<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/NCT03026153</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00040495</org_study_id>
    <nct_id>NCT03026153</nct_id>
  </id_info>
  <brief_title>Biologics Anchoring Study</brief_title>
  <official_title>Biologics Anchoring Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wake Forest University Health Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Wake Forest University Health Sciences</source>
  <oversight_info>
    <has_dmc>No</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>
      Biologics are used to treat conditions such as moderate-to-severe psoriasis, a chronic&#xD;
      condition that impairs quality of life as much or more than other major medical conditions.&#xD;
      Biopharmaceuticals are medications which are are isolated from biological sources including&#xD;
      microorganisms, animals or humans. These medications generally function to decrease&#xD;
      inflammation or disrupt the inflammatory cycle. Patients are often apprehensive about&#xD;
      choosing a biologic medication over other options due to anxiety regarding the need for&#xD;
      regular injections, leaving the patient undertreated and continuing to suffer with psoriasis.&#xD;
      Reducing fears of injections may improve adherence to treatment and may improve treatment&#xD;
      outcomes. Fear of injection is inherently subjective and may be easily modified. Anchoring is&#xD;
      the tendency for humans to rely on a specific value when making decisions and to make&#xD;
      judgments relative to that value. Patients who have never taken an injection will&#xD;
      subjectively view the idea of taking an injection relative to the &quot;not taking any injection&quot;&#xD;
      baseline. This comparison is scary and represents a considerable hurdle to taking a new&#xD;
      injectable medication that may be otherwise optimal for their treatment. Resetting the anchor&#xD;
      may be all that is needed to help patients overcome fear of injection. The objective is to&#xD;
      assess whether patients offered a once monthly injectable biologic would be more likely to&#xD;
      accept that biologic medication if they are first counseled about a daily injection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Biologics are used to treat a variety of medical conditions across multiple medical&#xD;
      specialties. In the Dermatology specialty, biologics are used to treat conditions such as&#xD;
      moderate-to-severe psoriasis, a chronic condition that impairs quality of life as much or&#xD;
      more than other major medical conditions. Biopharmaceuticals are medications which are are&#xD;
      isolated from biological sources including microorganisms, animals or humans. Examples of&#xD;
      biologic medications commonly used in dermatology include tumor necrosis factor-alpha&#xD;
      (TNF-alpha) blockers/inhibitors (etanercept, infliximab, certolizumab pegol, golimumab),&#xD;
      interleukin 12/23 blockers (ustekinumab), and interleukin 17A blockers (secukinumab,&#xD;
      ixekizumab).&#xD;
&#xD;
      These medications generally function to decrease inflammation or disrupt the inflammatory&#xD;
      cycle. Biologic medications are administered via injection by the patient or a healthcare&#xD;
      provider. Most of the medications require periodic injections approximately once per month.&#xD;
      Patients may undergo periodic lab monitoring to assess for side effects. Biologic medications&#xD;
      have revolutionized dermatology and the general medical field. Patients are often&#xD;
      apprehensive about choosing a biologic medication over other option due to anxiety regarding&#xD;
      the need for regular injections, leaving the patient undertreated and continuing to suffer&#xD;
      with psoriasis. Reducing fears of injections may improve adherence to treatment and may&#xD;
      improve treatment outcomes. Fear of injection is inherently subjective and may be easily&#xD;
      modified.&#xD;
&#xD;
      Anchoring is the tendency for humans to rely on a specific value when making decisions and to&#xD;
      make judgments relative to that value. Patients who have never taken an injection will&#xD;
      subjectively view the idea of taking an injection relative to the &quot;not taking any injection&quot;&#xD;
      baseline. This comparison is scary and represents a considerable hurdle to taking a new&#xD;
      injectable medication that may be otherwise optimal for their treatment.&#xD;
&#xD;
      Resetting the anchor may be all that is needed to help patients overcome fear of injection.&#xD;
      The investigators hypothesize that if a patient were first counseled about the possibility of&#xD;
      taking an injectable biologic medication daily, they would be much less hesitant to take a&#xD;
      monthly injection.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2016</start_date>
  <completion_date type="Actual">July 1, 2017</completion_date>
  <primary_completion_date type="Actual">March 16, 2017</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>Screening</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Oral survey responses Oral Survey Outcomes</measure>
