<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/NCT04400240</url>
  </required_header>
  <id_info>
    <org_study_id>00070647</org_study_id>
    <nct_id>NCT04400240</nct_id>
  </id_info>
  <brief_title>Care Coordination Approaches to Learning Lupus Self-management</brief_title>
  <acronym>CALLS</acronym>
  <official_title>Care Coordination Approaches to Learning Lupus Self-management</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of South Carolina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Care-coordination Approach to Learning Lupus Self-Management (CALLS) study was designed&#xD;
      to examine whether modeling and reinforcement from a lay patient navigator/care coordinator&#xD;
      improves disease self-management, indicators of disease activity, health related quality of&#xD;
      life (HRQOL), and 30-day readmission in SLE inpatient admissions. We recruited 30 patients&#xD;
      (~15 questionnaires and phone sessions and 15 questionnaires only) with active SLE upon&#xD;
      hospital admittance at the Medical University of South Carolina (MUSC). The lay patient&#xD;
      navigator/care coordinator was trained to deliver intervention content by twelve weekly&#xD;
      telephone sessions carried out across the course of the study. All participants were assessed&#xD;
      using validated measures of patient reported outcomes at baseline, mid-intervention (6 weeks&#xD;
      post-enrollment), and immediately following the intervention (12 weeks post-enrollment).&#xD;
      Outcomes for patients who agreed to phone sessions were compared with the outcomes of&#xD;
      patients who opted to participate in questionnaires only. The study lasted 12 months, with&#xD;
      recruitment and enrollment over 6 months, 3 months for intervention delivery and 3 months for&#xD;
      data analysis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Overview of Study Design. The Care-coordination Approach to Learning Lupus Self-Management&#xD;
      (CALLS) study is a double arm, pre-post pilot designed to examine whether modeling and&#xD;
      reinforcement from a lay patient navigator/care coordinator improves disease self-management,&#xD;
      indicators of disease activity, health related quality of life (HRQOL), and 30-day&#xD;
      readmission in SLE inpatient admissions. We will recruit 40 patients (20 questionnaires and&#xD;
      phone sessions and 20 questionnaires only) with active SLE upon hospital admittance at the&#xD;
      Medical University of South Carolina (MUSC). The lay patient navigator/care coordinator will&#xD;
      be trained to deliver intervention content by twelve weekly telephone sessions carried out&#xD;
      across the course of the study. All participants will be assessed using validated measures of&#xD;
      patient reported outcomes at baseline, mid-intervention (6 weeks post-enrollment), and&#xD;
      immediately following the intervention (12 weeks post-enrollment). Outcomes for patients who&#xD;
      agree to phone sessions will be compared with the outcomes of patients who opt to participate&#xD;
      in questionnaires only. The study will last 12 months with recruitment and enrollment over 6&#xD;
      months, 3 months for intervention delivery and 3 months for data analysis.&#xD;
&#xD;
      Study Population. The target population for this study will be SLE inpatient admissions at&#xD;
      MUSC. There are approximately 35 SLE and Scleroderma hospital admissions each month, so it is&#xD;
      expected that over a 3-month recruitment period, we will be able to recruit 40 participants&#xD;
      (20 questionnaires and phone sessions and 20 questionnaires only).&#xD;
&#xD;
      Recruitment of Lay Patient Navigator/Care Coordinator The PI will identify a suitable lay&#xD;
      patient navigator/care coordinator based on their maturity, emotional stability, and verbal&#xD;
      communication skills. Suitable candidates will have at least a high school diploma or&#xD;
      equivalency with at least one year of patient care experience in a health care facility; or a&#xD;
      Certified Nursing Assistant; or successful completion of a Nursing Assistant or Medical&#xD;
      Assistant course at an accredited institution or equivalent training; or EMT or Paramedic&#xD;
      certification; or a Bachelor's degree. They will possess the ability to understand and&#xD;
      implement a variety of detailed instructions in the execution of therapeutic procedures and&#xD;
      the ability to make accurate physical observation of patients.&#xD;
&#xD;
      Recruitment of SLE patients Admitted SLE patients will be referred by their physician for&#xD;
      participation in the study, who will provide a letter that will explain the study and provide&#xD;
      participants a number to call if they have questions or concerns prior to agreeing to&#xD;
