<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/NCT03304535</url>
  </required_header>
  <id_info>
    <org_study_id>IRB#15-XXX</org_study_id>
    <nct_id>NCT03304535</nct_id>
  </id_info>
  <brief_title>Social Worker in an Eye-Care Service</brief_title>
  <official_title>The Impact of a Social Worker in a Glaucoma Eye-Care Service: A Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wills Eye</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wills Eye</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to determine whether involvement with a social worker&#xD;
      helps reduce distress, depression, and increase patient activation in participants over a 6&#xD;
      month intervention period. The study will also describe common barriers to care that&#xD;
      participants face.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An appointment will be scheduled for participant to meet with a social worker. The&#xD;
      appointment may happen on day of participant's scheduled clinic appointment or on another&#xD;
      mutually decided upon date and time. Should participant choose to participate, this first&#xD;
      visit will be Visit 1 for the study.&#xD;
&#xD;
      Visit 1: Baseline&#xD;
&#xD;
      Informed consent will be obtained demonstrating an interest in participating.&#xD;
&#xD;
      A visit with the social worker will take place during Visit 1. This session will be held in a&#xD;
      private office and allows participant time for discussion regarding any challenges, struggles&#xD;
      and/or barriers they may be experiencing.&#xD;
&#xD;
      The following baseline questionnaires/surveys will be administered:&#xD;
&#xD;
      Modified Patient Activation Measure - measures participant confidence in taking care of their&#xD;
      own health.&#xD;
&#xD;
      Distress Thermometer - measures participant distress level during the past week.&#xD;
&#xD;
      Patient Health Questionnaire -measures depression symptoms and severity if any.&#xD;
&#xD;
      Clinical information will be taken from participant's medical record. There may be follow-up&#xD;
      questions related to data if information is unclear or incomplete.&#xD;
&#xD;
      Upon completion of Visit 1, participant will receive a satisfaction survey to evaluate how&#xD;
      participant satisfaction with social worker interaction.&#xD;
&#xD;
      Social Worker Interventions: After Visit 1 and before Visit 2&#xD;
&#xD;
      The social worker will develop an intervention for participant during Visit 1 appointment. As&#xD;
      many calls or in person meetings participant requires will take place. There will be no limit&#xD;
      and it will be determined by participant's needs.&#xD;
&#xD;
      Visit 2: Follow-up After 6 Months&#xD;
&#xD;
      Upon completion of participant's six month follow-up in the study, the following&#xD;
      questionnaires/surveys will be administered:&#xD;
&#xD;
      Modified Patient Activation Measure - measures how confident participant is at taking care of&#xD;
      their own health.&#xD;
&#xD;
      Distress Thermometer - measures how much distress participant has been experiencing in the&#xD;
      past week.&#xD;
&#xD;
      Patient Health Questionnaire - measures if participant has symptoms of depression and the&#xD;
      severity of those symptoms.&#xD;
&#xD;
      Satisfaction Survey - measures how satisfied participant is with the social worker&#xD;
      interaction.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2016</start_date>
  <completion_date type="Actual">August 2017</completion_date>
  <primary_completion_date type="Actual">August 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in response to Patient Health Questionnaire 9</measure>
    <time_frame>6 months</time_frame>
    <description>Measures participant levels of depression based on questions related to depressive symptoms. The investigator will assess change in the number of participants with major, moderate, and minimal depressive symptoms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in response to Distress thermometer</measure>
    <time_frame>6 months</time_frame>
    <description>Measures participant level of distress on a scale of 1 to 10 and asks additional questions regarding contributors to distress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in response to Modified Patient Activation Measure 13</measure>
    <time_frame>6 months</time_frame>
    <description>Measures participant self-capacity for and confidence regarding glaucoma management.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Descriptive results of the Social Worker Baseline Assessment</measure>
    <time_frame>6 months</time_frame>
    <description>Social worker will assess each participant's internal and external barriers to care, limitations, and strengths that may help them to manage their glaucoma.</description>
  </secondary_outcome>
  <enrollment type="Actual">40</enrollment>
  <condition>Glaucoma</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with any type of Glaucoma&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients seen at Wills Eye Hospital in the Glaucoma Service&#xD;
&#xD;
          -  Glaucoma of any type, characterized by glaucomatous optic neuropathy and corresponding&#xD;
             visual field (VF) defect&#xD;
&#xD;
          -  Referred to staff social worker for intervention&#xD;
&#xD;
          -  Ability to read, write, speak and understand English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Scott J Fudemberg, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wills Eye Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wills Eye Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Fudemberg SJ, Amarasekera DC, Silverstein MH, Linder KM, Heffner P, Hark LA, Waisbourd M. Overcoming Barriers to Eye Care: Patient Response to a Medical Social Worker in a Glaucoma Service. J Community Health. 2016 Aug;41(4):845-9. doi: 10.1007/s10900-016-0162-1.</citation>
    <PMID>26860278</PMID>
  </reference>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>February 22, 2016</study_first_submitted>
  <study_first_submitted_qc>October 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 9, 2017</study_first_posted>
  <last_update_submitted>October 3, 2017</last_update_submitted>
  <last_update_submitted_qc>October 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Wills Eye</investigator_affiliation>
    <investigator_full_name>Scott Fudemberg, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Glaucoma</keyword>
  <keyword>Social Worker</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glaucoma</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/NCT03304535
org study id: IRB#15-XXX
nct id: NCT03304535
lead sponsor: 
has dmc: No
The purpose of this research study is to determine whether involvement with a social worker
      helps reduce distress, depression, and increase patient activation in participants over a 6
      month intervention period. The study will also describe common barriers to care that
      participants face.
An appointment will be scheduled for participant to meet with a social worker. The
      appointment may happen on day of participant's scheduled clinic appointment or on another
      mutually decided upon date and time. Should participant choose to participate, this first
      visit will be Visit 1 for the study.

