<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/NCT03006718</url>
  </required_header>
  <id_info>
    <org_study_id>7618</org_study_id>
    <nct_id>NCT03006718</nct_id>
  </id_info>
  <brief_title>SCD-PROMIS: A Software Platform to Enhance Self-efficacy and Patient-provider Engagement for Patients With Sickle Cell Pain</brief_title>
  <official_title>SCD-PROMIS: A Software Platform to Enhance Self-efficacy and Patient-provider Engagement for Patients With Sickle Cell Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Julia Finkel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Arizona State University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Children's National Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Children's National Research Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall goal of the project is to reduce pain-related, 30-day readmission rates for&#xD;
      sickle cell disease (SCD) patients. The investigators want to see if a mobile phone&#xD;
      application (app) can help decrease the need for repeat admission to the hospital because of&#xD;
      sickle cell pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pain is the main reason why SCD patients are admitted and readmitted to the hospital. In&#xD;
      fact, readmission rates of SCD patients are higher than those of asthmatics and diabetics. In&#xD;
      order to reduce 30-day hospital readmission rates and improve patient care quality, the&#xD;
      Affordable Care Act and Centers for Medicare and Medicaid Services have established the&#xD;
      Readmissions Reduction Program. In keeping with this effort, the investigators propose a&#xD;
      methodology and supporting technology that has the potential to change the way SCD patients&#xD;
      are monitored after hospital discharge and in turn, decrease readmission rates. This&#xD;
      methodology also has the potential to enhance the quality of life of SCD patients by&#xD;
      improving patient reporting, self-efficacy, and increasing patient/provider engagement when&#xD;
      there is worsening pain and increased admission/readmission risk. This software platform uses&#xD;
      validated Patient Reported Outcome Measurement Information System (PROMIS) measures to&#xD;
      remotely monitor SCD patients' pain and related outcomes after hospital discharge. With this&#xD;
      initial study, the investigators propose to use this monitoring platform to identify the&#xD;
      predictors of readmission, to develop a readmission prediction engine, and to design the next&#xD;
      version of the app with built in interventions to address those readmission risks. This&#xD;
      monitoring platform could also increase healthcare provider engagement when there is a&#xD;
      worsening of patients' pain and/or an increased risk of readmission. In order to build and&#xD;
      optimize this monitoring platform, the investigators have assembled a team of engineers,&#xD;
      hematologists, pain researchers, and statisticians that have worked together, and who&#xD;
      collectively have the expertise to develop and test the feasibility and predictive value of&#xD;
      the application in a large population of SCD patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">September 2019</completion_date>
  <primary_completion_date type="Actual">September 2018</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Readmission rate</measure>
    <time_frame>35 days</time_frame>
    <description>The investigators want to determine if the use of this mobile app by itself reduces readmission rates. The investigators will compare the readmission rate of patients who use this mobile app with those who do not.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Readmission risk</measure>
    <time_frame>35 days</time_frame>
    <description>The rate of hospital readmission will be estimated by time periods (e.g., 1, 2, 3, and 4 weeks after discharge).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Compliance</measure>
    <time_frame>35 days</time_frame>
    <description>To evaluate our app design features, the investigators will track each user's interaction with the app for post-analysis to determine time spent answering the questions and the value of reminders. It is the investigators intent to determine if features will be used as intended by the app design.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Usability</measure>
    <time_frame>35 days</time_frame>
    <description>At the end of five weeks the investigators will administer a survey to parents and participants to determine the usability of this app.This information will lead to improvements on the design of future iterations of the app.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Sickle Cell Disease</condition>
  <condition>Anemia</condition>
  <condition>Anemia, Hemolytic</condition>
  <condition>Anemia, Sickle Cell</condition>