      participate. Participants who indicate interest in the study will be immediately screened for&#xD;
      eligibility, and if eligibility criteria are met, informed consent will be obtained. Once a&#xD;
      patient has been consented, they will be randomized to membership in one of the two study&#xD;
      arms. assigned to the intervention (complete questionnaires and phone sessions) or control&#xD;
      (complete questionnaires only) arm, and the rest of the recruitment visit will include&#xD;
      baseline self-report assessments and scheduling of phone sessions (if applicable).&#xD;
&#xD;
      Phone sessions: The CALLS program will focus on enhancing the health of SLE patients, with&#xD;
      emphasis on patient empowerment and promoting proactive participation in health care.&#xD;
      Recruitment and enrollment will occur on a rolling basis, and the program will consist of 12&#xD;
      weeks of service delivery that will include one standard educational session by telephone or&#xD;
      in-person meeting every week. The weekly educational session will be generally structured in&#xD;
      three parts: introduction, structured education, and problem solving. Weekly content will be&#xD;
      adapted from the twelve modules of the Peer Approaches to Lupus Self-management (PALS) study,&#xD;
      and further tailored according to prominent barriers to care in the scientific literature.&#xD;
      Content will include: 1) Medication adherence; 2) Communication with provider; 3) Patient&#xD;
      engagement; 4) Recognizing and treating depression; 5) Overcoming socioeconomic barriers; 6)&#xD;
      Social Support network; 7) Appointment/ Lab adherence; and 8) Transportation. The lay patient&#xD;
      navigator/care coordinator will respond to individual patient needs by tailoring intervention&#xD;
      content to personal requirements and facilitating care coordination and will be able to&#xD;
      address insurance, financial, and logistical issues (e.g., transportation, appointment&#xD;
      scheduling, child or elder care), while providing understandable health education that may&#xD;
      lessen fears of SLE diagnosis and treatment. Lay patient navigator/care coordinator&#xD;
      activities will be guided by frequent self-report assessments, which will help to identify&#xD;
      patient concerns across multiple domains, triage patients to appropriate resources, and&#xD;
      ultimately overcome barriers to health care. The lay patient navigator/care coordinator can&#xD;
      use baseline data collected prior to phone sessions to describe preliminary patient themes&#xD;
      (i.e., disease activity and damage, depression, medication adherence, communication with&#xD;
      provider, patient engagement) and subsequent assessments can be used to track progress.&#xD;
&#xD;
      Data Collection Schedule. Study questionnaires were carefully chosen based on available&#xD;
      evidence of previous validation and their ability to measure key elements of the study aims.&#xD;
      The primary method of data collection will be face-to-face interview. All study visits will&#xD;
      take place in an MUSC affiliated hospital, the Research Nexus or comparable private location&#xD;
      on the campus of MUSC. Indicators of medication adherence will be extracted from the&#xD;
      electronic medical records. Financial data will be extracted from the research data warehouse&#xD;
      for historical and patient-specific data for cost effectiveness. The MUSC REDCap system will&#xD;
      be used for data management.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</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 (Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Self-management measured using the Patient Activation Measure (PAM)</measure>
    <time_frame>Baseline to post-intervention, at 12 weeks</time_frame>
    <description>The Patient Activation Measure (PAM) assesses an individual's knowledge, skill, and confidence for managing their health and healthcare. Individuals who measure high on this assessment typically understand the importance of taking a proactive role in managing their health and have the skills and confidence to do so. The PAM survey measures patients on a 0-100 scale and can segment patients into one of four activation levels along an empirically derived continuum, including &quot;Believes Active Role Important&quot;, &quot;Confidence and Knowledge to Take Action&quot;, &quot;Taking Action&quot;, and &quot;Staying Course Under Stress&quot;. Each activation level reveals insight into an array of health-related characteristics, including attitudes, motivators, behaviors, and outcomes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Satisfaction in Quality of Life as assessed by the LUP-QOL (Lupus Quality of Life Questionnaire)</measure>
