<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/NCT04500106</url>
  </required_header>
  <id_info>
    <org_study_id>P20-184</org_study_id>
    <nct_id>NCT04500106</nct_id>
  </id_info>
  <brief_title>Study to Assess Participant/Caregiver/Investigator Satisfaction of Video-Assisted Telenursing in Adult Participants With Parkinson's Disease Treated With Levodopa-Carbidopa Intestinal Gel</brief_title>
  <acronym>FACILITATECARE</acronym>
  <official_title>An Observational Study to Investigate the Feasibility and Patient/Caregiver/Investigator Satisfaction of Video-assisted Telenursing Use in Nurse Support Programs With LCIG</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AbbVie</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AbbVie</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Parkinson's disease (PD) is a neurological condition, which affects the brain. PD gets worse&#xD;
      over time, but how quickly it progresses varies a lot from person to person. Some symptoms of&#xD;
      PD are tremors, stiffness, and slowness of movement. The purpose of this study is to see how&#xD;
      feasible and how satisfied participants/caregivers/investigators are with video-assisted&#xD;
      telenursing use in nurse support programs with LCIG.&#xD;
&#xD;
      LCIG is an approved drug to treat PD. Approximately 50 adult participants with advanced PD&#xD;
      will be enrolled in the study at approximately 10 sites across the world.&#xD;
&#xD;
      The study has 2 groups. In one group, around 25 participants will receive nurse support using&#xD;
      video devices. In the second group, around 25 participants will receive nurse support without&#xD;
      using video devices. All participants will attend a baseline visit and follow up visits at&#xD;
      Week 4 and Week 12. The planned observation period will be 12 weeks.&#xD;
&#xD;
      Participants who are prescribed LCIG by their physicians will have three study related&#xD;
      visits. Participants, caregivers, and investigators will be asked to complete questionnaires&#xD;
      for the study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 22, 2021</start_date>
  <completion_date type="Actual">October 14, 2021</completion_date>
  <primary_completion_date type="Actual">October 14, 2021</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>Participant Acceptance of the AbbVie Duodopa Specialist (ADS) Nurse Support and Communication Access</measure>
    <time_frame>At Week 12</time_frame>
    <description>Participant acceptance is measured by the participant satisfaction with the AbbVie Duodopa Specialist (ADS) nurse support and communication access (Visual Analog Sore from 1 to 10).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Participant Satisfaction With ADS Nurse Support and Communication Access</measure>
    <time_frame>Through Week 12</time_frame>
    <description>Participant Satisfaction is defined as participant satisfaction with the ADS nurse support and communication access at Week 4 (Visual Analog Scale [VAS] scoring from 1 to 10) and at Week 12 (VAS scoring from 8 to 10).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participant Satisfaction with the ADS Nurse Support and Communication Access</measure>
    <time_frame>At Week 12</time_frame>
    <description>Participant satisfaction with the ADS nurse support and communication access is based on scoring 8 to 10 on a VAS (Binary: Yes/No).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caregiver Satisfaction With ADS Nurse Support and Communication Access</measure>
    <time_frame>Baseline (Week 0) to Week 12</time_frame>
    <description>Caregiver satisfaction is measured as the satisfaction of caregiver with the ADS nurse support and communication access at weeks 4 and 12 (VAS from 1 to 10).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caregiver Acceptance of ADS Nurse Support and Communication Access</measure>
    <time_frame>Through Week 12</time_frame>
    <description>Caregiver acceptance is measured as the acceptance of caregiver with the ADS nurse support and communication access at weeks 4 and 12 (VAS from 1 to 10).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Investigator Satisfaction With Nurse Support</measure>
    <time_frame>At Week 12</time_frame>
    <description>Investigator satisfaction is measured as the satisfaction of investigator with the nurse support (VAS from 1 to 10).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Participant Satisfaction With Video Functionality of the Device</measure>
    <time_frame>Through Week 12</time_frame>
    <description>Participant satisfaction is defined as the measure of satisfaction of participant with the video functionality of the device specifically at weeks 4 and 12 (VAS from 1 to 10).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Caregiver Burden</measure>
    <time_frame>Baseline (Week 0) to Week 12</time_frame>
    <description>Change of caregiver burden will be measured by the Modified Caregiver Strain Index (MCSI). MCSI is a questionnaire comprising of 13 questions around major domains, to be filled by caregivers. The higher the score, the higher the level of caregiver strain. Scoring ranges from 0 to 26, with 0 indicating no strain and 26 indicating extreme strain.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">41</enrollment>
  <condition>Parkinson's Disease</condition>
  <arm_group>
    <arm_group_label>Participants With Nurse Support, Using Video Devices</arm_group_label>
    <description>Participants treated with Levodopa Carbidopa Intestinal Gel (LCIG) in accordance with approved label who are provided AbbVie Duodopa Specialist (ADS) nurse support, using video devices.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Participants With Nurse Support, Not Using Video Devices</arm_group_label>
