<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/NCT03291613</url>
  </required_header>
  <id_info>
    <org_study_id>1R43MD010746-01</org_study_id>
    <secondary_id>0308</secondary_id>
    <secondary_id>1R43MD010746-01</secondary_id>
    <nct_id>NCT03291613</nct_id>
  </id_info>
  <brief_title>Gaming Technology to Engage Adolescent Sickle Cell Patients in Pain Management</brief_title>
  <official_title>PINPOINT: Gaming Technology to Engage Adolescent Sickle Cell Patients in Precision Pain Management</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Klein Buendel, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hilton Publishing Company</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Minority Health and Health Disparities (NIMHD)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Klein Buendel, Inc.</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>
      Sickle cell disease (SCD) is a common genetic disorder characterized by episodes of pain, yet&#xD;
      assessments to identify type, intensity, frequency, and phase of pain among SCD adolescents&#xD;
      is lacking. Research shows that interactive gaming technology can enhance adolescents'&#xD;
      learning, and can be especially effective in delivering health-related messages and tools to&#xD;
      improve their self-care. Pinpoint is an interactive gaming tablet app that will be developed&#xD;
      with the significant input of clinical experts to assist SCD teens with better identification&#xD;
      and self-report of their pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sickle cell disease (SCD) is the most common inherited blood disorder in the U.S. and&#xD;
      disproportionately affects African Americans and Hispanics. Approximately, 1,000 U.S.&#xD;
      children are born with SCD annually. SCD results from abnormal hemoglobin and causes red&#xD;
      blood cells (RBCs) to become misshaped (&quot;sickle-shaped&quot;). Sickled cells can block the flow of&#xD;
      blood in small arteries causing tissue and organ damage and other life-threatening&#xD;
      comorbidities. SCD complications can be serious and have a significant impact upon well-being&#xD;
      and quality of life. Pain is the hallmark symptom associated with SCD, and is the most common&#xD;
      clinical problem seen in children and the number one cause of SCD-related hospital&#xD;
      admissions. If left untreated, these painful episodes can result in morbidity and mortality.&#xD;
      Accurate assessment of pain specifiers (type, frequency, and intensity of pain) can help with&#xD;
      ameliorating pain quickly and effectively. Despite children being accurate self-reporters of&#xD;
      their pain, strategies which are effective and engaging to assist with pain identification&#xD;
      are lacking. Reducing barriers to collection and promoting the value of accurate SCD pain&#xD;
      assessment is a need in pediatric medicine. Pinpoint will be an innovative interactive&#xD;
      assessment tool that engages patients while allowing physicians to collect important health&#xD;
      data. This project will test the feasibility of applying gamification principles to develop a&#xD;
      tablet application (&quot;app&quot;) for 13-17 year olds with SCD. Specifically, this Phase I SBIR&#xD;
      project will (1) develop a Pain Assessment Tool (PAT) to describe and categorize specific&#xD;
      types of pain experienced by adolescents with SCD; and (2) create an app (&quot;Pinpoint&quot;), that&#xD;
      will translate the PAT into gamified technology. The goal of Pinpoint is to engage adolescent&#xD;
      patients and improve pain specification by developing a game-based pain assessment tool&#xD;
      delivered via a tablet app to engage adolescent SCD patients, improve their pain&#xD;
      specification self-report, and improve pain management by clinicians. The PAT will be&#xD;
      developed using expert guidance from preeminent SCD clinicians. User-centered Design theory&#xD;
      will be applied in the development of the app and will be guided by iterative cognitive&#xD;
      interviews and focus groups with members of the target population, SCD teens. The project&#xD;
      specific aims are to (1) develop the PAT using guidance from an Expert Advisory Board (EAB)&#xD;
      of SCD clinicians; (2) conduct a series of cognitive interviews with adolescent SCD patients&#xD;
      to guide and refine PAT development; (3) conduct iterative focus groups with adolescent SCD&#xD;
      patients to guide and refine user interface design of the Pinpoint app; (4) program a&#xD;
      functional Pinpoint prototype; and (5) conduct usability testing of the prototype with 13-17&#xD;
      year old SCD patients to assess functionality, navigation, and satisfaction. This project is&#xD;
      innovative and timely. Pinpoint will be the first tablet app to identify and translate&#xD;
