<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/NCT02200510</url>
  </required_header>
  <id_info>
    <org_study_id>5K07HL108720</org_study_id>
    <nct_id>NCT02200510</nct_id>
  </id_info>
  <brief_title>Patient-Provider Tools to Improve the Transition to Adult Care in Sickle Cell Disease</brief_title>
  <acronym>iTransition</acronym>
  <official_title>Patient-Provider Interventions to Improve Transition to Adult Care in SCD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital Medical Center, Cincinnati</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's Hospital Medical Center, Cincinnati</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to develop patient-provider clinical support tools to improve&#xD;
      clinical practice, patient self-management, and disease outcomes in sickle cell disease&#xD;
      during transition to adult care. The investigators hypothesize that these clinical support&#xD;
      tools (patient tool, provider tool, and patient/parent web-based portal) will be feasible,&#xD;
      user friendly, and beneficial. The investigators hypothesize that participants will&#xD;
      demonstrate better disease self-efficacy at the end of the 6 week intervention and maintain&#xD;
      these gains during the follow-up period (up to 1 year post-intervention).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of the study is to develop patient-provider clinical support tools to improve&#xD;
      clinical practice, patient self-management, and disease outcomes in sickle cell disease&#xD;
      during transition to adult care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2011</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline on Disease Self-efficacy Measure at 6 Weeks</measure>
    <time_frame>baseline, 6 weeks (post-intervention)</time_frame>
    <description>Name of Measure: Sickle Cell Self-Efficacy Scale (SCSES). Construct: sickle cell self-efficacy (disease specific self-efficacy) 9 item measure of sickle cell disease self-efficacy (likert scale from 1 [not at all sure] to 5 [very sure]) developed by Edwards (see References).&#xD;
Responses on items are summed to compute a total score. Minimum score: 9 Maximum score: 45 Higher scores represent higher sickle cell self-efficacy (better outcome).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">78</enrollment>
  <condition>Sickle Cell Disease</condition>
  <arm_group>
    <arm_group_label>Self-Management Group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Self-management intervention for Adolescents with SCD - 6 week self-management group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patient Portal</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patient Portal Intervention for Adolescents with SCD - 6 week individual patient portal intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Self-management intervention for Adolescents with SCD</intervention_name>
    <description>Chronic Disease Self-Management Program</description>
    <arm_group_label>Self-Management Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Patient Portal Intervention for Adolescents with SCD</intervention_name>
    <description>MyChart for SCD intervention</description>
    <arm_group_label>Patient Portal</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Have sickle cell disease (SCD)&#xD;
&#xD;
          -  Between the ages of 13 and 24&#xD;
&#xD;
          -  Receive care at Cincinnati Children's Hospital Medical Center, University Hospital,&#xD;
             University of Cincinnati Med Peds Practice, a practice in the Ohio Valley SCD Network,&#xD;
             or another local provider&#xD;
&#xD;
          -  Parent/caregiver of a patient with SCD age 13-24 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Below age 13&#xD;
&#xD;
          -  Have significant health complication(s) that would interfere with completion of the&#xD;
             intervention (by physician report)&#xD;
&#xD;
          -  Have significant cognitive or developmental disabilities (by parent or physician&#xD;
             report) due to high demand on participants to understand questions&#xD;
&#xD;
          -  Are not a patient at Cincinnati Children's Hospital Medical Center, University&#xD;
             Hospital, University of Cincinnati Med Peds Practice, a practice in the Ohio Valley&#xD;
             SCD Network, or another local provider&#xD;
&#xD;
          -  Are not a parent/caregiver of a patient with SCD age 13-24 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>24 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lori E Crosby, PsyD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital Medical Center, Cincinnati</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Crosby LE, Smith T, Parr WD, Mitchell MJ. The Community Engagement and Translational Research Speaker Series: An Innovative Model of Health Education. J Community Med Health Educ. 2013 Jul 24;3:1000227. doi: 10.4172/2161-0711.1000227.</citation>
    <PMID>25414800</PMID>
  </reference>
  <reference>
    <citation>Edwards R, Telfair J, Cecil H, Lenoci J. Reliability and validity of a self-efficacy instrument specific to sickle cell disease. Behav Res Ther. 2000 Sep;38(9):951-63. doi: 10.1016/s0005-7967(99)00140-0.</citation>
    <PMID>10957829</PMID>
  </reference>
  <results_reference>
    <citation>Crosby LE, Joffe NE, Dunseath LA, Lee R. Design Joins the Battle Against Sickle-cell Disease. Des Manage Rev. 2013 Summer;24(2):48-53. doi: 10.1111/drev.10241. No abstract available.</citation>
    <PMID>25414599</PMID>
  </results_reference>
  <results_reference>
    <citation>Crosby, L.E., Hudepohl, M., Kalinyak, K., Britto, M., Goldstein, A., Brown, K., Culp, A., &amp; Joiner, C. H. (2013). Impact of use of a disease-specific patient portal on transition readiness and quality of life in adolescents with sickle cell disease [Abstract]. Blood, 122(21), 2982.</citation>
  </results_reference>
  <results_reference>
    <citation>Crosby, L. E., Joffe, N., Kalinyak, K., Bruck, A. &amp; Joiner, C. H. (2013). Six-month data from a pilot self-management intervention for adolescents with sickle cell disease [Abstract]. Blood, 122(21), 1675.</citation>
