<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/NCT01703429</url>
  </required_header>
  <id_info>
    <org_study_id>BU-11A-1296</org_study_id>
    <nct_id>NCT01703429</nct_id>
  </id_info>
  <brief_title>Complementary and Alternative Care in Multiple Sclerosis</brief_title>
  <acronym>CAM Care in MS</acronym>
  <official_title>Complementary and Alternative Medicine (CAM) in Multiple Sclerosis. A Prospective Observational Study of a CAM-using Cohort</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bastyr University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bastyr University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, observational study designed to describe disease progression, symptom&#xD;
      change, quality of life, diet and lifestyle habits, and frequency of adverse events among&#xD;
      patients with multiple sclerosis (MS) who use complementary and alternative medicine (CAM).&#xD;
      In addition to describing the patterns of CAM use, this study will also identify and describe&#xD;
      the positive deviants, those individuals with the highest quality of life and least amount of&#xD;
      disease activity. Positive deviants will be compared to controls in order to describe&#xD;
      medication, diet, and lifestyle patterns associated with a lack of MS disease progression and&#xD;
      high quality of life.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Anticipated">June 2030</completion_date>
  <primary_completion_date type="Anticipated">June 2030</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>&quot;CAM Therapies&quot; survey</measure>
    <time_frame>5 years</time_frame>
    <description>This survey has been developed to identify the complementary and alternative therapies most commonly used by individuals with MS. Results will be reported with descriptive statistics.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Modified Expanded Disability Severity Score (EDSS)</measure>
    <time_frame>5 years</time_frame>
    <description>The EDSS will be used to capture disease severity and rates of progression in this cohort.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>PROMIS: Global Health</measure>
    <time_frame>5 years</time_frame>
    <description>This outcome measure will be used to assess general health and well-being in this CAM using cohort.</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Multiple Sclerosis</condition>
  <arm_group>
    <arm_group_label>Individuals with MS</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Any individual with multiple sclerosis is invited to participate.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of multiple sclerosis (including relapsing remitting MS, secondary&#xD;
             progressive MS, primary progressive MS, clinically isolated syndromes (CIS),&#xD;
             radiologically-isolated syndromes (RIS), possible MS, or probable MS.&#xD;
&#xD;
          -  Age 18-100&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to read/write in English&#xD;
&#xD;
          -  Inability or unwillingness to complete surveys every six (6) months. (~ 90 min)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Laurie K Mischley, ND, PhD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bastyr University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Research Assistant</last_name>
    <email>neuroresearch@bastyr.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Bastyr University Clinical Research Center</name>
      <address>
        <city>Kenmore</city>
        <state>Washington</state>
        <zip>98028</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Laurie K Mischley, ND, PhD, MPH</last_name>
      <phone>425-602-3306</phone>
      <email>neuroresearch@bastyr.edu</email>
    </contact>
    <investigator>
      <last_name>Laurie K Mischley, ND, PhD, MPH</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>October 3, 2012</study_first_submitted>
  <study_first_submitted_qc>October 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2012</study_first_posted>
  <last_update_submitted>February 7, 2020</last_update_submitted>
  <last_update_submitted_qc>February 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Bastyr University</investigator_affiliation>
    <investigator_full_name>Laurie Mischley</investigator_full_name>
    <investigator_title>Clinical Research Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Multiple Sclerosis</keyword>
  <keyword>MS</keyword>
  <keyword>Complementary and Alternative</keyword>
  <keyword>CAM</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Sclerosis</mesh_term>
  </condition_browse>
  <!-- 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/NCT01703429
org study id: BU-11A-1296
nct id: NCT01703429
lead sponsor: 
has dmc: No
This is a prospective, observational study designed to describe disease progression, symptom
      change, quality of life, diet and lifestyle habits, and frequency of adverse events among
      patients with multiple sclerosis (MS) who use complementary and alternative medicine (CAM).
      In addition to describing the patterns of CAM use, this study will also identify and describe
      the positive deviants, those individuals with the highest quality of life and least amount of
      disease activity. Positive deviants will be compared to controls in order to describe
      medication, diet, and lifestyle patterns associated with a lack of MS disease progression and
      high quality of life.
observational model: Cohort
time perspective: Prospective
measure: "CAM Therapies" survey
time frame: 5 years
description: This survey has been developed to identify the complementary and alternative therapies most commonly used by individuals with MS. Results will be reported with descriptive statistics.
measure: Modified Expanded Disability Severity Score (EDSS)
time frame: 5 years
description: The EDSS will be used to capture disease severity and rates of progression in this cohort.
measure: PROMIS: Global Health
time frame: 5 years
description: This outcome measure will be used to assess general health and well-being in this CAM using cohort.
arm group label: Individuals with MS
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Laurie K Mischley, ND, PhD, MPH
role: Principal Investigator
affiliation: Bastyr University
last name: Research Assistant
email: neuroresearch@bastyr.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Bastyr University
investigator full name: Laurie Mischley
investigator title: Clinical Research Assistant Professor
mesh term: Multiple Sclerosis
mesh term: Sclerosis