    <time_frame>Baseline to post-intervention, at 12 weeks</time_frame>
    <description>Quality of life will be assessed by using The LUP-QOL (Lupus Quality of Life Questionnaire), which assesses areas of the participant's life that may be affected by lupus. The score ranges from 0-100. A score of '0' indicates the lowest quality of life, and a score of 100 indicates the best quality of life.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>30-day readmission</measure>
    <time_frame>Baseline to post-intervention, at 12 weeks</time_frame>
    <description>Change in cost due to readmission. Costs will include total charges associated with any healthcare encounters at the Medical University of South Carolina.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Systemic Lupus Erythematosus</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>complete questionnaires and phone sessions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>complete questionnaires only</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>CALLS</intervention_name>
    <description>The CALLS program will consist of 12 weeks of service delivery that will include one standard educational session by telephone or in-person meeting every week. The weekly educational session will be generally structured in three parts: introduction, structured education, and problem solving. Weekly content will be adapted from the twelve modules of the Peer Approaches to Lupus Self-management (PALS) study, and further tailored according to prominent barriers to care in the scientific literature. Content will include: 1) Medication adherence; 2) Communication with provider; 3) Patient engagement; 4) Recognizing and treating depression; 5) Overcoming socioeconomic barriers; 6) Social Support network; 7) Appointment/ Lab adherence; and 8) Transportation.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Hospital admission for SLE-related issue;&#xD;
&#xD;
          2. clinical diagnosis of systemic lupus erythematosus (SLE) from a physician;&#xD;
&#xD;
          3. 18 years of age or older;&#xD;
&#xD;
          4. able to provide informed consent and take part in ongoing assessment/evaluation&#xD;
             activities (self-reported questionnaires);&#xD;
&#xD;
          5. able to commit to duration of study (3 months);&#xD;
&#xD;
          6. able to communicate in English; and&#xD;
&#xD;
          7. have an active phone line (landline or cell phone) for the duration of the study, if&#xD;
             agreeing to phone sessions with the lay patient navigator/care coordinator.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. cognitive impairment;&#xD;
&#xD;
          2. acute decompensation of chronic conditions precluding participation;&#xD;
&#xD;
          3. conditions that preclude participation in assessments (e.g. blindness or deafness);&#xD;
             and&#xD;
&#xD;
          4. terminal illness or life expectancy less than 6 months as evaluated by physician.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <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>May 2020</verification_date>
  <study_first_submitted>May 8, 2020</study_first_submitted>
  <study_first_submitted_qc>May 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 22, 2020</study_first_posted>
  <last_update_submitted>May 19, 2020</last_update_submitted>
  <last_update_submitted_qc>May 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 22, 2020</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>Edith Williams</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lupus Erythematosus, Systemic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Results presented in peer-reviewed publications</ipd_description>
  </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/NCT04400240
org study id: 00070647
nct id: NCT04400240
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The Care-coordination Approach to Learning Lupus Self-Management (CALLS) study was designed
      to examine whether modeling and reinforcement from a lay patient navigator/care coordinator
      improves disease self-management, indicators of disease activity, health related quality of
      life (HRQOL), and 30-day readmission in SLE inpatient admissions. We recruited 30 patients
      (~15 questionnaires and phone sessions and 15 questionnaires only) with active SLE upon
      hospital admittance at the Medical University of South Carolina (MUSC). The lay patient
      navigator/care coordinator was trained to deliver intervention content by twelve weekly
      telephone sessions carried out across the course of the study. All participants were assessed
      using validated measures of patient reported outcomes at baseline, mid-intervention (6 weeks
      post-enrollment), and immediately following the intervention (12 weeks post-enrollment).
