<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/NCT03834922</url>
  </required_header>
  <id_info>
    <org_study_id>777500-IMI-PainCare PROMPT</org_study_id>
    <nct_id>NCT03834922</nct_id>
  </id_info>
  <brief_title>Providing Standardized Consented PROMs (Patient Reported Outcome Measures) for Improving Pain Treatment</brief_title>
  <acronym>PROMPT</acronym>
  <official_title>PROMPT Providing Standardized Consented PROMs (Patient Reported Outcome Measures) for Improving Pain Treatment A Multicenter, Non-interventional, Prospective Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prof. Dr. Winfried Meissner</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Grünenthal GmbH</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital Muenster</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Ambroise Paré Paris</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Novartis Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hôpital Raymond Poincaré</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Helsinki</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital St Luc, Brussels</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Oxford University Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital, Geneva</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Orthopedic Center Santy, Lyon, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Naples</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hospital Clínico Universitario de Valladolid</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Cancer Center Porto, Portugal</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Orthopedic Institute Banjika, Belgrade, Serbia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Cardiovascular Center Dedinje, Belgrade, Serbia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Homburg</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Barts &amp; The London NHS Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Insel Gruppe AG, University Hospital Bern</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital Dresden</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital Bergmannsheil Bochum</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Infirmerie Protestante Lyon</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Jena</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>
      PROMPT aims at improving management of acute and chronic pain by identifying a core set of&#xD;
      PROMs (patient reported outcome measures) that are predictive indicators of treatment success&#xD;
      in clinical practice and controlled trials. These will not only address pain intensities as&#xD;
      well as the functional consequences of pain for individuals but also identify patients at&#xD;
      risk of experiencing chronification of acute post-operative pain. Results will help health&#xD;
      care professionals to individualize pain management, and thus improve the quality of life of&#xD;
      pain patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In order to reach this objective, a non-interventional prospective data collection aiming at&#xD;
      reaching a consensus on a core set of PROMs which reliably predict and/or measure success in&#xD;
      acute and chronic pain treatments in real life conditions and identifying predictors for&#xD;
      chronification of postoperative pain will be conducted (PROMPT NIT-1). Aim of the data&#xD;
      collection is to evaluate the abilities of certain PROMs in assessing acute post-surgical&#xD;
      pain outcomes in daily routine care of patients after four different surgical procedures:&#xD;
      (total knee replacement, breast surgery, sternotomy and surgery related to endometriosis),&#xD;
      and to validate selected risk factors for chronification prospectively.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 24, 2019</start_date>
  <completion_date type="Actual">June 30, 2022</completion_date>
  <primary_completion_date type="Actual">June 30, 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>6 Months</target_duration>
  <primary_outcome>
    <measure>WP 2 - Acute pain: Sensitivity to change</measure>
    <time_frame>2019 - 2022</time_frame>
    <description>For WP2, the primary endpoint will be pain intensity at day 3 (NRS Scale from 0 to 10, 0 being no pain, 10 being worst pain imaginable). This primary endpoint (PROMs) will be used to assess sensitivity to change from POD3 to POD1.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>WP 3 - Chronification of pain: Incidence of chronic post-surgical pain (CPSP)</measure>
    <time_frame>2019 - 2022</time_frame>
    <description>For WP3, the primary end point will be the incidence of moderate to severe CPSP (Numeric rating scale ≥ 3/10) at 6 months using the average pain on the Brief Pain Inventory Questionnaire.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective physical activity and sleep, measured with Actigraph devices</measure>
    <time_frame>01/2020 to 12/2021</time_frame>
    <description>Correlation of physical activity data (average no. of steps of days 5 to 7) with PRO &quot;physical function&quot; on day 7;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association between other POD7 PROMs and activity/sleep</measure>
    <time_frame>01/2020 to 12/2021</time_frame>
    <description>Association between other POD7 PROMs and activity/sleep</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association between peri-operative processes and activity/sleep</measure>
    <time_frame>01/2020 to 12/2021</time_frame>
    <description>Association between peri-operative processes and activity/sleep</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Is decreased activity a predictor for chronic postsurgical pain?</measure>