      specific pain types for SCD into a gamified app using applied gamification principles.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 15, 2017</start_date>
  <completion_date type="Actual">September 30, 2017</completion_date>
  <primary_completion_date type="Actual">September 30, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>System Usability Questionnaire</measure>
    <time_frame>After 1-hour usability session</time_frame>
    <description>Ten likert-type questions assessing user-friendliness of technology. Each question has five answer options that range from &quot;Strongly Agree&quot; to &quot;Strongly Disagree&quot;. Scores range from 0-100. A score of 68 or above is considered above average. All scores averaged.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Sickle Cell Disease</condition>
  <arm_group>
    <arm_group_label>Pinpoint App</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tablet application.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pinpoint App</intervention_name>
    <description>Tablet app with pain assessment and communication education, and pain assessment tool.</description>
    <arm_group_label>Pinpoint App</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Phone Interview, Focus Group, and Usability Inclusion Criteria:&#xD;
&#xD;
          -  Be 13-17 years of age&#xD;
&#xD;
          -  Be diagnosed with Sickle Cell Disease&#xD;
&#xD;
          -  Able to read and speak English&#xD;
&#xD;
          -  Able to assent to participate&#xD;
&#xD;
        Phone Interview, Focus Group, and Usability Exclusion Criteria:&#xD;
&#xD;
          -  Not 13-17 years of age&#xD;
&#xD;
          -  Not diagnosed with Sickle Cell Disease&#xD;
&#xD;
          -  Unable to read and speak English&#xD;
&#xD;
          -  Unable to assent to participate&#xD;
&#xD;
        Healthcare Provider Interview Inclusion Criteria:&#xD;
&#xD;
          -  Be a healthcare provider to teens with sickle cell disease&#xD;
&#xD;
          -  Be 18 years of age or older&#xD;
&#xD;
          -  Able to read and speak English&#xD;
&#xD;
          -  Able to consent to participate&#xD;
&#xD;
        Healthcare Provider Interview Exclusion Criteria:&#xD;
&#xD;
          -  Not a healthcare provider to teens with sickle cell disease&#xD;
&#xD;
          -  Not 18 years of age or older&#xD;
&#xD;
          -  Unable to read and speak English&#xD;
&#xD;
          -  Unable to consent to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Valerie Myers, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Klein Buendel, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Klein Buendel, Inc.</name>
      <address>
        <city>Golden</city>
        <state>Colorado</state>
        <zip>80401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hilton Publishing Company</name>
      <address>
        <city>Munster</city>
        <state>Indiana</state>
        <zip>463213963</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Brawley OW, Cornelius LJ, Edwards LR, Gamble VN, Green BL, Inturrisi C, James AH, Laraque D, Mendez M, Montoya CJ, Pollock BH, Robinson L, Scholnik AP, Schori M. National Institutes of Health Consensus Development Conference statement: hydroxyurea treatment for sickle cell disease. Ann Intern Med. 2008 Jun 17;148(12):932-8. doi: 10.7326/0003-4819-148-12-200806170-00220. Epub 2008 May 5. No abstract available.</citation>
    <PMID>18458271</PMID>
  </reference>
  <reference>
    <citation>Cope A, Darbyshire PJ. Sickle cell disease, update on management. Paediatrics and Child Health. 2013;23(11):480-485.</citation>
  </reference>
  <reference>
    <citation>Mukerji I. About sickle cell disease.Sicklecellinfo.net Web site. Available at: http://www.sicklecellinfo.net/index.htm. Published 2004. Updated March 5, 2004. Accessed March 5, 2015.</citation>
  </reference>
  <reference>
    <citation>Bhagat VM, Baviskar SR, Mudey AB, Goyal RC. Poor health related quality of life among patients of sickle cell disease. Indian J Palliat Care. 2014 May;20(2):107-11. doi: 10.4103/0973-1075.132622.</citation>
    <PMID>25125865</PMID>
  </reference>
  <reference>
    <citation>Schnog JB, Duits AJ, Muskiet FA, ten Cate H, Rojer RA, Brandjes DP. Sickle cell disease; a general overview. Neth J Med. 2004 Nov;62(10):364-74.</citation>
    <PMID>15683091</PMID>
  </reference>
  <reference>
    <citation>Stinson J, Naser B. Pain management in children with sickle cell disease. Paediatr Drugs. 2003;5(4):229-41. doi: 10.2165/00128072-200305040-00003.</citation>
    <PMID>12662119</PMID>
  </reference>
  <reference>
    <citation>Ameringer S, Elswick RK Jr, Smith W. Fatigue in adolescents and young adults with sickle cell disease: biological and behavioral correlates and health-related quality of life. J Pediatr Oncol Nurs. 2014 Jan-Feb;31(1):6-17. doi: 10.1177/1043454213514632. Epub 2013 Dec 30.</citation>
    <PMID>24378816</PMID>
  </reference>
  <reference>
