<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/NCT03032341</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00040417</org_study_id>
    <nct_id>NCT03032341</nct_id>
  </id_info>
  <brief_title>Mobility Assessment Using Surrogates in Elderly Participants</brief_title>
  <acronym>MAT</acronym>
  <official_title>Mobility Assessment Using Surrogates in Elderly Participants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wake Forest University Health Sciences</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 purpose of this research study is to find out if mobility (the ability to move around)&#xD;
      can be reliably assessed by having the family or care giver caregiver take a video based test&#xD;
      for the patient. If this study shows that mobility can be assessed by family or caregiver,&#xD;
      this information can be used in situations where mobility cannot be measured directly in&#xD;
      patients. A total of 60 patients and 60 family/caregivers at Wake Forest Baptist Medical&#xD;
      Center will take part in this study. Patients physical function will be assessed using a test&#xD;
      that uses short movie clips to assess mobility. Patients will be asked to watch ten short&#xD;
      (~10 seconds each) movie clips that describe various tasks such as climbing up hills or&#xD;
      walking and estimate if they can perform the tasks. The familymember/caregiver will be also&#xD;
      asked to answer the questions on behalf of the patient. The family member/caregiver will be&#xD;
      asked to return to take the same test in the next 1-14 days. The patient will be in the study&#xD;
      for one day. There is no intervention, this is observational.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      According to the U.S. Census Bureau projections, the number of persons 65 years of age or&#xD;
      older will increase from roughly 40 million in the year 2010, to 88.5 million in 2050, a net&#xD;
      increase of 121%. During this same time period, the number of persons 85 years of age or&#xD;
      older will increase by 227%; accounting for nearly 5% of the U.S. population. Mobility and&#xD;
      functional status are important predictors of outcomes in this rapidly growing elderly&#xD;
      population. It has shown that walking speed and physical function, measured by Short Physical&#xD;
      Performance Battery (SPPB) are predictors of mortality in community-dwelling older men and&#xD;
      women. It was also reported that gait speed predicts incident disability in community&#xD;
      dwelling elderly subjects. In our prior study, we have demonstrated that, mobility, assessed&#xD;
      using an animated video clip based assessment tool, Mobility Assessment Tool-short form&#xD;
      (MAT-sf) predicts postoperative complications, length of stay and nursing home placement in&#xD;
      elderly patients (&gt;69) who were undergoing elective surgery that requires overnight&#xD;
      hospitalization and more clinical practices use physical function and mobility as a tool to&#xD;
      predict outcomes.&#xD;
&#xD;
      However, these assessments are not always readily available, especially in clinical&#xD;
      situations when acute illnesses or injuries occurred without any chance to assess the&#xD;
      baseline status, such as acute myocardial infract, rapidly progressing sepsis or catastrophic&#xD;
      trauma. In these cases, patients are often sedated, intubated, have altered mental status, or&#xD;
      too unstable to perform even non-invasive testing. Although some clinicians or researchers&#xD;
      feel that surrogate can accurately assess the patients' baseline physical function and&#xD;
      mobility status, it was never been tested.&#xD;
&#xD;
      The investigators hypothesize that mobility assessment done on surrogates, using MAT-sf will&#xD;
      have high compatibility with the assessment done on elderly patients. Surrogates are defined&#xD;
      as a person who spends &gt;2 hours a day or 8 hours a week with the patient and accompany the&#xD;
      patient to most of their medical appointments. The investigators will test the hypothesis at&#xD;
      the Preoperative Assessment Clinic since this clinic sees high volume of elderly patients and&#xD;
      patients at this clinic tend to have their caregiver with them during the appointments.&#xD;
&#xD;
      Investigators will enroll 20 patients in poor mobility group (MAT-sf &lt; 51.38 in men and&#xD;
      &lt;45.61 in women), 20 patients into the mid-mobility group (51.38&lt; MAT-sf≤65.5 in men and&#xD;
      45.61≤MAT-sf&lt;54.02) and 20 patients into the high mobility group (MAT-sf&gt;65.5 in men and&#xD;
      MAT-sf&gt;54.02 in women) for a total of 60 patients and one surrogate per patient for a total&#xD;
      of 120 unique participants.&#xD;
&#xD;
      To assess mobility, participants will be instructed on the use of the Mobility Assessment&#xD;
      Tool-short form (MAT-sf). The MAT-sf is a 10-item computer based assessment of mobility using&#xD;
      animated video clips. The 10 items in the MAT-sf cover a broad range of functioning. The&#xD;
      items include walking on level ground, a slow jog, walking outdoors on uneven terrain,&#xD;
      walking up a ramp with and without using a handrail, stepping over hurdles, ascending and&#xD;
