<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/NCT04401943</url>
  </required_header>
  <id_info>
    <org_study_id>19-083</org_study_id>
    <nct_id>NCT04401943</nct_id>
  </id_info>
  <brief_title>Online Fatigue Intervention Program for People With Scleroderma</brief_title>
  <acronym>FAME-ISS</acronym>
  <official_title>Pilot Study of an Online Fatigue Intervention Program for People With Scleroderma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of New Mexico</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of California, San Diego</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of New Mexico</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>
      This research is being done to evaluate if an online fatigue intervention program will&#xD;
      decrease fatigue, pain and increase confidence managing fatigue and being able to do daily&#xD;
      tasks. This study involves competing a series of questionnaires before and after the&#xD;
      intervention , and attending and participating in the online videoconference fatigue program&#xD;
      for 1 1/2 hour meetings each week over a 6-week period of time.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      If eligible and give consent, participants will be asked to complete 2 online questionnaires.&#xD;
      The first questionnaire asks basic information such as your age, gender, educational level,&#xD;
      and amount of time diagnosed with systemic sclerosis. The second questionnaire asks about&#xD;
      your disease symptoms.&#xD;
&#xD;
      You will also be asked to complete questionnaires about your fatigue, pain, mood, confidence&#xD;
      in managing your disease and performing daily tasks, and knowledge and use of energy saving&#xD;
      techniques.&#xD;
&#xD;
      Once you compete the questionnaires, you will be asked to compete a survey about times and&#xD;
      days you would be available to attend the online videoconference fatigue program meeting over&#xD;
      a 6 week period of time.&#xD;
&#xD;
      Once the time and dates for the fatigue program are scheduled, you will be expected to attend&#xD;
      and take part (using visual and audio) in each 1 ½ hour meeting for 6 weeks online.&#xD;
&#xD;
      The fatigue program includes information on causes of fatigue, ways to protect joint and save&#xD;
      energy, ways to manage stress, pain, good eating habits, and exercise. Outside of meetings,&#xD;
      you will also be expected to do any &quot;homework&quot; assignments in between the group meetings such&#xD;
      as setting goals and doing activities to reach your goals.&#xD;
&#xD;
      At the end of the 6 weeks, you will be asked to complete the same questionnaires you did at&#xD;
      the beginning of the study regarding, fatigue, pain, and ability to perform daily tasks. You&#xD;
      will also be asked to complete an evaluation of the course.&#xD;
&#xD;
      3 months later, you will be asked to take part in a 45 minute telephone interview to talk&#xD;
      about your fatigue and how you are using the ideas from the program.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">May 13, 2020</start_date>
  <completion_date type="Anticipated">August 2024</completion_date>
  <primary_completion_date type="Anticipated">June 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline Modified Fatigue Impact Scale at 6 weeks</measure>
    <time_frame>baseline, 6 weeks</time_frame>
    <description>self report of impact of fatigue on physical, cognitive and psychosocial functioning</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline Multidimensional Assessment of Fatigue at 6 weeks</measure>
    <time_frame>baseline, 6 weeks</time_frame>
    <description>Measures four subjective domains of fatigue: degree and severity, amount of distress it causes, timing, and degree to which fatigue interferes with the activities of daily living</description>
  </primary_outcome>
  <other_outcome>
    <measure>Change from baseline Hospital Anxiety and Depression Scale at 6 weeks</measure>
    <time_frame>baseline, 6 weeks</time_frame>
    <description>Measures anxiety and depression</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline PROMIS Self-Efficacy for Managing Symptoms at 6 weeks</measure>
    <time_frame>baseline, 6 weeks</time_frame>
    <description>Measures participants' confidence in managing symptoms so as not to interfere with the activities they perform in day to day life.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change from baseline Self-Efficacy for Performing Energy Conservation Strategies Assessment at 6 weeks</measure>
    <time_frame>baseline, 6 weeks</time_frame>
    <description>Measures participants' confidence in their ability to use energy conservation strategies</description>
  </other_outcome>
  <other_outcome>
    <measure>Energy Conservations Strategies Survey</measure>
    <time_frame>6 weeks</time_frame>
    <description>Measures people's use of energy conservation strategies</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">12</enrollment>
  <condition>Systemic Sclerosis</condition>
  <arm_group>
    <arm_group_label>Fatigue intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>the Fatigue intervention is a 6 week intervention delivered using video teleconferencing</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>online fatigue intervention</intervention_name>
    <description>on line teleconferencing fatigue intervention for 6 weeks on causes of fatigue, ways to protect joint and save energy, ways to manage stress, pain, good eating habits, and exercise.</description>
    <arm_group_label>Fatigue intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Resident of the United States&#xD;
&#xD;
          -  Diagnosis of systemic scleroderma&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Have use of a device with internet and email access, and video conferencing&#xD;
             capabilities (both audio and visual)&#xD;
&#xD;
          -  Communicate in English&#xD;
&#xD;
          -  Have fatigue (combined score of &gt;12 on 3 questions that rate degree of fatigue,&#xD;
             severity of fatigue, and level of stress caused by fatigue on a scale from 1 - 10)&#xD;
&#xD;
          -  Be willing and available to complete the study protocol which consists of attending a&#xD;
             1.5 hour virtual meeting once a week for 6 weeks.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Not having use of a device with internet, email access, and video conferencing&#xD;
             capabilities (both audio and visual)&#xD;
&#xD;
          -  Not able to communicate in English&#xD;
&#xD;
          -  Score &lt; 12 on the fatigue screening questions&#xD;
&#xD;
          -  Not willing or not able to complete the study protocol or participate in the program&#xD;
             at the designated times and days.&#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>Janet L Poole, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of New Mexico</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of New Mexico</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87131-0001</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>May 13, 2020</study_first_submitted>
  <study_first_submitted_qc>May 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>June 15, 2023</last_update_submitted>
  <last_update_submitted_qc>June 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Scleroderma, Systemic</mesh_term>
    <mesh_term>Scleroderma, Diffuse</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/NCT04401943
org study id: 19-083
nct id: NCT04401943
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This research is being done to evaluate if an online fatigue intervention program will
      decrease fatigue, pain and increase confidence managing fatigue and being able to do daily
      tasks. This study involves competing a series of questionnaires before and after the
      intervention , and attending and participating in the online videoconference fatigue program
      for 1 1/2 hour meetings each week over a 6-week period of time.
If eligible and give consent, participants will be asked to complete 2 online questionnaires.
      The first questionnaire asks basic information such as your age, gender, educational level,
      and amount of time diagnosed with systemic sclerosis. The second questionnaire asks about
      your disease symptoms.

