xml: <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/NCT06035939</url>
    </required_header>
    <id_info>
      <org_study_id>Pro00127137</org_study_id>
      <secondary_id>1R01NR020606-01</secondary_id>
      <nct_id>NCT06035939</nct_id>
    </id_info>
    <brief_title>SMYLS Multi-site Trial</brief_title>
    <official_title>Self-Management for Youth Living With Sickle Cell Disease: SMYLS Multi-site Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Medical University of South Carolina</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute of Nursing Research (NINR)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Medical University of South Carolina</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to find out whether a web-based intervention using a mobile app&#xD;
        is helpful for teens and young adults with sickle cell disease (SCD) in learning how to care&#xD;
        for and manage their symptoms.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The purpose of this study is to test the effectiveness of and identify barriers and&#xD;
        facilitators to the implementation of SMYLS, an mHealth intervention designed to facilitate&#xD;
        self-management behaviors in adolescents and young adults (AYA) with sickle cell disease&#xD;
        (SCD). Specifically, the investigators propose to determine the effect of the intervention on&#xD;
        the primary outcome of self-management behaviors and the secondary outcomes of quality of&#xD;
        life, transition readiness, healthcare utilization, and pain interference. In addition, the&#xD;
        investigators will explore how patient activation moderates development of self-management&#xD;
        behaviors and systemic, structural, and social variables that moderate relationships between&#xD;
        patient activation, the primary outcome, and secondary outcomes.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">January 2028</completion_date>
    <primary_completion_date type="Anticipated">July 2027</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Self-management behaviors</measure>
      <time_frame>baseline and 1, 3, 6, 9, 12 months</time_frame>
      <description>Adolescent and young adult self-report using the Transition Readiness Assessment Questionnaire 5th version (TRAQ-5; 20 items). The instrument consists of 5 scales. Individual item scores range from 1 - 5. Scale scores are determined by calculating the average of the item scores within each scale. Higher scores indicate greater transition readiness and self-management behaviors.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Engagement in intervention/control (categorical)</measure>
      <time_frame>baseline and 1, 3, 6, 9, 12 months</time_frame>
      <description>Categorized into none, low, moderate and high. For intervention arm, categories are based on scope (number of components), duration (number of weeks), and frequency (number of times per week). For control arm, categories are based on duration and frequency as for intervention group parameters.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Engagement in intervention/control (continuous)</measure>
      <time_frame>Ongoing</time_frame>
      <description>Number of times the application is accessed (intervention = full application; control = educational component only).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Health-related quality of life</measure>
      <time_frame>baseline and 1, 3, 6, 9, and 12 months</time_frame>
      <description>Adolescent and young adult self report using the Pediatric Quality of Life Inventory (PedsQL) with Sickle Cell Disease Module (43 items). Items are scaled from 0 (Never) to 4 (Almost always). Scores are reverse scored and linearly transformed to a 0 - 100 scale. Higher scores indicate better health-related quality of life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of attended SCD clinic visits</measure>
      <time_frame>baseline and 1, 3, 6, 9, and 12 months</time_frame>
      <description>Number of attended SCD clinic visits documented in the medical record</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of ED visits</measure>
      <time_frame>baseline and 1, 3, 6, 9, and 12 months</time_frame>
      <description>Number of ED visits documented in the medical record</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of hospitalizations</measure>
      <time_frame>baseline and 1, 3, 6, 9, and 12 months</time_frame>
      <description>Number of hospitalizations documented in the medical record</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain interference</measure>
      <time_frame>baseline and 1, 3, 6, 9, and 12, months</time_frame>
      <description>Adolescent and young adult self report using the Patient Reported Outcomes Measurement Inventory System (PROMIS) Pain Interference v2 Pediatric Short Form (8 items). Raw scores range from 0 - 32 with higher scores indicating greater pain interference.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Transition readiness</measure>
      <time_frame>baseline and 1, 3, 6, 9, and 12 months</time_frame>
      <description>Adolescent and young adult self report using the Transition Intervention Program - Readiness for Transition (TIP-RFT; 22 items). Scores for each item range from 0 - 4, with a total possible summed score ranging from 0 - 88. Lower scores indicate higher transition readiness.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Patient activation</measure>
      <time_frame>baseline and 1, 3, 6, 9, and 12 months</time_frame>
      <description>Moderator variable; adolescent and young adult self-report using the Patient Activation Measure (PAM-13). Raw scores are transformed to a scale of 0 - 100 with 100 being the highest activation level.</description>
    </other_outcome>
    <other_outcome>
      <measure>Neurocognitive/executive functioning</measure>
      <time_frame>baseline, 9 months</time_frame>
