- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02320994
Managing Aftercare for Stroke (MAS): MAS-I - a Cross Sectional Study of Post-rehabilitation Stroke Burden and Patients' Needs (MAS-I)
December 15, 2021 updated by: Andreas Meisel, Charite University, Berlin, Germany
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).
The 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.
Study Overview
Status
Completed
Conditions
Detailed Description
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.
Study Type
Observational
Enrollment (Actual)
64
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Berlin, Germany, 10117
- Charité - Universitätsmedizin Berlin (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients in long term course after a moderate to severe ischemic stroke
Description
Inclusion Criteria:
- Age ≥18 years
- Participation in one of the previously conducted stroke cohort studies: STRAWINSKI or PREDICT
- Modified Rankin Score (mRS) recorded as = 1 - 5 (at last follow up during cohort study)
- Informed consent signed by patient or legal representative
Exclusion Criteria:
- Unwilling to have pseudonymised data stored, analyzed & anonymously published.
- Patients participating in the previous studies recruited in centres outside Berlin
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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stroke patients
post-rehabilitation stroke patients
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Prevalence of unmet Needs
Time Frame: once
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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).
|
once
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
post-stroke checklist
Time Frame: once
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Evaluation of post-stroke checklist as a valid tool to screen for relevant burden of disease after stroke.
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once
|
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Standard practice evaluation
Time Frame: once
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Comparison of Standard practice in relation to evidence-based recommendations and current Clinical Guidelines for the management of stroke.
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once
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Andreas Meisel, Prof. Dr. med., Charité - Universitätsmedizin Berlin, NeuroCure Clinical Research Center & Center for Stroke Research Berlin
- Principal Investigator: Ian Wellwood, Prof. Dr., Charité - Universitätsmedizin Berlin, Center for Stroke Research Berlin (CSB)
- Principal Investigator: Jörg Wissel, Prof. Dr., Neurologie und Psychosomatik am Wittenbergplatz
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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. Erratum In: Eur Stroke J. 2019 Dec;4(4):NP2-NP4.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2014
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
December 16, 2014
First Submitted That Met QC Criteria
December 16, 2014
First Posted (Estimate)
December 19, 2014
Study Record Updates
Last Update Posted (Actual)
January 4, 2022
Last Update Submitted That Met QC Criteria
December 15, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MAS-I
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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