      Visit 1: Baseline

      Informed consent will be obtained demonstrating an interest in participating.

      A visit with the social worker will take place during Visit 1. This session will be held in a
      private office and allows participant time for discussion regarding any challenges, struggles
      and/or barriers they may be experiencing.

      The following baseline questionnaires/surveys will be administered:

      Modified Patient Activation Measure - measures participant confidence in taking care of their
      own health.

      Distress Thermometer - measures participant distress level during the past week.

      Patient Health Questionnaire -measures depression symptoms and severity if any.

      Clinical information will be taken from participant's medical record. There may be follow-up
      questions related to data if information is unclear or incomplete.

      Upon completion of Visit 1, participant will receive a satisfaction survey to evaluate how
      participant satisfaction with social worker interaction.

      Social Worker Interventions: After Visit 1 and before Visit 2

      The social worker will develop an intervention for participant during Visit 1 appointment. As
      many calls or in person meetings participant requires will take place. There will be no limit
      and it will be determined by participant's needs.

      Visit 2: Follow-up After 6 Months

      Upon completion of participant's six month follow-up in the study, the following
      questionnaires/surveys will be administered:

      Modified Patient Activation Measure - measures how confident participant is at taking care of
      their own health.

      Distress Thermometer - measures how much distress participant has been experiencing in the
      past week.

      Patient Health Questionnaire - measures if participant has symptoms of depression and the
      severity of those symptoms.

      Satisfaction Survey - measures how satisfied participant is with the social worker
      interaction.
observational model: Cohort
time perspective: Prospective
measure: Change in response to Patient Health Questionnaire 9
time frame: 6 months
description: Measures participant levels of depression based on questions related to depressive symptoms. The investigator will assess change in the number of participants with major, moderate, and minimal depressive symptoms.
measure: Change in response to Distress thermometer
time frame: 6 months
description: Measures participant level of distress on a scale of 1 to 10 and asks additional questions regarding contributors to distress.
measure: Change in response to Modified Patient Activation Measure 13
time frame: 6 months
description: Measures participant self-capacity for and confidence regarding glaucoma management.
measure: Descriptive results of the Social Worker Baseline Assessment
time frame: 6 months
description: Social worker will assess each participant's internal and external barriers to care, limitations, and strengths that may help them to manage their glaucoma.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Scott J Fudemberg, MD
role: Principal Investigator
affiliation: Wills Eye Hospital
facility: 
country: United States
citation: Fudemberg SJ, Amarasekera DC, Silverstein MH, Linder KM, Heffner P, Hark LA, Waisbourd M. Overcoming Barriers to Eye Care: Patient Response to a Medical Social Worker in a Glaucoma Service. J Community Health. 2016 Aug;41(4):845-9. doi: 10.1007/s10900-016-0162-1.
PMID: 26860278
responsible party type: Principal Investigator
investigator affiliation: Wills Eye
investigator full name: Scott Fudemberg, MD
investigator title: Principal Investigator
mesh term: Glaucoma
sharing ipd: No