      You will also be asked to complete questionnaires about your fatigue, pain, mood, confidence
      in managing your disease and performing daily tasks, and knowledge and use of energy saving
      techniques.

      Once you compete the questionnaires, you will be asked to compete a survey about times and
      days you would be available to attend the online videoconference fatigue program meeting over
      a 6 week period of time.

      Once the time and dates for the fatigue program are scheduled, you will be expected to attend
      and take part (using visual and audio) in each 1 ½ hour meeting for 6 weeks online.

      The fatigue program includes information on causes of fatigue, ways to protect joint and save
      energy, ways to manage stress, pain, good eating habits, and exercise. Outside of meetings,
      you will also be expected to do any "homework" assignments in between the group meetings such
      as setting goals and doing activities to reach your goals.

      At the end of the 6 weeks, you will be asked to complete the same questionnaires you did at
      the beginning of the study regarding, fatigue, pain, and ability to perform daily tasks. You
      will also be asked to complete an evaluation of the course.

      3 months later, you will be asked to take part in a 45 minute telephone interview to talk
      about your fatigue and how you are using the ideas from the program.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Change from baseline Modified Fatigue Impact Scale at 6 weeks
time frame: baseline, 6 weeks
description: self report of impact of fatigue on physical, cognitive and psychosocial functioning
measure: Change from baseline Multidimensional Assessment of Fatigue at 6 weeks
time frame: baseline, 6 weeks
description: Measures four subjective domains of fatigue: degree and severity, amount of distress it causes, timing, and degree to which fatigue interferes with the activities of daily living
measure: Change from baseline Hospital Anxiety and Depression Scale at 6 weeks
time frame: baseline, 6 weeks
description: Measures anxiety and depression
measure: Change from baseline PROMIS Self-Efficacy for Managing Symptoms at 6 weeks
time frame: baseline, 6 weeks
description: Measures participants' confidence in managing symptoms so as not to interfere with the activities they perform in day to day life.
measure: Change from baseline Self-Efficacy for Performing Energy Conservation Strategies Assessment at 6 weeks
time frame: baseline, 6 weeks
description: Measures participants' confidence in their ability to use energy conservation strategies
measure: Energy Conservations Strategies Survey
time frame: 6 weeks
description: Measures people's use of energy conservation strategies
arm group label: Fatigue intervention
arm group type: Experimental
description: the Fatigue intervention is a 6 week intervention delivered using video teleconferencing
intervention type: Other
intervention name: online fatigue intervention
description: on line teleconferencing fatigue intervention for 6 weeks on causes of fatigue, ways to protect joint and save energy, ways to manage stress, pain, good eating habits, and exercise.
arm group label: Fatigue intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Janet L Poole, PhD
role: Principal Investigator
affiliation: University of New Mexico
facility: 
country: United States
responsible party type: Sponsor
mesh term: Scleroderma, Systemic
mesh term: Scleroderma, Diffuse
sharing ipd: No