      descending stairs with and without the use of a handrail, and climbing stairs while carrying&#xD;
      bags. The items were previously selected based on individual response and information curves&#xD;
      derived from Item Response Theory. Each item is accompanied by an animated video clip&#xD;
      together with the responses for that question (number of minutes, number of times, yes/no).&#xD;
      The test will be performed on an I-PAD and scores will be saved to an exportable file. The&#xD;
      time required to do the test with instructions from the examiner is expected to be no longer&#xD;
      than 5 minutes. While the patient is completing the MAT-sf assessment, the surrogate will be&#xD;
      directed to a separate room to complete MAT-sf for the patient (&quot;Do you think Mr ** can climb&#xD;
      up this hill?) , so there is no interaction between the patient and the surrogate during the&#xD;
      assessment. Investigators will measure the compatibility between patients-surrogates mobility&#xD;
      using MAT-sf and will also assess the stability of surrogate MAT-sf.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 17, 2017</start_date>
  <completion_date type="Actual">April 6, 2017</completion_date>
  <primary_completion_date type="Actual">April 6, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in MAT-sf score between patients and surrogates</measure>
    <time_frame>1-14 days</time_frame>
    <description>Investigators will measure the compatibility between patients-surrogates mobility using MAT-sf.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">130</enrollment>
  <condition>Mobility Limitation</condition>
  <arm_group>
    <arm_group_label>Patient group</arm_group_label>
    <description>20 patient in poor mobility group (MAT-sf &lt; 51.38 in men and &lt;45.61 in women), mid-mobility group (51.38&lt; MAT-sf≤65.5 in men and 45.61≤MAT-sf&lt;54.02) and high mobility group (MAT-sf&gt;65.5 in men and MAT-sf&gt;54.02 in women) for a total of 60 patients.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Surrogate group</arm_group_label>
    <description>A family member/caregiver that attends visits with the patient and will be asked to answer the Mobility Assessment Test questionnaire on behalf of the patient at the initial visit and the follow up visit 1-14 days later.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        60 patients being seen in the post operative assessment clinic will be asked to complete&#xD;
        the Mobility Assessment Tool. A family member/caregiver of each patient will be asked to&#xD;
        complete the test on the behalf of the patient at the same visit and asked to complete&#xD;
        again 1-14 days later.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged 70 years and older being seen at the PAC;&#xD;
&#xD;
          -  Patients who have caregiver or family who meet the criteria for surrogate as above;&#xD;
&#xD;
          -  Patients scheduled for elective surgical procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have a language barrier which will prohibit them from understanding the&#xD;
             questionnaire and directions connected to the use of the MAT-sf;&#xD;
&#xD;
          -  Patients who are not able to sign their own surgical consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sunghye Kim, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wake Forest University Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wake Forest University Health Sciences</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>January 18, 2017</study_first_submitted>
  <study_first_submitted_qc>January 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>December 1, 2017</last_update_submitted>
  <last_update_submitted_qc>December 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wake Forest University Health Sciences</investigator_affiliation>
    <investigator_full_name>Sunghye Kim</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>mobility assessment tool</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mobility Limitation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03032341
org study id: IRB00040417
nct id: NCT03032341
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this research study is to find out if mobility (the ability to move around)
      can be reliably assessed by having the family or care giver caregiver take a video based test
      for the patient. If this study shows that mobility can be assessed by family or caregiver,
      this information can be used in situations where mobility cannot be measured directly in
      patients. A total of 60 patients and 60 family/caregivers at Wake Forest Baptist Medical
      Center will take part in this study. Patients physical function will be assessed using a test
      that uses short movie clips to assess mobility. Patients will be asked to watch ten short
      (~10 seconds each) movie clips that describe various tasks such as climbing up hills or
      walking and estimate if they can perform the tasks. The familymember/caregiver will be also
      asked to answer the questions on behalf of the patient. The family member/caregiver will be
      asked to return to take the same test in the next 1-14 days. The patient will be in the study
      for one day. There is no intervention, this is observational.
