<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/NCT03824210</url>
  </required_header>
  <id_info>
    <org_study_id>RD2018-70</org_study_id>
    <nct_id>NCT03824210</nct_id>
  </id_info>
  <brief_title>A Study to Co-produce a Young Carers App</brief_title>
  <official_title>A Study to Co-produce, and Explore the Impact of, an App-based Support Intervention on Young Carers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>East and North Hertfordshire NHS Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>East and North Hertfordshire NHS 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>
      This study will co-produce and pilot-test a mobile phone App and a booklet, with input from&#xD;
      local secondary schools and carer support groups to develop and pilot-test the App, in order&#xD;
      to ensure it is designed to meet young people's needs. This App will serve to increase&#xD;
      knowledge, information and provide strong links for young carers and local support&#xD;
      available.This is a mixed methods study, using a transformative design. A transformative&#xD;
      approach centres on users' needs and uses their experiences to shape how the App will look&#xD;
      (in this case, uses are young carers). Carers will co-produce the App and booklet. The study&#xD;
      will explore how a free app-based online support tool can help enhance support for young&#xD;
      carers. Young carers have been involved since the outset and drove this planned study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will provide evidence about App usage in young carers (YCs), there is no evidence&#xD;
      to date on this to the researcher's knowledge. While there are articles and reports on young&#xD;
      carers and their experiences there is very little actual empirical research, partly due to&#xD;
      the hard-to-reach population and their carer responsibilities and associated experiences&#xD;
      (such as carer burden).&#xD;
&#xD;
      The study seeks to identify the gap between estimated and actual numbers of young carers, as&#xD;
      part of Stage 3, which will again add to the evidence base as this has not previously been&#xD;
      reported. The study will be able to describe the impact of a technology-based intervention to&#xD;
      increase support for YCs.&#xD;
&#xD;
      This research will also contribute to understanding how App-based support can help YC,&#xD;
      specifically exploring how receiving centralised, comprehensive information regarding:&#xD;
      looking after their own health; having time off from carer duties and resources to support&#xD;
      them getting this; self-awareness or self-identification of carer responsibilities and the&#xD;
      impact of being a carer, might help.&#xD;
&#xD;
      Young Carers have also talked about the need for networks and support; these individuals will&#xD;
      then be able to access Young Carers in Herts - and find support locally via professionals&#xD;
      (they can access links to counsellors via the App -in order to receive mental health support)&#xD;
      as well as other young carers (peer support, identified as very important in other recent&#xD;
      local work).&#xD;
&#xD;
      This proposed research, through the qualitative interviews and focus groups, will also allow&#xD;
      investigators to contribute an in-depth picture of (including a longitudinal description from&#xD;
      the YCs in-depth interviews over the course of a year) of young carers' needs, and identify&#xD;
      where needs are not being met and what could be done to improve their experiences. Having&#xD;
      contextual data from interviews from peers (senior school age children), who may themselves&#xD;
      end up becoming young carers, will also give us data to contrast.&#xD;
&#xD;
      This research will also help primary and secondary care providers to understand the needs and&#xD;
      identification of this group. Although the study is not explicitly looking at this, the&#xD;
      researchers hope to look at this in future work.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 20, 2019</start_date>
  <completion_date type="Anticipated">December 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2020</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>To understand young carer experiences, co-produce and develop an App for young carers 11yrs-18yrs age range in order to improve outcomes for family members and young carers</measure>
    <time_frame>18 months</time_frame>
    <description>Measured by qualitative feedback on the app via transcriptions. Includes understanding of transition points such as admission/discharge to hospital.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Formulation of a Young Carer Handbook</measure>
    <time_frame>18 months</time_frame>
    <description>Co-creation of a Young Carer Handbook</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gain understanding of App usage</measure>
    <time_frame>18 months</time_frame>
    <description>Number of views and downloads</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Explore usefulness of the App and experience of caring over time</measure>
    <time_frame>18 months</time_frame>
    <description>Transcripts of qualitative feedback</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Capture information on referral rates of Young Carers before and after App introduction</measure>
    <time_frame>18 months</time_frame>
    <description>Number of referrals of Young carers in Herts</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Caring</condition>
  <arm_group>
    <arm_group_label>Stage 1</arm_group_label>
    <description>School children age 11-18 (from two nominated schools) and young carers 11-18</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Stage 2</arm_group_label>
    <description>Young carers from Young Carers in Herts 11-18</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>App</intervention_name>
    <description>Mobile phone app</description>
    <arm_group_label>Stage 1</arm_group_label>
    <arm_group_label>Stage 2</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Young Carers in Hertfordshire&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  School children from nominated schools in Hertfordshire (stage 1)&#xD;
&#xD;
          -  Ability to provide informed consent (consent processes/literature will be age&#xD;
             appropriate 11-17) (stage 2)&#xD;
&#xD;
          -  Able to complete questionnaires (stage 2)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Does not speak or understand English&#xD;
&#xD;
          -  Lacks mental capacity&#xD;
&#xD;
          -  Young carers outside Hertfordshire&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>11 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Natalie Pattison</last_name>
    <phone>07543220056</phone>
    <email>Natalie.pattison@nhs.net</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jodie Deards</last_name>
    <phone>07554438517</phone>
    <email>Jodie.deards1@nhs.net</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>East and North Hertfordshire NHS Trust</name>
      <address>
        <city>Stevenage</city>
        <zip>SG14AB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Natalie Pattison</last_name>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>May 22, 2019</last_update_submitted>
  <last_update_submitted_qc>May 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Identifiable data will not be shared with other researchers. The publication plan in the study protocol will be followed.</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/NCT03824210
org study id: RD2018-70
nct id: NCT03824210
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will co-produce and pilot-test a mobile phone App and a booklet, with input from
      local secondary schools and carer support groups to develop and pilot-test the App, in order
      to ensure it is designed to meet young people's needs. This App will serve to increase
      knowledge, information and provide strong links for young carers and local support
      available.This is a mixed methods study, using a transformative design. A transformative
      approach centres on users' needs and uses their experiences to shape how the App will look
      (in this case, uses are young carers). Carers will co-produce the App and booklet. The study
      will explore how a free app-based online support tool can help enhance support for young
      carers. Young carers have been involved since the outset and drove this planned study.
This study will provide evidence about App usage in young carers (YCs), there is no evidence
      to date on this to the researcher's knowledge. While there are articles and reports on young
      carers and their experiences there is very little actual empirical research, partly due to
      the hard-to-reach population and their carer responsibilities and associated experiences
      (such as carer burden).

      The study seeks to identify the gap between estimated and actual numbers of young carers, as
      part of Stage 3, which will again add to the evidence base as this has not previously been
      reported. The study will be able to describe the impact of a technology-based intervention to
      increase support for YCs.

      This research will also contribute to understanding how App-based support can help YC,
      specifically exploring how receiving centralised, comprehensive information regarding:
      looking after their own health; having time off from carer duties and resources to support
      them getting this; self-awareness or self-identification of carer responsibilities and the
      impact of being a carer, might help.

      Young Carers have also talked about the need for networks and support; these individuals will
      then be able to access Young Carers in Herts - and find support locally via professionals
      (they can access links to counsellors via the App -in order to receive mental health support)
      as well as other young carers (peer support, identified as very important in other recent
      local work).

      This proposed research, through the qualitative interviews and focus groups, will also allow
      investigators to contribute an in-depth picture of (including a longitudinal description from
      the YCs in-depth interviews over the course of a year) of young carers' needs, and identify
      where needs are not being met and what could be done to improve their experiences. Having
      contextual data from interviews from peers (senior school age children), who may themselves
      end up becoming young carers, will also give us data to contrast.

      This research will also help primary and secondary care providers to understand the needs and
      identification of this group. Although the study is not explicitly looking at this, the
      researchers hope to look at this in future work.
observational model: Other
time perspective: Prospective
measure: To understand young carer experiences, co-produce and develop an App for young carers 11yrs-18yrs age range in order to improve outcomes for family members and young carers
time frame: 18 months
description: Measured by qualitative feedback on the app via transcriptions. Includes understanding of transition points such as admission/discharge to hospital.
measure: Formulation of a Young Carer Handbook
time frame: 18 months
description: Co-creation of a Young Carer Handbook
measure: Gain understanding of App usage
time frame: 18 months
description: Number of views and downloads
measure: Explore usefulness of the App and experience of caring over time
time frame: 18 months
description: Transcripts of qualitative feedback
measure: Capture information on referral rates of Young Carers before and after App introduction
time frame: 18 months
description: Number of referrals of Young carers in Herts
arm group label: Stage 1
description: School children age 11-18 (from two nominated schools) and young carers 11-18
arm group label: Stage 2
description: Young carers from Young Carers in Herts 11-18
intervention type: Other
intervention name: App
description: Mobile phone app
arm group label: Stage 1
arm group label: Stage 2
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 11 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Natalie Pattison
phone: 07543220056
email: Natalie.pattison@nhs.net
last name: Jodie Deards
phone: 07554438517
email: Jodie.deards1@nhs.net
facility: 
status: Recruiting
contact: 
country: United Kingdom
responsible party type: Sponsor
sharing ipd: No
ipd description: Identifiable data will not be shared with other researchers. The publication plan in the study protocol will be followed.