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/NCT05962203</url>
    </required_header>
    <id_info>
      <org_study_id>BB 161/22</org_study_id>
      <nct_id>NCT05962203</nct_id>
    </id_info>
    <brief_title>SHIP-AGE: Frailty, Renal Function, and Multi-component Primary Care in Rural Mecklenburg-Western Pomerania</brief_title>
    <acronym>MV-FIT</acronym>
    <official_title>SHIP-AGE: Frailty, Renal Function, and Multi-component Primary Care in Rural Mecklenburg-Western Pomerania.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Medicine Greifswald</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University Medicine Greifswald</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>
        Chronic kidney disease (CKD) is a leading risk factor for cardiovascular and all-cause&#xD;
        mortality among the elderly. Mecklenburg-Western Pomerania has the largest prevalence of CKD&#xD;
        in Germany and Europe. The CKD impact in primary care strategies to reduce frailty syndrome&#xD;
        in the elderly is unknown. For this purpose, about 820 elderly participants will be included&#xD;
        in an observational study (MV-FIT), who will undergo an multi-factorial geriatric assessment,&#xD;
        monitoring &amp; management program, specifically designed to avoid frailty. The goal of the&#xD;
        full-scale study is to evaluate the impact of CKD in multi-component primary care strategies&#xD;
        to reduce frailty among elderly persons in rural Mecklenburg-Western Pomerania. MV-FIT will&#xD;
        be conducted on individuals in rural Mecklenburg-Western Pomerania, who will be observed over&#xD;
        a period of 3 years. The Study of Health in Pomerania (SHIP) is a population-based&#xD;
        epidemiological, two independent-cohort, study (SHIP and SHIP-TREND). SHIP cohorts have been&#xD;
        followed for &gt;24 years. SHIP/SHIP TEND participants &gt;60 years or older will studied by a&#xD;
        follow-up survey. The aim is to gain new insights into the development of frailty and to&#xD;
        develop strategies for keeping those affected healthy.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Our study is a longitudinal population-based epidemiological SHIP-cohort study combined with&#xD;
        a prospective, multi-centered, observational/interventional investigation. MV-FIT is an&#xD;
        observational study of individuals aged 65 years or older with mGFR &gt;30 mL/min (n=~820). All&#xD;
        participants in the observational/interventional study will receive guideline-based,&#xD;
        multi-factorial geriatric assessment, monitoring &amp; managements (multi-component healthcare).&#xD;
        Subjects will be stratified by mGFR. Objectives are 1) to implement multi-component&#xD;
        healthcare specifically comprised of components to reduce frailty and incident falls, 2) to&#xD;
        improve compliance and adherence to the multi-component healthcare for frailty and&#xD;
        improvement of patient welfare, ability to live independently, quality-of-life, number of&#xD;
        falls, referrals to nursing homes, all-cause mortality in primary care of the elderly, 3) to&#xD;
        seek the elderly individuals' experience during the course of multi-factorial primary care&#xD;
        intervention through In-depth interviews, 4) to clarify the burden of CKD on frailty and&#xD;
        health status, and 5) to identify novel risk factors and mechanisms for frailty and&#xD;
        pre-frailty. MV-FIT data will be corroborated by SHIP/SHIP-TREND data.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2029</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2028</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>Multivariable logistic regression; Multivariable Cox regression, Chi-Square-Test, Propensity score matching</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Frailty</measure>
      <time_frame>from baseline to follow-up at 36 month</time_frame>
      <description>The primary outcome will be frailty from baseline to follow-up at 36 months post subject inclusion (i.e. Frail vs. non-Frail). The frailty phenotype defines frailty as a clinical syndrome meeting three or more of five phenotypic criteria: (1) unintentional body weight loss (2) slow walking pace, (3) self-reported exhaustion, (4) muscle weakness, and (5) self-reported low physical activity.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>body weight loss</measure>
      <time_frame>36 months</time_frame>
      <description>unintentional body weight loss (determined weight in kilograms); see phenotype criteria (# 1) above</description>
    </primary_outcome>
    <primary_outcome>
      <measure>slow walking pace</measure>
      <time_frame>36 months</time_frame>
      <description>slow walking pace (determined by walking speed measurements in m/sec); see phenotype criteria (# 2) above</description>
    </primary_outcome>
    <primary_outcome>
      <measure>exhaustion</measure>
      <time_frame>36 months</time_frame>
      <description>self-reported exhaustion (determined by questionnaire), see phenotype criteria (# 3) above</description>
    </primary_outcome>
    <primary_outcome>
      <measure>muscle weakness</measure>
      <time_frame>36 months</time_frame>
      <description>muscle weakness (determined by handgrip and jump strengths in kg); see phenotype criteria (# 4) above</description>
    </primary_outcome>
    <primary_outcome>
      <measure>low physical activity</measure>
      <time_frame>36 months</time_frame>
      <description>(5) self-reported low physical activity (determinded by questionnaire); see phenotype criteria (# 5) above</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Frailty transition</measure>
      <time_frame>36 months</time_frame>