  </results_reference>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>July 21, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <results_first_submitted>February 9, 2018</results_first_submitted>
  <results_first_submitted_qc>May 16, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">June 15, 2018</results_first_posted>
  <last_update_submitted>May 16, 2018</last_update_submitted>
  <last_update_submitted_qc>May 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Anemia, Sickle Cell</keyword>
  <keyword>Transition to Adult Care</keyword>
  <keyword>Self Care</keyword>
  <keyword>Personal Electronic Health Records</keyword>
  <keyword>Adolescent</keyword>
  <keyword>Young Adult</keyword>
  <keyword>Disease Management</keyword>
  <keyword>Physician-Patient Relations</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anemia, Sickle Cell</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Self-Management Group</title>
          <description>Self-management intervention for Adolescents with SCD - 6 week self-management group&#xD;
Self-management intervention for Adolescents with SCD: Chronic Disease Self-Management Program</description>
        </group>
        <group group_id="P2">
          <title>Patient Portal</title>
          <description>Patient Portal Intervention for Adolescents with SCD - 6 week individual patient portal intervention&#xD;
Patient Portal Intervention for Adolescents with SCD: MyChart for SCD intervention</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="31">Number who only completed self-management or completed it before portal (could do 6 months later).</participants>
                <participants group_id="P2" count="47">Number who only completed portal or completed it before self-management (could do 6 months later).</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22">This is the number of participants with baseline and post data.</participants>
                <participants group_id="P2" count="44">This number is the number of participants with both baseline and post data.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>potential COI - joined study team</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Participants who completed baseline measures</population>
      <group_list>
        <group group_id="B1">
          <title>Self-Management Group</title>
          <description>Self-management intervention for Adolescents with SCD - 6 week self-management group&#xD;
Self-management intervention for Adolescents with SCD: Chronic Disease Self-Management Program</description>
        </group>
        <group group_id="B2">
          <title>Patient Portal</title>
          <description>Patient Portal Intervention for Adolescents with SCD - 6 week individual patient portal intervention&#xD;
Patient Portal Intervention for Adolescents with SCD: MyChart for SCD intervention</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="22"/>
            <count group_id="B2" value="44"/>
            <count group_id="B3" value="66"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="18.77" spread="2.22"/>
                    <measurement group_id="B2" value="18.82" spread="2.72"/>
                    <measurement group_id="B3" value="18.795" spread="2.47"/>
                  </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="10"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="34"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="32"/>
                  </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 group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="66"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline on Disease Self-efficacy Measure at 6 Weeks</title>
        <description>Name of Measure: Sickle Cell Self-Efficacy Scale (SCSES). Construct: sickle cell self-efficacy (disease specific self-efficacy) 9 item measure of sickle cell disease self-efficacy (likert scale from 1 [not at all sure] to 5 [very sure]) developed by Edwards (see References).&#xD;
Responses on items are summed to compute a total score. Minimum score: 9 Maximum score: 45 Higher scores represent higher sickle cell self-efficacy (better outcome).</description>
        <time_frame>baseline, 6 weeks (post-intervention)</time_frame>
        <population>Participants with completed baseline and post measures.</population>
        <group_list>
          <group group_id="O1">
            <title>Self-Management Group</title>
            <description>Self-management intervention for Adolescents with SCD - 6 week self-management group&#xD;
Self-management intervention for Adolescents with SCD: Chronic Disease Self-Management Program</description>
          </group>
          <group group_id="O2">
            <title>Patient Portal</title>
            <description>Patient Portal Intervention for Adolescents with SCD - 6 week individual patient portal intervention&#xD;
Patient Portal Intervention for Adolescents with SCD: MyChart for SCD intervention</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline on Disease Self-efficacy Measure at 6 Weeks</title>
          <description>Name of Measure: Sickle Cell Self-Efficacy Scale (SCSES). Construct: sickle cell self-efficacy (disease specific self-efficacy) 9 item measure of sickle cell disease self-efficacy (likert scale from 1 [not at all sure] to 5 [very sure]) developed by Edwards (see References).&#xD;
Responses on items are summed to compute a total score. Minimum score: 9 Maximum score: 45 Higher scores represent higher sickle cell self-efficacy (better outcome).</description>
          <population>Participants with completed baseline and post measures.</population>
          <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="22"/>
                <count group_id="O2" value="44"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.2" spread="5.49"/>
                    <measurement group_id="O2" value="33.09" spread="7.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Because this was a pilot study, the goal was to detect effects sizes for a larger R01 or R21.</non_inferiority_desc>