    <time_frame>1 day</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Moderate-to-severe Psoriasis</condition>
  <arm_group>
    <arm_group_label>Control group - Oral Survey 1</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Oral survey 1 will be administered as control intervention: patients will be asked how willing they would be to take an injectable medication to control their psoriasis which required once-monthly injections</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention Group - Oral Survey 2</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Oral Survey 2 will be administered as the intervention : patients will be asked how willing they would be to take an injectable medication to control their psoriasis which required once-daily injections, then surveyor would ask how willing they would be to take an injectable medication which required only once-monthly injections</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control Group Oral Survey 1</intervention_name>
    <description>Oral survey 1 will be administered as control intervention: patients will be asked how willing they would be to take an injectable medication to control their psoriasis which required once-monthly injections</description>
    <arm_group_label>Control group - Oral Survey 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Intervention Group Oral Survey 2</intervention_name>
    <description>Oral Survey 2 will be administered as the intervention: patients will be asked how willing they would be to take an injectable medication to control their psoriasis which required once-daily injections, then surveyor would ask how willing they would be to take an injectable medication which required only once-monthly injections</description>
    <arm_group_label>Intervention Group - Oral Survey 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  moderate-to-severe psoriasis&#xD;
&#xD;
          -  not currently managed with biologic or other injectable medication&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Individuals younger than 18 (line of questioning necessary for the study may be beyond&#xD;
             understanding in this age group)&#xD;
&#xD;
          -  Currently managed with biologic medication or other injectable medication&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Steve R Feldman, MD,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Wake Forest University Health Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dept of Dermatology, WFUHS</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Chandler D, Bewley A. Biologics in dermatology. Pharmaceuticals (Basel). 2013 Apr 17;6(4):557-78. doi: 10.3390/ph6040557.</citation>
    <PMID>24276125</PMID>
  </reference>
  <reference>
    <citation>Wilson TD, Houston CE, Etling KM, Brekke N. A new look at anchoring effects: basic anchoring and its antecedents. J Exp Psychol Gen. 1996 Dec;125(4):387-402. doi: 10.1037//0096-3445.125.4.387.</citation>
    <PMID>8945789</PMID>
  </reference>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>January 13, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>June 7, 2018</last_update_submitted>
  <last_update_submitted_qc>June 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psoriasis</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/NCT03026153
org study id: IRB00040495
nct id: NCT03026153
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Biologics are used to treat conditions such as moderate-to-severe psoriasis, a chronic
      condition that impairs quality of life as much or more than other major medical conditions.
      Biopharmaceuticals are medications which are are isolated from biological sources including
      microorganisms, animals or humans. These medications generally function to decrease
      inflammation or disrupt the inflammatory cycle. Patients are often apprehensive about
      choosing a biologic medication over other options due to anxiety regarding the need for
      regular injections, leaving the patient undertreated and continuing to suffer with psoriasis.
      Reducing fears of injections may improve adherence to treatment and may improve treatment
      outcomes. Fear of injection is inherently subjective and may be easily modified. Anchoring is
      the tendency for humans to rely on a specific value when making decisions and to make
      judgments relative to that value. Patients who have never taken an injection will
      subjectively view the idea of taking an injection relative to the "not taking any injection"
      baseline. This comparison is scary and represents a considerable hurdle to taking a new
      injectable medication that may be otherwise optimal for their treatment. Resetting the anchor
      may be all that is needed to help patients overcome fear of injection. The objective is to
      assess whether patients offered a once monthly injectable biologic would be more likely to
      accept that biologic medication if they are first counseled about a daily injection.
