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/NCT06015789</url>
    </required_header>
    <id_info>
      <org_study_id>5886</org_study_id>
      <nct_id>NCT06015789</nct_id>
    </id_info>
    <brief_title>Self-care in Patients Affected by Inflammatory Bowel Disease and Caregivers' Contribution to Self-care</brief_title>
    <official_title>Self-care in Patients Affected by Inflammatory Bowel Disease and Caregivers' Contribution to Self-care</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The Inflammatory Bowel Disease (IBD) is a chronic inflammatory disease of the&#xD;
        gastrointestinal tract including Crohn's disease and Ulcerative Colitis. The course of IBD is&#xD;
        frequently progressive and can be hardly predictable, with sudden exacerbations of intestinal&#xD;
        symptoms. Epidemiological studies have shown that IBD has an increasing prevalence to reach&#xD;
        10 million people in 2030. These diseases require frequent interactions between patients and&#xD;
        the healthcare system, or symptom management with continuous therapies, gastroenterological&#xD;
        visits, surgery, contacts for resolution of urgent symptoms from telephone and email, access&#xD;
        to the emergency, hospitalizations, nutritional counseling, psychological interventions and&#xD;
        follow-up controls. An IBD can completely disrupt a family's ability to function normally and&#xD;
        often imposes a strain on family members' relationships. In the model of self-care in chronic&#xD;
        diseases, according to Riegel's &quot;Middle Range Theory&quot;, there are external factors, predictive&#xD;
        factors that can influence and limit the patient's attitude and therefore his self-esteem,&#xD;
        the ability to implement decision-making behaviors to improve and increase his self-care.&#xD;
        There are also factors that influence a person's self-care decisions: the particular&#xD;
        caregivers. In this process, the role of the caregiver and the dyad he establishes with the&#xD;
        patient can influence the whole process of self-confidence and self-care. The objectives of&#xD;
        the study are to investigate and describe self-care in patients with IBD and how their&#xD;
        caregivers in dyadic interaction can contribute.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 4, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 5, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Evaluate the factors that affect the self-care of the patient with IBD, of the caregiver and of their dyadic interaction;</measure>
      <time_frame>Day 0, 6 months, 12 months</time_frame>
      <description>Evaluate through the administration of validated questionnaires the level of self-care of outpatient or inpatient IBD patients and their caregivers and correlate it with quality of life, anxiety, stress and other predictive factors</description>
    </primary_outcome>
    <enrollment type="Anticipated">250</enrollment>
    <condition>Inflammatory Bowel Diseases</condition>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Questionnaire</intervention_name>
      <description>Administration of questionnaires for the evaluation of self-care</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The research is multicenter and will be conducted in the IBD units and in the medical&#xD;
          departments of the centers that will decide to join, during visits or hospitalization. Male&#xD;
          or female patient, adult.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  age 18 or older;&#xD;
  &#xD;
            -  voluntary participation in the study;&#xD;
  &#xD;
            -  patient with the diagnosis of IBD outpatients and non-hospitalized;&#xD;
  &#xD;
            -  caregiver of patients with IBD diagnosis outpatients and hospitalised;&#xD;
  &#xD;
            -  Reading and signing informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  patients with a diagnosis of IBD for less than 12 months;&#xD;
  &#xD;
            -  caregivers of patients with an IBD diagnosis for fewer than 12 months;&#xD;
  &#xD;
            -  patients operated for less than 6 months; care providers of patients operating less&#xD;
               than six months;&#xD;
  &#xD;
            -  reduced mastery of the Italian language;&#xD;
  &#xD;
            -  subjects suffering from serious psychiatric disorders;&#xD;
  &#xD;
            -  serious clinical conditions that would not allow the completion of the questionnaire;&#xD;
  &#xD;
            -  refusal to sign the informed consent to participate in the study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 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>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Intestinal Diseases</mesh_term>
      <mesh_term>Inflammatory Bowel Diseases</mesh_term>
    </condition_browse>
    <!-- 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/NCT06015789
  org study id: 5886
  nct id: NCT06015789
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The Inflammatory Bowel Disease (IBD) is a chronic inflammatory disease of the
        gastrointestinal tract including Crohn's disease and Ulcerative Colitis. The course of IBD is
        frequently progressive and can be hardly predictable, with sudden exacerbations of intestinal
        symptoms. Epidemiological studies have shown that IBD has an increasing prevalence to reach
        10 million people in 2030. These diseases require frequent interactions between patients and
        the healthcare system, or symptom management with continuous therapies, gastroenterological
        visits, surgery, contacts for resolution of urgent symptoms from telephone and email, access
        to the emergency, hospitalizations, nutritional counseling, psychological interventions and
        follow-up controls. An IBD can completely disrupt a family's ability to function normally and
        often imposes a strain on family members' relationships. In the model of self-care in chronic
        diseases, according to Riegel's "Middle Range Theory", there are external factors, predictive
        factors that can influence and limit the patient's attitude and therefore his self-esteem,
        the ability to implement decision-making behaviors to improve and increase his self-care.
        There are also factors that influence a person's self-care decisions: the particular
        caregivers. In this process, the role of the caregiver and the dyad he establishes with the
        patient can influence the whole process of self-confidence and self-care. The objectives of
        the study are to investigate and describe self-care in patients with IBD and how their
        caregivers in dyadic interaction can contribute.
  observational model: Other
  time perspective: Prospective
  measure: Evaluate the factors that affect the self-care of the patient with IBD, of the caregiver and of their dyadic interaction;
  time frame: Day 0, 6 months, 12 months
  description: Evaluate through the administration of validated questionnaires the level of self-care of outpatient or inpatient IBD patients and their caregivers and correlate it with quality of life, anxiety, stress and other predictive factors
  intervention type: Other
  intervention name: Questionnaire
  description: Administration of questionnaires for the evaluation of self-care
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  responsible party type: Sponsor
  mesh term: Intestinal Diseases
  mesh term: Inflammatory Bowel Diseases