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/NCT05998577</url>
    </required_header>
    <id_info>
      <org_study_id>NL82286.068.22</org_study_id>
      <nct_id>NCT05998577</nct_id>
    </id_info>
    <brief_title>A Personalized Approach to Abdominal Pain in Irritable Bowel Syndrome and Inflammatory Bowel Disease Using Experience Sampling Method (ESM) and a Digital Food Diary (Traqq)</brief_title>
    <acronym>PERCEPTIvE</acronym>
    <official_title>A Personalized Approach to Abdominal Pain in Irritable Bowel Syndrome and Inflammatory Bowel Disease Using Experience Sampling Method (ESM) and a Digital Food Diary (Traqq)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Maastricht University Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Maastricht University Medical Center</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Apart from its use to provide insight in IBS disease courses and in clinical research, ESM&#xD;
        can provide patients with feedback about individual triggers of their symptoms, and thereby&#xD;
        function as part of a personalized therapeutic strategy. This is also true for IBD-IBS.&#xD;
        Treatment strategies in IBS and IBD-IBS are largely based on reassurance, identification and&#xD;
        elimination of triggering factors, and in more severe cases pharmaco- and psychotherapy. The&#xD;
        ESM approach has the potential to increase therapeutic efficacy in IBS and IBD-IBS and will&#xD;
        assist patients in disease self-management. The Traqq application can provide more detailed&#xD;
        information about the dietary pattern of IBS and IBD-IBS patients. Traqq in combination with&#xD;
        ESM will give an overview of abdominal pain and associated symptoms and psychosocial factors&#xD;
        are exposed to during the day. The insight provided using ESM and Traqq may improve patient&#xD;
        understanding of their personal symptom dynamics and triggers, as well as the physician's&#xD;
        insight into the symptom patters of the specific patients, which may aid treatment choice and&#xD;
        eventually improve the outcome of any treatment provided in daily clinical care.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is an unicenter, prospective, proof-of-concept randomized controlled, non-blinded&#xD;
        intervention study that focuses on two patient populations, with overlapping symptom patterns&#xD;
        and treatment approaches, i.e. patients with IBS and IBD-IBS.&#xD;
  &#xD;
        Following written informed consent, the eligibility screening is performed and instructions&#xD;
        about the study procedures will be given. Hereafter, both groups will independently be&#xD;
        randomized into i) an ESM/Traqq arm or ii) a standard care arm. The intervention group and&#xD;
        the control group will complete the IBS-SSS, EO-5D-5L, GAD-7, PHQ-9, VSI, and MFl-20 as well&#xD;
        as the Rome IV criteria for IBS and functional dyspepsia at baseline and the intervention&#xD;
        group will complete thereafter the ESM and Traqq applications during the first week. After&#xD;
        this week, the data will be analysed to identify associations between abdominal pain and&#xD;
        psychosocial factors, diet or other GI associated symptoms. About two weeks later,&#xD;
        participants will have their second visitation at the outpatient clinic with their treating&#xD;
        physician. In the intervention group, but not the control group, the patient and the treating&#xD;
        physician will receive the results of the personal data of the patients based on ESM and&#xD;
        Traqq. The insight participants and their physicians get from this information, will help&#xD;
        them to make changes in lifestyle factors that affect their symptoms or to choose a&#xD;
        pharmacological or non-pharmacological treatment. However, the study protocol will not&#xD;
        indicate which treatment choice should be made by the patient and their treating physicians.&#xD;
        That choice will still be based on shared decision making, just as in the standard care arm,&#xD;
        only with the additional data provided. Furthermore, if the patients are referred to a&#xD;
        dietician, psychologist, or both, the digital data obtained in the intervention group can be&#xD;
        used to personalize the therapy. After giving informed consent by the participant for the&#xD;
        data of ESM and Traqq being sent to the dietician or psychologist they are referred to, the&#xD;
        coordinating investigator will send the data digitally to the dietician or psychologist that&#xD;
        is needed for the personalized treatment. Participants in the control arm will get a&#xD;
        consultation with the gastroenterologist as usual after the same period of time as the&#xD;
        intervention group get their consultation. The participants of the control group will be&#xD;
        given treatment advice only based on this consultation, the PDSkeuzehulp by shared decision&#xD;
        making, according to standard care. Twelve weeks after the second outpatient visit,&#xD;
        independently of the chosen treatment approach, the participants in both study groups will be&#xD;
        asked to complete IBS-SSS, EQ-5D-5L, GAD-7, PHO-9, VSI, MFI-20 and Rome IV criteria for IBS&#xD;
        and functional dyspepsia for the second time to evaluate whether there is an effect on 1)&#xD;
        reduction of abdominal pain and 2) quality of life, psychological aspects or fatigue of the&#xD;
        participants due to the insight provided by ESM and Traqq.&#xD;
  &#xD;