    <citation>Dampier C, Ely B, Brodecki D, O'Neal P. Characteristics of pain managed at home in children and adolescents with sickle cell disease by using diary self-reports. J Pain. 2002 Dec;3(6):461-70. doi: 10.1054/jpai.2002.128064.</citation>
    <PMID>14622732</PMID>
  </reference>
  <reference>
    <citation>Schatz J, Schlenz AM, McClellan CB, Puffer ES, Hardy S, Pfeiffer M, Roberts CW. Changes in coping, pain, and activity after cognitive-behavioral training: a randomized clinical trial for pediatric sickle cell disease using smartphones. Clin J Pain. 2015 Jun;31(6):536-47. doi: 10.1097/AJP.0000000000000183.</citation>
    <PMID>25503599</PMID>
  </reference>
  <reference>
    <citation>Dampier C, Lieff S, LeBeau P, Rhee S, McMurray M, Rogers Z, Smith-Whitley K, Wang W; Comprehensive Sickle Cell Centers (CSCC) Clinical Trial Consortium (CTC). Health-related quality of life in children with sickle cell disease: a report from the Comprehensive Sickle Cell Centers Clinical Trial Consortium. Pediatr Blood Cancer. 2010 Sep;55(3):485-94. doi: 10.1002/pbc.22497.</citation>
    <PMID>20658620</PMID>
  </reference>
  <reference>
    <citation>Crandall M, Savedra M. Multidimensional assessment using the adolescent pediatric pain tool: a case report. J Spec Pediatr Nurs. 2005 Jul-Sep;10(3):115-23. doi: 10.1111/j.1744-6155.2005.00023.x.</citation>
    <PMID>16083431</PMID>
  </reference>
  <reference>
    <citation>Franck LS, Treadwell M, Jacob E, Vichinsky E. Assessment of sickle cell pain in children and young adults using the adolescent pediatric pain tool. J Pain Symptom Manage. 2002 Feb;23(2):114-20. doi: 10.1016/s0885-3924(01)00407-9.</citation>
    <PMID>11844631</PMID>
  </reference>
  <reference>
    <citation>Lopez G, Liles DK, Knupp CL. Edmonton Symptom Assessment System for outpatient symptom monitoring of sickle cell disease. South Med J. 2014 Dec;107(12):768-72. doi: 10.14423/SMJ.0000000000000209.</citation>
    <PMID>25502156</PMID>
  </reference>
  <reference>
    <citation>Panepinto JA, O'Mahar KM, DeBaun MR, Loberiza FR, Scott JP. Health-related quality of life in children with sickle cell disease: child and parent perception. Br J Haematol. 2005 Aug;130(3):437-44. doi: 10.1111/j.1365-2141.2005.05622.x.</citation>
    <PMID>16042695</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>September 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <results_first_submitted>July 25, 2018</results_first_submitted>
  <results_first_submitted_qc>January 14, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">February 6, 2019</results_first_posted>
  <last_update_submitted>January 14, 2019</last_update_submitted>
  <last_update_submitted_qc>January 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Sickle Cell Disease</keyword>
  <keyword>Adolescence</keyword>
  <keyword>Pain Assessment</keyword>
  <keyword>Tablet Application</keyword>
  <keyword>Pain</keyword>
  <keyword>mHealth</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anemia, Sickle Cell</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 30, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/13/NCT03291613/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 30, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/13/NCT03291613/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Pinpoint App Usability Testing</title>
          <description>Participants used the Pinpoint tablet app for one hour.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Pinpoint App Usability Testing</title>
          <description>Participants used the Pinpoint tablet app for one hour.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="12"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14.58" spread="1.00"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>System Usability Questionnaire</title>
        <description>Ten likert-type questions assessing user-friendliness of technology. Each question has five answer options that range from &quot;Strongly Agree&quot; to &quot;Strongly Disagree&quot;. Scores range from 0-100. A score of 68 or above is considered above average. All scores averaged.</description>
        <time_frame>After 1-hour usability session</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Pinpoint App</title>
            <description>Tablet application.&#xD;
Pinpoint App: Tablet app with pain assessment and communication education, and pain assessment tool.</description>
          </group>
        </group_list>
        <measure>
          <title>System Usability Questionnaire</title>
          <description>Ten likert-type questions assessing user-friendliness of technology. Each question has five answer options that range from &quot;Strongly Agree&quot; to &quot;Strongly Disagree&quot;. Scores range from 0-100. A score of 68 or above is considered above average. All scores averaged.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86.67" spread="11.56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Pinpoint App</title>
          <description>Tablet application.&#xD;