  <condition>Hematologic Diseases</condition>
  <arm_group>
    <arm_group_label>Patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants must have SCD (HbSS, HbSC, HbSβ0 thalassemia, HbSβ+ thalassemia, HbSOArab), within the age range of 8 - 21 years, and be admitted to the hospital for vaso-occlusive crisis (VOE)-related pain. The investigators will also collect Proxy PROMIS measures from parents of participants between the ages of 8 and 17-years who have agreed to participate in the study.&#xD;
All participants will use the PROMIS for Pain Management App over 5 consecutive weeks (starting at hospital discharge).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PROMIS for Pain Management App</intervention_name>
    <description>At hospital discharge, the investigators will collect baseline surveys, a blood sample, and download the PROMIS for Pain Management App onto the subject's mobile device. For five consecutive weeks, PROMIS measures will be collected through weekly surveys. The investigators plan to compensate patients for their time. Patients will come back to the hospital after 35 days for a final blood draw and set of surveys. In the event a patient gets readmitted, the investigators will record that admission. The investigators will also collect Proxy PROMIS measures from parents of participants between the ages of 8 and 17-years who have agreed to participate in the study. It is the goal of the investigators to engage one of the parents in the reporting of weekly validated Proxy PROMIS measures.</description>
    <arm_group_label>Patients</arm_group_label>
    <other_name>SCD-PROMIS</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Participants with Sickle Cell Disease (SCD) (HbSS, HbSC, HbSβ0 thalassemia, HbSβ+&#xD;
             thalassemia, HbSOArab) admitted to the hospital for vaso-occlusive crisis&#xD;
             (VOE)-related pain within the age range of 8 - 21 years.&#xD;
&#xD;
          2. Ability to provide informed consent/assent, comply with study related procedures,&#xD;
             evaluations, and follow-up. In the event that a patient does not have a smart mobile&#xD;
             device (i.e., one that can support the study application), one will be provided for&#xD;
             the patient. Patients younger than the age of 11 years may use their parents phone if&#xD;
             they do not have one. If a patient has a smart mobile device but their parent does not&#xD;
             want them to use the device for the study, the patient may use their parent's phone&#xD;
             instead.&#xD;
&#xD;
          3. Parent of participants with SCD (HbSS, HbSC, HbSβ0 thalassemia, HbSβ+ thalassemia&#xD;
             HbSOArab) admitted to the hospital for vaso-occlusive crisis (VOE)-related pain within&#xD;
             the age range of 8 - 17 years who has assented to participate in the study.&#xD;
&#xD;
          4. Ability to provide informed consent, comply with study related procedures,&#xD;
             evaluations, and follow-up. In the event that a parent does not have a mobile device,&#xD;
             one will be provided for the duration of the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Inability to give informed consent/assent as determined by the investigators&#xD;
&#xD;
          2. Patients with SCD who were admitted for reasons other than VOE-related pain&#xD;
&#xD;
          3. Parents of patients with SCD who were admitted for reasons other than VOE-related pain&#xD;
             or do not assent to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Julia Finkel, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's National Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's National Hospital</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>December 22, 2016</study_first_submitted>
  <study_first_submitted_qc>December 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <last_update_submitted>February 22, 2021</last_update_submitted>
  <last_update_submitted_qc>February 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 24, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Children's National Research Institute</investigator_affiliation>
    <investigator_full_name>Julia Finkel</investigator_full_name>
    <investigator_title>ANESTHESIOLOGIST</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anemia</mesh_term>
    <mesh_term>Anemia, Sickle Cell</mesh_term>
    <mesh_term>Hematologic Diseases</mesh_term>
    <mesh_term>Anemia, Hemolytic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03006718
org study id: 7618
nct id: NCT03006718
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The overall goal of the project is to reduce pain-related, 30-day readmission rates for
      sickle cell disease (SCD) patients. The investigators want to see if a mobile phone
      application (app) can help decrease the need for repeat admission to the hospital because of
      sickle cell pain.