      Outcomes for patients who agreed to phone sessions were compared with the outcomes of
      patients who opted to participate in questionnaires only. The study lasted 12 months, with
      recruitment and enrollment over 6 months, 3 months for intervention delivery and 3 months for
      data analysis.
Overview of Study Design. The Care-coordination Approach to Learning Lupus Self-Management
      (CALLS) study is a double arm, pre-post pilot designed to examine whether modeling and
      reinforcement from a lay patient navigator/care coordinator improves disease self-management,
      indicators of disease activity, health related quality of life (HRQOL), and 30-day
      readmission in SLE inpatient admissions. We will recruit 40 patients (20 questionnaires and
      phone sessions and 20 questionnaires only) with active SLE upon hospital admittance at the
      Medical University of South Carolina (MUSC). The lay patient navigator/care coordinator will
      be trained to deliver intervention content by twelve weekly telephone sessions carried out
      across the course of the study. All participants will be assessed using validated measures of
      patient reported outcomes at baseline, mid-intervention (6 weeks post-enrollment), and
      immediately following the intervention (12 weeks post-enrollment). Outcomes for patients who
      agree to phone sessions will be compared with the outcomes of patients who opt to participate
      in questionnaires only. The study will last 12 months with recruitment and enrollment over 6
      months, 3 months for intervention delivery and 3 months for data analysis.

      Study Population. The target population for this study will be SLE inpatient admissions at
      MUSC. There are approximately 35 SLE and Scleroderma hospital admissions each month, so it is
      expected that over a 3-month recruitment period, we will be able to recruit 40 participants
      (20 questionnaires and phone sessions and 20 questionnaires only).

      Recruitment of Lay Patient Navigator/Care Coordinator The PI will identify a suitable lay
      patient navigator/care coordinator based on their maturity, emotional stability, and verbal
      communication skills. Suitable candidates will have at least a high school diploma or
      equivalency with at least one year of patient care experience in a health care facility; or a
      Certified Nursing Assistant; or successful completion of a Nursing Assistant or Medical
      Assistant course at an accredited institution or equivalent training; or EMT or Paramedic
      certification; or a Bachelor's degree. They will possess the ability to understand and
      implement a variety of detailed instructions in the execution of therapeutic procedures and
      the ability to make accurate physical observation of patients.

      Recruitment of SLE patients Admitted SLE patients will be referred by their physician for
      participation in the study, who will provide a letter that will explain the study and provide
      participants a number to call if they have questions or concerns prior to agreeing to
      participate. Participants who indicate interest in the study will be immediately screened for
      eligibility, and if eligibility criteria are met, informed consent will be obtained. Once a
      patient has been consented, they will be randomized to membership in one of the two study
      arms. assigned to the intervention (complete questionnaires and phone sessions) or control
      (complete questionnaires only) arm, and the rest of the recruitment visit will include
      baseline self-report assessments and scheduling of phone sessions (if applicable).

      Phone sessions: The CALLS program will focus on enhancing the health of SLE patients, with
      emphasis on patient empowerment and promoting proactive participation in health care.
      Recruitment and enrollment will occur on a rolling basis, and the program will consist of 12
      weeks of service delivery that will include one standard educational session by telephone or
      in-person meeting every week. The weekly educational session will be generally structured in
      three parts: introduction, structured education, and problem solving. Weekly content will be
      adapted from the twelve modules of the Peer Approaches to Lupus Self-management (PALS) study,
      and further tailored according to prominent barriers to care in the scientific literature.
