xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06031909</url>
    </required_header>
    <id_info>
      <org_study_id>AZ 220/21</org_study_id>
      <nct_id>NCT06031909</nct_id>
    </id_info>
    <brief_title>Multimodal Assessment of Frailty in Acute Stroke Patients</brief_title>
    <acronym>MAFASP</acronym>
    <official_title>Multimodal Assessment of Frailty in Acute Stroke Patients Treated at a Certified Stroke-unit</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Giessen</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Giessen</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this study is to investigate the influence of frailty on clinical and stroke&#xD;
        characteristics, treatment and outcomes in patients with acute stroke.&#xD;
  &#xD;
        The main questions it aims to answer are:&#xD;
  &#xD;
          1. How prevalent is frailty in patients with stroke?&#xD;
  &#xD;
          2. Which impairments (e.g. undernutrion, impaired mobility, laboratory markers) contribute&#xD;
             to frailty?&#xD;
  &#xD;
          3. Is the outcome of frail patients worse than those without?&#xD;
  &#xD;
          4. Are in-hospital complications more frequent in frail patients than those without?&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Stroke is one of the most common causes of disability and mortality worldwide. A recognized&#xD;
        complication in stroke patients is frailty, which is associated with increased costs, poorer&#xD;
        prognosis, and higher mortality rates. However, there is currently no uniform definition or&#xD;
        diagnostic criteria for frailty in stroke patients, and there is a need for standardized&#xD;
        frailty assessments in this patient population.&#xD;
  &#xD;
        The aim of this study is to determine the prevalence of frailty in stroke patients at the&#xD;
        Stroke Unit of the University Hospital Giessen and to analyze the associated characteristics&#xD;
        and impacts on clinical outcomes. A multimodal frailty assessment will be conducted to&#xD;
        capture a wide range of frailty features and investigate their significance. The study&#xD;
        includes all stroke patients admitted to the certified stroke- unit of the University&#xD;
        Hospital Giessen within a 3-month period. There are no inclusion criteria related to age,&#xD;
        gender, or type of stroke.&#xD;
  &#xD;
        The multimodal frailty assessment encompasses determining appropriate blood values (e.g.,&#xD;
        CRP, albumin), assessing muscle strength/mass through handheld dynamometry and sonographic&#xD;
        muscle diameter, utilizing scores like the Clinical Frailty Scale (CFS) and the Groningen&#xD;
        Frailty Indicator (GFI), evaluating nutritional status (BMI), collecting image-based frailty&#xD;
        data (e.g., sarcopenia, cerebral white matter lesions, lacunar strokes, brain atrophy), and&#xD;
        conducting suitable one-year follow-ups. Additionally, demographic and clinical data such as&#xD;
        age, gender, type of stroke, and treatment details will be recorded.&#xD;
  &#xD;
        The primary outcome is the prevalence of frailty among stroke patients. Secondary outcomes&#xD;
        include the characteristics and impacts of frailty in stroke patients, including correlations&#xD;
        between various frailty features and clinical outcomes such as length of hospital stay,&#xD;
        mortality, and functional outcome.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">October 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 31, 2024</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>12 Months</target_duration>
    <primary_outcome>
      <measure>Prevalence of frailty in stroke patients</measure>
      <time_frame>30 days</time_frame>
      <description>Percentage of patients with frailty treated for stroke compared to all patients admitted for stroke</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Rate of good functional outcome</measure>
      <time_frame>12 months</time_frame>
      <description>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</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Patient reported outcome measures (PROM)</measure>
      <time_frame>12 months</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Functional impairment in activities of daily living</measure>
      <time_frame>12 months</time_frame>
      <description>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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mortality rate</measure>
      <time_frame>From date of admission until death or last follow-up, whichever comes first, assessed up to 12 months.</time_frame>
      <description>Rate of death observed during the follow-up period</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cognitive outcome</measure>
      <time_frame>12 months</time_frame>
      <description>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)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of rehospitalization</measure>
      <time_frame>12 months</time_frame>
      <description>Percentage of patients needed to be hospitalized due to unplanned events during the follow-up</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Major adverse cardiovascular events (MACE)</measure>
      <time_frame>From date of admission until MACE or last follow-up, whichever comes first, assessed up to 12 months.</time_frame>
      <description>Rate of patients suffering from newly detected myocardial infarction, non-fatal stroke or cardiovascular death</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Stroke</condition>
    <condition>Frailty</condition>
    <arm_group>
      <arm_group_label>Stroke patients</arm_group_label>
      <description>Stroke patients admitted to the certified stroke-unit of the Department of Neurology, University Hospital Giessen, Germany.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Multimodal frailty assessment</intervention_name>
      <description>Different domains are assessed during hospital stay, these include:&#xD;
  Clinical scores: Clinical Frailty scale (CFS), Groningen Frailty index (GFI)&#xD;
  Brain frailty: assessing white matter hyperintensieties, atrophy and lacunar strokes in initial brain imaging&#xD;
  Laboratory values: laboratory Frailty index (FI-Lab), inflammatory markers&#xD;
  Nutrition: Controlling nutritional status score (CONUT-score), body mass index, dysphagia assessment (FOIS)&#xD;
  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.</description>
      <arm_group_label>Stroke patients</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          All patients admitted with the diagnosis of acute stroke treated at the certified&#xD;
          stroke-unit will be included. All patients who consent for participation are further&#xD;