Pain is the main reason why SCD patients are admitted and readmitted to the hospital. In
      fact, readmission rates of SCD patients are higher than those of asthmatics and diabetics. In
      order to reduce 30-day hospital readmission rates and improve patient care quality, the
      Affordable Care Act and Centers for Medicare and Medicaid Services have established the
      Readmissions Reduction Program. In keeping with this effort, the investigators propose a
      methodology and supporting technology that has the potential to change the way SCD patients
      are monitored after hospital discharge and in turn, decrease readmission rates. This
      methodology also has the potential to enhance the quality of life of SCD patients by
      improving patient reporting, self-efficacy, and increasing patient/provider engagement when
      there is worsening pain and increased admission/readmission risk. This software platform uses
      validated Patient Reported Outcome Measurement Information System (PROMIS) measures to
      remotely monitor SCD patients' pain and related outcomes after hospital discharge. With this
      initial study, the investigators propose to use this monitoring platform to identify the
      predictors of readmission, to develop a readmission prediction engine, and to design the next
      version of the app with built in interventions to address those readmission risks. This
      monitoring platform could also increase healthcare provider engagement when there is a
      worsening of patients' pain and/or an increased risk of readmission. In order to build and
      optimize this monitoring platform, the investigators have assembled a team of engineers,
      hematologists, pain researchers, and statisticians that have worked together, and who
      collectively have the expertise to develop and test the feasibility and predictive value of
      the application in a large population of SCD patients.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Readmission rate
time frame: 35 days
description: The investigators want to determine if the use of this mobile app by itself reduces readmission rates. The investigators will compare the readmission rate of patients who use this mobile app with those who do not.
measure: Readmission risk
time frame: 35 days
description: The rate of hospital readmission will be estimated by time periods (e.g., 1, 2, 3, and 4 weeks after discharge).
measure: Patient Compliance
time frame: 35 days
description: To evaluate our app design features, the investigators will track each user's interaction with the app for post-analysis to determine time spent answering the questions and the value of reminders. It is the investigators intent to determine if features will be used as intended by the app design.
measure: Patient Usability
time frame: 35 days
description: At the end of five weeks the investigators will administer a survey to parents and participants to determine the usability of this app.This information will lead to improvements on the design of future iterations of the app.
arm group label: Patients
arm group type: Experimental
description: Participants must have SCD (HbSS, HbSC, HbSβ0 thalassemia, HbSβ+ thalassemia, HbSOArab), within the age range of 8 - 21 years, and be admitted to the hospital for vaso-occlusive crisis (VOE)-related pain. The investigators will also collect Proxy PROMIS measures from parents of participants between the ages of 8 and 17-years who have agreed to participate in the study.
All participants will use the PROMIS for Pain Management App over 5 consecutive weeks (starting at hospital discharge).
intervention type: Other
intervention name: PROMIS for Pain Management App
description: At hospital discharge, the investigators will collect baseline surveys, a blood sample, and download the PROMIS for Pain Management App onto the subject's mobile device. For five consecutive weeks, PROMIS measures will be collected through weekly surveys. The investigators plan to compensate patients for their time. Patients will come back to the hospital after 35 days for a final blood draw and set of surveys. In the event a patient gets readmitted, the investigators will record that admission. The investigators will also collect Proxy PROMIS measures from parents of participants between the ages of 8 and 17-years who have agreed to participate in the study. It is the goal of the investigators to engage one of the parents in the reporting of weekly validated Proxy PROMIS measures.
arm group label: Patients
other name: SCD-PROMIS
criteria: 
gender: All
minimum age: 8 Years
maximum age: 21 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Julia Finkel, MD
role: Principal Investigator
affiliation: Children's National Research Institute
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Children's National Research Institute
investigator full name: Julia Finkel
investigator title: ANESTHESIOLOGIST
mesh term: Anemia
mesh term: Anemia, Sickle Cell
mesh term: Hematologic Diseases
mesh term: Anemia, Hemolytic
sharing ipd: No