      <description>Moderator variable; adolescent's parent/caregiver report using the Behavior Rating Inventory of Executive Function, 2nd ed. (BRIEF-2; 12 items). Raw scale scores are transformed to T scores. T scores from 60-64 are mildly elevated problems with executive functioning, T scores from 65-69 are considered potentially clinically elevated problems with executive functioning, and T scores at or above 70 are considered clinically elevated problems with executive functioning.</description>
    </other_outcome>
    <other_outcome>
      <measure>Social resources and conditions</measure>
      <time_frame>baseline, 9 months</time_frame>
      <description>Moderator variable; based on residential address using the Child Opportunity Index (COI). 9-month measurement will assess change in address and change in COI. All United States neighborhoods are scored and ranked from lowest to highest opportunity. Five levels of opportunity are used (very low, low, moderate, high, very high) and scores range from 1 (lowest opportunity) to 100 (highest opportunity).</description>
    </other_outcome>
    <other_outcome>
      <measure>Depressive symptoms</measure>
      <time_frame>baseline, 9 months</time_frame>
      <description>Moderator variable; adolescent and young adult self report using the Patient Reported Outcomes Measurement Information System (PROMIS) Depressive Symptoms v2 Pediatric Short Form (8 items). Raw scores range from 0 - 32 with higher scores indicating greater depressive symptoms.</description>
    </other_outcome>
    <other_outcome>
      <measure>Anxiety</measure>
      <time_frame>baseline, 9 months</time_frame>
      <description>Moderator variable; adolescent and young adult self report using the Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety v2 Pediatric Short Form (8 items). Raw scores range from 0 - 32 with higher scores indicating greater anxiety.</description>
    </other_outcome>
    <other_outcome>
      <measure>Fatigue</measure>
      <time_frame>baseline, 9 months</time_frame>
      <description>Moderator variable; adolescent and young adult self report using the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue v2 Pediatric Short Form (10 items). Raw scores range from 0 - 40 with higher scores indicating greater fatigue.</description>
    </other_outcome>
    <other_outcome>
      <measure>Family functioning</measure>
      <time_frame>baseline, 9 months</time_frame>
      <description>Moderator variable; parent/caregiver of adolescent report using the McMaster Family Functioning Assessment Device (12 items). Items response options range from 1 (strongly agree) to 4 (strongly disagree). All odd items are reverse scored. After reverse scoring, all items are summed. Lower total scores indicate higher levels of family functioning.</description>
    </other_outcome>
    <other_outcome>
      <measure>Health literacy</measure>
      <time_frame>baseline, 9 months</time_frame>
      <description>Moderator variable; adolescent and young adult self report using the Newest Vital Sign (NVS; 6 items). Items are scored from 0 - 6 and summed. Total scores of 0 - 1 indicate a high likelihood of limited literacy, 2 - 3 a possibility of limited literacy, and 4 - 6 adequate literacy.</description>
    </other_outcome>
    <other_outcome>
      <measure>Perceived stigma</measure>
      <time_frame>baseline, 9 months</time_frame>
      <description>Moderator variable; adolescent and young adult self report using the Child Stigma Scale (8 items). Each item is rated from from 0 (Never) to 4 (Very often). Higher scores indicate greater perceived stigma.</description>
    </other_outcome>
    <other_outcome>
      <measure>Sleep disturbance</measure>
      <time_frame>baseline, 9 months</time_frame>
      <description>Moderator variable; adolescent and young adult self report using the Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance v1 Pediatric Short Form (4 items). Raw scores range from 0 - 16 with higher scores indicating greater sleep disturbance.</description>
    </other_outcome>
    <other_outcome>
      <measure>Perceived discrimination</measure>
      <time_frame>baseline, 9 months</time_frame>
      <description>Moderator variable; adolescent and young adult self report using the Discrimination subscale of the Interpersonal Processes of Care instrument (2 items). Response options range from 1 (Never) to 5 (Always). Total score is calculated as the mean of responses, with higher scores indicating higher frequency of discrimination.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">272</enrollment>
    <condition>Sickle Cell Disease</condition>
    <arm_group>
      <arm_group_label>Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Study participants randomized to receive the intervention.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Study participants randomized to receive enhanced usual care (control).</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Voice Crisis Alert V2</intervention_name>
      <description>The mHealth self-management intervention consists of the following components: 1) condition-specific electronic educational materials; 2) pain/symptom monitoring and tracking; 3) health history information documentation; 4) medication tracking; 5) secure messaging with a provider; 6) functioning monitoring and tracking; and 7) transmission of health information (graphs with recorded pain and functioning histories) to a provider.</description>
      <arm_group_label>Intervention</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Electronic educational materials</intervention_name>
      <description>The control arm will receive enhanced usual care, which will consist of usual educational materials distributed at the clinic plus a version of the intervention (Voice Crisis Alert V2) that only includes the electronic educational materials.</description>
      <arm_group_label>Control</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  documentation in the electronic health record of any type of SCD&#xD;
