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

Overview

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.

Full Title of Study: “Managing Aftercare for Stroke (MAS): MAS-II – A Longitudinal Complex-interventional Study in Post-rehabilitation Stroke Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 22, 2020

Interventions

  • 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.

Arms, Groups and Cohorts

  • Other: comprehensive multidisciplinary stroke care

Clinical Trial Outcome Measures

Primary 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 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Charite University, Berlin, Germany
  • Collaborator
    • Center for Stroke Research Berlin
  • Provider of Information About this Clinical Study
    • Principal Investigator: Andreas Meisel, Prof. Dr. med. – Charite University, Berlin, Germany
  • Overall Official(s)
    • Andreas Meisel, Prof. Dr. med., Principal Investigator, Charite University, Berlin, Germany

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