Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2026-01-05 @ 2:00 PM
Study NCT ID:
NCT02320994
Status:
COMPLETED
Last Update Posted:
2022-01-04
First Post:
2014-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Managing Aftercare for Stroke (MAS): MAS-I - a Cross Sectional Study of Post-rehabilitation Stroke Burden and Patients' Needs
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D020521', 'term': 'Stroke'}], '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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-15', 'studyFirstSubmitDate': '2014-12-16', 'studyFirstSubmitQcDate': '2014-12-16', 'lastUpdatePostDateStruct': {'date': '2022-01-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of unmet Needs', 'timeFrame': 'once', 'description': 'Unmet needs of patients and carers after discharge from Rehabilitation. Score of variables examined (self-reported stroke related need, post-stroke spasticity, post-stroke pain, post-stroke aphasia, neuropsychological impairment, post-stroke depression, post-stroke dementia, inadequate secondary prevention, social care need and carer burden).'}], 'secondaryOutcomes': [{'measure': 'post-stroke checklist', 'timeFrame': 'once', 'description': 'Evaluation of post-stroke checklist as a valid tool to screen for relevant burden of disease after stroke.'}, {'measure': 'Standard practice evaluation', 'timeFrame': 'once', 'description': 'Comparison of Standard practice in relation to evidence-based recommendations and current Clinical Guidelines for the management of stroke.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stroke', 'aftercare'], 'conditions': ['Ischemic Stroke']}, 'referencesModule': {'references': [{'pmid': '31008354', 'type': 'RESULT', 'citation': 'Hotter B, Padberg I, Liebenau A, Knispel P, Heel S, Steube D, Wissel J, Wellwood I, Meisel A. Identifying unmet needs in long-term stroke care using in-depth assessment and the Post-Stroke Checklist - The Managing Aftercare for Stroke (MAS-I) study. Eur Stroke J. 2018 Sep;3(3):237-245. doi: 10.1177/2396987318771174. Epub 2018 Apr 19.'}, {'pmid': '31492151', 'type': 'RESULT', 'citation': 'Lehnerer S, Hotter B, Padberg I, Knispel P, Remstedt D, Liebenau A, Grittner U, Wellwood I, Meisel A; BSA Long Term Care Study Group. Social work support and unmet social needs in life after stroke: a cross-sectional exploratory study. BMC Neurol. 2019 Sep 6;19(1):220. doi: 10.1186/s12883-019-1451-y.'}, {'pmid': '32280291', 'type': 'RESULT', 'citation': 'Padberg I, Hotter B, Liebenau A, Knispel P, Lehnerer S, Heel S, Wellwood I, Meisel A. Unmet Need for Social and Emotional Support and Lack of Recalled Screening Is Associated with Depression in the Long-Term Course After Stroke. Risk Manag Healthc Policy. 2020 Apr 1;13:285-293. doi: 10.2147/RMHP.S228265. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': 'In this first step of the study the investigators will assess the needs, disease burden and current treatments of long-term stroke patients (phase MAS-I).\n\nThe ultimate aim of the complete MAS project (MAS I, II \\& III) is the development of a model of stroke aftercare delivery that can be evaluated to estimate effects in both our local and the wider stroke population.', 'detailedDescription': 'After discharge from hospital the current healthcare system in Germany allows considerable flexibility (therefore complexity) of patient access and mobility between multiple care providers in the community setting. The investigators believe this aftercare could be better coordinated by a specialized coordinated stroke aftercare service. Comprehensive coordinated multidisciplinary care is a proven concept with proven benefits in both acute and rehabilitation care provided in stroke units and neurorehabilitation centres. In this study the investigators postulate that a similar coordinated approach to care can be extended to the phase after in-patient rehabilitation has ended (i.e. "long-term management" as opposed to "early supported discharge") for disabled patients with stroke living in the community.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients in long term course after a moderate to severe ischemic stroke', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years\n* Participation in one of the previously conducted stroke cohort studies: STRAWINSKI or PREDICT\n* Modified Rankin Score (mRS) recorded as = 1 - 5 (at last follow up during cohort study)\n* Informed consent signed by patient or legal representative\n\nExclusion Criteria:\n\n* Unwilling to have pseudonymised data stored, analyzed \\& anonymously published.\n* Patients participating in the previous studies recruited in centres outside Berlin'}, 'identificationModule': {'nctId': 'NCT02320994', 'acronym': 'MAS-I', 'briefTitle': "Managing Aftercare for Stroke (MAS): MAS-I - a Cross Sectional Study of Post-rehabilitation Stroke Burden and Patients' Needs", 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': "Managing Aftercare for Stroke (MAS): MAS-I - a Cross Sectional Study of Post-rehabilitation Stroke Burden and Patients' Needs", 'orgStudyIdInfo': {'id': 'MAS-I'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'stroke patients', 'description': 'post-rehabilitation stroke patients'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charité - Universitätsmedizin Berlin (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center)', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Andreas Meisel, Prof. Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charité - Universitätsmedizin Berlin, NeuroCure Clinical Research Center & Center for Stroke Research Berlin'}, {'name': 'Ian Wellwood, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charité - Universitätsmedizin Berlin, Center for Stroke Research Berlin (CSB)'}, {'name': 'Jörg Wissel, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Neurologie und Psychosomatik am Wittenbergplatz'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'collaborators': [{'name': 'Prof. Dr. Ian Wellwood', 'class': 'UNKNOWN'}, {'name': 'Prof. Dr. Jörg Wissel', 'class': 'UNKNOWN'}, {'name': 'NeuroCure Clinical Research Center, Charite, Berlin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med.', 'investigatorFullName': 'Andreas Meisel', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}