Ischemic StrokeMAS-INCT02320994
Managing Aftercare for Stroke (MAS): MAS-I - a Cross Sectional Study of Post-rehabilitation Stroke Burden and Patients' Needs
An observational study of Ischemic Stroke, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- How many people
- 64 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2014to Dec 2015
- Phase
- Observational
- 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
Study population: Patients in long term course after a moderate to severe ischemic stroke
Who may be able to join
- 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
Who cannot join
- Unwilling to have pseudonymised data stored, analyzed \& anonymously published.
- Patients participating in the previous studies recruited in centres outside Berlin
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charité - Universitätsmedizin Berlin (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center)
Berlin, 10117
About this study
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.
Read the 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.
- Conditions
- Ischemic Stroke
- Keywords
- stroke, aftercare
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| stroke patients | post-rehabilitation stroke patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of unmet Needs
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).
Measured: once
Secondary outcomes (2)
post-stroke checklist
Evaluation of post-stroke checklist as a valid tool to screen for relevant burden of disease after stroke.
Measured: once
Standard practice evaluation
Comparison of Standard practice in relation to evidence-based recommendations and current Clinical Guidelines for the management of stroke.
Measured: once
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ischemic 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Prof. Dr. Ian Wellwood, Prof. Dr. Jörg Wissel, NeuroCure Clinical Research Center, Charite, Berlin
- Responsible party
- Principal investigator, Andreas Meisel, Charite University, Berlin, Germany
- Investigators
- Andreas Meisel, Prof. Dr. med., Principal investigator, Charité - Universitätsmedizin Berlin, NeuroCure Clinical Research Center & Center for Stroke Research BerlinIan Wellwood, Prof. Dr., Principal investigator, Charité - Universitätsmedizin Berlin, Center for Stroke Research Berlin (CSB)Jörg Wissel, Prof. Dr., Principal investigator, Neurologie und Psychosomatik am Wittenbergplatz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02320994
- Sponsor's protocol ID
- MAS-I
- Acronym
- MAS-I
- Status last verified
- Dec 2021
- First submitted
- 16 Dec 2014
- Last updated
- 4 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Hotter B, Padberg I, Liebenau A, Knispel P, Heel S, Steube D, Wissel J, Wellwood I, Meisel A. Identifying unmet needs in long-term stroke care using in-depth assessment and the Post-Stroke Checklist - The Managing Aftercare for Stroke (MAS-I) study. Eur Stroke J. 2018 Sep;3(3):237-245. doi: 10.1177/2396987318771174. Epub 2018 Apr 19.
PubMed 31008354Lehnerer S, Hotter B, Padberg I, Knispel P, Remstedt D, Liebenau A, Grittner U, Wellwood I, Meisel A; BSA Long Term Care Study Group. Social work support and unmet social needs in life after stroke: a cross-sectional exploratory study. BMC Neurol. 2019 Sep 6;19(1):220. doi: 10.1186/s12883-019-1451-y.
PubMed 31492151Padberg I, Hotter B, Liebenau A, Knispel P, Lehnerer S, Heel S, Wellwood I, Meisel A. Unmet Need for Social and Emotional Support and Lack of Recalled Screening Is Associated with Depression in the Long-Term Course After Stroke. Risk Manag Healthc Policy. 2020 Apr 1;13:285-293. doi: 10.2147/RMHP.S228265. eCollection 2020.
PubMed 32280291
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managing Aftercare for Stroke (MAS): MAS-I - a Cross Sectional Study of Post-rehabilitation Stroke Burden and Patients' Needs
- ClinicalTrials.gov ID
- NCT02320994
- Acronym / sponsor ID
- MAS-I / MAS-I
- Conditions
- Ischemic Stroke
- Keywords
- stroke, aftercare
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Prof. Dr. Ian Wellwood, Prof. Dr. Jörg Wissel, NeuroCure Clinical Research Center, Charite, Berlin
- Study start
- Nov 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 19 Dec 2014 (estimated)
- 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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stroke patients | – | –post-rehabilitation stroke patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in long term course after a moderate to severe ischemic stroke
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Unwilling to have pseudonymised data stored, analyzed \& anonymously published.
- Patients participating in the previous studies recruited in centres outside Berlin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
2 secondary outcomes
post-stroke checklist
Time frame: once
Standard practice evaluation
Time frame: once
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 4 Jan 2022.
- Results publication: PubMed 31008354Hotter B, Padberg I, Liebenau A, Knispel P, Heel S, Steube D, Wissel J, Wellwood I, Meisel A. Identifying unmet needs in long-term stroke care using in-depth assessment and the Post-Stroke Checklist - The Managing Aftercare for Stroke (MAS-I) study. Eur Stroke J. 2018 Sep;3(3):237-245. doi: 10.1177/2396987318771174. Epub 2018 Apr 19.
- Results publication: PubMed 31492151Lehnerer S, Hotter B, Padberg I, Knispel P, Remstedt D, Liebenau A, Grittner U, Wellwood I, Meisel A; BSA Long Term Care Study Group. Social work support and unmet social needs in life after stroke: a cross-sectional exploratory study. BMC Neurol. 2019 Sep 6;19(1):220. doi: 10.1186/s12883-019-1451-y.
- Results publication: PubMed 32280291Padberg I, Hotter B, Liebenau A, Knispel P, Lehnerer S, Heel S, Wellwood I, Meisel A. Unmet Need for Social and Emotional Support and Lack of Recalled Screening Is Associated with Depression in the Long-Term Course After Stroke. Risk Manag Healthc Policy. 2020 Apr 1;13:285-293. doi: 10.2147/RMHP.S228265. eCollection 2020.
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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
Charité - Universitätsmedizin Berlin, NeuroCure Clinical Research Center & Center for Stroke Research Berlin
Ian Wellwood, Prof. Dr. principal investigator
Charité - Universitätsmedizin Berlin, Center for Stroke Research Berlin (CSB)
Jörg Wissel, Prof. Dr. principal investigator
Neurologie und Psychosomatik am Wittenbergplatz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic 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 4 inclusion and 2 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 4 Jan 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?
Prevalence of unmet Needs (time frame: once). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02320994, which also lists 3 linked publications.
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 4 Jan 2022.