    <time_frame>01/2020 to 12/2021</time_frame>
    <description>Is decreased activity a predictor for chronic postsurgical pain on POM6?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Do activity trajectories since surgery parallel trajectories of other outcomes?</measure>
    <time_frame>01/2020 to 12/2021</time_frame>
    <description>Do activity trajectories since surgery parallel trajectories of other outcomes?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of activity difference between POD5-7 and preop with POD7 oucomes</measure>
    <time_frame>01/2020 to 12/2021</time_frame>
    <description>Correlation of activity difference between POD5-7 and preop with POD7 oucomes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Association between ambient light intensity and outcomes on POD7</measure>
    <time_frame>01/2020 to 12/2021</time_frame>
    <description>Association between ambient light intensity and outcomes on POD7</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">3322</enrollment>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>Total knee arthroplasty</arm_group_label>
    <description>Patients undergoing total knee arthroplasty</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sternotomy</arm_group_label>
    <description>Patients undergoing sternotomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Breast</arm_group_label>
    <description>Patients undergoing breast surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Endometriosis</arm_group_label>
    <description>Patients undergoing endometriosis-related surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Prospective data collection</intervention_name>
    <description>No intervention. It's a prospective data collection.</description>
    <arm_group_label>Breast</arm_group_label>
    <arm_group_label>Endometriosis</arm_group_label>
    <arm_group_label>Sternotomy</arm_group_label>
    <arm_group_label>Total knee arthroplasty</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing one of the following types of surgery: TKA, breast, sternotomy and&#xD;
        endometriosis related surgery. Only female patients will be included in the Breast Surgery&#xD;
        and Endometriosis group. For the other surgeries, there will not be a special preference in&#xD;
        the distribution by sex or age for the recruitment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient is of consenting age (&gt;18 years old)&#xD;
&#xD;
          -  Elective surgery&#xD;
&#xD;
          -  Planned stay in hospital for the surgery&#xD;
&#xD;
          -  First contact with the patient before surgery&#xD;
&#xD;
          -  Patient agrees to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient is unable to give consent&#xD;
&#xD;
          -  Cognitive impairment&#xD;
&#xD;
          -  Questionnaire is not available in a language the patient is fluent in&#xD;
&#xD;
          -  Patient not willing to answer the follow-up questionnaire&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>For the groups 'Breast' and 'Endometriosis', only female patients can be included.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Winfried Meissner, Prof.</last_name>
    <role>Study Chair</role>
    <affiliation>Jena University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Hiltrud Liedgens, Dr.</last_name>
    <role>Study Chair</role>
    <affiliation>Grünenthal GmbH</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Esther Pogatzki-Zahn, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Münster</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dominique Fletcher, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Ambroise Paré Paris</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shaloo Pandhi</last_name>
    <role>Principal Investigator</role>
    <affiliation>Novartis</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jena University Hospital</name>
      <address>
        <city>Jena</city>
        <state>Thuringia</state>
        <zip>07747</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>February 7, 2019</study_first_submitted>
  <study_first_submitted_qc>February 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <last_update_submitted>November 1, 2022</last_update_submitted>
  <last_update_submitted_qc>November 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Jena</investigator_affiliation>
    <investigator_full_name>Prof. Dr. Winfried Meissner</investigator_full_name>
    <investigator_title>Study coordinator</investigator_title>
  </responsible_party>
  <keyword>Acute pain</keyword>
  <keyword>Chronification of pain</keyword>
  <keyword>Pain treatment</keyword>
  <keyword>Pain management</keyword>
  <keyword>Postoperative pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</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/NCT03834922
org study id: 777500-IMI-PainCare PROMPT
nct id: NCT03834922
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has dmc: No
is fda regulated drug: No
is fda regulated device: No
PROMPT aims at improving management of acute and chronic pain by identifying a core set of
      PROMs (patient reported outcome measures) that are predictive indicators of treatment success
      in clinical practice and controlled trials. These will not only address pain intensities as
      well as the functional consequences of pain for individuals but also identify patients at
      risk of experiencing chronification of acute post-operative pain. Results will help health
      care professionals to individualize pain management, and thus improve the quality of life of
      pain patients.