According to the U.S. Census Bureau projections, the number of persons 65 years of age or
      older will increase from roughly 40 million in the year 2010, to 88.5 million in 2050, a net
      increase of 121%. During this same time period, the number of persons 85 years of age or
      older will increase by 227%; accounting for nearly 5% of the U.S. population. Mobility and
      functional status are important predictors of outcomes in this rapidly growing elderly
      population. It has shown that walking speed and physical function, measured by Short Physical
      Performance Battery (SPPB) are predictors of mortality in community-dwelling older men and
      women. It was also reported that gait speed predicts incident disability in community
      dwelling elderly subjects. In our prior study, we have demonstrated that, mobility, assessed
      using an animated video clip based assessment tool, Mobility Assessment Tool-short form
      (MAT-sf) predicts postoperative complications, length of stay and nursing home placement in
      elderly patients (>69) who were undergoing elective surgery that requires overnight
      hospitalization and more clinical practices use physical function and mobility as a tool to
      predict outcomes.

      However, these assessments are not always readily available, especially in clinical
      situations when acute illnesses or injuries occurred without any chance to assess the
      baseline status, such as acute myocardial infract, rapidly progressing sepsis or catastrophic
      trauma. In these cases, patients are often sedated, intubated, have altered mental status, or
      too unstable to perform even non-invasive testing. Although some clinicians or researchers
      feel that surrogate can accurately assess the patients' baseline physical function and
      mobility status, it was never been tested.

      The investigators hypothesize that mobility assessment done on surrogates, using MAT-sf will
      have high compatibility with the assessment done on elderly patients. Surrogates are defined
      as a person who spends >2 hours a day or 8 hours a week with the patient and accompany the
      patient to most of their medical appointments. The investigators will test the hypothesis at
      the Preoperative Assessment Clinic since this clinic sees high volume of elderly patients and
      patients at this clinic tend to have their caregiver with them during the appointments.

      Investigators will enroll 20 patients in poor mobility group (MAT-sf < 51.38 in men and
      <45.61 in women), 20 patients into the mid-mobility group (51.38< MAT-sf≤65.5 in men and
      45.61≤MAT-sf<54.02) and 20 patients into the high mobility group (MAT-sf>65.5 in men and
      MAT-sf>54.02 in women) for a total of 60 patients and one surrogate per patient for a total
      of 120 unique participants.

      To assess mobility, participants will be instructed on the use of the Mobility Assessment
      Tool-short form (MAT-sf). The MAT-sf is a 10-item computer based assessment of mobility using
      animated video clips. The 10 items in the MAT-sf cover a broad range of functioning. The
      items include walking on level ground, a slow jog, walking outdoors on uneven terrain,
      walking up a ramp with and without using a handrail, stepping over hurdles, ascending and
      descending stairs with and without the use of a handrail, and climbing stairs while carrying
      bags. The items were previously selected based on individual response and information curves
      derived from Item Response Theory. Each item is accompanied by an animated video clip
      together with the responses for that question (number of minutes, number of times, yes/no).
      The test will be performed on an I-PAD and scores will be saved to an exportable file. The
      time required to do the test with instructions from the examiner is expected to be no longer
      than 5 minutes. While the patient is completing the MAT-sf assessment, the surrogate will be
      directed to a separate room to complete MAT-sf for the patient ("Do you think Mr ** can climb
      up this hill?) , so there is no interaction between the patient and the surrogate during the
      assessment. Investigators will measure the compatibility between patients-surrogates mobility
      using MAT-sf and will also assess the stability of surrogate MAT-sf.
observational model: Case-Control
time perspective: Prospective
measure: Change in MAT-sf score between patients and surrogates
time frame: 1-14 days
description: Investigators will measure the compatibility between patients-surrogates mobility using MAT-sf.
arm group label: Patient group
description: 20 patient in poor mobility group (MAT-sf < 51.38 in men and <45.61 in women), mid-mobility group (51.38< MAT-sf≤65.5 in men and 45.61≤MAT-sf<54.02) and high mobility group (MAT-sf>65.5 in men and MAT-sf>54.02 in women) for a total of 60 patients.
arm group label: Surrogate group
description: A family member/caregiver that attends visits with the patient and will be asked to answer the Mobility Assessment Test questionnaire on behalf of the patient at the initial visit and the follow up visit 1-14 days later.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 70 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Sunghye Kim, MD
role: Principal Investigator
affiliation: Wake Forest University Health Sciences
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Wake Forest University Health Sciences
investigator full name: Sunghye Kim
investigator title: Assistant Professor
mesh term: Mobility Limitation
sharing ipd: No