    <description>Participants treated with Levodopa Carbidopa Intestinal Gel (LCIG) in accordance with approved label who are provided AbbVie Duodopa Specialist (ADS) nurse support, not using video devices.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Adult participants with advanced Parkinson's Disease&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Eligible for Levodopa-Carbidopa Intestinal Gel (LCIG) therapy in accordance with the&#xD;
             approved local LCIG label in the participating country&#xD;
&#xD;
          -  Formerly LCIG-naive participants who have completed an in-hospital titration, have a&#xD;
             Percutaneous Endoscopic transGastric Jejunostomy (PEG-J) placed and are discharged&#xD;
             from hospital&#xD;
&#xD;
          -  Decision to treat with LCIG made by the investigator prior to any decision to approach&#xD;
             the participant to participate in this study&#xD;
&#xD;
          -  Owns a telecommunication device equipped for videoconferencing (smart phone, tablet,&#xD;
             laptop)&#xD;
&#xD;
          -  Willing and able (based on investigator's judgment) to handle the video functionality&#xD;
             of the device&#xD;
&#xD;
          -  Caregiver willing to provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any condition included in the contraindications section of the approved local LCIG&#xD;
             label in the participating country&#xD;
&#xD;
          -  Lack of caregiver support&#xD;
&#xD;
          -  Participation in a concurrent interventional clinical trial&#xD;
&#xD;
          -  Lack of motivation or insufficient language skills to complete the study&#xD;
             questionnaires&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>ABBVIE INC.</last_name>
    <role>Study Director</role>
    <affiliation>AbbVie</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Royal Brisbane and Women's Hospital /ID# 223138</name>
      <address>
        <city>Herston</city>
        <state>Queensland</state>
        <zip>4029</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kingston Centre /ID# 222563</name>
      <address>
        <city>Cheltenham</city>
        <state>Victoria</state>
        <zip>3192</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Royal Melbourne Hospital /ID# 223005</name>
      <address>
        <city>Parkville</city>
        <state>Victoria</state>
        <zip>3050</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Soroka University Medical Center /ID# 222754</name>
      <address>
        <city>Beer Sheva</city>
        <state>HaDarom</state>
        <zip>8410101</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Chaim Sheba Medical Center /ID# 222470</name>
      <address>
        <city>Ramat Gan</city>
        <state>Tel-Aviv</state>
        <zip>5265601</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaplan Medical Center /ID# 222753</name>
      <address>
        <city>Rehovot</city>
        <zip>7661041</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tel Aviv Medical Center /ID# 222471</name>
      <address>
        <city>Tel Aviv</city>
        <zip>64239</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego /ID# 222934</name>
      <address>
        <city>Wroclaw</city>
        <state>Dolnoslaskie</state>
        <zip>50-369</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mazowiecki Szpital Brodnowski /ID# 222933</name>
      <address>
        <city>Warszawa</city>
        <state>Mazowieckie</state>
        <zip>03-242</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>COPERNICUS Podmiot Leczniczy Sp. z o.o. - Szpital sw. Wojciecha Adalberta /ID# 222932</name>
      <address>
        <city>Gdansk</city>
        <state>Pomorskie</state>
        <zip>80-462</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Luzerner Kantonsspital /ID# 223038</name>
      <address>
        <city>Luzern 16</city>
        <state>Luzern</state>
        <zip>6000</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kantonsspital St. Gallen /ID# 227012</name>
      <address>
        <city>St. Gallen</city>
        <state>Sankt Gallen</state>
        <zip>9007</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsspital Zürich /ID# 223035</name>
      <address>
        <city>Zürich</city>
        <state>Zuerich</state>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Israel</country>
    <country>Poland</country>
    <country>Switzerland</country>
  </location_countries>
  <link>
    <url>https://www.abbvieclinicaltrials.com/study/?id=P20-184&amp;Latitude=&amp;Longitude=&amp;LocationName=#additional-resources-section</url>
    <description>clinical study report synopsis</description>
  </link>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>August 3, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>January 31, 2023</last_update_submitted>
  <last_update_submitted_qc>January 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 2, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Levodopa-Carbidopa</keyword>
  <keyword>LCIG</keyword>
  <keyword>FACILITATE-CARE</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04500106
org study id: P20-184
nct id: NCT04500106
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Parkinson's disease (PD) is a neurological condition, which affects the brain. PD gets worse
      over time, but how quickly it progresses varies a lot from person to person. Some symptoms of
      PD are tremors, stiffness, and slowness of movement. The purpose of this study is to see how
      feasible and how satisfied participants/caregivers/investigators are with video-assisted
      telenursing use in nurse support programs with LCIG.

