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/NCT05993572</url>
    </required_header>
    <id_info>
      <org_study_id>2023-3-24</org_study_id>
      <nct_id>NCT05993572</nct_id>
    </id_info>
    <brief_title>HEalthy Aging Through YASAM</brief_title>
    <acronym>HEAT-YASAM</acronym>
    <official_title>HEalthy Aging Through YASAM: Prospective Longitudinal Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Gulhane Training and Research Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Provincial Health Services Authority</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Gulhane Training and Research Hospital</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>
        Depending on the YASAM project which was established to home-visit evaluate&#xD;
        community-dwelling older adults (80 years of age and over), we aimed to determine the&#xD;
        prevalence (prevalence) of geriatric syndromes (dependence, frailty, malnutrition,&#xD;
        depression, dementia, comorbidity burden, polypharmacy) in these individuals and to determine&#xD;
        possible changes in the follow-up of the patients during the 2-year follow-up period. (HEAVEN&#xD;
        trial)&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Individuals over the age of 80 who will participate in the YASAM project will first be&#xD;
        informed by phone and their appointments will be made. Subsequently, a home visit will be&#xD;
        conducted after obtaining verbal and written consent from the patients and their relatives.&#xD;
  &#xD;
        The chronic diseases and medications of the patients will be questioned and controlled from&#xD;
        the electronic data set. To determine the level of frailty and dependency, the Katz,&#xD;
        Lawton-Brody, and Clinical Frailty scales will be filled in, respectively, by the previously&#xD;
        trained health personnel, by interviewing their relatives. Mini-Cog, Mini Mental Status&#xD;
        Assessment, Mini Nutrition Assessment, and Geriatric Depression (Yesavage) Assessments will&#xD;
        be planned. According to dependency status, individuals will be re-evaluated in the 1st or&#xD;
        2nd month. If the patients are fully independent, control follow-up is planned in the 3rd&#xD;
        month. Written file records will be created by obtaining the consent of the patients and&#xD;
        their relatives at each patient visit. Each team will be responsible for the follow-up of 300&#xD;
        patients. It is planned to include a total of 6000 individuals in the first phase, which is&#xD;
        carried out in 20 centers throughout the province of Balıkesir and whose coordination center&#xD;
        is Atatürk city hospital. In the follow-ups, it is planned to include the whole cohort&#xD;
        consisting of 40 thousand individuals over the age of 80, by increasing the number of teams.&#xD;
        The short-term results of the patient's follow-up (1st, 3rd, and 6th-month results), changes&#xD;
        in mortality, addiction, frailty level, and changes in nutrition and cognitive functions&#xD;
        within the specified period will be evaluated as short-term results. It is aimed to record&#xD;
        the long-term outcomes (1st and 2nd year) of the same variables.&#xD;
  &#xD;
        Since the whole population will be included in the study, sample size and power analysis were&#xD;
        not performed.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Actual">June 15, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 1, 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>2 Years</target_duration>
    <primary_outcome>
      <measure>Short term Healthy Aging status (mortality)</measure>
      <time_frame>1-,3-,6- month</time_frame>
      <description>Outcomes were evaluated according to the national electronic database.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Short term Healthy Aging status (changes dependency )</measure>
      <time_frame>1-,3-,6- month</time_frame>
      <description>Outcomes were evaluated according to the specific test Katz scales the 1 is minimum and 6 is maximum value for scale, and higher scores mean a better outcome, higher scores mean a better outcome for dependency)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Short term Healthy Aging status (changes in frailty level)</measure>
      <time_frame>1-,3-,6- month</time_frame>
      <description>Outcomes were evaluated according to the specific test (Fraility via Clinical fraility scales the 1 is minimum and 9 is maximum value for scale, and higher scores mean a worse outcome).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Short term Healthy Aging status (changes in nutrition)</measure>
      <time_frame>1-,3-,6- month</time_frame>
      <description>Outcomes were evaluated according to the specific test (MNA scale for nutritional status the 0 is minimum and 14 is maximum value for scale, and higher scores mean a better outcome).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Short term Healthy Aging status (changes in cognitive functions)</measure>
      <time_frame>1-,3-,6- month</time_frame>
      <description>Outcomes were evaluated according to the specific test (cognitive functions with MMSE scale, the 0 is minimum and 30 is maximum value for scale, and higher scores mean a better outcome)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Short term Healthy Aging status (changes in mood)</measure>
      <time_frame>1-,3-,6- month</time_frame>
      <description>Outcomes were evaluated according to the specific test (Outcomes were evaluated according to the specific test ( Yesavage for Depression status the 0 is minimum and 15 is maximum value for scale, and higher scores mean a worse outcome)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Short term Healthy Aging status (changes in mobility status)</measure>
      <time_frame>1-,3-,6- month</time_frame>
      <description>Outcomes were evaluated according to the specific test (Chair stand test higher scores (&gt;13,5 seconds) means a worse outcome for mobility status).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Long term Healthy Aging status (mortality)</measure>
      <time_frame>1- and 2- year</time_frame>
      <description>Outcomes were evaluated according to the national electronic database.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Long term Healthy Aging status (changes dependency )</measure>
      <time_frame>1- and 2- year</time_frame>
