<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/NCT04488471</url>
  </required_header>
  <id_info>
    <org_study_id>STH21414</org_study_id>
    <nct_id>NCT04488471</nct_id>
  </id_info>
  <brief_title>Impact of Isolation in Patients With IBD During the COVID-19 Crisis</brief_title>
  <official_title>Impact of Isolation in Patients With IBD During the 2020 COVID-19 Crisis: a Mixed Methods Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sheffield Teaching Hospitals NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sheffield Teaching Hospitals NHS Foundation Trust</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 coronavirus pandemic has changed healthcare dramatically in a short time. Individuals&#xD;
      with chronic illnesses and services for them have had to adapt and change to deal with&#xD;
      requirements for shielding and social isolation to reduce infection risk and management of&#xD;
      medication investigation and ongoing review.&#xD;
&#xD;
      It is increasingly recognised that the pandemic and the changes to daily life will have had a&#xD;
      series of impacts on patients and health care services, including impacts on patients&#xD;
      psychological well-being and the opportunity to seek medical care for non-CoViD illness.&#xD;
&#xD;
      Psychological symptoms such as depression, anxiety and hopelessness is well described in&#xD;
      adults and young people with inflammatory bowel disease. Quarantine has also been associated&#xD;
      with these psychological symptoms and also post-traumatic stress. It is important to identify&#xD;
      the extent of and factors that influence negative psychological consequences of isolation in&#xD;
      patients with inflammatory bowel disease.&#xD;
&#xD;
      This study will aim to assess what impact the isolation of patients during social isolation&#xD;
      had in terms of psychological well-being - and what are the factors affecting this impact,&#xD;
      particularly in younger and old age groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will use both questionnaires and semi-structured interviews to understand how IBD&#xD;
      patients have been impacted psychologically by the CoViD-19 pandemic and identify various&#xD;
      factors that may affect the extent to which patients have been impacted. This study will also&#xD;
      incorporate longitudinal questionnaire follow-up of the same patients, in order to try and&#xD;
      understand the long-term impact of the pandemic, and to assess changes in psychological&#xD;
      impact accompanying changes in the national situation.&#xD;
&#xD;
      Patients identified from those attending the IBD clinic will be contacted. As part of the&#xD;
      NHSE and local Trust CoViD response, lists of all patients attending the IBD clinics and&#xD;
      those deemed to be at high risk of infection have been created.&#xD;
&#xD;
      This study aims to recruit 100 patients from the high-risk group and 100 patients from the&#xD;
      non-high-risk group. Basedon an approximately 33% response rate, we have therefore elected to&#xD;
      identify 300 patients from the high-risk groups and 300 from non-high-risk groups. These 600&#xD;
      patients in total will be contacted via the post, and mailed:&#xD;
&#xD;
        1. An explanatory cover letter, with instructions on how to participate in the study&#xD;
&#xD;
        2. Participant information sheet (PIS)&#xD;
&#xD;
        3. Consent form&#xD;
&#xD;
        4. Questionnaires&#xD;
&#xD;
        5. A stamped and addressed return envelope&#xD;
&#xD;
      Completion of questionnaire and return to site will constitute as consent for this data to be&#xD;
      used. Postal recruitment is being used to maximise the chances of reaching those who may have&#xD;
      been most affected by isolation and may have limited access to the internet. The consent form&#xD;
      will apply to the optional interview component.&#xD;
&#xD;
      The PIS will include information signposting patients to help and support should they have&#xD;
      difficulties or concerns relating to the study or the psychological impact of their condition&#xD;
      or current situation.&#xD;
&#xD;
      Record of who has been contacted to participate will be kept on NHS computers, with patient&#xD;
      hospital numbers corresponding to anonymous and non-identifiable study identification&#xD;
      numbers. Keeping record will permit there to be available data regarding the questionnaire&#xD;
      return rate. This will also potentially allow for demographic details to be retrieved from&#xD;
      patient records regarding those who did not return responses, to facilitate both assessment&#xD;
      of differences between responders and non-responders and provide information about those who&#xD;
      elected not to participate.&#xD;
&#xD;
      In addition, a sub-set of 32 young people will be contacted and recruited. This sub-set have&#xD;
      already undertaken the assessment of psychological morbidity, outlined below, during a&#xD;
      previous, pre-CoViD outbreak study (STH20960 IRAS: 269881) and have agreed to further&#xD;
      follow-up. These patients will also be contacted via the post to complete the same set of&#xD;
      questionnaires and therefore provide follow-up, to assess whether measures of psychological&#xD;