      Content will include: 1) Medication adherence; 2) Communication with provider; 3) Patient
      engagement; 4) Recognizing and treating depression; 5) Overcoming socioeconomic barriers; 6)
      Social Support network; 7) Appointment/ Lab adherence; and 8) Transportation. The lay patient
      navigator/care coordinator will respond to individual patient needs by tailoring intervention
      content to personal requirements and facilitating care coordination and will be able to
      address insurance, financial, and logistical issues (e.g., transportation, appointment
      scheduling, child or elder care), while providing understandable health education that may
      lessen fears of SLE diagnosis and treatment. Lay patient navigator/care coordinator
      activities will be guided by frequent self-report assessments, which will help to identify
      patient concerns across multiple domains, triage patients to appropriate resources, and
      ultimately overcome barriers to health care. The lay patient navigator/care coordinator can
      use baseline data collected prior to phone sessions to describe preliminary patient themes
      (i.e., disease activity and damage, depression, medication adherence, communication with
      provider, patient engagement) and subsequent assessments can be used to track progress.

      Data Collection Schedule. Study questionnaires were carefully chosen based on available
      evidence of previous validation and their ability to measure key elements of the study aims.
      The primary method of data collection will be face-to-face interview. All study visits will
      take place in an MUSC affiliated hospital, the Research Nexus or comparable private location
      on the campus of MUSC. Indicators of medication adherence will be extracted from the
      electronic medical records. Financial data will be extracted from the research data warehouse
      for historical and patient-specific data for cost effectiveness. The MUSC REDCap system will
      be used for data management.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Care Provider)
measure: Change in Self-management measured using the Patient Activation Measure (PAM)
time frame: Baseline to post-intervention, at 12 weeks
description: The Patient Activation Measure (PAM) assesses an individual's knowledge, skill, and confidence for managing their health and healthcare. Individuals who measure high on this assessment typically understand the importance of taking a proactive role in managing their health and have the skills and confidence to do so. The PAM survey measures patients on a 0-100 scale and can segment patients into one of four activation levels along an empirically derived continuum, including "Believes Active Role Important", "Confidence and Knowledge to Take Action", "Taking Action", and "Staying Course Under Stress". Each activation level reveals insight into an array of health-related characteristics, including attitudes, motivators, behaviors, and outcomes.
measure: Satisfaction in Quality of Life as assessed by the LUP-QOL (Lupus Quality of Life Questionnaire)
time frame: Baseline to post-intervention, at 12 weeks
description: Quality of life will be assessed by using The LUP-QOL (Lupus Quality of Life Questionnaire), which assesses areas of the participant's life that may be affected by lupus. The score ranges from 0-100. A score of '0' indicates the lowest quality of life, and a score of 100 indicates the best quality of life.
measure: 30-day readmission
time frame: Baseline to post-intervention, at 12 weeks
description: Change in cost due to readmission. Costs will include total charges associated with any healthcare encounters at the Medical University of South Carolina.
arm group label: Intervention
arm group type: Experimental
description: complete questionnaires and phone sessions
arm group label: Control
arm group type: No Intervention
description: complete questionnaires only
intervention type: Behavioral
intervention name: CALLS
description: The CALLS program will consist of 12 weeks of service delivery that will include one standard educational session by telephone or in-person meeting every week. The weekly educational session will be generally structured in three parts: introduction, structured education, and problem solving. Weekly content will be adapted from the twelve modules of the Peer Approaches to Lupus Self-management (PALS) study, and further tailored according to prominent barriers to care in the scientific literature. Content will include: 1) Medication adherence; 2) Communication with provider; 3) Patient engagement; 4) Recognizing and treating depression; 5) Overcoming socioeconomic barriers; 6) Social Support network; 7) Appointment/ Lab adherence; and 8) Transportation.
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Medical University of South Carolina
investigator full name: Edith Williams
investigator title: Associate Professor
mesh term: Lupus Erythematosus, Systemic
sharing ipd: No
ipd description: Results presented in peer-reviewed publications