<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/NCT02194816</url>
  </required_header>
  <id_info>
    <org_study_id>BU-13A-1332</org_study_id>
    <nct_id>NCT02194816</nct_id>
  </id_info>
  <brief_title>Modifiable Variables in Parkinsonism (MVP)</brief_title>
  <official_title>Modifiable Variables in Parkinsonism (MVP) [Formerly CAM Care in PD]</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>
      We are trying to identify factors associated with improved quality of life and fewer PD&#xD;
      symptoms. We are attempting to identify practices, beliefs, and therapies used by individuals&#xD;
      who report excellent quality of life, few PD symptoms, and reduced rates of progression.&#xD;
      After agreeing to participate, we will ask participants to fill our questionnaires about&#xD;
      their experience with PD, their health in general, along with their food intake every six&#xD;
      months for five years.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, observational study designed to describe disease progression, symptom&#xD;
      change, quality of life, diet and lifestyle habits among patients with Parkinson's disease&#xD;
      (PD). This study will identify and describe those individuals with the highest quality of&#xD;
      life and least amount of disease activity, in order to describe medication, diet, and&#xD;
      lifestyle patterns associated with a lack of PD disease progression and high quality of life.&#xD;
&#xD;
      Participants will be asked to complete online surveys every six months for five years. The&#xD;
      time requirement is about an hour to an hour and a half every six months. Participants do not&#xD;
      need to answer questions if they do not feel comfortable answering.&#xD;
&#xD;
      At each six month time point we will send participants an email with the link to the CAM Care&#xD;
      in PD survey, a questionnaire about health and wellbeing (completed in REDCap). After&#xD;
      participants have completed this survey we will send participants a link to the second&#xD;
      survey, about dietary intake (completed on ASA24.gov). Because there is a designated window&#xD;
      of time during which surveys must be completed, participants may receive a gentle reminder&#xD;
      from us if time is running out.&#xD;
&#xD;
      This study is not designed to provide care. Participants are encouraged to consult with any&#xD;
      providers you wish. Participants will not directly benefit from the study, but information&#xD;
      gathered during the course of this study may help us begin to assess the longer-term effects&#xD;
      of complementary and integrative care on health, disease progression and quality of life in&#xD;
      PD patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">December 2030</completion_date>
  <primary_completion_date type="Anticipated">December 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>CAM Care for PD 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 PD. Results will be reported with descriptive statistics.</description>
  </primary_outcome>
  <primary_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 the cohort.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient-Reported Outcomes in PD (PRO-PD)</measure>
    <time_frame>5 years</time_frame>
    <description>This outcome measure is a series of 33 slider bars, developed for this study, to evaluate the individual's perception of symptom severity. The cumulative score for all 33 listed symptoms will be reported as the PRO-PD score.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Qualitative</measure>
    <time_frame>5 years</time_frame>
    <description>Participants will be given 'free space' to provide additional information they consider relevant.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>Parkinson's Disease</condition>
  <condition>Parkinsonism</condition>
  <condition>MSA - Multiple System Atrophy</condition>
  <condition>Progressive Supranuclear Palsy</condition>
  <condition>Shy-Drager Syndrome</condition>
  <condition>Corticobasal Degeneration</condition>
  <condition>Dementia With Lewy Bodies</condition>
  <condition>Pick Disease</condition>
  <condition>Olivopontocerebellar Atrophies</condition>
  <arm_group>
    <arm_group_label>Parkinson's Disease Patients</arm_group_label>
    <description>Any individuals who has a diagnosis of Parkinson's disease (PD), parkinsonism, or a parkinson's plus syndrome will be allowed to participate.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Any individual with PD is invited to participate.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parkinson's disease (PD)&#xD;
&#xD;
          -  Parkinsonism&#xD;
&#xD;
          -  Parkinson-plus syndromes (e.g. Multiple System Atrophy (MSA), Progressive Supranuclear&#xD;
             Palsy (PSP), Corticobasal degeneration (CBGD), Dementia with Lewy bodies)&#xD;
&#xD;
          -  Must have online access, an email address, basic computer literacy&#xD;
&#xD;
          -  Must be willing to complete online surveys every 6 months for 5 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to read/write English&#xD;
&#xD;
          -  Inability or unwillingness to complete surveys every six (6) months (~90 min)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</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>
    <phone>425-602-3306</phone>
    <email>neuroresearch@bastyr.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Bastyr University</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>
  <reference>
    <citation>Tomlinson CL, Stowe R, Patel S, Rick C, Gray R, Clarke CE. Systematic review of levodopa dose equivalency reporting in Parkinson's disease. Mov Disord. 2010 Nov 15;25(15):2649-53. doi: 10.1002/mds.23429.</citation>
    <PMID>21069833</PMID>
  </reference>
  <reference>
    <citation>Meissner WG, Frasier M, Gasser T, Goetz CG, Lozano A, Piccini P, Obeso JA, Rascol O, Schapira A, Voon V, Weiner DM, Tison F, Bezard E. Priorities in Parkinson's disease research. Nat Rev Drug Discov. 2011 May;10(5):377-93. doi: 10.1038/nrd3430.</citation>
    <PMID>21532567</PMID>
  </reference>
  <reference>
    <citation>Positive Deviance Initiative. 2010 [cited 2012 30 Dec 2012]; Available from: http://www.positivedeviance.org/about_pd/index.html</citation>
  </reference>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>July 17, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <last_update_submitted>March 10, 2022</last_update_submitted>
  <last_update_submitted_qc>March 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 25, 2022</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>Assistant Research Scientist</investigator_title>
  </responsible_party>
  <keyword>Parkinson's Disease</keyword>
  <keyword>PD</keyword>
  <keyword>Complementary and Alternative</keyword>
  <keyword>CAM</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
    <mesh_term>Multiple System Atrophy</mesh_term>
    <mesh_term>Shy-Drager Syndrome</mesh_term>
    <mesh_term>Parkinsonian Disorders</mesh_term>
    <mesh_term>Supranuclear Palsy, Progressive</mesh_term>
    <mesh_term>Lewy Body Disease</mesh_term>
    <mesh_term>Pick Disease of the Brain</mesh_term>
    <mesh_term>Corticobasal Degeneration</mesh_term>
    <mesh_term>Olivopontocerebellar Atrophies</mesh_term>
    <mesh_term>Atrophy</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/NCT02194816
org study id: BU-13A-1332
nct id: NCT02194816
lead sponsor: 
has dmc: No
We are trying to identify factors associated with improved quality of life and fewer PD
      symptoms. We are attempting to identify practices, beliefs, and therapies used by individuals
      who report excellent quality of life, few PD symptoms, and reduced rates of progression.
      After agreeing to participate, we will ask participants to fill our questionnaires about
      their experience with PD, their health in general, along with their food intake every six
      months for five years.
This is a prospective, observational study designed to describe disease progression, symptom
      change, quality of life, diet and lifestyle habits among patients with Parkinson's disease
      (PD). This study will identify and describe those individuals with the highest quality of
      life and least amount of disease activity, in order to describe medication, diet, and
      lifestyle patterns associated with a lack of PD disease progression and high quality of life.