Pinpoint App: Tablet app with pain assessment and communication education, and pain assessment tool.</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="12"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="12"/>
              </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="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT 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>Valerie Myers, PhD</name_or_title>
      <organization>Klein Buendel</organization>
      <phone>3035654343</phone>
      <email>vmyers@kleinbuendel.com</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/NCT03291613
org study id: 1R43MD010746-01
secondary id: 0308
secondary id: 1R43MD010746-01
nct id: NCT03291613
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Sickle cell disease (SCD) is a common genetic disorder characterized by episodes of pain, yet
      assessments to identify type, intensity, frequency, and phase of pain among SCD adolescents
      is lacking. Research shows that interactive gaming technology can enhance adolescents'
      learning, and can be especially effective in delivering health-related messages and tools to
      improve their self-care. Pinpoint is an interactive gaming tablet app that will be developed
      with the significant input of clinical experts to assist SCD teens with better identification
      and self-report of their pain.
Sickle cell disease (SCD) is the most common inherited blood disorder in the U.S. and
      disproportionately affects African Americans and Hispanics. Approximately, 1,000 U.S.
      children are born with SCD annually. SCD results from abnormal hemoglobin and causes red
      blood cells (RBCs) to become misshaped ("sickle-shaped"). Sickled cells can block the flow of
      blood in small arteries causing tissue and organ damage and other life-threatening
      comorbidities. SCD complications can be serious and have a significant impact upon well-being
      and quality of life. Pain is the hallmark symptom associated with SCD, and is the most common
      clinical problem seen in children and the number one cause of SCD-related hospital
      admissions. If left untreated, these painful episodes can result in morbidity and mortality.
      Accurate assessment of pain specifiers (type, frequency, and intensity of pain) can help with
      ameliorating pain quickly and effectively. Despite children being accurate self-reporters of
      their pain, strategies which are effective and engaging to assist with pain identification
      are lacking. Reducing barriers to collection and promoting the value of accurate SCD pain
      assessment is a need in pediatric medicine. Pinpoint will be an innovative interactive
      assessment tool that engages patients while allowing physicians to collect important health
      data. This project will test the feasibility of applying gamification principles to develop a
      tablet application ("app") for 13-17 year olds with SCD. Specifically, this Phase I SBIR
      project will (1) develop a Pain Assessment Tool (PAT) to describe and categorize specific
      types of pain experienced by adolescents with SCD; and (2) create an app ("Pinpoint"), that
      will translate the PAT into gamified technology. The goal of Pinpoint is to engage adolescent
      patients and improve pain specification by developing a game-based pain assessment tool
      delivered via a tablet app to engage adolescent SCD patients, improve their pain
      specification self-report, and improve pain management by clinicians. The PAT will be
      developed using expert guidance from preeminent SCD clinicians. User-centered Design theory
      will be applied in the development of the app and will be guided by iterative cognitive
      interviews and focus groups with members of the target population, SCD teens. The project
      specific aims are to (1) develop the PAT using guidance from an Expert Advisory Board (EAB)
      of SCD clinicians; (2) conduct a series of cognitive interviews with adolescent SCD patients
      to guide and refine PAT development; (3) conduct iterative focus groups with adolescent SCD
      patients to guide and refine user interface design of the Pinpoint app; (4) program a
      functional Pinpoint prototype; and (5) conduct usability testing of the prototype with 13-17
      year old SCD patients to assess functionality, navigation, and satisfaction. This project is
      innovative and timely. Pinpoint will be the first tablet app to identify and translate
      specific pain types for SCD into a gamified app using applied gamification principles.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: System Usability Questionnaire
time frame: After 1-hour usability session
description: Ten likert-type questions assessing user-friendliness of technology. Each question has five answer options that range from "Strongly Agree" to "Strongly Disagree". Scores range from 0-100. A score of 68 or above is considered above average. All scores averaged.
