StrokeMAFASPNCT06031909
Multimodal Assessment of Frailty in Acute Stroke Patients
An observational study of Stroke and Frailty, run by University of Giessen at 1 site in Germany.
Trial summary
The goal of this study is to investigate the influence of frailty on clinical and stroke characteristics, treatment and outcomes in patients with acute stroke. The main questions it aims to answer are: 1. How prevalent is frailty in patients with stroke? 2. Which impairments (e.g. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Multimodal frailty assessment
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2023to 31 Oct 2024
- How long will I take part?
- 12 Months
- 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: All patients admitted with the diagnosis of acute stroke treated at the certified stroke-unit will be included. All patients who consent for participation are further eligible for the outcome assessment.
Who may be able to join
- treated at the certified stroke-unit of the Dpt. of Neurology, University Hospital Giessen
- diagnosis of ischemic (including transient ischemic attack) or hemorrhagic stroke
Who cannot join
- withdrawal of care within 24 hours after admission
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Neurology, University Hospital Giessen
Giessen, Hesse, 35392
Stefan Gerner, MD, stefan.gerner@neuro.med.uni-giessen.de
Thorsten Doeppner, MD, thorsten.doeppner@neuro.med.uni-giessen.de
About this study
Official title: Multimodal Assessment of Frailty in Acute Stroke Patients Treated at a Certified Stroke-unit
The goal of this study is to investigate the influence of frailty on clinical and stroke characteristics, treatment and outcomes in patients with acute stroke.
The main questions it aims to answer are:
- How prevalent is frailty in patients with stroke?
- Which impairments (e.g. undernutrion, impaired mobility, laboratory markers) contribute to frailty?
- Is the outcome of frail patients worse than those without?
- Are in-hospital complications more frequent in frail patients than those without?
Read the detailed description
Stroke is one of the most common causes of disability and mortality worldwide. A recognized complication in stroke patients is frailty, which is associated with increased costs, poorer prognosis, and higher mortality rates. However, there is currently no uniform definition or diagnostic criteria for frailty in stroke patients, and there is a need for standardized frailty assessments in this patient population.
The aim of this study is to determine the prevalence of frailty in stroke patients at the Stroke Unit of the University Hospital Giessen and to analyze the associated characteristics and impacts on clinical outcomes. A multimodal frailty assessment will be conducted to capture a wide range of frailty features and investigate their significance. The study includes all stroke patients admitted to the certified stroke- unit of the University Hospital Giessen within a 3-month period. There are no inclusion criteria related to age, gender, or type of stroke.
The multimodal frailty assessment encompasses determining appropriate blood values (e.g., CRP, albumin), assessing muscle strength/mass through handheld dynamometry and sonographic muscle diameter, utilizing scores like the Clinical Frailty Scale (CFS) and the Groningen Frailty Indicator (GFI), evaluating nutritional status (BMI), collecting image-based frailty data (e.g., sarcopenia, cerebral white matter lesions, lacunar strokes, brain atrophy), and conducting suitable one-year follow-ups. Additionally, demographic and clinical data such as age, gender, type of stroke, and treatment details will be recorded.
The primary outcome is the prevalence of frailty among stroke patients. Secondary outcomes include the characteristics and impacts of frailty in stroke patients, including correlations between various frailty features and clinical outcomes such as length of hospital stay, mortality, and functional outcome.
- Being tested
- Multimodal frailty assessment
- Keywords
- frailty, outcome, elderly
- Medical subject headings
- Stroke, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal frailty assessmentDiagnostic test
Different domains are assessed during hospital stay, these include:
- Clinical scores: Clinical Frailty scale (CFS), Groningen Frailty index (GFI)
- Brain frailty: assessing white matter hyperintensieties, atrophy and lacunar strokes in initial brain imaging
- Laboratory values: laboratory Frailty index (FI-Lab), inflammatory markers
- Nutrition: Controlling nutritional status score (CONUT-score), body mass index, dysphagia assessment (FOIS)
- Mobility/strengths: de Morton Mobility Index (DEMMI), grip strenghts of non-paralytic arm via dynamometer, muscle mass estimated by sonographic measurement of the biceps brachii muscle and the rectus femoris muscle.
| Study group | Role | What they receive |
|---|---|---|
| Stroke patients | Stroke patients admitted to the certified stroke-unit of the Department of Neurology, University Hospital Giessen, Germany. Receives: Diagnostic Test: Multimodal frailty assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of frailty in stroke patients
Percentage of patients with frailty treated for stroke compared to all patients admitted for stroke
Measured: 30 days
Rate of good functional outcome
Percentage of patients achieving a score of 0 to 2 on the modified Rankin scale (higher values indicating worse outcome, ranging from 0, no deficit, to 6, death) at 12 months follow-up
Measured: 12 months
Secondary outcomes (6)
Patient reported outcome measures (PROM)
Health-related quality measured using the visual analogue scale (VAS) of the Euroquol EQ-5D-3L tool. Score ranging from 0 to 100, with higher values indicating better quality of life.