  &#xD;
            -  owns mobile device compatible with the intervention&#xD;
  &#xD;
            -  access to the internet&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Plans to relocate outside of study site area in the next 12 months&#xD;
  &#xD;
            -  Plans to transition to adult care in 12 months or less&#xD;
  &#xD;
            -  Parent/caregiver or provider report of neurocognitive impairment that precludes&#xD;
               ability to use intervention and participate in study&#xD;
  &#xD;
            -  non-English speaking&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>14 Years</minimum_age>
      <maximum_age>21 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Shannon Phillips, PhD, RN</last_name>
      <phone>843-792-9379</phone>
      <email>phillipss@musc.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Margie Prentice, MBA</last_name>
      <phone>843-792-4771</phone>
      <email>prenticm@musc.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Medical University of South Carolina</name>
        <address>
          <city>Charleston</city>
          <state>South Carolina</state>
          <zip>29425</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Medical University of South Carolina</investigator_affiliation>
      <investigator_full_name>Shannon Phillips</investigator_full_name>
      <investigator_title>Associate Professor-Faculty</investigator_title>
    </responsible_party>
    <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>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06035939
  org study id: Pro00127137
  secondary id: 1R01NR020606-01
  nct id: NCT06035939
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The purpose of this study is to find out whether a web-based intervention using a mobile app
        is helpful for teens and young adults with sickle cell disease (SCD) in learning how to care
        for and manage their symptoms.
  The purpose of this study is to test the effectiveness of and identify barriers and
        facilitators to the implementation of SMYLS, an mHealth intervention designed to facilitate
        self-management behaviors in adolescents and young adults (AYA) with sickle cell disease
        (SCD). Specifically, the investigators propose to determine the effect of the intervention on
        the primary outcome of self-management behaviors and the secondary outcomes of quality of
        life, transition readiness, healthcare utilization, and pain interference. In addition, the
        investigators will explore how patient activation moderates development of self-management
        behaviors and systemic, structural, and social variables that moderate relationships between
        patient activation, the primary outcome, and secondary outcomes.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Single (Investigator)
  measure: Self-management behaviors
  time frame: baseline and 1, 3, 6, 9, 12 months
  description: Adolescent and young adult self-report using the Transition Readiness Assessment Questionnaire 5th version (TRAQ-5; 20 items). The instrument consists of 5 scales. Individual item scores range from 1 - 5. Scale scores are determined by calculating the average of the item scores within each scale. Higher scores indicate greater transition readiness and self-management behaviors.
  measure: Engagement in intervention/control (categorical)
  time frame: baseline and 1, 3, 6, 9, 12 months
  description: Categorized into none, low, moderate and high. For intervention arm, categories are based on scope (number of components), duration (number of weeks), and frequency (number of times per week). For control arm, categories are based on duration and frequency as for intervention group parameters.
  measure: Engagement in intervention/control (continuous)
  time frame: Ongoing
  description: Number of times the application is accessed (intervention = full application; control = educational component only).
  measure: Health-related quality of life
  time frame: baseline and 1, 3, 6, 9, and 12 months
  description: Adolescent and young adult self report using the Pediatric Quality of Life Inventory (PedsQL) with Sickle Cell Disease Module (43 items). Items are scaled from 0 (Never) to 4 (Almost always). Scores are reverse scored and linearly transformed to a 0 - 100 scale. Higher scores indicate better health-related quality of life.
  measure: Number of attended SCD clinic visits
  time frame: baseline and 1, 3, 6, 9, and 12 months
  description: Number of attended SCD clinic visits documented in the medical record
  measure: Number of ED visits
  time frame: baseline and 1, 3, 6, 9, and 12 months
  description: Number of ED visits documented in the medical record
  measure: Number of hospitalizations
  time frame: baseline and 1, 3, 6, 9, and 12 months
  description: Number of hospitalizations documented in the medical record
  measure: Pain interference
  time frame: baseline and 1, 3, 6, 9, and 12, months
  description: Adolescent and young adult self report using the Patient Reported Outcomes Measurement Inventory System (PROMIS) Pain Interference v2 Pediatric Short Form (8 items). Raw scores range from 0 - 32 with higher scores indicating greater pain interference.
  measure: Transition readiness
  time frame: baseline and 1, 3, 6, 9, and 12 months
  description: Adolescent and young adult self report using the Transition Intervention Program - Readiness for Transition (TIP-RFT; 22 items). Scores for each item range from 0 - 4, with a total possible summed score ranging from 0 - 88. Lower scores indicate higher transition readiness.
  measure: Patient activation
  time frame: baseline and 1, 3, 6, 9, and 12 months
  description: Moderator variable; adolescent and young adult self-report using the Patient Activation Measure (PAM-13). Raw scores are transformed to a scale of 0 - 100 with 100 being the highest activation level.