arm group label: Pinpoint App
arm group type: Experimental
description: Tablet application.
intervention type: Other
intervention name: Pinpoint App
description: Tablet app with pain assessment and communication education, and pain assessment tool.
arm group label: Pinpoint App
criteria: 
gender: All
minimum age: 13 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Valerie Myers, PhD
role: Principal Investigator
affiliation: Klein Buendel, Inc.
facility: 
facility: 
country: United States
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PMID: 18458271
citation: Cope A, Darbyshire PJ. Sickle cell disease, update on management. Paediatrics and Child Health. 2013;23(11):480-485.
citation: Mukerji I. About sickle cell disease.Sicklecellinfo.net Web site. Available at: http://www.sicklecellinfo.net/index.htm. Published 2004. Updated March 5, 2004. Accessed March 5, 2015.
citation: Bhagat VM, Baviskar SR, Mudey AB, Goyal RC. Poor health related quality of life among patients of sickle cell disease. Indian J Palliat Care. 2014 May;20(2):107-11. doi: 10.4103/0973-1075.132622.
PMID: 25125865
citation: Schnog JB, Duits AJ, Muskiet FA, ten Cate H, Rojer RA, Brandjes DP. Sickle cell disease; a general overview. Neth J Med. 2004 Nov;62(10):364-74.
PMID: 15683091
citation: Stinson J, Naser B. Pain management in children with sickle cell disease. Paediatr Drugs. 2003;5(4):229-41. doi: 10.2165/00128072-200305040-00003.
PMID: 12662119
citation: Ameringer S, Elswick RK Jr, Smith W. Fatigue in adolescents and young adults with sickle cell disease: biological and behavioral correlates and health-related quality of life. J Pediatr Oncol Nurs. 2014 Jan-Feb;31(1):6-17. doi: 10.1177/1043454213514632. Epub 2013 Dec 30.
PMID: 24378816
citation: Dampier C, Ely B, Brodecki D, O'Neal P. Characteristics of pain managed at home in children and adolescents with sickle cell disease by using diary self-reports. J Pain. 2002 Dec;3(6):461-70. doi: 10.1054/jpai.2002.128064.
PMID: 14622732
citation: Schatz J, Schlenz AM, McClellan CB, Puffer ES, Hardy S, Pfeiffer M, Roberts CW. Changes in coping, pain, and activity after cognitive-behavioral training: a randomized clinical trial for pediatric sickle cell disease using smartphones. Clin J Pain. 2015 Jun;31(6):536-47. doi: 10.1097/AJP.0000000000000183.
PMID: 25503599
citation: Dampier C, Lieff S, LeBeau P, Rhee S, McMurray M, Rogers Z, Smith-Whitley K, Wang W; Comprehensive Sickle Cell Centers (CSCC) Clinical Trial Consortium (CTC). Health-related quality of life in children with sickle cell disease: a report from the Comprehensive Sickle Cell Centers Clinical Trial Consortium. Pediatr Blood Cancer. 2010 Sep;55(3):485-94. doi: 10.1002/pbc.22497.
PMID: 20658620
citation: Crandall M, Savedra M. Multidimensional assessment using the adolescent pediatric pain tool: a case report. J Spec Pediatr Nurs. 2005 Jul-Sep;10(3):115-23. doi: 10.1111/j.1744-6155.2005.00023.x.
PMID: 16083431
citation: Franck LS, Treadwell M, Jacob E, Vichinsky E. Assessment of sickle cell pain in children and young adults using the adolescent pediatric pain tool. J Pain Symptom Manage. 2002 Feb;23(2):114-20. doi: 10.1016/s0885-3924(01)00407-9.
PMID: 11844631
citation: Lopez G, Liles DK, Knupp CL. Edmonton Symptom Assessment System for outpatient symptom monitoring of sickle cell disease. South Med J. 2014 Dec;107(12):768-72. doi: 10.14423/SMJ.0000000000000209.
PMID: 25502156
citation: Panepinto JA, O'Mahar KM, DeBaun MR, Loberiza FR, Scott JP. Health-related quality of life in children with sickle cell disease: child and parent perception. Br J Haematol. 2005 Aug;130(3):437-44. doi: 10.1111/j.1365-2141.2005.05622.x.
PMID: 16042695
responsible party type: Sponsor
mesh term: Anemia, Sickle Cell
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 