<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/NCT03811808</url>
  </required_header>
  <id_info>
    <org_study_id>STU 082015-008</org_study_id>
    <nct_id>NCT03811808</nct_id>
  </id_info>
  <brief_title>Multiple System Atrophy Multidisciplinary Clinic</brief_title>
  <official_title>Multiple System Atrophy Multidisciplinary Clinic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas Southwestern Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Texas Southwestern Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective cohort study to examine the disease burden of multiple system atrophy&#xD;
      and the impact of multidisciplinary care on quality of life and caregiver burden. Data will&#xD;
      be collected through valid rating scales completed by patients and caregivers at home or in&#xD;
      the MSA clinic.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Procedures:&#xD;
&#xD;
      Participants and caregivers will attend a multidisciplinary MSA clinic one day every four&#xD;
      months. In addition to the standard of care, they will be asked to complete both online and&#xD;
      paper questionnaires, including the following:&#xD;
&#xD;
        -  UMSARS (Unified MSA Rating Scale)&#xD;
&#xD;
        -  MSA QOL&#xD;
&#xD;
        -  CES-D&#xD;
&#xD;
        -  OHQ&#xD;
&#xD;
        -  Compass-31&#xD;
&#xD;
        -  BIC&#xD;
&#xD;
        -  UPDRS&#xD;
&#xD;
        -  SARA&#xD;
&#xD;
        -  MDS Scale&#xD;
&#xD;
        -  CGI&#xD;
&#xD;
        -  MoCA&#xD;
&#xD;
      Participants will be part of the study as long as they are a patient of the MSA clinic, and&#xD;
      will be contacted for follow-up information up to five years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>March 2016</start_date>
  <completion_date type="Anticipated">March 2026</completion_date>
  <primary_completion_date type="Anticipated">March 2026</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Multiple System Atrophy-Quality of Life (MSA-QoL)</measure>
    <time_frame>at 5 year evaluation</time_frame>
    <description>The disease burden of MSA and impact of multidisciplinary care on the quality of life of patients as measured by the MSA-Quality of Life (QOL) questionnaire completed every four months by the patients. The scale measures how MSA affects a person's quality of life in day to day activities. The scale ranges from No problem to Extreme Problem. The More Extreme Problem sections selected the more their quality of life is affected by the disease.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Unified Multiple System Atrophy Rating Scale (UMSARS)</measure>
    <time_frame>at 5 year evaluation</time_frame>
    <description>The UMSARS completed every four months by the physician. The scale measures how MSA has progressed from baseline. The higher the score the higher the progression is.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caregiver Burden Index/ The Zarit Burden Interview</measure>
    <time_frame>at 5 year evaluation</time_frame>
    <description>The disease burden of MSA and impact of multidisciplinary care on caregiver burden as measured by the Burden Index of Caregivers (BIC) questionnaire and The Zarit Burden Interview completed every four months by the caregivers. The higher the higher the score the more burden the caregiver has.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Composite Autonomic Symptom Score (CONPASS 31)</measure>
    <time_frame>at 5 year evaluation</time_frame>
    <description>Compass 31 scale includes 31 questions and it will be used to assess autonomic symptoms that provides clinically relevant scores of autonomic symptom severity based. The higher the score the more autonomic symptoms present</description>
  </other_outcome>
  <other_outcome>
    <measure>Center for Epidemiologic Studies Depression Scale (CES-D)</measure>
    <time_frame>at 5 year evaluation</time_frame>
    <description>The CES-D measures symptoms defined by the American Psychiatric Association' Diagnostic and Statistical Manual (DSM-V) for a major depressive episode. The higher the scores and indicative for depression present.</description>
  </other_outcome>
  <other_outcome>
    <measure>The Orthostatic Hypotension Questionnaire (OHQ)</measure>
    <time_frame>at 5 year evaluation</time_frame>
    <description>The OHQ is used to assess the comprehensive symptom burden and severity of neurogenic orthostatic hypotension (NOH).</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Multiple System Atrophy (MSA)</condition>
  <arm_group>
    <arm_group_label>MSA patients</arm_group_label>
    <description>patients diagnosed with possible or probable multiple system atrophy</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Adults 18 years or older with diagnosis of possible or probable MSA&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject must be a patient in the UT Southwestern MSA clinic and be able to attend the&#xD;
             multidisciplinary clinic every 4 months&#xD;
&#xD;
          -  Patients with possible or probable MSA based on established criteria&#xD;
&#xD;
          -  Subjects must be 18 years or older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients that are unable to give consent&#xD;
&#xD;
          -  Minor patients (younger than age 18)&#xD;
&#xD;
          -  Non-English speaking patients&#xD;
&#xD;
          -  Subjects that are diagnosed with dementia&#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>Steven Vernino, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>UT Southwestern Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Amy Conger</last_name>
    <phone>214-648-0214</phone>
    <email>Amy.Conger@UTSouthwestern.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Steve Hopkins, CCRC</last_name>
    <phone>214-648-9275</phone>
    <email>Steve.Hopkins@UTSouthwestern.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>UT Southwestern Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Amy Conger</last_name>
      <phone>214-648-0214</phone>
      <email>Amy.Conger@UTSouthwestern.edu</email>
    </contact>
    <contact_backup>
      <last_name>Steve Hopkins, CCRP</last_name>
      <phone>214-648-9275</phone>
      <email>Steve.Hopkins@UTSouthwestern.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Steven Vernino, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>December 5, 2017</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>April 24, 2023</last_update_submitted>
  <last_update_submitted_qc>April 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Texas Southwestern Medical Center</investigator_affiliation>
    <investigator_full_name>Steven Vernino</investigator_full_name>
    <investigator_title>PROFESSOR</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple System Atrophy</mesh_term>
    <mesh_term>Shy-Drager Syndrome</mesh_term>
    <mesh_term>Atrophy</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/NCT03811808
org study id: STU 082015-008
nct id: NCT03811808
lead sponsor: 
has dmc: No
This is a prospective cohort study to examine the disease burden of multiple system atrophy
      and the impact of multidisciplinary care on quality of life and caregiver burden. Data will
      be collected through valid rating scales completed by patients and caregivers at home or in
      the MSA clinic.
Study Procedures:

      Participants and caregivers will attend a multidisciplinary MSA clinic one day every four
      months. In addition to the standard of care, they will be asked to complete both online and
      paper questionnaires, including the following:

        -  UMSARS (Unified MSA Rating Scale)

        -  MSA QOL

        -  CES-D

        -  OHQ

        -  Compass-31

        -  BIC

        -  UPDRS

        -  SARA

        -  MDS Scale

        -  CGI

        -  MoCA

      Participants will be part of the study as long as they are a patient of the MSA clinic, and
      will be contacted for follow-up information up to five years.
observational model: Cohort
time perspective: Prospective
measure: Multiple System Atrophy-Quality of Life (MSA-QoL)
time frame: at 5 year evaluation
description: The disease burden of MSA and impact of multidisciplinary care on the quality of life of patients as measured by the MSA-Quality of Life (QOL) questionnaire completed every four months by the patients. The scale measures how MSA affects a person's quality of life in day to day activities. The scale ranges from No problem to Extreme Problem. The More Extreme Problem sections selected the more their quality of life is affected by the disease.
measure: Unified Multiple System Atrophy Rating Scale (UMSARS)
time frame: at 5 year evaluation
description: The UMSARS completed every four months by the physician. The scale measures how MSA has progressed from baseline. The higher the score the higher the progression is.
measure: Caregiver Burden Index/ The Zarit Burden Interview
time frame: at 5 year evaluation
description: The disease burden of MSA and impact of multidisciplinary care on caregiver burden as measured by the Burden Index of Caregivers (BIC) questionnaire and The Zarit Burden Interview completed every four months by the caregivers. The higher the higher the score the more burden the caregiver has.
measure: Composite Autonomic Symptom Score (CONPASS 31)
time frame: at 5 year evaluation
description: Compass 31 scale includes 31 questions and it will be used to assess autonomic symptoms that provides clinically relevant scores of autonomic symptom severity based. The higher the score the more autonomic symptoms present
measure: Center for Epidemiologic Studies Depression Scale (CES-D)
time frame: at 5 year evaluation
description: The CES-D measures symptoms defined by the American Psychiatric Association' Diagnostic and Statistical Manual (DSM-V) for a major depressive episode. The higher the scores and indicative for depression present.
measure: The Orthostatic Hypotension Questionnaire (OHQ)
time frame: at 5 year evaluation
description: The OHQ is used to assess the comprehensive symptom burden and severity of neurogenic orthostatic hypotension (NOH).
arm group label: MSA patients
description: patients diagnosed with possible or probable multiple system atrophy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Steven Vernino, M.D.
role: Principal Investigator
affiliation: UT Southwestern Medical Center
last name: Amy Conger
phone: 214-648-0214
email: Amy.Conger@UTSouthwestern.edu
last name: Steve Hopkins, CCRC
phone: 214-648-9275
email: Steve.Hopkins@UTSouthwestern.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Texas Southwestern Medical Center
investigator full name: Steven Vernino
investigator title: PROFESSOR
mesh term: Multiple System Atrophy
mesh term: Shy-Drager Syndrome
mesh term: Atrophy
sharing ipd: No