      <description>Outcomes were evaluated according to the specific test Katz scales the 1 is minimum and 6 is maximum value for scale, and higher scores mean a better outcome, higher scores mean a better outcome for dependency)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Long term Healthy Aging status (changes in frailty level)</measure>
      <time_frame>1- and 2- year</time_frame>
      <description>Outcomes were evaluated according to the specific test (Fraility via Clinical fraility scales the 1 is minimum and 9 is maximum value for scale, and higher scores mean a worse outcome.)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Long term Healthy Aging status (changes in nutrition)</measure>
      <time_frame>1- and 2- year</time_frame>
      <description>Outcomes were evaluated according to the specific test (MNA scale for nutritional status the 1 is minimum and 14 is maximum value for scale, and higher scores mean a better outcome).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Long term Healthy Aging status (changes in cognitive functions)</measure>
      <time_frame>1- and 2- year</time_frame>
      <description>Outcomes were evaluated according to the specific test (cognitive functions with MMSE scale, the 0 is minimum and 30 is maximum value for scale, and higher scores mean a better outcome).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Long term Healthy Aging status (changes in mood)</measure>
      <time_frame>1- and 2- year</time_frame>
      <description>Outcomes were evaluated according to the specific test ( Yesavage scale for Depression status the 0 is minimum and 15 is maximum value for scale, and higher scores mean a worse outcome).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Long term Healthy Aging status (changes in mobility status)</measure>
      <time_frame>1- and 2- year</time_frame>
      <description>Outcomes were evaluated according to the specific test (Outcomes were evaluated according to the specific test (Chair stand test higher scores (&gt;13,5 seconds) means a worse outcome for mobility status).</description>
    </primary_outcome>
    <enrollment type="Anticipated">2000</enrollment>
    <condition>Frailty</condition>
    <condition>Dementia</condition>
    <condition>Depression</condition>
    <condition>Malnutrition</condition>
    <condition>Old Age; Debility</condition>
    <condition>Drug Use</condition>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Comprehensive Geriatric Assessment</intervention_name>
      <description>Comprehensive Geriatric Assessments include functional status, fraility comorbidity, cognition, mental health, social support, nutrition, and geriatric syndromes</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          It is planned to include a total of 6000 individuals in the first phase, which is carried&#xD;
          out in 20 centers throughout the province of Balıkesir (rural and central area) and whose&#xD;
          coordination center is Balikesir Atatürk City Hospital. In the follow-ups, it is planned to&#xD;
          include the whole cohort consisting of individuals over the age of 40 thousand 80, by&#xD;
          increasing the number of teams.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  80 years and over older adults&#xD;
  &#xD;
            -  individuals giving verbal and written consent for the YASAM project&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  &lt;80 years older adults&#xD;
  &#xD;
            -  those who did not give verbal and written consent for the YASAM project&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>80 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Bilal Katipoglu</last_name>
      <role>Study Director</role>
      <affiliation>Gulhane Training and Research Hospital</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Balikesir Ataturk City Hospital</name>
        <address>
          <city>Balikesir</city>
          <state>None Selected</state>
          <zip>10100</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Gulhane Training and Research Hospital</investigator_affiliation>
      <investigator_full_name>Bilal Katipoglu</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Malnutrition</mesh_term>
      <mesh_term>Frailty</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</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/NCT05993572
  org study id: 2023-3-24
  nct id: NCT05993572
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Depending on the YASAM project which was established to home-visit evaluate
        community-dwelling older adults (80 years of age and over), we aimed to determine the
        prevalence (prevalence) of geriatric syndromes (dependence, frailty, malnutrition,
        depression, dementia, comorbidity burden, polypharmacy) in these individuals and to determine
        possible changes in the follow-up of the patients during the 2-year follow-up period. (HEAVEN
        trial)
  Individuals over the age of 80 who will participate in the YASAM project will first be
        informed by phone and their appointments will be made. Subsequently, a home visit will be
        conducted after obtaining verbal and written consent from the patients and their relatives.
  
        The chronic diseases and medications of the patients will be questioned and controlled from
        the electronic data set. To determine the level of frailty and dependency, the Katz,
        Lawton-Brody, and Clinical Frailty scales will be filled in, respectively, by the previously
        trained health personnel, by interviewing their relatives. Mini-Cog, Mini Mental Status
        Assessment, Mini Nutrition Assessment, and Geriatric Depression (Yesavage) Assessments will
        be planned. According to dependency status, individuals will be re-evaluated in the 1st or
        2nd month. If the patients are fully independent, control follow-up is planned in the 3rd
        month. Written file records will be created by obtaining the consent of the patients and
        their relatives at each patient visit. Each team will be responsible for the follow-up of 300
        patients. It is planned to include a total of 6000 individuals in the first phase, which is
        carried out in 20 centers throughout the province of Balıkesir and whose coordination center
        is Atatürk city hospital. In the follow-ups, it is planned to include the whole cohort
        consisting of 40 thousand individuals over the age of 80, by increasing the number of teams.
