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

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
comprehensive multidisciplinary stroke care
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Stroke focused on measuring Stroke, Aftercare, Comprehensive Care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NeuroCure Clinical Research Center (NCRC), Charité

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

comprehensive multidisciplinary stroke care

Arm Description

Outcomes

Primary Outcome Measures

"EuroQol five dimensions questionnaire" (EuroQoL-5D)
questionnaire for self-completion by patients for use as a measure of health outcome

Secondary Outcome Measures

Post Stroke Checklist (PSC)
checklist that helps identify post-stroke problems
modified Rankin Scale (mRS)
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)
scale is used to measure performance in activities of daily living
modified Ashworth Scale (mAS)
scale is used as a measure of spasticity
Pain Detect (PD-Q)
questionnaire for self-completion by patients for the identification of neuropathic pain
Freiburg questionnaire for coping (FKV)
questionnaire is used to assess disease processing modes at the levels of cognition, emotion, and behavior
Montreal Cognitive Assessment (MoCA)
cognitive screening test in the detection of mild cognitive impairment
partial Aachen Aphasia Test (AAT)
test is used to diagnose and describe aphasic disturbances
Hamilton rating scale for depression
questionnaire is used to provide an indication of depression
"Morisky Medication Adherence Scale" (MMAS)
questionnaire is used to assess patients' medication-taking behaviour
"Nikolaus score for evaluation of social conditions" (SoS)
score is used to assess patients' social work intervention
"Häusliche Pflegeskala" (HPS)
questionnaire is used to assess social work Intervention and couple's counselling
Hospital Anxiety Depression Scale (HADS)
questionnaire for self-completion by patients to determine the levels of anxiety and depression

Full Information

First Posted
March 27, 2017
Last Updated
March 24, 2022
Sponsor
Charite University, Berlin, Germany
Collaborators
Center for Stroke Research Berlin, Hebrew University of Jerusalem, NeuroCure Clinical Research Center, Charite, Berlin
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1. Study Identification

Unique Protocol Identification Number
NCT03097146
Brief Title
Managing Aftercare for Stroke (MAS): MAS-II - A Longitudinal Complex-interventional Study in Post-rehabilitation Stroke Patients
Official Title
Managing Aftercare for Stroke (MAS): MAS-II - A Longitudinal Complex-interventional Study in Post-rehabilitation Stroke Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
April 11, 2017 (Actual)
Primary Completion Date
December 22, 2020 (Actual)
Study Completion Date
March 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
Center for Stroke Research Berlin, Hebrew University of Jerusalem, NeuroCure Clinical Research Center, Charite, Berlin

4. Oversight

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

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Aftercare, Comprehensive Care

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
comprehensive multidisciplinary stroke care
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
comprehensive multidisciplinary stroke care
Intervention Description
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.
Primary Outcome Measure Information:
Title
"EuroQol five dimensions questionnaire" (EuroQoL-5D)
Description
questionnaire for self-completion by patients for use as a measure of health outcome
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Post Stroke Checklist (PSC)
Description
checklist that helps identify post-stroke problems
Time Frame
12 Months
Title
modified Rankin Scale (mRS)
Description
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
Time Frame
12 Months
Title
Barthel-Index (BI)
Description
scale is used to measure performance in activities of daily living
Time Frame
12 Months
Title
modified Ashworth Scale (mAS)
Description
scale is used as a measure of spasticity
Time Frame
12 Months
Title
Pain Detect (PD-Q)
Description
questionnaire for self-completion by patients for the identification of neuropathic pain
Time Frame
12 Months
Title
Freiburg questionnaire for coping (FKV)
Description
questionnaire is used to assess disease processing modes at the levels of cognition, emotion, and behavior
Time Frame
12 Months
Title
Montreal Cognitive Assessment (MoCA)
Description
cognitive screening test in the detection of mild cognitive impairment
Time Frame
12 Months
Title
partial Aachen Aphasia Test (AAT)
Description
test is used to diagnose and describe aphasic disturbances
Time Frame
12 Months
Title
Hamilton rating scale for depression
Description
questionnaire is used to provide an indication of depression
Time Frame
12 Months
Title
"Morisky Medication Adherence Scale" (MMAS)
Description
questionnaire is used to assess patients' medication-taking behaviour
Time Frame
12 Months
Title
"Nikolaus score for evaluation of social conditions" (SoS)
Description
score is used to assess patients' social work intervention
Time Frame
12 Months
Title
"Häusliche Pflegeskala" (HPS)
Description
questionnaire is used to assess social work Intervention and couple's counselling
Time Frame
12 Months
Title
Hospital Anxiety Depression Scale (HADS)
Description
questionnaire for self-completion by patients to determine the levels of anxiety and depression
Time Frame
12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Meisel, Prof. Dr. med.
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
NeuroCure Clinical Research Center (NCRC), Charité
City
Berlin
ZIP/Postal Code
10117
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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