      LCIG is an approved drug to treat PD. Approximately 50 adult participants with advanced PD
      will be enrolled in the study at approximately 10 sites across the world.

      The study has 2 groups. In one group, around 25 participants will receive nurse support using
      video devices. In the second group, around 25 participants will receive nurse support without
      using video devices. All participants will attend a baseline visit and follow up visits at
      Week 4 and Week 12. The planned observation period will be 12 weeks.

      Participants who are prescribed LCIG by their physicians will have three study related
      visits. Participants, caregivers, and investigators will be asked to complete questionnaires
      for the study.
observational model: Cohort
time perspective: Prospective
measure: Participant Acceptance of the AbbVie Duodopa Specialist (ADS) Nurse Support and Communication Access
time frame: At Week 12
description: Participant acceptance is measured by the participant satisfaction with the AbbVie Duodopa Specialist (ADS) nurse support and communication access (Visual Analog Sore from 1 to 10).
measure: Participant Satisfaction With ADS Nurse Support and Communication Access
time frame: Through Week 12
description: Participant Satisfaction is defined as participant satisfaction with the ADS nurse support and communication access at Week 4 (Visual Analog Scale [VAS] scoring from 1 to 10) and at Week 12 (VAS scoring from 8 to 10).
measure: Participant Satisfaction with the ADS Nurse Support and Communication Access
time frame: At Week 12
description: Participant satisfaction with the ADS nurse support and communication access is based on scoring 8 to 10 on a VAS (Binary: Yes/No).
measure: Caregiver Satisfaction With ADS Nurse Support and Communication Access
time frame: Baseline (Week 0) to Week 12
description: Caregiver satisfaction is measured as the satisfaction of caregiver with the ADS nurse support and communication access at weeks 4 and 12 (VAS from 1 to 10).
measure: Caregiver Acceptance of ADS Nurse Support and Communication Access
time frame: Through Week 12
description: Caregiver acceptance is measured as the acceptance of caregiver with the ADS nurse support and communication access at weeks 4 and 12 (VAS from 1 to 10).
measure: Investigator Satisfaction With Nurse Support
time frame: At Week 12
description: Investigator satisfaction is measured as the satisfaction of investigator with the nurse support (VAS from 1 to 10).
measure: Participant Satisfaction With Video Functionality of the Device
time frame: Through Week 12
description: Participant satisfaction is defined as the measure of satisfaction of participant with the video functionality of the device specifically at weeks 4 and 12 (VAS from 1 to 10).
measure: Change of Caregiver Burden
time frame: Baseline (Week 0) to Week 12
description: Change of caregiver burden will be measured by the Modified Caregiver Strain Index (MCSI). MCSI is a questionnaire comprising of 13 questions around major domains, to be filled by caregivers. The higher the score, the higher the level of caregiver strain. Scoring ranges from 0 to 26, with 0 indicating no strain and 26 indicating extreme strain.
arm group label: Participants With Nurse Support, Using Video Devices
description: Participants treated with Levodopa Carbidopa Intestinal Gel (LCIG) in accordance with approved label who are provided AbbVie Duodopa Specialist (ADS) nurse support, using video devices.
arm group label: Participants With Nurse Support, Not Using Video Devices
description: Participants treated with Levodopa Carbidopa Intestinal Gel (LCIG) in accordance with approved label who are provided AbbVie Duodopa Specialist (ADS) nurse support, not using video devices.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: ABBVIE INC.
role: Study Director
affiliation: AbbVie
facility: 
facility: 
facility: 
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country: Australia
country: Israel
country: Poland
country: Switzerland
url: https://www.abbvieclinicaltrials.com/study/?id=P20-184&Latitude=&Longitude=&LocationName=#additional-resources-section
description: clinical study report synopsis
responsible party type: Sponsor
mesh term: Parkinson Disease
sharing ipd: Undecided