Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2025-12-25 @ 8:43 PM
Study NCT ID:
NCT00687869
Status:
COMPLETED
Last Update Posted:
2013-09-19
First Post:
2008-05-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Participative Rehabilitation in Stroke Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D010358', 'term': 'Patient Participation'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019090', 'term': 'Case Management'}], 'ancestors': [{'id': 'D010347', 'term': 'Patient Care Planning'}, {'id': 'D003191', 'term': 'Comprehensive Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 322}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-18', 'studyFirstSubmitDate': '2008-05-28', 'studyFirstSubmitQcDate': '2008-05-28', 'lastUpdatePostDateStruct': {'date': '2013-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'physical scale of the Stroke Impact Scale 3.0', 'timeFrame': 'before discharge from acute care, four weeks after discharge from the hospital or rehabilitation (in case of referral to a medical rehabilitation) immediately before randomization (baseline assessment), and 12 months after randomization'}], 'secondaryOutcomes': [{'measure': 'Health related quality of life, depression, mortality, recurrent stroke and/or TIA/PRIND', 'timeFrame': 'before discharge from acute care, four weeks after discharge from the hospital or rehabilitation (in case of referral to a medical rehabilitation) immediately before randomization (baseline assessment), and 12 months after randomization'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stroke', 'rehabilitation', 'patient care management', 'patient participation'], 'conditions': ['Stroke']}, 'referencesModule': {'references': [{'pmid': '25920942', 'type': 'DERIVED', 'citation': 'Saal S, Becker C, Lorenz S, Schubert M, Kuss O, Stang A, Muller T, Kraft A, Behrens J. Effect of a stroke support service in Germany: a randomized trial. Top Stroke Rehabil. 2015 Dec;22(6):429-36. doi: 10.1179/1074935714Z.0000000047. Epub 2015 Apr 28.'}]}, 'descriptionModule': {'briefSummary': 'Primary objective of this study is to determine whether a case management of stroke patients after discharge to home or to nursing home results in improving physical and cognitive capacity one year after discharge.', 'detailedDescription': 'In a randomized trial, the project Participative rehabilitation process management "Stroke in Saxony-Anhalt" (PaReSiS) implements a case management trial, explicitly including all providers in the course of illness, treatment and rehabilitation. To achieve this, patients in the intervention group have the opportunity to choose, specifically and according to their own needs, from the offers of a web portal and a telephone hotline, from individual counselling and info sessions as well as from home visits. Patients in the control group receive patient-information-notes beyond primary care. There will be qualitative interviews with the persons concerned and/or their relatives in both groups in order to validate the instruments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Acute cerebrovascular event (ischemic stroke or intra-cerebral bleeding) with signs and symptoms of an acute stroke according to the diagnosis I61 and I63 of the ICD-10-GM 2008\n* Differentiation between ischemic or haemorrhagic stroke by the use of CT or MRT\n* Resident in Saxony-Anhalt or Saxony or Thuringia\n* Able to understand German language\n\nExclusion Criteria:\n\n* Reinfarction\n* Alcoholism\n* Death in acute care\n* NIHHS \\> 25\n* Homelessness'}, 'identificationModule': {'nctId': 'NCT00687869', 'acronym': 'PaReSiS', 'briefTitle': 'Participative Rehabilitation in Stroke Patients', 'organization': {'class': 'OTHER', 'fullName': 'Martin-Luther-Universität Halle-Wittenberg'}, 'officialTitle': 'Participative Rehabilitation Process Management "Stroke in Saxony-Anhalt"', 'orgStudyIdInfo': {'id': '01GX0711'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Case management', 'description': 'Case management with patient-information-notes, telephone hotline, individual counselling using home visits, e-mail and telephone contact, web portal', 'interventionNames': ['Behavioral: Case management']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'usual care', 'description': 'Usual stroke aftercare plus patient-information-notes', 'interventionNames': ['Behavioral: Case management']}], 'interventions': [{'name': 'Case management', 'type': 'BEHAVIORAL', 'description': 'Case management with patient-information-notes, telephone hotline, individual counselling using home visits, e-mail and telephone contact, web portal', 'armGroupLabels': ['Case management']}, {'name': 'Case management', 'type': 'BEHAVIORAL', 'description': 'Usual stroke aftercare plus patient-information-notes', 'armGroupLabels': ['usual care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Halle', 'country': 'Germany', 'facility': 'Institute for Health and Nursing Science, Medical faculty, Martin-Luther-University Halle-Wittenberg, Halle (Saale)', 'geoPoint': {'lat': 51.48158, 'lon': 11.97947}}], 'overallOfficials': [{'name': 'Johann Behrens, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute for Health and Nursing Science, Medical faculty, Martin-Luther-University Halle-Wittenberg, Halle (Saale)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Martin-Luther-Universität Halle-Wittenberg', 'class': 'OTHER'}, 'collaborators': [{'name': 'Forschungsverbund Rehabilitationswissenschaften Sachsen-Anhalt', 'class': 'UNKNOWN'}, {'name': 'Deutsche Rentenversicherung', 'class': 'OTHER'}, {'name': 'Universitätsklinik und Poliklinik für Neurologie', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. phil. habil.', 'investigatorFullName': 'Johann Behrens', 'investigatorAffiliation': 'Martin-Luther-Universität Halle-Wittenberg'}}}}