      <description>Frailty transition (pre-frailty, in which one or two criteria (see above) are present)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>mGFR transition</measure>
      <time_frame>36 months</time_frame>
      <description>mGFR transition (transition from GFR KDIGO (Kidney Disease: Improving Global Outcomes) Stage 2 CKD in mL/min per 1.73 m2 to KDIGO Stage 3 in mL/min per 1.73 m2)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>patient welfare</measure>
      <time_frame>36 months</time_frame>
      <description>self-reported patient welfare (questionnaire)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>ability to live independently</measure>
      <time_frame>36 months</time_frame>
      <description>self-reported ability to live independently (Barthel Index for Activities of Daily Living (ADL))</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>cognitive decline</measure>
      <time_frame>36 months</time_frame>
      <description>cognitive decline</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>number of falls</measure>
      <time_frame>36 months</time_frame>
      <description>self-reported number of falls</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>admission to hospitals</measure>
      <time_frame>36 months</time_frame>
      <description>self-reported admission to hospitals</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>referrals to nursing homes</measure>
      <time_frame>36 months</time_frame>
      <description>self-reported referrals to nursing homes</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>mortality</measure>
      <time_frame>36 months</time_frame>
      <description>all-cause mortality in primary care</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">820</enrollment>
    <condition>Frailty Syndrome</condition>
    <arm_group>
      <arm_group_label>Multi-factorial geriatric assessment, monitoring &amp; management systems</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>All participants in the observational/interventional study (MV-FIT) will receive guideline-based, multi-factorial geriatric assessment, monitoring &amp; managements (multi-component healthcare). Other: GFR Measuremments, Blood sampling, Urine sampling</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Multi-factorial geriatric assessment, monitoring &amp; management systems</intervention_name>
      <description>Multi-factorial geriatric assessment, monitoring &amp; management systems, e.g. community-based and home-based exercise programs, polypharmacy</description>
      <arm_group_label>Multi-factorial geriatric assessment, monitoring &amp; management systems</arm_group_label>
      <other_name>Community-based and home-based exercise programs</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  age 65 years or older&#xD;
  &#xD;
            -  mGFR &gt; 30 mL/min per 1.73 m2&#xD;
  &#xD;
            -  being able to understand and give written informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  bedridden&#xD;
  &#xD;
            -  palliative&#xD;
  &#xD;
            -  inability to consent&#xD;
  &#xD;
            -  severe dementia&#xD;
  &#xD;
            -  inability to speak&#xD;
  &#xD;
            -  lack of compliance (paracusis, inability to fulfill at least 60% of the assessments)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>65 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Maik Gollasch, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Medicine Greifswald</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Maik Gollasch, MD, PhD</last_name>
      <phone>+493836257594</phone>
      <email>maik.gollasch@med.uni-greifswald.de</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Julia Rüdebusch, PhD</last_name>
      <phone>+49 (0) 3834-86-7423</phone>
      <email>julia.ruedebusch@uni-greifswald.de</email>
    </overall_contact_backup>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 13, 2023</study_first_submitted>
    <study_first_submitted_qc>July 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 18, 2023</last_update_submitted>
    <last_update_submitted_qc>July 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Chronic kidney disease</keyword>
    <keyword>Frailty</keyword>
    <keyword>Falls</keyword>
    <keyword>Cognitive decline</keyword>
    <keyword>Multi-component interventions</keyword>
    <keyword>Rural communities</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Frailty</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT05962203
  org study id: BB 161/22
  nct id: NCT05962203
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Chronic kidney disease (CKD) is a leading risk factor for cardiovascular and all-cause
        mortality among the elderly. Mecklenburg-Western Pomerania has the largest prevalence of CKD
        in Germany and Europe. The CKD impact in primary care strategies to reduce frailty syndrome
        in the elderly is unknown. For this purpose, about 820 elderly participants will be included
        in an observational study (MV-FIT), who will undergo an multi-factorial geriatric assessment,
        monitoring & management program, specifically designed to avoid frailty. The goal of the
        full-scale study is to evaluate the impact of CKD in multi-component primary care strategies
        to reduce frailty among elderly persons in rural Mecklenburg-Western Pomerania. MV-FIT will
        be conducted on individuals in rural Mecklenburg-Western Pomerania, who will be observed over
        a period of 3 years. The Study of Health in Pomerania (SHIP) is a population-based
        epidemiological, two independent-cohort, study (SHIP and SHIP-TREND). SHIP cohorts have been
        followed for >24 years. SHIP/SHIP TEND participants >60 years or older will studied by a
        follow-up survey. The aim is to gain new insights into the development of frailty and to
        develop strategies for keeping those affected healthy.
