xml: <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/NCT06016543</url>
    </required_header>
    <id_info>
      <org_study_id>ROMPS-Pilot</org_study_id>
      <nct_id>NCT06016543</nct_id>
    </id_info>
    <brief_title>Role of OMT in the Management of the Persistent Post-COVID-19 Symptoms</brief_title>
    <acronym>ROMPS</acronym>
    <official_title>Role of OMT in the Management of the Persistent Post-COVID-19 Symptoms - A Pilot Prospective Cohort Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>A.T. Still University of Health Sciences</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>American Osteopathic Association</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>A.T. Still University of Health Sciences</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>
        The goal of this observational study is to determine the feasibility of conducting a&#xD;
        large-scale study on the effect of using osteopathic manipulative treatment (OMT) to treat&#xD;
        patients with post-COVID-19 symptoms. The main questions it aims to answer are:&#xD;
  &#xD;
          1. Is it feasible to conduct a large-scale study of the effect of OMT on patients with&#xD;
             post-COVID-19 symptoms (based on how many patients agree to participate and how many&#xD;
             complete the study)?&#xD;
  &#xD;
          2. How much change in patients' post-COVID-19 symptom severity, quality of life, and&#xD;
             ability to return to work can we expect to see following OMT?&#xD;
  &#xD;
        Participants will receive OMT as directed by their physician and complete questionnaires&#xD;
        after every other OMT session.&#xD;
  &#xD;
          1. Participants will complete questionnaires about their post-COVID-19 symptoms, quality of&#xD;
             life, ability to return to work, and adverse events they experienced 3 days after every&#xD;
             other OMT session.&#xD;
  &#xD;
          2. Participants will be sent links to the questionnaires for 4 months or when their&#xD;
             symptoms resolve, whichever comes first.&#xD;
  &#xD;
          3. Additionally, participants will complete a follow-up questionnaire 2 months after they&#xD;
             stop receiving OMT for their post-COVID-19 symptoms or 6 months after enrollment in the&#xD;
             study, whichever comes first.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 18, 2023</start_date>
    <completion_date type="Anticipated">February 17, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 17, 2024</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>Patient recruitment rate (feasibility)</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>Proportion of patients who enroll in the study out of the number of patients who were eligible for and invited to enroll in the study.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Data completion rate (feasibility)</measure>
      <time_frame>Through study completion, an average of 1 year</time_frame>
      <description>Proportions of participants and physicians who complete all their questionnaires.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Neurocognitive and psychological symptoms</measure>
      <time_frame>3 days after every other OMT session for up to 4 months after enrollment and 2 months after the participant's final OMT session</time_frame>
      <description>Measured using the Rivermead Post Concussion Symptoms Questionnaire</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Physical symptoms</measure>
      <time_frame>3 days after every other OMT session for up to 4 months after enrollment and 2 months after the participant's final OMT session</time_frame>
      <description>Measured using the Long COVID-Household Pulse Survey</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Global health</measure>
      <time_frame>3 days after every other OMT session for up to 4 months after enrollment and 2 months after the participant's final OMT session</time_frame>
      <description>Measured using the PROMIS SF v1.2 Global Health scale</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Return to work</measure>
      <time_frame>3 days after every other OMT session for up to 4 months after enrollment and 2 months after the participant's final OMT session</time_frame>
      <description>For participants who were employed prior to COVID-19, their current working status will be assessed on a 4-point scale (1. returned to full-time work without restrictions, 2. returned to full-time work but with modified job duties, 3) returned to work but with reduced working hours, 4. have not been able to return to work.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Severity of potential adverse events from OMT</measure>
      <time_frame>3 days after every other OMT session for up to 4 months after enrollment</time_frame>
      <description>Measured by comparing the severity of potential adverse events from OMT during the 3 days following OMT to the severity during the week before OMT.</description>
    </other_outcome>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Post-Acute COVID-19 Syndrome</condition>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>osteopathic manipulative treatment (OMT)</intervention_name>
      <description>Osteopathic manipulative treatment provided at the discretion of the treating physician and based on the patient's response to previous treatments.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients of clinics in the United States where members of the practice-based research&#xD;
          network, DO-Touch.NET, practice osteopathic manipulative treatment.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  at least one symptom of post-COVID-19 (eg, fatigue, dyspnea, anosmia, arthralgia,&#xD;
               headache, sleep disturbances, anxiety/depression, or other problems related to mental&#xD;
               health) which was new after diagnosis with COVID-19 and has persisted for at least 4&#xD;
               weeks after diagnosis&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  unable to speak, read, and write in English&#xD;
  &#xD;
            -  not mentally competent to give informed consent&#xD;
  &#xD;
            -  inability to complete surveys/questionnaires online&#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>Brian F Degenhardt, DO</last_name>
      <role>Principal Investigator</role>
      <affiliation>A.T. Still University of Health Sciences</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Corey Luebbering, MPH</last_name>
      <phone>660-626-2293</phone>
      <email>dotouchnet@atsu.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jane C Johnson, MA</last_name>
      <phone>660-626-2331</phone>
      <email>jjohnson@atsu.edu</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>osteopathic manipulative treatment</keyword>
    <keyword>long COVID</keyword>
    <keyword>post-COVID conditions</keyword>
    <keyword>post-acute sequelae of SARS-CoV-2 infection</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>COVID-19</mesh_term>
      <mesh_term>Post-Acute COVID-19 Syndrome</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06016543
  org study id: ROMPS-Pilot
  nct id: NCT06016543
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to determine the feasibility of conducting a
        large-scale study on the effect of using osteopathic manipulative treatment (OMT) to treat
        patients with post-COVID-19 symptoms. The main questions it aims to answer are:
  