          eligible for the outcome assessment.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  treated at the certified stroke-unit of the Dpt. of Neurology, University Hospital&#xD;
               Giessen&#xD;
  &#xD;
            -  diagnosis of ischemic (including transient ischemic attack) or hemorrhagic stroke&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  withdrawal of care within 24 hours after admission&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Stefan Gerner, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Department of Neurology, University Hospital Giessen/Germany</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Thorsten Doeppner, MD</last_name>
      <role>Study Chair</role>
      <affiliation>Department of Neurology, University Hospital Giessen/Germany</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Hagen Huttner, MD, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>Department of Neurology, University Hospital Giessen/Germany</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Stefan Gerner, MD</last_name>
      <phone>+49-641/985-45301</phone>
      <email>stefan.gerner@neuro.med.uni-giessen.de</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Thorsten Doeppner, MD</last_name>
      <phone>+49-641/985-45301</phone>
      <email>thorsten.doeppner@neuro.med.uni-giessen.de</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Department of Neurology, University Hospital Giessen</name>
        <address>
          <city>Gießen</city>
          <state>Hesse</state>
          <zip>35392</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Stefan Gerner, MD</last_name>
        <email>stefan.gerner@neuro.med.uni-giessen.de</email>
      </contact>
      <contact_backup>
        <last_name>Thorsten Doeppner, MD</last_name>
        <email>thorsten.doeppner@neuro.med.uni-giessen.de</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Germany</country>
    </location_countries>
    <link>
      <url>https://www.ukgm.de/ugm_2/deu/ugi_neu/index.html</url>
      <description>website of the recruiting site: Dpt. of Neurology, University Hospital Giessen</description>
    </link>
    <reference>
      <citation>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.</citation>
      <PMID>28419988</PMID>
    </reference>
    <reference>
      <citation>Giede-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.</citation>
      <PMID>30717052</PMID>
    </reference>
    <reference>
      <citation>Gerner 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.</citation>
      <PMID>32623428</PMID>
    </reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 30, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Giessen</investigator_affiliation>
      <investigator_full_name>Stefan Gerner</investigator_full_name>
      <investigator_title>Principal Investigator, Associate professor</investigator_title>
    </responsible_party>
    <keyword>frailty</keyword>
    <keyword>outcome</keyword>
    <keyword>elderly</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stroke</mesh_term>
      <mesh_term>Frailty</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>Reasonable requests can be sent by mail.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06031909
  org study id: AZ 220/21
  nct id: NCT06031909
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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. undernutrion, impaired mobility, laboratory markers) contribute
             to frailty?
  
          3. Is the outcome of frail patients worse than those without?
  
          4. Are in-hospital complications more frequent in frail patients than those without?
  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.
  observational model: Cohort
  time perspective: Prospective
  measure: Prevalence of frailty in stroke patients
  time frame: 30 days
  description: Percentage of patients with frailty treated for stroke compared to all patients admitted for stroke
  measure: Rate of good functional outcome
  time frame: 12 months
  description: 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
  measure: Patient reported outcome measures (PROM)
  time frame: 12 months
  description: 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.
  measure: Functional impairment in activities of daily living
  time frame: 12 months
  description: 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).
  measure: Mortality rate
  time frame: From date of admission until death or last follow-up, whichever comes first, assessed up to 12 months.
  description: Rate of death observed during the follow-up period
  measure: Cognitive outcome
  time frame: 12 months
  description: 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)
  measure: Rate of rehospitalization
  time frame: 12 months
  description: Percentage of patients needed to be hospitalized due to unplanned events during the follow-up
  measure: 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.
  description: Rate of patients suffering from newly detected myocardial infarction, non-fatal stroke or cardiovascular death
  arm group label: Stroke patients
  description: Stroke patients admitted to the certified stroke-unit of the Department of Neurology, University Hospital Giessen, Germany.
  intervention type: Diagnostic Test
  intervention name: Multimodal frailty assessment
  description: 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.
  arm group label: Stroke patients
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Stefan Gerner, MD
  role: Principal Investigator
  affiliation: Department of Neurology, University Hospital Giessen/Germany
  last name: Thorsten Doeppner, MD
  role: Study Chair
  affiliation: Department of Neurology, University Hospital Giessen/Germany
  last name: Hagen Huttner, MD, PhD
  role: Study Chair
  affiliation: Department of Neurology, University Hospital Giessen/Germany
  last name: Stefan Gerner, MD
  phone: +49-641/985-45301
  email: stefan.gerner@neuro.med.uni-giessen.de
  last name: Thorsten Doeppner, MD
  phone: +49-641/985-45301
  email: thorsten.doeppner@neuro.med.uni-giessen.de
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Germany
  url: https://www.ukgm.de/ugm_2/deu/ugi_neu/index.html
  description: website of the recruiting site: Dpt. of Neurology, University Hospital Giessen
  citation: 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.
  PMID: 28419988
  citation: Giede-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.
  PMID: 30717052
  citation: Gerner 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.
  PMID: 32623428
  responsible party type: Principal Investigator
  investigator affiliation: University of Giessen
  investigator full name: Stefan Gerner
  investigator title: Principal Investigator, Associate professor
  mesh term: Stroke
  mesh term: Frailty
  sharing ipd: Undecided
  ipd description: Reasonable requests can be sent by mail.