        After those twelve weeks, the coordinating investigator will contact the participants of the&#xD;
        intervention group and control group by phone for the last time. Participants are asked what&#xD;
        treatment they have gotten and what lifestyle modifications they have done to reduce&#xD;
        abdominal pain. To improve compliance for completing the questionnaires by the control group,&#xD;
        the participants in the control group will get the opportunity to use the ESM and Traqq&#xD;
        applications after the study has been completed. This will not be part of this study but can&#xD;
        be beneficial for those individuals who have not got any additional insight about their&#xD;
        symptoms by getting the standard care.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 19, 2023</start_date>
    <completion_date type="Anticipated">May 19, 2025</completion_date>
    <primary_completion_date type="Anticipated">May 19, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>IBS-SSS</measure>
      <time_frame>12 weeks after outpatient clinic visit</time_frame>
      <description>Change in IBS-SSS to see whether IBS symptoms are improved</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>GAD-7</measure>
      <time_frame>12 weeks after outpatient clinic visit</time_frame>
      <description>Change in GAD-7 to see whether complaints of anxiety are improved</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>MFI-20</measure>
      <time_frame>12 weeks after outpatient clinic visit</time_frame>
      <description>Change in MFI-20 to see whether fatigue is improved</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PHQ-9</measure>
      <time_frame>12 weeks after outpatient clinic visit</time_frame>
      <description>Change in PHQ-9 to see whether complaints of depression are improved</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>VSI</measure>
      <time_frame>12 weeks after outpatient clinic visit</time_frame>
      <description>Change in VSI to see whether complaints of GI related anxiety are improved</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>EQ-5D-5L</measure>
      <time_frame>12 weeks after outpatient clinic visit</time_frame>
      <description>Change in EQ-5D-5L to see whether quality of life is improved</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Irritable Bowel Syndrome</condition>
    <condition>Inflammatory Bowel Diseases</condition>
    <condition>Crohn Disease</condition>
    <condition>Ulcerative Colitis</condition>
    <condition>Functional Gastrointestinal Disorders</condition>
    <condition>Lifestyle Factors</condition>
    <arm_group>
      <arm_group_label>ESM/Traqq</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Use of ESM and Traqq for one week to get a personalised analysis of the abdominal pain and triggerfactors that can be used at the outpatient clinic visit to select an effective treatment option.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard care</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Will not be using ESM and Traqq, but will only get a standard outpatient clinic visit together with PDSkeuzehulp to make a decision for a treatment.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>ESM and Traqq</intervention_name>
      <description>Two telephone applications: ESM is a psychosocial diary and Traqq is a food diary to measure abdominal pain as well as possible triggerfactors (i.e. diet, stress, anxiety)</description>
      <arm_group_label>ESM/Traqq</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion criteria IBS patients&#xD;
  &#xD;
            -  A diagnosis of IBS according to Rome IV criteria, as follows:&#xD;
  &#xD;
                 -  Recurrent abdominal pain, on average, at least 1 day per week in the last 3&#xD;
                    months, associated with 2 or more of the following criteria:&#xD;
  &#xD;
                 -  Related to defecation;&#xD;
  &#xD;
                 -  Associated with a change in stool frequency; oAssociated with a change in stool&#xD;
                    form (appearance).&#xD;
  &#xD;
                 -  Criteria fulfilled for the last 3 months with symptom onset at least 6 months&#xD;
                    prior to diagnosis.&#xD;
  &#xD;
            -  Minimal baseline score of 150 points on the IBS-SSS scale&#xD;
  &#xD;
            -  Age between 18 and 70 years;&#xD;
  &#xD;
            -  Ability to understand and speak the Dutch language&#xD;
  &#xD;
            -  Ability to understand how to utilize the ESM and Traqq applications.&#xD;
  &#xD;
          Inclusion criteria IBD patients&#xD;
  &#xD;
            -  Patients with IBD diagnosed in accordance with current ECCO guidelines, with IBD- IBS&#xD;
               and with chronic abdominal pain, as follows:&#xD;
  &#xD;
                 -  MIAH score &lt;3&#xD;
  &#xD;
                 -  Fecal calprotectin &lt; 150 ug/g&#xD;
  &#xD;
                 -  Fulfilling the Rome IV criteria for IBS.&#xD;
  &#xD;
            -  Age between 18 and 70 years;&#xD;
  &#xD;
            -  Minimal baseline score of 150 points on the IBS-SSS scale&#xD;
  &#xD;
            -  Ability to understand and speak the Dutch language&#xD;
  &#xD;
            -  Ability to understand how to utilize the ESM and Traqq applications.&#xD;
  &#xD;
          Exclusion criteria IBS patients&#xD;
  &#xD;
            -  Any organic explanation for the abdominal symptoms;&#xD;
  &#xD;
            -  A history of abdominal surgery, except for uncomplicated appendectomy, laparoscopic&#xD;
               cholecystectomy and hysterectomy is present;&#xD;
  &#xD;