          1. Is it feasible to conduct a large-scale study of the effect of OMT on patients with
             post-COVID-19 symptoms (based on how many patients agree to participate and how many
             complete the study)?
  
          2. How much change in patients' post-COVID-19 symptom severity, quality of life, and
             ability to return to work can we expect to see following OMT?
  
        Participants will receive OMT as directed by their physician and complete questionnaires
        after every other OMT session.
  
          1. Participants will complete questionnaires about their post-COVID-19 symptoms, quality of
             life, ability to return to work, and adverse events they experienced 3 days after every
             other OMT session.
  
          2. Participants will be sent links to the questionnaires for 4 months or when their
             symptoms resolve, whichever comes first.
  
          3. Additionally, participants will complete a follow-up questionnaire 2 months after they
             stop receiving OMT for their post-COVID-19 symptoms or 6 months after enrollment in the
             study, whichever comes first.
  observational model: Cohort
  time perspective: Prospective
  measure: Patient recruitment rate (feasibility)
  time frame: Through study completion, an average of 1 year
  description: Proportion of patients who enroll in the study out of the number of patients who were eligible for and invited to enroll in the study.
  measure: Data completion rate (feasibility)
  time frame: Through study completion, an average of 1 year
  description: Proportions of participants and physicians who complete all their questionnaires.
  measure: Neurocognitive and psychological symptoms
  time frame: 3 days after every other OMT session for up to 4 months after enrollment and 2 months after the participant's final OMT session
  description: Measured using the Rivermead Post Concussion Symptoms Questionnaire
  measure: Physical symptoms
  time frame: 3 days after every other OMT session for up to 4 months after enrollment and 2 months after the participant's final OMT session
  description: Measured using the Long COVID-Household Pulse Survey
  measure: Global health
  time frame: 3 days after every other OMT session for up to 4 months after enrollment and 2 months after the participant's final OMT session
  description: Measured using the PROMIS SF v1.2 Global Health scale
  measure: Return to work
  time frame: 3 days after every other OMT session for up to 4 months after enrollment and 2 months after the participant's final OMT session
  description: For participants who were employed prior to COVID-19, their current working status will be assessed on a 4-point scale (1. returned to full-time work without restrictions, 2. returned to full-time work but with modified job duties, 3) returned to work but with reduced working hours, 4. have not been able to return to work.
  measure: Severity of potential adverse events from OMT
  time frame: 3 days after every other OMT session for up to 4 months after enrollment
  description: Measured by comparing the severity of potential adverse events from OMT during the 3 days following OMT to the severity during the week before OMT.
  intervention type: Procedure
  intervention name: osteopathic manipulative treatment (OMT)
  description: Osteopathic manipulative treatment provided at the discretion of the treating physician and based on the patient's response to previous treatments.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Brian F Degenhardt, DO
  role: Principal Investigator
  affiliation: A.T. Still University of Health Sciences
  last name: Corey Luebbering, MPH
  phone: 660-626-2293
  email: dotouchnet@atsu.edu
  last name: Jane C Johnson, MA
  phone: 660-626-2331
  email: jjohnson@atsu.edu
  responsible party type: Sponsor
  mesh term: COVID-19
  mesh term: Post-Acute COVID-19 Syndrome
  sharing ipd: No