<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/NCT03796923</url>
  </required_header>
  <id_info>
    <org_study_id>MOCATRANFRAELRCT</org_study_id>
    <nct_id>NCT03796923</nct_id>
  </id_info>
  <brief_title>Models of Care in the Transition From the Secondary to the Primary Sector Among the Frailest Elderly</brief_title>
  <official_title>Models of Care in the Transition From the Secondary to the Primary Sector Among the Frailest Elderly +75; a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Aarhus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Aarhus</source>
  <oversight_info>
    <has_dmc>Yes</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>
      In most Western countries the elderly population increases rapidly. In Denmark, the&#xD;
      population of elderly aged 75 years or older may amount to nearly 15 % of the entire&#xD;
      population in 2050 compared to 9 % today (2017). A large part of the elderly population is at&#xD;
      high risk of hospitalization including more admissions and increased morbidity and mortality.&#xD;
      The number of hospital beds is declining persistently, calling for shorter lengths of stay&#xD;
      (LOS). Increasingly complex treatments now take place outside hospital. Presently, many&#xD;
      Danish regional hospitals establish geriatric wards and other geriatric in-hospital and&#xD;
      outpatient services to overcome these challenges. The aim of the present PhD-study is to&#xD;
      investigate the effects of different models of transitional care among the frailest elderly&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Design Population: The frailest acutely admitted geriatric patients aged +75. Intervention:&#xD;
      Early follow-up visits after discharge. Comparison: Usual care follow-up. Outcomes: The&#xD;
      primary outcome is readmission within 30 days after discharge. Secondary outcomes are:&#xD;
      mortality 30 days after discharge and 90 days after admission, length of stay (LOS), direct&#xD;
      discharge from the Emergency Department, time at home before readmission, duration of&#xD;
      readmission and physical functional status 30 days after discharge.&#xD;
&#xD;
      Methods The first study is conducted as a randomized controlled trial (RCT) using two&#xD;
      different degrees of intervention. The second study is a cohort study of an unexposed control&#xD;
      group. The third study is sub-group analyses of the RCT data according to frailty status and&#xD;
      type of dwelling.&#xD;
&#xD;
      A focus group comprised of included patients and relatives will be set to identify additional&#xD;
      patient related outcome measures (PROMs) and to participate in an advisory group throughout&#xD;
      the remaining project.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">November 16, 2020</completion_date>
  <primary_completion_date type="Actual">September 16, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Readmission</measure>
    <time_frame>30 days</time_frame>
    <description>Readmission within 30 days after discharge</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>90 days after admission and 30 days after primary discharge</time_frame>
    <description>Mortality within 90 days after admission and 30 days after discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay (LOS)</measure>
    <time_frame>30 days after primary discharge</time_frame>
    <description>Length of stay during primary admission and total length of stay including following readmissions</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Physical functional status 30 days after discharge</measure>
    <time_frame>30 days after discharge</time_frame>
    <description>Functional Recovery Score ADL and Functional Recovery Score I-ADL: sum-score, range 100-0 (100 is the highest physical functional status score possible, 0 is the lowest)</description>
  </other_outcome>
  <other_outcome>
    <measure>Duration of readmission</measure>
    <time_frame>30 days after discharge</time_frame>
    <description>Duration of readmission</description>
  </other_outcome>
  <other_outcome>
    <measure>Time at home before readmission</measure>
    <time_frame>30 days after discharge</time_frame>
    <description>Time at home before readmission</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of patients discharged directly from the Emergency Department (ED)</measure>
    <time_frame>30 days after discharge</time_frame>
    <description>Patients discharged directly from the ED</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">3340</enrollment>
  <condition>Frail Elderly Syndrome</condition>
  <condition>Transitional Care</condition>
  <condition>Frailty</condition>
  <condition>Readmission</condition>
  <condition>Aging</condition>
  <condition>Elderly</condition>
  <arm_group>
    <arm_group_label>Intervention I</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention (I): early follow-up visit from the community nurse within 24 hours after discharge</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention II</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention (II): early follow-up by the geriatric team within 24 hours after discharge</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Usual care: individualized follow-up performed by the GP and municipality services</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Early follow-up visit after discharge</intervention_name>
    <description>Early follow-up visit and different degrees of specialized care after discharge</description>
    <arm_group_label>Intervention I</arm_group_label>
    <arm_group_label>Intervention II</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Comprehensive geriatric assessment (CGA)</intervention_name>
    <description>Comprehensive geriatric assessment (CGA) during admission</description>
    <arm_group_label>Intervention I</arm_group_label>
    <arm_group_label>Intervention II</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Continued geriatric care</intervention_name>
    <description>Continued specialized geriatric care after discharge</description>
    <arm_group_label>Intervention II</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Possible follow-up visit from GP</intervention_name>
    <description>Usual care: follow up visit from GP within one week after discharge</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Aged 75 years or older&#xD;
&#xD;
          -  Living within the municipality of Aarhus (except for the control group, see below)&#xD;