      morbidity changed following the onset of the CoViD crisis.&#xD;
&#xD;
      Patients will be asked to complete the following questionnaires:&#xD;
&#xD;
        1. IBD symptoms: IBD control questionnaire&#xD;
&#xD;
        2. Experience during the CoViD periods of isolation&#xD;
&#xD;
        3. Impact of event scale (iES-15 questionnaire)&#xD;
&#xD;
        4. Depression Anxiety Stress Scale-21 (DASS-21)&#xD;
&#xD;
      Background information, as listed below, will be collected in order to try and identify&#xD;
      demographic and disease related details which may affect the level of psychological impact&#xD;
      for IBD patients:&#xD;
&#xD;
        1. Age&#xD;
&#xD;
        2. Ethnicity&#xD;
&#xD;
        3. Postcode (used to calculate indices of deprivation scores, using the Indices of Multiple&#xD;
           Deprivation [IMD] tool)&#xD;
&#xD;
        4. Disease type&#xD;
&#xD;
        5. Medication&#xD;
&#xD;
        6. BSG risk group&#xD;
&#xD;
      The same patients will be contacted and asked to complete the questionnaires again after 6&#xD;
      and 12 months to assess changes in psychological impact and relationship to societal&#xD;
      requirements for isolation.&#xD;
&#xD;
      Semi structured interviews will be undertaken with approximately 20 participants. More may be&#xD;
      undertaken until saturation point is reached.&#xD;
&#xD;
      Semi-structured interviews will be undertaken to provide further detail about the experience&#xD;
      of isolation during the pandemic to explore issues to include factors which improve or worsen&#xD;
      the experience of isolation including:&#xD;
&#xD;
        -  The effect of the isolation itself&#xD;
&#xD;
        -  The effect of variations in information provision&#xD;
&#xD;
        -  Concern about infection risk and its variation during the period of &quot;lock-down&quot;&#xD;
&#xD;
        -  Delays to presentation with flare symptoms&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 30, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2022</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>What impact has the isolation of patients during social isolation had in terms of psychological morbidity?</measure>
    <time_frame>Changes in psychological morbidity at 12 months</time_frame>
    <description>Psychological morbidity will be assessed through the 4 questionnaires</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Have levels of psychological morbidity in young people changed from levels prior to the CoViD pandemic?</measure>
    <time_frame>Changes in psychological morbidity at 12 months</time_frame>
    <description>psychological morbidity will be assessed via comparison of questionnaires from affiliated study against the time points of this study</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">232</enrollment>
  <condition>Inflammatory Bowel Diseases</condition>
  <arm_group>
    <arm_group_label>high-risk group</arm_group_label>
    <description>IBD patients who were high risk of infection and were shielding</description>
  </arm_group>
  <arm_group>
    <arm_group_label>low-risk group</arm_group_label>
    <description>IBD patients who were low risk of infection and were following standard quarantine guidance</description>
  </arm_group>
  <arm_group>
    <arm_group_label>young people from affiliated study</arm_group_label>
    <description>32 IBD patients from an affiliated study</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with a clinical diagnosis of IBD who are treated in the clinics of Sheffield&#xD;
        Teaching Hosptials NHS FT&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  IBD Patients who utilise the IBD Clinics at Sheffield Teaching Hospitals NHS FT&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients who are not part of the IBD clinics at STH NHS FT&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alan Lobo, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Sheffield Teaching Hospitals NHS FT</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Luke Barron, MSc</last_name>
    <phone>01142711899</phone>
    <email>luke.barron@nhs.net</email>
  </overall_contact>
  <location>
    <facility>
      <name>Sheffield Teaching Hospitals NHS FT</name>
      <address>
        <city>Sheffield</city>
        <zip>S10 2JF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Luke Barron, MSc</last_name>
      <phone>01142711899</phone>
      <email>luke.barron@nhs.net</email>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>July 27, 2020</last_update_submitted>
  <last_update_submitted_qc>July 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2020</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>Inflammatory Bowel Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>no IPD will be shared with other researchers</ipd_description>
  </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/NCT04488471
org study id: STH21414
nct id: NCT04488471
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The coronavirus pandemic has changed healthcare dramatically in a short time. Individuals
      with chronic illnesses and services for them have had to adapt and change to deal with
      requirements for shielding and social isolation to reduce infection risk and management of
      medication investigation and ongoing review.

      It is increasingly recognised that the pandemic and the changes to daily life will have had a
      series of impacts on patients and health care services, including impacts on patients
      psychological well-being and the opportunity to seek medical care for non-CoViD illness.

      Psychological symptoms such as depression, anxiety and hopelessness is well described in
      adults and young people with inflammatory bowel disease. Quarantine has also been associated
      with these psychological symptoms and also post-traumatic stress. It is important to identify
      the extent of and factors that influence negative psychological consequences of isolation in
      patients with inflammatory bowel disease.

      This study will aim to assess what impact the isolation of patients during social isolation
      had in terms of psychological well-being - and what are the factors affecting this impact,
      particularly in younger and old age groups.
This study will use both questionnaires and semi-structured interviews to understand how IBD
      patients have been impacted psychologically by the CoViD-19 pandemic and identify various
      factors that may affect the extent to which patients have been impacted. This study will also
      incorporate longitudinal questionnaire follow-up of the same patients, in order to try and
      understand the long-term impact of the pandemic, and to assess changes in psychological
      impact accompanying changes in the national situation.

      Patients identified from those attending the IBD clinic will be contacted. As part of the
      NHSE and local Trust CoViD response, lists of all patients attending the IBD clinics and
      those deemed to be at high risk of infection have been created.

      This study aims to recruit 100 patients from the high-risk group and 100 patients from the
      non-high-risk group. Basedon an approximately 33% response rate, we have therefore elected to
      identify 300 patients from the high-risk groups and 300 from non-high-risk groups. These 600
      patients in total will be contacted via the post, and mailed:

        1. An explanatory cover letter, with instructions on how to participate in the study

        2. Participant information sheet (PIS)

        3. Consent form

        4. Questionnaires

        5. A stamped and addressed return envelope

      Completion of questionnaire and return to site will constitute as consent for this data to be
      used. Postal recruitment is being used to maximise the chances of reaching those who may have
      been most affected by isolation and may have limited access to the internet. The consent form
      will apply to the optional interview component.

      The PIS will include information signposting patients to help and support should they have
      difficulties or concerns relating to the study or the psychological impact of their condition
      or current situation.

      Record of who has been contacted to participate will be kept on NHS computers, with patient
      hospital numbers corresponding to anonymous and non-identifiable study identification
      numbers. Keeping record will permit there to be available data regarding the questionnaire
      return rate. This will also potentially allow for demographic details to be retrieved from
      patient records regarding those who did not return responses, to facilitate both assessment
      of differences between responders and non-responders and provide information about those who
      elected not to participate.

      In addition, a sub-set of 32 young people will be contacted and recruited. This sub-set have
      already undertaken the assessment of psychological morbidity, outlined below, during a
      previous, pre-CoViD outbreak study (STH20960 IRAS: 269881) and have agreed to further
      follow-up. These patients will also be contacted via the post to complete the same set of
      questionnaires and therefore provide follow-up, to assess whether measures of psychological
      morbidity changed following the onset of the CoViD crisis.

      Patients will be asked to complete the following questionnaires:

        1. IBD symptoms: IBD control questionnaire

        2. Experience during the CoViD periods of isolation

        3. Impact of event scale (iES-15 questionnaire)

        4. Depression Anxiety Stress Scale-21 (DASS-21)

      Background information, as listed below, will be collected in order to try and identify
      demographic and disease related details which may affect the level of psychological impact
      for IBD patients:

        1. Age

        2. Ethnicity

        3. Postcode (used to calculate indices of deprivation scores, using the Indices of Multiple
           Deprivation [IMD] tool)

        4. Disease type

        5. Medication

        6. BSG risk group

      The same patients will be contacted and asked to complete the questionnaires again after 6
      and 12 months to assess changes in psychological impact and relationship to societal
      requirements for isolation.

      Semi structured interviews will be undertaken with approximately 20 participants. More may be
      undertaken until saturation point is reached.

      Semi-structured interviews will be undertaken to provide further detail about the experience
      of isolation during the pandemic to explore issues to include factors which improve or worsen
      the experience of isolation including:

        -  The effect of the isolation itself

        -  The effect of variations in information provision

        -  Concern about infection risk and its variation during the period of "lock-down"

        -  Delays to presentation with flare symptoms
observational model: Cohort
time perspective: Prospective
measure: What impact has the isolation of patients during social isolation had in terms of psychological morbidity?
time frame: Changes in psychological morbidity at 12 months
description: Psychological morbidity will be assessed through the 4 questionnaires
measure: Have levels of psychological morbidity in young people changed from levels prior to the CoViD pandemic?
time frame: Changes in psychological morbidity at 12 months
description: psychological morbidity will be assessed via comparison of questionnaires from affiliated study against the time points of this study
arm group label: high-risk group
description: IBD patients who were high risk of infection and were shielding
arm group label: low-risk group
description: IBD patients who were low risk of infection and were following standard quarantine guidance
arm group label: young people from affiliated study
description: 32 IBD patients from an affiliated study
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Alan Lobo, MD
role: Study Chair
affiliation: Sheffield Teaching Hospitals NHS FT
last name: Luke Barron, MSc
phone: 01142711899
email: luke.barron@nhs.net
facility: 
status: Recruiting
contact: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Inflammatory Bowel Diseases
sharing ipd: No
ipd description: no IPD will be shared with other researchers