Measured: 12 months
Functional impairment in activities of daily living
Impairment in activities of daily living measuring the score on the Barthel-Index (BI; ranging from 0 to 100, with higher values indicating less impairment in activities of daily living).
Measured: 12 months
Mortality rate
Rate of death observed during the follow-up period
Measured: From date of admission until death or last follow-up, whichever comes first, assessed up to 12 months.
Cognitive outcome
Assessment of cognition using the telephone Montreal Cognitive Assessment test (tMOCA; ranging from 0 to 22, with a score of 18 or below indicating mild cognitive dysfunction)
Measured: 12 months
Rate of rehospitalization
Percentage of patients needed to be hospitalized due to unplanned events during the follow-up
Measured: 12 months
Major adverse cardiovascular events (MACE)
Rate of patients suffering from newly detected myocardial infarction, non-fatal stroke or cardiovascular death
Measured: From date of admission until MACE or last follow-up, whichever comes first, assessed up to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start1 Aug 2023
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Oct 2024 (estimated)
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 StrokeStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- University of Giessen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefan Gerner, University of Giessen
- Investigators
- Stefan Gerner, MD, Principal investigator, Department of Neurology, University Hospital Giessen/GermanyThorsten Doeppner, MD, Study chair, Department of Neurology, University Hospital Giessen/GermanyHagen Huttner, MD, PhD, Study chair, Department of Neurology, University Hospital Giessen/Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06031909
- Sponsor's protocol ID
- AZ 220/21
- Acronym
- MAFASP
- Status last verified
- Sep 2023
- First submitted
- 30 Aug 2023
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Reasonable requests can be sent by mail.
Publications
Giede-Jeppe A, Bobinger T, Gerner ST, Sembill JA, Sprugel MI, Beuscher VD, Lucking H, Hoelter P, Kuramatsu JB, Huttner HB. Neutrophil-to-Lymphocyte Ratio Is an Independent Predictor for In-Hospital Mortality in Spontaneous Intracerebral Hemorrhage. Cerebrovasc Dis. 2017;44(1-2):26-34. doi: 10.1159/000468996. Epub 2017 Apr 19.
PubMed 28419988Giede-Jeppe A, Reichl J, Sprugel MI, Lucking H, Hoelter P, Eyupoglu IY, Kuramatsu JB, Huttner HB, Gerner ST. Neutrophil-to-lymphocyte ratio as an independent predictor for unfavorable functional outcome in aneurysmal subarachnoid hemorrhage. J Neurosurg. 2019 Feb 1;132(2):400-407. doi: 10.3171/2018.9.JNS181975. Print 2020 Feb 1.
PubMed 30717052Gerner ST, Reichl J, Custal C, Brandner S, Eyupoglu IY, Lucking H, Holter P, Kallmunzer B, Huttner HB. Long-Term Complications and Influence on Outcome in Patients Surviving Spontaneous Subarachnoid Hemorrhage. Cerebrovasc Dis. 2020;49(3):307-315. doi: 10.1159/000508577. Epub 2020 Jul 3.
PubMed 32623428
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Assessment of Frailty in Acute Stroke Patients Treated at a Certified Stroke-unit
- ClinicalTrials.gov ID
- NCT06031909
- Acronym / sponsor ID
- MAFASP / AZ 220/21
- Keywords
- frailty, outcome, elderly
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of GiessenUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 11 Sep 2023 (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.
The goal of this study is to investigate the influence of frailty on clinical and stroke characteristics, treatment and outcomes in patients with acute stroke.
The main questions it aims to answer are:
- How prevalent is frailty in patients with stroke?
- Which impairments (e.g. undernutrion, impaired mobility, laboratory markers) contribute to frailty?
- Is the outcome of frail patients worse than those without?
- Are in-hospital complications more frequent in frail patients than those without?
Detailed description
Stroke is one of the most common causes of disability and mortality worldwide. A recognized complication in stroke patients is frailty, which is associated with increased costs, poorer prognosis, and higher mortality rates. However, there is currently no uniform definition or diagnostic criteria for frailty in stroke patients, and there is a need for standardized frailty assessments in this patient population.
The aim of this study is to determine the prevalence of frailty in stroke patients at the Stroke Unit of the University Hospital Giessen and to analyze the associated characteristics and impacts on clinical outcomes. A multimodal frailty assessment will be conducted to capture a wide range of frailty features and investigate their significance. The study includes all stroke patients admitted to the certified stroke- unit of the University Hospital Giessen within a 3-month period. There are no inclusion criteria related to age, gender, or type of stroke.
The multimodal frailty assessment encompasses determining appropriate blood values (e.g., CRP, albumin), assessing muscle strength/mass through handheld dynamometry and sonographic muscle diameter, utilizing scores like the Clinical Frailty Scale (CFS) and the Groningen Frailty Indicator (GFI), evaluating nutritional status (BMI), collecting image-based frailty data (e.g., sarcopenia, cerebral white matter lesions, lacunar strokes, brain atrophy), and conducting suitable one-year follow-ups. Additionally, demographic and clinical data such as age, gender, type of stroke, and treatment details will be recorded.