  Our study is a longitudinal population-based epidemiological SHIP-cohort study combined with
        a prospective, multi-centered, observational/interventional investigation. MV-FIT is an
        observational study of individuals aged 65 years or older with mGFR >30 mL/min (n=~820). All
        participants in the observational/interventional study will receive guideline-based,
        multi-factorial geriatric assessment, monitoring & managements (multi-component healthcare).
        Subjects will be stratified by mGFR. Objectives are 1) to implement multi-component
        healthcare specifically comprised of components to reduce frailty and incident falls, 2) to
        improve compliance and adherence to the multi-component healthcare for frailty and
        improvement of patient welfare, ability to live independently, quality-of-life, number of
        falls, referrals to nursing homes, all-cause mortality in primary care of the elderly, 3) to
        seek the elderly individuals' experience during the course of multi-factorial primary care
        intervention through In-depth interviews, 4) to clarify the burden of CKD on frailty and
        health status, and 5) to identify novel risk factors and mechanisms for frailty and
        pre-frailty. MV-FIT data will be corroborated by SHIP/SHIP-TREND data.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Multivariable logistic regression; Multivariable Cox regression, Chi-Square-Test, Propensity score matching
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Frailty
  time frame: from baseline to follow-up at 36 month
  description: The primary outcome will be frailty from baseline to follow-up at 36 months post subject inclusion (i.e. Frail vs. non-Frail). The frailty phenotype defines frailty as a clinical syndrome meeting three or more of five phenotypic criteria: (1) unintentional body weight loss (2) slow walking pace, (3) self-reported exhaustion, (4) muscle weakness, and (5) self-reported low physical activity.
  measure: body weight loss
  time frame: 36 months
  description: unintentional body weight loss (determined weight in kilograms); see phenotype criteria (# 1) above
  measure: slow walking pace
  time frame: 36 months
  description: slow walking pace (determined by walking speed measurements in m/sec); see phenotype criteria (# 2) above
  measure: exhaustion
  time frame: 36 months
  description: self-reported exhaustion (determined by questionnaire), see phenotype criteria (# 3) above
  measure: muscle weakness
  time frame: 36 months
  description: muscle weakness (determined by handgrip and jump strengths in kg); see phenotype criteria (# 4) above
  measure: low physical activity
  time frame: 36 months
  description: (5) self-reported low physical activity (determinded by questionnaire); see phenotype criteria (# 5) above
  measure: Frailty transition
  time frame: 36 months
  description: Frailty transition (pre-frailty, in which one or two criteria (see above) are present)
  measure: mGFR transition
  time frame: 36 months
  description: mGFR transition (transition from GFR KDIGO (Kidney Disease: Improving Global Outcomes) Stage 2 CKD in mL/min per 1.73 m2 to KDIGO Stage 3 in mL/min per 1.73 m2)
  measure: patient welfare
  time frame: 36 months
  description: self-reported patient welfare (questionnaire)
  measure: ability to live independently
  time frame: 36 months
  description: self-reported ability to live independently (Barthel Index for Activities of Daily Living (ADL))
  measure: cognitive decline
  time frame: 36 months
  description: cognitive decline
  measure: number of falls
  time frame: 36 months
  description: self-reported number of falls
  measure: admission to hospitals
  time frame: 36 months
  description: self-reported admission to hospitals
  measure: referrals to nursing homes
  time frame: 36 months
  description: self-reported referrals to nursing homes
  measure: mortality
  time frame: 36 months
  description: all-cause mortality in primary care
  arm group label: Multi-factorial geriatric assessment, monitoring & management systems
  arm group type: Experimental
  description: All participants in the observational/interventional study (MV-FIT) will receive guideline-based, multi-factorial geriatric assessment, monitoring & managements (multi-component healthcare). Other: GFR Measuremments, Blood sampling, Urine sampling
  intervention type: Diagnostic Test
  intervention name: Multi-factorial geriatric assessment, monitoring & management systems
  description: Multi-factorial geriatric assessment, monitoring & management systems, e.g. community-based and home-based exercise programs, polypharmacy
  arm group label: Multi-factorial geriatric assessment, monitoring & management systems
  other name: Community-based and home-based exercise programs
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: 100 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Maik Gollasch, MD, PhD
  role: Principal Investigator
  affiliation: University Medicine Greifswald
  last name: Maik Gollasch, MD, PhD
  phone: +493836257594
  email: maik.gollasch@med.uni-greifswald.de
  last name: Julia Rüdebusch, PhD
  phone: +49 (0) 3834-86-7423
  email: julia.ruedebusch@uni-greifswald.de
  responsible party type: Sponsor
  mesh term: Frailty
  sharing ipd: No