StrokeNCT03097146
Managing Aftercare for Stroke (MAS): MAS-II - A Longitudinal Complex-interventional Study in Post-rehabilitation Stroke Patients
A study testing comprehensive multidisciplinary stroke care in people with Stroke, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- comprehensive multidisciplinary stroke care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteGermany
- Study dates
- 11 Apr 2017to 1 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unwillingness to participate in "AmbulanzPartner"
- Unwilling to have pseudonymized data stored, analysed, and anonymously published
- Patients being committed to psychiatric institutions or prisons
Trial locations and contacts
1 site in 1 country.
Germany1 site
NeuroCure Clinical Research Center (NCRC), Charité
Berlin, 10117
About this study
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.
- Conditions
- Stroke
- Being tested
- comprehensive multidisciplinary stroke care
- Keywords
- Stroke, Aftercare, Comprehensive Care
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
comprehensive multidisciplinary stroke careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| comprehensive multidisciplinary stroke care | Other | Not described Receives: Other: comprehensive multidisciplinary stroke care |
What is being measured
The primary outcome is the main question the study is designed to answer.
"EuroQol five dimensions questionnaire" (EuroQoL-5D)
questionnaire for self-completion by patients for use as a measure of health outcome
Measured: 12 Months
Secondary outcomes (13)
Post Stroke Checklist (PSC)
checklist that helps identify post-stroke problems
Measured: 12 Months
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
Measured: 12 Months
Barthel-Index (BI)
scale is used to measure performance in activities of daily living
Measured: 12 Months
modified Ashworth Scale (mAS)
scale is used as a measure of spasticity
Measured: 12 Months
Pain Detect (PD-Q)
questionnaire for self-completion by patients for the identification of neuropathic pain
Measured: 12 Months
Freiburg questionnaire for coping (FKV)
questionnaire is used to assess disease processing modes at the levels of cognition, emotion, and behavior
Measured: 12 Months
Montreal Cognitive Assessment (MoCA)
cognitive screening test in the detection of mild cognitive impairment
Measured: 12 Months
partial Aachen Aphasia Test (AAT)
test is used to diagnose and describe aphasic disturbances
Measured: 12 Months
Hamilton rating scale for depression
questionnaire is used to provide an indication of depression
Measured: 12 Months
"Morisky Medication Adherence Scale" (MMAS)
questionnaire is used to assess patients' medication-taking behaviour
Measured: 12 Months
"Nikolaus score for evaluation of social conditions" (SoS)
score is used to assess patients' social work intervention
Measured: 12 Months
"Häusliche Pflegeskala" (HPS)
questionnaire is used to assess social work Intervention and couple's counselling
Measured: 12 Months
Hospital Anxiety Depression Scale (HADS)
questionnaire for self-completion by patients to determine the levels of anxiety and depression
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study start11 Apr 2017
- Primary completion22 Dec 2020
- Study completion1 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Stroke Research Berlin, Hebrew University of Jerusalem, NeuroCure Clinical Research Center, Charite, Berlin
- Responsible party
- Principal investigator, Andreas Meisel, Charite University, Berlin, Germany
- Investigators
- Andreas Meisel, Prof. Dr. med., Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03097146
- Sponsor's protocol ID
- MAS-II
- Status last verified
- Mar 2022
- First submitted
- 27 Mar 2017
- Last updated
- 25 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managing Aftercare for Stroke (MAS): MAS-II - A Longitudinal Complex-interventional Study in Post-rehabilitation Stroke Patients
- ClinicalTrials.gov ID
- NCT03097146
- Acronym / sponsor ID
- MAS-II
- Conditions
- Stroke
- Keywords
- Stroke, Aftercare, Comprehensive Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Center for Stroke Research Berlin, Hebrew University of Jerusalem, NeuroCure Clinical Research Center, Charite, Berlin
- Study start
- 11 Apr 2017 (actual)
- Primary completion
- 22 Dec 2020 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 31 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| comprehensive multidisciplinary stroke care | Other | Other: comprehensive multidisciplinary stroke care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Unwillingness to participate in "AmbulanzPartner"
- Unwilling to have pseudonymized data stored, analysed, and anonymously published
- Patients being committed to psychiatric institutions or prisons
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| comprehensive multidisciplinary stroke carePatients 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. | Other | comprehensive multidisciplinary stroke care |
Primary outcome
"EuroQol five dimensions questionnaire" (EuroQoL-5D)
Time frame: 12 Months
questionnaire for self-completion by patients for use as a measure of health outcome
13 secondary outcomes
Post Stroke Checklist (PSC)
Time frame: 12 Months
modified Rankin Scale (mRS)
Time frame: 12 Months
Barthel-Index (BI)
Time frame: 12 Months
modified Ashworth Scale (mAS)
Time frame: 12 Months
Pain Detect (PD-Q)
Time frame: 12 Months
Freiburg questionnaire for coping (FKV)
Time frame: 12 Months
Montreal Cognitive Assessment (MoCA)
Time frame: 12 Months
partial Aachen Aphasia Test (AAT)
Time frame: 12 Months
Hamilton rating scale for depression
Time frame: 12 Months
"Morisky Medication Adherence Scale" (MMAS)
Time frame: 12 Months
"Nikolaus score for evaluation of social conditions" (SoS)
Time frame: 12 Months
"Häusliche Pflegeskala" (HPS)
Time frame: 12 Months
Hospital Anxiety Depression Scale (HADS)
Time frame: 12 Months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Meisel, Prof. Dr. med. principal investigator
Charite University, Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing comprehensive multidisciplinary stroke care in people with Stroke, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
"EuroQol five dimensions questionnaire" (EuroQoL-5D) (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2022.