Biologics are used to treat a variety of medical conditions across multiple medical
      specialties. In the Dermatology specialty, biologics are used to treat conditions such as
      moderate-to-severe psoriasis, a chronic condition that impairs quality of life as much or
      more than other major medical conditions. Biopharmaceuticals are medications which are are
      isolated from biological sources including microorganisms, animals or humans. Examples of
      biologic medications commonly used in dermatology include tumor necrosis factor-alpha
      (TNF-alpha) blockers/inhibitors (etanercept, infliximab, certolizumab pegol, golimumab),
      interleukin 12/23 blockers (ustekinumab), and interleukin 17A blockers (secukinumab,
      ixekizumab).

      These medications generally function to decrease inflammation or disrupt the inflammatory
      cycle. Biologic medications are administered via injection by the patient or a healthcare
      provider. Most of the medications require periodic injections approximately once per month.
      Patients may undergo periodic lab monitoring to assess for side effects. Biologic medications
      have revolutionized dermatology and the general medical field. Patients are often
      apprehensive about choosing a biologic medication over other option due to anxiety regarding
      the need for regular injections, leaving the patient undertreated and continuing to suffer
      with psoriasis. Reducing fears of injections may improve adherence to treatment and may
      improve treatment outcomes. Fear of injection is inherently subjective and may be easily
      modified.

      Anchoring is the tendency for humans to rely on a specific value when making decisions and to
      make judgments relative to that value. Patients who have never taken an injection will
      subjectively view the idea of taking an injection relative to the "not taking any injection"
      baseline. This comparison is scary and represents a considerable hurdle to taking a new
      injectable medication that may be otherwise optimal for their treatment.

      Resetting the anchor may be all that is needed to help patients overcome fear of injection.
      The investigators hypothesize that if a patient were first counseled about the possibility of
      taking an injectable biologic medication daily, they would be much less hesitant to take a
      monthly injection.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: Single (Participant)
measure: Oral survey responses Oral Survey Outcomes
time frame: 1 day
arm group label: Control group - Oral Survey 1
arm group type: Other
description: Oral survey 1 will be administered as control intervention: patients will be asked how willing they would be to take an injectable medication to control their psoriasis which required once-monthly injections
arm group label: Intervention Group - Oral Survey 2
arm group type: Other
description: Oral Survey 2 will be administered as the intervention : patients will be asked how willing they would be to take an injectable medication to control their psoriasis which required once-daily injections, then surveyor would ask how willing they would be to take an injectable medication which required only once-monthly injections
intervention type: Behavioral
intervention name: Control Group Oral Survey 1
description: Oral survey 1 will be administered as control intervention: patients will be asked how willing they would be to take an injectable medication to control their psoriasis which required once-monthly injections
arm group label: Control group - Oral Survey 1
intervention type: Behavioral
intervention name: Intervention Group Oral Survey 2
description: Oral Survey 2 will be administered as the intervention: patients will be asked how willing they would be to take an injectable medication to control their psoriasis which required once-daily injections, then surveyor would ask how willing they would be to take an injectable medication which required only once-monthly injections
arm group label: Intervention Group - Oral Survey 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Steve R Feldman, MD,PhD
role: Principal Investigator
affiliation: Wake Forest University Health Sciences
facility: 
country: United States
citation: Chandler D, Bewley A. Biologics in dermatology. Pharmaceuticals (Basel). 2013 Apr 17;6(4):557-78. doi: 10.3390/ph6040557.
PMID: 24276125
citation: Wilson TD, Houston CE, Etling KM, Brekke N. A new look at anchoring effects: basic anchoring and its antecedents. J Exp Psychol Gen. 1996 Dec;125(4):387-402. doi: 10.1037//0096-3445.125.4.387.
PMID: 8945789
responsible party type: Sponsor
mesh term: Psoriasis
sharing ipd: No