need for acute psychiatric inpatient care\n* Residence in Zurich city\n* Health insurance for Home Treatment\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT03320720', 'briefTitle': 'Evaluation of Home Treatment for Acute Psychiatric Care', 'organization': {'class': 'OTHER', 'fullName': 'Psychiatric University Hospital, Zurich'}, 'officialTitle': 'Evaluation of Home Treatment for Acute Psychiatric Care of the Psychiatric University Hospital Zurich (Switzerland)', 'orgStudyIdInfo': {'id': 'HT201701349'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Home Treatment', 'description': 'Patients with acute mental illness are treated at their houses by a mobile and multiprofessional care team instead of being treated as inpatients if their medical condition permits.', 'interventionNames': ['Other: Home Treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment-as-usual', 'description': 'Patients with acute mental illness are treated as inpatients in a psychiatric clinic.', 'interventionNames': ['Other: Treatment-as-usual']}], 'interventions': [{'name': 'Home Treatment', 'type': 'OTHER', 'description': 'Patients with acute mental illness in need of inpatient care are treated at their houses by a mobile and multiprofessional care team if their health condition permits.', 'armGroupLabels': ['Home Treatment']}, {'name': 'Treatment-as-usual', 'type': 'OTHER', 'description': 'Patients with acute mental illness in need of inpatient care are treated in a psychiatric clinic.', 'armGroupLabels': ['Treatment-as-usual']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8032', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'contacts': [{'name': 'Matthias Jäger, MD', 'role': 'CONTACT', 'email': 'matthias.jaeger@puk.zh.ch', 'phone': '0041 44 384 26 37'}, {'name': 'PhD', 'role': 'CONTACT', 'email': 'matthias.jaeger@puk.zh.ch', 'phone': '0041 44 384 34 41'}], 'facility': 'Psychiatric University Hospital Zurich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'centralContacts': [{'name': 'Matthias Jäger, MD', 'role': 'CONTACT', 'email': 'matthias.jaeger@puk.zh.ch', 'phone': '0041 44 384 26 37'}, {'name': 'Sonja Mötteli, PhD', 'role': 'CONTACT', 'email': 'sonja.moetteli@puk.zh.ch', 'phone': '0041 44 384 34 41'}], 'overallOfficials': [{'name': 'Matthias Jäger, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Psychiatric University Hospital, Zurich'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Psychiatric University Hospital, Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PD Dr. med.', 'investigatorFullName': 'Matthias Jäger', 'investigatorAffiliation': 'Psychiatric University Hospital, Zurich'}}}}