  measure: Neurocognitive/executive functioning
  time frame: baseline, 9 months
  description: Moderator variable; adolescent's parent/caregiver report using the Behavior Rating Inventory of Executive Function, 2nd ed. (BRIEF-2; 12 items). Raw scale scores are transformed to T scores. T scores from 60-64 are mildly elevated problems with executive functioning, T scores from 65-69 are considered potentially clinically elevated problems with executive functioning, and T scores at or above 70 are considered clinically elevated problems with executive functioning.
  measure: Social resources and conditions
  time frame: baseline, 9 months
  description: Moderator variable; based on residential address using the Child Opportunity Index (COI). 9-month measurement will assess change in address and change in COI. All United States neighborhoods are scored and ranked from lowest to highest opportunity. Five levels of opportunity are used (very low, low, moderate, high, very high) and scores range from 1 (lowest opportunity) to 100 (highest opportunity).
  measure: Depressive symptoms
  time frame: baseline, 9 months
  description: Moderator variable; adolescent and young adult self report using the Patient Reported Outcomes Measurement Information System (PROMIS) Depressive Symptoms v2 Pediatric Short Form (8 items). Raw scores range from 0 - 32 with higher scores indicating greater depressive symptoms.
  measure: Anxiety
  time frame: baseline, 9 months
  description: Moderator variable; adolescent and young adult self report using the Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety v2 Pediatric Short Form (8 items). Raw scores range from 0 - 32 with higher scores indicating greater anxiety.
  measure: Fatigue
  time frame: baseline, 9 months
  description: Moderator variable; adolescent and young adult self report using the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue v2 Pediatric Short Form (10 items). Raw scores range from 0 - 40 with higher scores indicating greater fatigue.
  measure: Family functioning
  time frame: baseline, 9 months
  description: Moderator variable; parent/caregiver of adolescent report using the McMaster Family Functioning Assessment Device (12 items). Items response options range from 1 (strongly agree) to 4 (strongly disagree). All odd items are reverse scored. After reverse scoring, all items are summed. Lower total scores indicate higher levels of family functioning.
  measure: Health literacy
  time frame: baseline, 9 months
  description: Moderator variable; adolescent and young adult self report using the Newest Vital Sign (NVS; 6 items). Items are scored from 0 - 6 and summed. Total scores of 0 - 1 indicate a high likelihood of limited literacy, 2 - 3 a possibility of limited literacy, and 4 - 6 adequate literacy.
  measure: Perceived stigma
  time frame: baseline, 9 months
  description: Moderator variable; adolescent and young adult self report using the Child Stigma Scale (8 items). Each item is rated from from 0 (Never) to 4 (Very often). Higher scores indicate greater perceived stigma.
  measure: Sleep disturbance
  time frame: baseline, 9 months
  description: Moderator variable; adolescent and young adult self report using the Patient Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance v1 Pediatric Short Form (4 items). Raw scores range from 0 - 16 with higher scores indicating greater sleep disturbance.
  measure: Perceived discrimination
  time frame: baseline, 9 months
  description: Moderator variable; adolescent and young adult self report using the Discrimination subscale of the Interpersonal Processes of Care instrument (2 items). Response options range from 1 (Never) to 5 (Always). Total score is calculated as the mean of responses, with higher scores indicating higher frequency of discrimination.
  arm group label: Intervention
  arm group type: Experimental
  description: Study participants randomized to receive the intervention.
  arm group label: Control
  arm group type: Active Comparator
  description: Study participants randomized to receive enhanced usual care (control).
  intervention type: Behavioral
  intervention name: Voice Crisis Alert V2
  description: The mHealth self-management intervention consists of the following components: 1) condition-specific electronic educational materials; 2) pain/symptom monitoring and tracking; 3) health history information documentation; 4) medication tracking; 5) secure messaging with a provider; 6) functioning monitoring and tracking; and 7) transmission of health information (graphs with recorded pain and functioning histories) to a provider.
  arm group label: Intervention
  intervention type: Behavioral
  intervention name: Electronic educational materials
  description: The control arm will receive enhanced usual care, which will consist of usual educational materials distributed at the clinic plus a version of the intervention (Voice Crisis Alert V2) that only includes the electronic educational materials.
  arm group label: Control
  criteria: 
  gender: All
  minimum age: 14 Years
  maximum age: 21 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Shannon Phillips, PhD, RN
  phone: 843-792-9379
  email: phillipss@musc.edu
  last name: Margie Prentice, MBA
  phone: 843-792-4771
  email: prenticm@musc.edu
  facility: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Medical University of South Carolina
  investigator full name: Shannon Phillips
  investigator title: Associate Professor-Faculty
  mesh term: Anemia, Sickle Cell
  sharing ipd: No