            <p_value>0.575</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>0.33</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Because this was a pilot study, the goal was to detect effects sizes for a larger R01 or R21.</non_inferiority_desc>
            <p_value>0.721</p_value>
            <method>ANOVA</method>
            <param_type>Mean Difference (Final Values)</param_type>
            <param_value>.138</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>During the 6 months participants were enrolled in the study.</time_frame>
      <desc>An adverse event (AE) for the current study is an unfavorable medical occurrence in a participant temporally associated with the subject's participation in the research, whether or not considered related to the subject's participation in the research. A serious adverse event (SAE) may or may not result in death, be life threatening, or require hospitalization. Since this population has frequent hospitalizations, only unexpected adverse events were reported here.</desc>
      <group_list>
        <group group_id="E1">
          <title>Self-Management Group</title>
          <description>Self-management intervention for Adolescents with SCD - 6 week self-management group&#xD;
Self-management intervention for Adolescents with SCD: Chronic Disease Self-Management Program</description>
        </group>
        <group group_id="E2">
          <title>Patient Portal</title>
          <description>Patient Portal Intervention for Adolescents with SCD - 6 week individual patient portal intervention&#xD;
Patient Portal Intervention for Adolescents with SCD: MyChart for SCD intervention</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="1" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="44"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="44"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>4</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="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="44"/>
              </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>
    <limitations_and_caveats>Pilot feasibility studies with convenience samples.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Lori Crosby</name_or_title>
      <organization>CincinnatiChildrens</organization>
      <phone>5136365380</phone>
      <email>lori.crosby@cchmc.org</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/NCT02200510
org study id: 5K07HL108720
nct id: NCT02200510
lead sponsor: 
has dmc: No
The purpose of the study is to develop patient-provider clinical support tools to improve
      clinical practice, patient self-management, and disease outcomes in sickle cell disease
      during transition to adult care. The investigators hypothesize that these clinical support
      tools (patient tool, provider tool, and patient/parent web-based portal) will be feasible,
      user friendly, and beneficial. The investigators hypothesize that participants will
      demonstrate better disease self-efficacy at the end of the 6 week intervention and maintain
      these gains during the follow-up period (up to 1 year post-intervention).
The purpose of the study is to develop patient-provider clinical support tools to improve
      clinical practice, patient self-management, and disease outcomes in sickle cell disease
      during transition to adult care.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change From Baseline on Disease Self-efficacy Measure at 6 Weeks
time frame: baseline, 6 weeks (post-intervention)
description: Name of Measure: Sickle Cell Self-Efficacy Scale (SCSES). Construct: sickle cell self-efficacy (disease specific self-efficacy) 9 item measure of sickle cell disease self-efficacy (likert scale from 1 [not at all sure] to 5 [very sure]) developed by Edwards (see References).
Responses on items are summed to compute a total score. Minimum score: 9 Maximum score: 45 Higher scores represent higher sickle cell self-efficacy (better outcome).
arm group label: Self-Management Group
arm group type: Other
description: Self-management intervention for Adolescents with SCD - 6 week self-management group
arm group label: Patient Portal
arm group type: Other
description: Patient Portal Intervention for Adolescents with SCD - 6 week individual patient portal intervention
intervention type: Behavioral
intervention name: Self-management intervention for Adolescents with SCD
description: Chronic Disease Self-Management Program
arm group label: Self-Management Group
intervention type: Behavioral
intervention name: Patient Portal Intervention for Adolescents with SCD
description: MyChart for SCD intervention
arm group label: Patient Portal
criteria: 
gender: All
minimum age: 13 Years
maximum age: 24 Years
healthy volunteers: No
last name: Lori E Crosby, PsyD
role: Principal Investigator
affiliation: Children's Hospital Medical Center, Cincinnati
facility: 
country: United States
citation: Crosby LE, Smith T, Parr WD, Mitchell MJ. The Community Engagement and Translational Research Speaker Series: An Innovative Model of Health Education. J Community Med Health Educ. 2013 Jul 24;3:1000227. doi: 10.4172/2161-0711.1000227.
PMID: 25414800
citation: Edwards R, Telfair J, Cecil H, Lenoci J. Reliability and validity of a self-efficacy instrument specific to sickle cell disease. Behav Res Ther. 2000 Sep;38(9):951-63. doi: 10.1016/s0005-7967(99)00140-0.
PMID: 10957829
citation: Crosby LE, Joffe NE, Dunseath LA, Lee R. Design Joins the Battle Against Sickle-cell Disease. Des Manage Rev. 2013 Summer;24(2):48-53. doi: 10.1111/drev.10241. No abstract available.
PMID: 25414599
citation: Crosby, L.E., Hudepohl, M., Kalinyak, K., Britto, M., Goldstein, A., Brown, K., Culp, A., & Joiner, C. H. (2013). Impact of use of a disease-specific patient portal on transition readiness and quality of life in adolescents with sickle cell disease [Abstract]. Blood, 122(21), 2982.
citation: Crosby, L. E., Joffe, N., Kalinyak, K., Bruck, A. & Joiner, C. H. (2013). Six-month data from a pilot self-management intervention for adolescents with sickle cell disease [Abstract]. Blood, 122(21), 1675.
responsible party type: Sponsor
mesh term: Anemia, Sickle Cell
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Pilot feasibility studies with convenience samples.
point of contact: 