            -  Pregnant or lactating at the baseline visit.&#xD;
  &#xD;
          Exclusion criteria IBD patients&#xD;
  &#xD;
            -  Uncertainty about the absence of active inflammation&#xD;
  &#xD;
            -  Uncertainty about other explanatory causes for the GI symptoms, such as bile acid&#xD;
               malabsorption, intestinal stenosis, or small intestinal bacterial overgrowth;&#xD;
  &#xD;
            -  Pregnant or lactating at the baseline visit.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Daan Bosch, BSc</last_name>
      <phone>0433-884295</phone>
      <email>daan.bosch@maastrichtuniversity.nl</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Zlatan Mujagic, MD, PhD</last_name>
      <phone>0433-875021</phone>
      <email>z.mujagic@maastrichtuniversity.nl</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Maastricht UMC+</name>
        <address>
          <city>Maastricht</city>
          <state>Limburg</state>
          <zip>6229HX</zip>
          <country>Netherlands</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Daan Bosch, BSc</last_name>
        <phone>0433-884295</phone>
        <email>daan.bosch@maastrichtuniversity.nl</email>
      </contact>
      <contact_backup>
        <last_name>Zlatan Mujagic, MD, PhD</last_name>
        <phone>0433-875021</phone>
        <email>z.mujagic@maastrichtuniversity.nl</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Netherlands</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Experience Sampling Method</keyword>
    <keyword>Traqq</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Crohn Disease</mesh_term>
      <mesh_term>Intestinal Diseases</mesh_term>
      <mesh_term>Inflammatory Bowel Diseases</mesh_term>
      <mesh_term>Irritable Bowel Syndrome</mesh_term>
      <mesh_term>Gastrointestinal Diseases</mesh_term>
      <mesh_term>Digestive System Diseases</mesh_term>
      <mesh_term>Syndrome</mesh_term>
      <mesh_term>Abdominal Pain</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>All research data will be saved as an SPSS file with all available metadata such as variables, value labels and definitions of missing data in accordance with the existing codebooks. In addition, the research data will be saved as csv files. After completion of the study, the data will be archived and the data will be stored in accordance with the required format of the relevant data archive.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_info_type>Analytic Code</ipd_info_type>
    </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/NCT05998577
  org study id: NL82286.068.22
  nct id: NCT05998577
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Apart from its use to provide insight in IBS disease courses and in clinical research, ESM
        can provide patients with feedback about individual triggers of their symptoms, and thereby
        function as part of a personalized therapeutic strategy. This is also true for IBD-IBS.
        Treatment strategies in IBS and IBD-IBS are largely based on reassurance, identification and
        elimination of triggering factors, and in more severe cases pharmaco- and psychotherapy. The
        ESM approach has the potential to increase therapeutic efficacy in IBS and IBD-IBS and will
        assist patients in disease self-management. The Traqq application can provide more detailed
        information about the dietary pattern of IBS and IBD-IBS patients. Traqq in combination with
        ESM will give an overview of abdominal pain and associated symptoms and psychosocial factors
        are exposed to during the day. The insight provided using ESM and Traqq may improve patient
        understanding of their personal symptom dynamics and triggers, as well as the physician's
        insight into the symptom patters of the specific patients, which may aid treatment choice and
        eventually improve the outcome of any treatment provided in daily clinical care.
  This is an unicenter, prospective, proof-of-concept randomized controlled, non-blinded
        intervention study that focuses on two patient populations, with overlapping symptom patterns
        and treatment approaches, i.e. patients with IBS and IBD-IBS.
  
        Following written informed consent, the eligibility screening is performed and instructions
        about the study procedures will be given. Hereafter, both groups will independently be
        randomized into i) an ESM/Traqq arm or ii) a standard care arm. The intervention group and
        the control group will complete the IBS-SSS, EO-5D-5L, GAD-7, PHQ-9, VSI, and MFl-20 as well
        as the Rome IV criteria for IBS and functional dyspepsia at baseline and the intervention
        group will complete thereafter the ESM and Traqq applications during the first week. After
        this week, the data will be analysed to identify associations between abdominal pain and
        psychosocial factors, diet or other GI associated symptoms. About two weeks later,
        participants will have their second visitation at the outpatient clinic with their treating
        physician. In the intervention group, but not the control group, the patient and the treating
        physician will receive the results of the personal data of the patients based on ESM and
        Traqq. The insight participants and their physicians get from this information, will help
        them to make changes in lifestyle factors that affect their symptoms or to choose a
        pharmacological or non-pharmacological treatment. However, the study protocol will not
        indicate which treatment choice should be made by the patient and their treating physicians.