The primary outcome is the prevalence of frailty among stroke patients. Secondary outcomes include the characteristics and impacts of frailty in stroke patients, including correlations between various frailty features and clinical outcomes such as length of hospital stay, mortality, and functional outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke patients | – | Diagnostic Test: Multimodal frailty assessmentStroke patients admitted to the certified stroke-unit of the Department of Neurology, University Hospital Giessen, Germany. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients admitted with the diagnosis of acute stroke treated at the certified stroke-unit will be included. All patients who consent for participation are further eligible for the outcome assessment.
Key inclusion criteria (2 listed)
- treated at the certified stroke-unit of the Dpt. of Neurology, University Hospital Giessen
- diagnosis of ischemic (including transient ischemic attack) or hemorrhagic stroke
Key exclusion criteria (1 listed)
- withdrawal of care within 24 hours after admission
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 |
|---|---|---|
| Multimodal frailty assessmentDifferent domains are assessed during hospital stay, these include: * Clinical scores: Clinical Frailty scale (CFS), Groningen Frailty index (GFI) * Brain frailty: assessing white matter hyperintensieties, atrophy and lacunar strokes in initial brain imaging * Laboratory values: laboratory Frailty index (FI-Lab), inflammatory markers * Nutrition: Controlling nutritional status score (CONUT-score), body mass index, dysphagia assessment (FOIS) * Mobility/strengths: de Morton Mobility Index (DEMMI), grip strenghts of non-paralytic arm via dynamometer, muscle mass estimated by sonographic measurement of the biceps brachii muscle and the rectus femoris muscle. | Diagnostic test | Stroke patients |
Primary outcome
Prevalence of frailty in stroke patients
Time frame: 30 days
Percentage of patients with frailty treated for stroke compared to all patients admitted for stroke
Rate of good functional outcome
Time frame: 12 months
Percentage of patients achieving a score of 0 to 2 on the modified Rankin scale (higher values indicating worse outcome, ranging from 0, no deficit, to 6, death) at 12 months follow-up
6 secondary outcomes
Patient reported outcome measures (PROM)
Time frame: 12 months
Functional impairment in activities of daily living
Time frame: 12 months
Mortality rate
Time frame: From date of admission until death or last follow-up, whichever comes first, assessed up to 12 months.
Cognitive outcome
Time frame: 12 months
Rate of rehospitalization
Time frame: 12 months
Major adverse cardiovascular events (MACE)
Time frame: From date of admission until MACE or last follow-up, whichever comes first, assessed up to 12 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
- Background: PubMed 28419988Giede-Jeppe A, Bobinger T, Gerner ST, Sembill JA, Sprugel MI, Beuscher VD, Lucking H, Hoelter P, Kuramatsu JB, Huttner HB. Neutrophil-to-Lymphocyte Ratio Is an Independent Predictor for In-Hospital Mortality in Spontaneous Intracerebral Hemorrhage. Cerebrovasc Dis. 2017;44(1-2):26-34. doi: 10.1159/000468996. Epub 2017 Apr 19.
- Background: PubMed 30717052Giede-Jeppe A, Reichl J, Sprugel MI, Lucking H, Hoelter P, Eyupoglu IY, Kuramatsu JB, Huttner HB, Gerner ST. Neutrophil-to-lymphocyte ratio as an independent predictor for unfavorable functional outcome in aneurysmal subarachnoid hemorrhage. J Neurosurg. 2019 Feb 1;132(2):400-407. doi: 10.3171/2018.9.JNS181975. Print 2020 Feb 1.
- Background: PubMed 32623428Gerner ST, Reichl J, Custal C, Brandner S, Eyupoglu IY, Lucking H, Holter P, Kallmunzer B, Huttner HB. Long-Term Complications and Influence on Outcome in Patients Surviving Spontaneous Subarachnoid Hemorrhage. Cerebrovasc Dis. 2020;49(3):307-315. doi: 10.1159/000508577. Epub 2020 Jul 3.
- website of the recruiting site: Dpt. of Neurology, University Hospital GiessenLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Reasonable requests can be sent by mail.
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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.
Stefan Gerner, MD principal investigator
Department of Neurology, University Hospital Giessen/Germany
Thorsten Doeppner, MD study chair
Department of Neurology, University Hospital Giessen/Germany
Hagen Huttner, MD, PhD study chair
Department of Neurology, University Hospital Giessen/Germany
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 Stroke and Frailty, run by University of Giessen 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 11 Sep 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefan Gerner, MD (+49-641/985-45301, stefan.gerner@neuro.med.uni-giessen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of frailty in stroke patients (time frame: 30 days). The study lists 2 primary outcomes in all. 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 NCT06031909, 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 11 Sep 2023.