In order to reach this objective, a non-interventional prospective data collection aiming at
      reaching a consensus on a core set of PROMs which reliably predict and/or measure success in
      acute and chronic pain treatments in real life conditions and identifying predictors for
      chronification of postoperative pain will be conducted (PROMPT NIT-1). Aim of the data
      collection is to evaluate the abilities of certain PROMs in assessing acute post-surgical
      pain outcomes in daily routine care of patients after four different surgical procedures:
      (total knee replacement, breast surgery, sternotomy and surgery related to endometriosis),
      and to validate selected risk factors for chronification prospectively.
observational model: Cohort
time perspective: Prospective
measure: WP 2 - Acute pain: Sensitivity to change
time frame: 2019 - 2022
description: For WP2, the primary endpoint will be pain intensity at day 3 (NRS Scale from 0 to 10, 0 being no pain, 10 being worst pain imaginable). This primary endpoint (PROMs) will be used to assess sensitivity to change from POD3 to POD1.
measure: WP 3 - Chronification of pain: Incidence of chronic post-surgical pain (CPSP)
time frame: 2019 - 2022
description: For WP3, the primary end point will be the incidence of moderate to severe CPSP (Numeric rating scale ≥ 3/10) at 6 months using the average pain on the Brief Pain Inventory Questionnaire.
measure: Objective physical activity and sleep, measured with Actigraph devices
time frame: 01/2020 to 12/2021
description: Correlation of physical activity data (average no. of steps of days 5 to 7) with PRO "physical function" on day 7;
measure: Association between other POD7 PROMs and activity/sleep
time frame: 01/2020 to 12/2021
description: Association between other POD7 PROMs and activity/sleep
measure: Association between peri-operative processes and activity/sleep
time frame: 01/2020 to 12/2021
description: Association between peri-operative processes and activity/sleep
measure: Is decreased activity a predictor for chronic postsurgical pain?
time frame: 01/2020 to 12/2021
description: Is decreased activity a predictor for chronic postsurgical pain on POM6?
measure: Do activity trajectories since surgery parallel trajectories of other outcomes?
time frame: 01/2020 to 12/2021
description: Do activity trajectories since surgery parallel trajectories of other outcomes?
measure: Correlation of activity difference between POD5-7 and preop with POD7 oucomes
time frame: 01/2020 to 12/2021
description: Correlation of activity difference between POD5-7 and preop with POD7 oucomes
measure: Association between ambient light intensity and outcomes on POD7
time frame: 01/2020 to 12/2021
description: Association between ambient light intensity and outcomes on POD7
arm group label: Total knee arthroplasty
description: Patients undergoing total knee arthroplasty
arm group label: Sternotomy
description: Patients undergoing sternotomy
arm group label: Breast
description: Patients undergoing breast surgery
arm group label: Endometriosis
description: Patients undergoing endometriosis-related surgery
intervention type: Other
intervention name: Prospective data collection
description: No intervention. It's a prospective data collection.
arm group label: Breast
arm group label: Endometriosis
arm group label: Sternotomy
arm group label: Total knee arthroplasty
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
gender based: Yes
gender description: For the groups 'Breast' and 'Endometriosis', only female patients can be included.
minimum age: 18 Years
maximum age: N/A
last name: Winfried Meissner, Prof.
role: Study Chair
affiliation: Jena University Hospital
last name: Hiltrud Liedgens, Dr.
role: Study Chair
affiliation: Grünenthal GmbH
last name: Esther Pogatzki-Zahn, Prof.
role: Principal Investigator
affiliation: University Hospital Münster
last name: Dominique Fletcher, Prof.
role: Principal Investigator
affiliation: Hospital Ambroise Paré Paris
last name: Shaloo Pandhi
role: Principal Investigator
affiliation: Novartis
facility: 
country: Germany
responsible party type: Sponsor-Investigator
investigator affiliation: University of Jena
investigator full name: Prof. Dr. Winfried Meissner
investigator title: Study coordinator
mesh term: Pain, Postoperative
sharing ipd: No