      Participants will be asked to complete online surveys every six months for five years. The
      time requirement is about an hour to an hour and a half every six months. Participants do not
      need to answer questions if they do not feel comfortable answering.

      At each six month time point we will send participants an email with the link to the CAM Care
      in PD survey, a questionnaire about health and wellbeing (completed in REDCap). After
      participants have completed this survey we will send participants a link to the second
      survey, about dietary intake (completed on ASA24.gov). Because there is a designated window
      of time during which surveys must be completed, participants may receive a gentle reminder
      from us if time is running out.

      This study is not designed to provide care. Participants are encouraged to consult with any
      providers you wish. Participants will not directly benefit from the study, but information
      gathered during the course of this study may help us begin to assess the longer-term effects
      of complementary and integrative care on health, disease progression and quality of life in
      PD patients.
observational model: Cohort
time perspective: Prospective
measure: CAM Care for PD survey
time frame: 5 years
description: This survey has been developed to identify the complementary and alternative therapies most commonly used by individuals with PD. Results will be reported with descriptive statistics.
measure: PROMIS: Global Health
time frame: 5 years
description: This outcome measure will be used to assess general health and well-being in the cohort.
measure: Patient-Reported Outcomes in PD (PRO-PD)
time frame: 5 years
description: This outcome measure is a series of 33 slider bars, developed for this study, to evaluate the individual's perception of symptom severity. The cumulative score for all 33 listed symptoms will be reported as the PRO-PD score.
measure: Qualitative
time frame: 5 years
description: Participants will be given 'free space' to provide additional information they consider relevant.
arm group label: Parkinson's Disease Patients
description: Any individuals who has a diagnosis of Parkinson's disease (PD), parkinsonism, or a parkinson's plus syndrome will be allowed to participate.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Laurie K Mischley, ND, PhD, MPH
role: Principal Investigator
affiliation: Bastyr University
last name: Research Assistant
phone: 425-602-3306
email: neuroresearch@bastyr.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
citation: Tomlinson CL, Stowe R, Patel S, Rick C, Gray R, Clarke CE. Systematic review of levodopa dose equivalency reporting in Parkinson's disease. Mov Disord. 2010 Nov 15;25(15):2649-53. doi: 10.1002/mds.23429.
PMID: 21069833
citation: Meissner WG, Frasier M, Gasser T, Goetz CG, Lozano A, Piccini P, Obeso JA, Rascol O, Schapira A, Voon V, Weiner DM, Tison F, Bezard E. Priorities in Parkinson's disease research. Nat Rev Drug Discov. 2011 May;10(5):377-93. doi: 10.1038/nrd3430.
PMID: 21532567
citation: Positive Deviance Initiative. 2010 [cited 2012 30 Dec 2012]; Available from: http://www.positivedeviance.org/about_pd/index.html
responsible party type: Principal Investigator
investigator affiliation: Bastyr University
investigator full name: Laurie Mischley
investigator title: Assistant Research Scientist
mesh term: Parkinson Disease
mesh term: Multiple System Atrophy
mesh term: Shy-Drager Syndrome
mesh term: Parkinsonian Disorders
mesh term: Supranuclear Palsy, Progressive
mesh term: Lewy Body Disease
mesh term: Pick Disease of the Brain
mesh term: Corticobasal Degeneration
mesh term: Olivopontocerebellar Atrophies
mesh term: Atrophy