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Managing Aftercare for Stroke (MAS): MAS-II - A Longitudinal Complex-interventional Study in Post-rehabilitation Stroke Patients

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Andreas Meisel, Charite University, Berlin, Germany
Sponsor:
Collaborators:
Center for Stroke Research Berlin
Hebrew University of Jerusalem
NeuroCure Clinical Research Center, Charite, Berlin
Information provided by (Responsible Party):
Andreas Meisel, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT03097146
First received: March 27, 2017
Last updated: June 29, 2017
Last verified: June 2017
  Purpose
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.

Condition Intervention
Stroke Other: comprehensive multidisciplinary stroke care

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Managing Aftercare for Stroke (MAS): MAS-II - A Longitudinal Complex-interventional Study in Post-rehabilitation Stroke Patients

Resource links provided by NLM:


Further study details as provided by Andreas Meisel, Charite University, Berlin, Germany:

Primary Outcome Measures:
  • "EuroQol five dimensions questionnaire" (EuroQoL-5D) [ Time Frame: 12 Months ]
    questionnaire for self-completion by patients for use as a measure of health outcome


Secondary Outcome Measures:
  • Post Stroke Checklist (PSC) [ Time Frame: 12 Months ]
    checklist that helps identify post-stroke problems

  • modified Rankin Scale (mRS) [ Time Frame: 12 Months ]
    scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability

  • Barthel-Index (BI) [ Time Frame: 12 Months ]
    scale is used to measure performance in activities of daily living

  • modified Ashworth Scale (mAS) [ Time Frame: 12 Months ]
    scale is used as a measure of spasticity

  • Pain Detect (PD-Q) [ Time Frame: 12 Months ]
    questionnaire for self-completion by patients for the identification of neuropathic pain

  • Freiburg questionnaire for coping (FKV) [ Time Frame: 12 Months ]
    questionnaire is used to assess disease processing modes at the levels of cognition, emotion, and behavior

  • Montreal Cognitive Assessment (MoCA) [ Time Frame: 12 Months ]
    cognitive screening test in the detection of mild cognitive impairment

  • partial Aachen Aphasia Test (AAT) [ Time Frame: 12 Months ]
    test is used to diagnose and describe aphasic disturbances

  • Hamilton rating scale for depression [ Time Frame: 12 Months ]
    questionnaire is used to provide an indication of depression

  • "Morisky Medication Adherence Scale" (MMAS) [ Time Frame: 12 Months ]
    questionnaire is used to assess patients' medication-taking behaviour

  • "Nikolaus score for evaluation of social conditions" (SoS) [ Time Frame: 12 Months ]
    score is used to assess patients' social work intervention

  • "Häusliche Pflegeskala" (HPS) [ Time Frame: 12 Months ]
    questionnaire is used to assess social work Intervention and couple's counselling

  • Hospital Anxiety Depression Scale (HADS) [ Time Frame: 12 Months ]
    questionnaire for self-completion by patients to determine the levels of anxiety and depression


Estimated Enrollment: 100
Actual Study Start Date: April 11, 2017
Estimated Study Completion Date: December 1, 2019
Estimated Primary Completion Date: September 1, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
comprehensive multidisciplinary stroke care Other: comprehensive multidisciplinary stroke care
Patients will be treated in the pathological domain. Some of this treatment will be applied by the outpatient clinic itself (i.e. changes in medical secondary prevention or additional prescriptions, social work interventions), whereas most of it will be referred to other providers, if possible in vicinity to the patients' home. In order to ease treatment prescriptions and allow to measure treatment uptake, patients will also enrol in the case management system "Ambulanzpartner". This allows the outpatient center to streamline prescription processes and measure uptake of therapies.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with ischemic stroke
  • Age ≥18 years
  • At the time of V1 completion of rehabilitation or no rehabilitation planned
  • Informed consent signed by patient or legal representative
  • stroke patients with a stratified mRS score
  • within six months after the index event

Exclusion Criteria:

  • Unwillingness to participate in "AmbulanzPartner"
  • Unwilling to have pseudonymized data stored, analysed, and anonymously published
  • Patients being committed to psychiatric institutions or prisons
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03097146

Contacts
Contact: Andreas Meisel, Prof. Dr. med. +49 30 450 560026 andreas.meisel@charite.de
Contact: Benjamin Hotter, Dr. med. +49 30 450 639729 Benjamin.Hotter@charite.de

Locations
Germany
NeuroCure Clinical Research Center (NCRC), Charité Recruiting
Berlin, Germany, 10117
Contact: Andreas Meisel, Prof. Dr. med.    +49 30 450 560026    andreas.meisel@charite.de   
Contact: Benjamin Hotter, Dr. med.    +49 30 450 639 729    benjamin.hotter@charite.de   
Sponsors and Collaborators
Charite University, Berlin, Germany
Center for Stroke Research Berlin
Hebrew University of Jerusalem
NeuroCure Clinical Research Center, Charite, Berlin
Investigators
Principal Investigator: Andreas Meisel, Prof. Dr. med. Charite University, Berlin, Germany
  More Information

Responsible Party: Andreas Meisel, Prof. Dr. med., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT03097146     History of Changes
Other Study ID Numbers: MAS-II
Study First Received: March 27, 2017
Last Updated: June 29, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Andreas Meisel, Charite University, Berlin, Germany:
Stroke
Aftercare
Comprehensive Care

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

ClinicalTrials.gov processed this record on September 25, 2017