<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/NCT03777527</url>
  </required_header>
  <id_info>
    <org_study_id>5843</org_study_id>
    <nct_id>NCT03777527</nct_id>
  </id_info>
  <brief_title>PICU Patient Diary</brief_title>
  <official_title>My PICU Diary: a Patient Diary for Critically Ill Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McMaster University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>McMaster University</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 PICU-Diary study is a prospective single centre pilot study in the Pediatric Critical&#xD;
      Care Unit at McMaster Children's Hospital. We will evaluate the impressions of family&#xD;
      caregivers and healthcare providers on the PICU Patient Diary, and its acceptability for use&#xD;
      in the PICU, using mixed methods. We will assess the feasibility of assessing the impact of a&#xD;
      patient diary on PICU outcomes and psychological distress in critically ill children, 1 month&#xD;
      following PICU discharge.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There is considerable need for research dedicated to exploring interventions to improve the&#xD;
      psychological and functional effects of critical care admission on patients and families.&#xD;
      Patient diaries are one approach that has been used in several adult critical care groups and&#xD;
      has been shown to positively impact patient care by helping patients better understand their&#xD;
      illness, acting as a therapeutic tool and debriefing aid, and providing an outlet for&#xD;
      caregivers to participate in care plans. However, to date, there is minimal research&#xD;
      available in the pediatric population.&#xD;
&#xD;
      The specific objectives of this study are to evaluate the acceptability and impressions of a&#xD;
      patient diary as a supportive measure for critically ill children in the PICU. Our secondary&#xD;
      objective is to evaluate the feasibility of measuring the impact of a patient diary on&#xD;
      psychological distress in critically ill children, following discharge from the PICU.&#xD;
&#xD;
      The purpose of this diary is to support the recovery of critically ill children and their&#xD;
      family members by:&#xD;
&#xD;
        1. Helping patients understand visually and in written form as age appropriate, what has&#xD;
           happened to them during their PICU stay, how ill they were, and in so doing, reduce&#xD;
           anxiety and post-traumatic stress symptoms; AND&#xD;
&#xD;
        2. Serving as an engagement tool to help families take on an informed, active role in their&#xD;
           child's care plan.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">October 30, 2019</start_date>
  <completion_date type="Anticipated">June 30, 2021</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</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 Diary Acceptability</measure>
    <time_frame>1 day</time_frame>
    <description>Acceptability of the diary to family members, patients, and healthcare providers in the PICU to determine the perception of impact of the diary on patient recovery. Information collected with surveys and qualitative interviews.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasability of measuring psychological well-being</measure>
    <time_frame>1 day</time_frame>
    <description>Patient reported outcome measure of psychological well-being after critical illness with Children's Critical Illness Impact Scale</description>
  </primary_outcome>
  <enrollment type="Actual">20</enrollment>
  <condition>Critical Illness</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Critically ill patients and their families admitted to the PICU at McMaster Children's&#xD;
        Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Consecutive patients admitted to the PICU will be screened for eligibility to&#xD;
             participate in the evaluation component of the PICU Diary study&#xD;
&#xD;
          -  We will offer a PICU Diary to families of any critically ill children admitted to the&#xD;
             PICU for at least 72 hours and who are fluent in the English language&#xD;
&#xD;
          -  Eligible patients and their families will be approached for consent to participate, by&#xD;
             a member of the investigator team (MB, KC, SB or CC). For those who consent to&#xD;
             participate, they will be oriented to the diary and its use.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Stay less than 72 hours&#xD;
&#xD;
          -  Not fluent in the English language&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Karen Choong, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>McMaster University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>McMaster Children's Hospital</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8S4K1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>February 23, 2021</last_update_submitted>
  <last_update_submitted_qc>February 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 25, 2021</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>Critical Illness</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/NCT03777527
org study id: 5843
nct id: NCT03777527
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The PICU-Diary study is a prospective single centre pilot study in the Pediatric Critical
      Care Unit at McMaster Children's Hospital. We will evaluate the impressions of family
      caregivers and healthcare providers on the PICU Patient Diary, and its acceptability for use
      in the PICU, using mixed methods. We will assess the feasibility of assessing the impact of a
      patient diary on PICU outcomes and psychological distress in critically ill children, 1 month
      following PICU discharge.
There is considerable need for research dedicated to exploring interventions to improve the
      psychological and functional effects of critical care admission on patients and families.
      Patient diaries are one approach that has been used in several adult critical care groups and
      has been shown to positively impact patient care by helping patients better understand their
      illness, acting as a therapeutic tool and debriefing aid, and providing an outlet for
      caregivers to participate in care plans. However, to date, there is minimal research
      available in the pediatric population.

      The specific objectives of this study are to evaluate the acceptability and impressions of a
      patient diary as a supportive measure for critically ill children in the PICU. Our secondary
      objective is to evaluate the feasibility of measuring the impact of a patient diary on
      psychological distress in critically ill children, following discharge from the PICU.

      The purpose of this diary is to support the recovery of critically ill children and their
      family members by:

        1. Helping patients understand visually and in written form as age appropriate, what has
           happened to them during their PICU stay, how ill they were, and in so doing, reduce
           anxiety and post-traumatic stress symptoms; AND

        2. Serving as an engagement tool to help families take on an informed, active role in their
           child's care plan.
observational model: Cohort
time perspective: Prospective
measure: Patient Diary Acceptability
time frame: 1 day
description: Acceptability of the diary to family members, patients, and healthcare providers in the PICU to determine the perception of impact of the diary on patient recovery. Information collected with surveys and qualitative interviews.
measure: Feasability of measuring psychological well-being
time frame: 1 day
description: Patient reported outcome measure of psychological well-being after critical illness with Children's Critical Illness Impact Scale
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Karen Choong, MD
role: Principal Investigator
affiliation: McMaster University
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Critical Illness
sharing ipd: No