        The short-term results of the patient's follow-up (1st, 3rd, and 6th-month results), changes
        in mortality, addiction, frailty level, and changes in nutrition and cognitive functions
        within the specified period will be evaluated as short-term results. It is aimed to record
        the long-term outcomes (1st and 2nd year) of the same variables.
  
        Since the whole population will be included in the study, sample size and power analysis were
        not performed.
  observational model: Cohort
  time perspective: Prospective
  measure: Short term Healthy Aging status (mortality)
  time frame: 1-,3-,6- month
  description: Outcomes were evaluated according to the national electronic database.
  measure: Short term Healthy Aging status (changes dependency )
  time frame: 1-,3-,6- month
  description: Outcomes were evaluated according to the specific test Katz scales the 1 is minimum and 6 is maximum value for scale, and higher scores mean a better outcome, higher scores mean a better outcome for dependency)
  measure: Short term Healthy Aging status (changes in frailty level)
  time frame: 1-,3-,6- month
  description: Outcomes were evaluated according to the specific test (Fraility via Clinical fraility scales the 1 is minimum and 9 is maximum value for scale, and higher scores mean a worse outcome).
  measure: Short term Healthy Aging status (changes in nutrition)
  time frame: 1-,3-,6- month
  description: Outcomes were evaluated according to the specific test (MNA scale for nutritional status the 0 is minimum and 14 is maximum value for scale, and higher scores mean a better outcome).
  measure: Short term Healthy Aging status (changes in cognitive functions)
  time frame: 1-,3-,6- month
  description: Outcomes were evaluated according to the specific test (cognitive functions with MMSE scale, the 0 is minimum and 30 is maximum value for scale, and higher scores mean a better outcome)
  measure: Short term Healthy Aging status (changes in mood)
  time frame: 1-,3-,6- month
  description: Outcomes were evaluated according to the specific test (Outcomes were evaluated according to the specific test ( Yesavage for Depression status the 0 is minimum and 15 is maximum value for scale, and higher scores mean a worse outcome)
  measure: Short term Healthy Aging status (changes in mobility status)
  time frame: 1-,3-,6- month
  description: Outcomes were evaluated according to the specific test (Chair stand test higher scores (>13,5 seconds) means a worse outcome for mobility status).
  measure: Long term Healthy Aging status (mortality)
  time frame: 1- and 2- year
  description: Outcomes were evaluated according to the national electronic database.
  measure: Long term Healthy Aging status (changes dependency )
  time frame: 1- and 2- year
  description: Outcomes were evaluated according to the specific test Katz scales the 1 is minimum and 6 is maximum value for scale, and higher scores mean a better outcome, higher scores mean a better outcome for dependency)
  measure: Long term Healthy Aging status (changes in frailty level)
  time frame: 1- and 2- year
  description: Outcomes were evaluated according to the specific test (Fraility via Clinical fraility scales the 1 is minimum and 9 is maximum value for scale, and higher scores mean a worse outcome.)
  measure: Long term Healthy Aging status (changes in nutrition)
  time frame: 1- and 2- year
  description: Outcomes were evaluated according to the specific test (MNA scale for nutritional status the 1 is minimum and 14 is maximum value for scale, and higher scores mean a better outcome).
  measure: Long term Healthy Aging status (changes in cognitive functions)
  time frame: 1- and 2- year
  description: Outcomes were evaluated according to the specific test (cognitive functions with MMSE scale, the 0 is minimum and 30 is maximum value for scale, and higher scores mean a better outcome).
  measure: Long term Healthy Aging status (changes in mood)
  time frame: 1- and 2- year
  description: Outcomes were evaluated according to the specific test ( Yesavage scale for Depression status the 0 is minimum and 15 is maximum value for scale, and higher scores mean a worse outcome).
  measure: Long term Healthy Aging status (changes in mobility status)
  time frame: 1- and 2- year
  description: Outcomes were evaluated according to the specific test (Outcomes were evaluated according to the specific test (Chair stand test higher scores (>13,5 seconds) means a worse outcome for mobility status).
  intervention type: Diagnostic Test
  intervention name: Comprehensive Geriatric Assessment
  description: Comprehensive Geriatric Assessments include functional status, fraility comorbidity, cognition, mental health, social support, nutrition, and geriatric syndromes
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 80 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Bilal Katipoglu
  role: Study Director
  affiliation: Gulhane Training and Research Hospital
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Gulhane Training and Research Hospital
  investigator full name: Bilal Katipoglu
  investigator title: Associate Professor
  mesh term: Malnutrition
  mesh term: Frailty
  sharing ipd: Undecided