&#xD;
          -  MPI-score = 2 (moderate frailty) or MPI score = 3 (severe frailty)&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          -  Included in any other kind of follow-up schemes&#xD;
&#xD;
          -  Declared terminally ill or undergoing palliative care at admission&#xD;
&#xD;
          -  Admitted from one specific temporary nursing home with geriatric medical assistance&#xD;
&#xD;
          -  Discharge or transfer to another department, including hospice&#xD;
&#xD;
          -  MPI-score = 1 (low frailty)&#xD;
&#xD;
          -  Discharged to one specific temporary nursing home with geriatric medical assistance&#xD;
&#xD;
          -  The patient does not want a visit after discharge&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>75 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Else Marie S Damsgaard, Prof., DMSci</last_name>
    <role>Study Chair</role>
    <affiliation>University of Aarhus</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aarhus University</name>
      <address>
        <city>Aarhus</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>April 29, 2021</last_update_submitted>
  <last_update_submitted_qc>April 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Elderly</keyword>
  <keyword>Hospital at home</keyword>
  <keyword>Readmission</keyword>
  <keyword>Transitional care</keyword>
  <keyword>Frailty</keyword>
  <keyword>Patient Related Outcome Measures</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>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 8, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/23/NCT03796923/Prot_002.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03796923
org study id: MOCATRANFRAELRCT
nct id: NCT03796923
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In most Western countries the elderly population increases rapidly. In Denmark, the
      population of elderly aged 75 years or older may amount to nearly 15 % of the entire
      population in 2050 compared to 9 % today (2017). A large part of the elderly population is at
      high risk of hospitalization including more admissions and increased morbidity and mortality.
      The number of hospital beds is declining persistently, calling for shorter lengths of stay
      (LOS). Increasingly complex treatments now take place outside hospital. Presently, many
      Danish regional hospitals establish geriatric wards and other geriatric in-hospital and
      outpatient services to overcome these challenges. The aim of the present PhD-study is to
      investigate the effects of different models of transitional care among the frailest elderly
      patients.
Design Population: The frailest acutely admitted geriatric patients aged +75. Intervention:
      Early follow-up visits after discharge. Comparison: Usual care follow-up. Outcomes: The
      primary outcome is readmission within 30 days after discharge. Secondary outcomes are:
      mortality 30 days after discharge and 90 days after admission, length of stay (LOS), direct
      discharge from the Emergency Department, time at home before readmission, duration of
      readmission and physical functional status 30 days after discharge.

      Methods The first study is conducted as a randomized controlled trial (RCT) using two
      different degrees of intervention. The second study is a cohort study of an unexposed control
      group. The third study is sub-group analyses of the RCT data according to frailty status and
      type of dwelling.

      A focus group comprised of included patients and relatives will be set to identify additional
      patient related outcome measures (PROMs) and to participate in an advisory group throughout
      the remaining project.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Readmission
time frame: 30 days
description: Readmission within 30 days after discharge
measure: Mortality
time frame: 90 days after admission and 30 days after primary discharge
description: Mortality within 90 days after admission and 30 days after discharge
measure: Length of stay (LOS)
time frame: 30 days after primary discharge
description: Length of stay during primary admission and total length of stay including following readmissions
measure: Physical functional status 30 days after discharge
time frame: 30 days after discharge
description: Functional Recovery Score ADL and Functional Recovery Score I-ADL: sum-score, range 100-0 (100 is the highest physical functional status score possible, 0 is the lowest)
measure: Duration of readmission
time frame: 30 days after discharge
description: Duration of readmission
measure: Time at home before readmission
time frame: 30 days after discharge
description: Time at home before readmission
measure: Number of patients discharged directly from the Emergency Department (ED)
time frame: 30 days after discharge
description: Patients discharged directly from the ED
arm group label: Intervention I
arm group type: Active Comparator
description: Intervention (I): early follow-up visit from the community nurse within 24 hours after discharge
arm group label: Intervention II
arm group type: Experimental
description: Intervention (II): early follow-up by the geriatric team within 24 hours after discharge
arm group label: Control
arm group type: Other
description: Usual care: individualized follow-up performed by the GP and municipality services
intervention type: Other
intervention name: Early follow-up visit after discharge
description: Early follow-up visit and different degrees of specialized care after discharge
arm group label: Intervention I
arm group label: Intervention II
intervention type: Other
intervention name: Comprehensive geriatric assessment (CGA)
description: Comprehensive geriatric assessment (CGA) during admission
arm group label: Intervention I
arm group label: Intervention II
intervention type: Other
intervention name: Continued geriatric care
description: Continued specialized geriatric care after discharge
arm group label: Intervention II
intervention type: Other
intervention name: Possible follow-up visit from GP
description: Usual care: follow up visit from GP within one week after discharge
arm group label: Control
criteria: 
gender: All
minimum age: 75 Years
maximum age: N/A
healthy volunteers: No
last name: Else Marie S Damsgaard, Prof., DMSci
role: Study Chair
affiliation: University of Aarhus
facility: 
country: Denmark
responsible party type: Sponsor
mesh term: Frailty
sharing ipd: Undecided
provided document: 