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Managing Aftercare for Stroke (MAS): MAS-I - a Cross Sectional Study of Post-rehabilitation Stroke Burden and Patients' Needs (MAS-I)

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ClinicalTrials.gov Identifier: NCT02320994
Recruitment Status : Completed
First Posted : December 19, 2014
Last Update Posted : November 29, 2018
Sponsor:
Collaborators:
Prof. Dr. Ian Wellwood
Prof. Dr. Jörg Wissel
NeuroCure Clinical Research Center, Charite, Berlin
Information provided by (Responsible Party):
Andreas Meisel, Charite University, Berlin, Germany

Brief Summary:

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.


Condition or disease
Ischemic Stroke

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
Actual Enrollment : 64 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Managing Aftercare for Stroke (MAS): MAS-I - a Cross Sectional Study of Post-rehabilitation Stroke Burden and Patients' Needs
Study Start Date : November 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Group/Cohort
stroke patients
post-rehabilitation stroke patients



Primary Outcome Measures :
  1. Prevalence of unmet Needs [ Time Frame: once ]
    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).


Secondary Outcome Measures :
  1. post-stroke checklist [ Time Frame: once ]
    Evaluation of post-stroke checklist as a valid tool to screen for relevant burden of disease after stroke.

  2. Standard practice evaluation [ Time Frame: once ]
    Comparison of Standard practice in relation to evidence-based recommendations and current Clinical Guidelines for the management of stroke.


Biospecimen Retention:   Samples Without DNA
blood samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients in long term course after a moderate to severe ischemic stroke
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02320994


Locations
Germany
Charité - Universitätsmedizin Berlin (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center)
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Prof. Dr. Ian Wellwood
Prof. Dr. Jörg Wissel
NeuroCure Clinical Research Center, Charite, Berlin
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

Additional Information:
Publications of Results:
Hotter, Benjamin, Inken Padberg, Andrea Liebenau, Petra Knispel, Sabine Heel, Diethard Steube, Jörg Wissel, Ian Wellwood, and Andreas Meisel. 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. European Stroke Journal 0, no. 0 (2396987318771174)

Responsible Party: Andreas Meisel, Prof. Dr. med., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02320994     History of Changes
Other Study ID Numbers: MAS-I
First Posted: December 19, 2014    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: November 2018

Keywords provided by Andreas Meisel, Charite University, Berlin, Germany:
stroke
aftercare

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases