<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/NCT03798756</url>
  </required_header>
  <id_info>
    <org_study_id>RG-0275-18 V1.0</org_study_id>
    <nct_id>NCT03798756</nct_id>
  </id_info>
  <brief_title>Automated Check-in Data Collection Study</brief_title>
  <acronym>ACDC</acronym>
  <official_title>Automated Check-in Data Collection Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Keele University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Keele 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 aim of this study is to examine patient acceptability, for providing brief research&#xD;
      information, whilst self-completing an automated check-in screen prior to any general&#xD;
      practice consultation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Automated Check-in Data Collection (AC DC) Study, is a pilot feasibility study, observing&#xD;
      patients consulting in general practice and completing an automated check-in screen prior to&#xD;
      their booked appointment, to confirm their attendance. Participants will be recruited over&#xD;
      three weeks from approximately 11 participating general practices.&#xD;
&#xD;
      The primary objective of the study is to assess patient acceptability for answering brief&#xD;
      research questions in the general practice waiting room, using an automated check-in screen.&#xD;
      This will be measured by observing the percentage of completed automated check-in screens&#xD;
      with entered research data.&#xD;
&#xD;
      Secondary objectives will assess check-in completion of self-reported pain and willingness to&#xD;
      be contacted about future research studies of relevance. Reported severity of bodily pain&#xD;
      experienced over the last 4 weeks and the proportion of patients agreeing to be contacted&#xD;
      about future research studies of relevance, will be observed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 14, 2019</start_date>
  <completion_date type="Actual">April 14, 2019</completion_date>
  <primary_completion_date type="Actual">April 14, 2019</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>Self-reported Bodily Pain</measure>
    <time_frame>Through study completion at 1st visit (Day 1)</time_frame>
    <description>To assess what self-reported degrees of pain were reported by participants and what proportion of participants did answer a research question within the general practice waiting room using an automated check-in screen.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bodily Pain Response</measure>
    <time_frame>Through study completion at 1st visit (Day 1)</time_frame>
    <description>Proportion of participants answering the bodily pain research question using an automated check-in screen.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Consent to Contact Response</measure>
    <time_frame>Through study completion at 1st visit (Day 1)</time_frame>
    <description>Proportion of participants answering the consent to contact research question using an automated check-in screen.</description>
  </secondary_outcome>
  <enrollment type="Actual">9274</enrollment>
  <condition>Primary Care</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All patients of age 18 and over, who can read and respond in English and with a booked&#xD;
        appointment, consulting with any Health Care Professional (HCP) at their general practice,&#xD;
        during the recruitment period will be eligible to participate. All patients are required to&#xD;
        confirm their attendance at the general practice by using the automated check-in screen. If&#xD;
        the patient completing the automated check-in screen is 18 years of age or over, the&#xD;
        additional two research questions will appear for completion.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients 18 years of age or over attending participating general practices for a&#xD;
             consultation with any healthcare professional.&#xD;
&#xD;
          -  Patients registered with the participating general practice during the specified&#xD;
             recruitment period.&#xD;
&#xD;
          -  Patients able to read and respond in English.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Patients under the age of 18 attending the general practice for a consultation with a&#xD;
        healthcare professional.&#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>
  <overall_official>
    <last_name>Christian D Mallen</last_name>
    <role>Study Director</role>
    <affiliation>University of Keele</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>New Cross Hospital</name>
      <address>
        <city>Wolverhampton</city>
        <zip>WV10 0QP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>September 14, 2018</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <results_first_submitted>February 23, 2021</results_first_submitted>
  <results_first_submitted_qc>March 23, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">April 19, 2021</results_first_posted>
  <last_update_submitted>March 23, 2021</last_update_submitted>
  <last_update_submitted_qc>March 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 5, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/56/NCT03798756/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Cohort</title>
          <description>Automated check-in</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="9274"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9274"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Cohort</title>
          <description>This was a Cohort, there were no arms. It was an entire group.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="9274"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="9274"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5982"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3292"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="9274"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5653"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3621"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United Kingdom</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="9274"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9274"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Patients checking in for a consultation, answering a research question, using check-in sceen</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="9274"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9274"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Self-reported Bodily Pain</title>
        <description>To assess what self-reported degrees of pain were reported by participants and what proportion of participants did answer a research question within the general practice waiting room using an automated check-in screen.</description>
        <time_frame>Through study completion at 1st visit (Day 1)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bodily Pain</title>
            <description>To assess patient acceptability of answering a research question on bodily pain, in the general practice waiting room using an automated check-in screen.</description>
          </group>
        </group_list>
        <measure>
          <title>Self-reported Bodily Pain</title>
          <description>To assess what self-reported degrees of pain were reported by participants and what proportion of participants did answer a research question within the general practice waiting room using an automated check-in screen.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9274"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2937"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Very mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1061"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mild</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1446"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Moderate</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2344"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="1125"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Very Severe</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not documented</title>
                  <measurement_list>
                    <measurement group_id="O1" value="352"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Bodily Pain Response</title>
        <description>Proportion of participants answering the bodily pain research question using an automated check-in screen.</description>
        <time_frame>Through study completion at 1st visit (Day 1)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cohort</title>
            <description>Automated check-in</description>
          </group>
        </group_list>
        <measure>
          <title>Bodily Pain Response</title>
          <description>Proportion of participants answering the bodily pain research question using an automated check-in screen.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9274"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8922"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Consent to Contact Response</title>
        <description>Proportion of participants answering the consent to contact research question using an automated check-in screen.</description>
        <time_frame>Through study completion at 1st visit (Day 1)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bodily Pain</title>
            <description>To assess patient acceptability of answering a research question on bodily pain, in the general practice waiting room using an automated check-in screen.</description>
          </group>
        </group_list>
        <measure>
          <title>Consent to Contact Response</title>
          <description>Proportion of participants answering the consent to contact research question using an automated check-in screen.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="9274"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8285"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Cohort</title>
          <description>All those patients checking-in for a pre-booked consultation using an automated check-in screen and answering at least one research question</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Mrs Sarah Lawton</name_or_title>
      <organization>Keele University</organization>
      <phone>01782 734887</phone>
      <email>s.a.lawton@keele.ac.uk</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03798756
org study id: RG-0275-18 V1.0
nct id: NCT03798756
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to examine patient acceptability, for providing brief research
      information, whilst self-completing an automated check-in screen prior to any general
      practice consultation.
The Automated Check-in Data Collection (AC DC) Study, is a pilot feasibility study, observing
      patients consulting in general practice and completing an automated check-in screen prior to
      their booked appointment, to confirm their attendance. Participants will be recruited over
      three weeks from approximately 11 participating general practices.

      The primary objective of the study is to assess patient acceptability for answering brief
      research questions in the general practice waiting room, using an automated check-in screen.
      This will be measured by observing the percentage of completed automated check-in screens
      with entered research data.

      Secondary objectives will assess check-in completion of self-reported pain and willingness to
      be contacted about future research studies of relevance. Reported severity of bodily pain
      experienced over the last 4 weeks and the proportion of patients agreeing to be contacted
      about future research studies of relevance, will be observed.
observational model: Cohort
time perspective: Prospective
measure: Self-reported Bodily Pain
time frame: Through study completion at 1st visit (Day 1)
description: To assess what self-reported degrees of pain were reported by participants and what proportion of participants did answer a research question within the general practice waiting room using an automated check-in screen.
measure: Bodily Pain Response
time frame: Through study completion at 1st visit (Day 1)
description: Proportion of participants answering the bodily pain research question using an automated check-in screen.
measure: Consent to Contact Response
time frame: Through study completion at 1st visit (Day 1)
description: Proportion of participants answering the consent to contact research question using an automated check-in screen.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Christian D Mallen
role: Study Director
affiliation: University of Keele
facility: 
country: United Kingdom
responsible party type: Sponsor
sharing ipd: Undecided
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 