        That choice will still be based on shared decision making, just as in the standard care arm,
        only with the additional data provided. Furthermore, if the patients are referred to a
        dietician, psychologist, or both, the digital data obtained in the intervention group can be
        used to personalize the therapy. After giving informed consent by the participant for the
        data of ESM and Traqq being sent to the dietician or psychologist they are referred to, the
        coordinating investigator will send the data digitally to the dietician or psychologist that
        is needed for the personalized treatment. Participants in the control arm will get a
        consultation with the gastroenterologist as usual after the same period of time as the
        intervention group get their consultation. The participants of the control group will be
        given treatment advice only based on this consultation, the PDSkeuzehulp by shared decision
        making, according to standard care. Twelve weeks after the second outpatient visit,
        independently of the chosen treatment approach, the participants in both study groups will be
        asked to complete IBS-SSS, EQ-5D-5L, GAD-7, PHO-9, VSI, MFI-20 and Rome IV criteria for IBS
        and functional dyspepsia for the second time to evaluate whether there is an effect on 1)
        reduction of abdominal pain and 2) quality of life, psychological aspects or fatigue of the
        participants due to the insight provided by ESM and Traqq.
  
        After those twelve weeks, the coordinating investigator will contact the participants of the
        intervention group and control group by phone for the last time. Participants are asked what
        treatment they have gotten and what lifestyle modifications they have done to reduce
        abdominal pain. To improve compliance for completing the questionnaires by the control group,
        the participants in the control group will get the opportunity to use the ESM and Traqq
        applications after the study has been completed. This will not be part of this study but can
        be beneficial for those individuals who have not got any additional insight about their
        symptoms by getting the standard care.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: IBS-SSS
  time frame: 12 weeks after outpatient clinic visit
  description: Change in IBS-SSS to see whether IBS symptoms are improved
  measure: GAD-7
  time frame: 12 weeks after outpatient clinic visit
  description: Change in GAD-7 to see whether complaints of anxiety are improved
  measure: MFI-20
  time frame: 12 weeks after outpatient clinic visit
  description: Change in MFI-20 to see whether fatigue is improved
  measure: PHQ-9
  time frame: 12 weeks after outpatient clinic visit
  description: Change in PHQ-9 to see whether complaints of depression are improved
  measure: VSI
  time frame: 12 weeks after outpatient clinic visit
  description: Change in VSI to see whether complaints of GI related anxiety are improved
  measure: EQ-5D-5L
  time frame: 12 weeks after outpatient clinic visit
  description: Change in EQ-5D-5L to see whether quality of life is improved
  arm group label: ESM/Traqq
  arm group type: Experimental
  description: Use of ESM and Traqq for one week to get a personalised analysis of the abdominal pain and triggerfactors that can be used at the outpatient clinic visit to select an effective treatment option.
  arm group label: Standard care
  arm group type: No Intervention
  description: Will not be using ESM and Traqq, but will only get a standard outpatient clinic visit together with PDSkeuzehulp to make a decision for a treatment.
  intervention type: Device
  intervention name: ESM and Traqq
  description: Two telephone applications: ESM is a psychosocial diary and Traqq is a food diary to measure abdominal pain as well as possible triggerfactors (i.e. diet, stress, anxiety)
  arm group label: ESM/Traqq
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Daan Bosch, BSc
  phone: 0433-884295
  email: daan.bosch@maastrichtuniversity.nl
  last name: Zlatan Mujagic, MD, PhD
  phone: 0433-875021
  email: z.mujagic@maastrichtuniversity.nl
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Netherlands
  responsible party type: Sponsor
  mesh term: Crohn Disease
  mesh term: Intestinal Diseases
  mesh term: Inflammatory Bowel Diseases
  mesh term: Irritable Bowel Syndrome
  mesh term: Gastrointestinal Diseases
  mesh term: Digestive System Diseases
  mesh term: Syndrome
  mesh term: Abdominal Pain
  sharing ipd: Yes
  ipd description: All research data will be saved as an SPSS file with all available metadata such as variables, value labels and definitions of missing data in accordance with the existing codebooks. In addition, the research data will be saved as csv files. After completion of the study, the data will be archived and the data will be stored in accordance with the required format of the relevant data archive.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd info type: Analytic Code