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Trial record 1 of 1 for:    NCT02320994
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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

Tracking Information
First Submitted Date December 16, 2014
First Posted Date December 19, 2014
Last Update Posted Date November 29, 2018
Study Start Date November 2014
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 16, 2014)
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).
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 16, 2014)
  • post-stroke checklist [ Time Frame: once ]
    Evaluation of post-stroke checklist as a valid tool to screen for relevant burden of disease after stroke.
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Managing Aftercare for Stroke (MAS): MAS-I - a Cross Sectional Study of Post-rehabilitation Stroke Burden and Patients' Needs
Official Title Managing Aftercare for Stroke (MAS): MAS-I - a Cross Sectional Study of Post-rehabilitation Stroke Burden and Patients' Needs
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.

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
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
blood samples
Sampling Method Probability Sample
Study Population Patients in long term course after a moderate to severe ischemic stroke
Condition Ischemic Stroke
Intervention Not Provided
Study Groups/Cohorts stroke patients
post-rehabilitation stroke patients
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 20, 2016)
64
Original Estimated Enrollment
 (submitted: December 16, 2014)
100
Actual Study Completion Date December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT02320994
Other Study ID Numbers MAS-I
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Andreas Meisel, Charite University, Berlin, Germany
Study Sponsor Charite University, Berlin, Germany
Collaborators
  • 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
PRS Account Charite University, Berlin, Germany
Verification Date November 2018