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Biologics Anchoring Study

Primary Purpose

Moderate-to-severe Psoriasis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Control Group Oral Survey 1
Intervention Group Oral Survey 2
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Moderate-to-severe Psoriasis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • moderate-to-severe psoriasis
  • not currently managed with biologic or other injectable medication

Exclusion Criteria:

  • Individuals younger than 18 (line of questioning necessary for the study may be beyond understanding in this age group)
  • Currently managed with biologic medication or other injectable medication

Sites / Locations

  • Dept of Dermatology, WFUHS

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Control group - Oral Survey 1

Intervention Group - Oral Survey 2

Arm 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

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

Outcomes

Primary Outcome Measures

Oral survey responses Oral Survey Outcomes

Secondary Outcome Measures

Full Information

First Posted
January 13, 2017
Last Updated
June 7, 2018
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03026153
Brief Title
Biologics Anchoring Study
Official Title
Biologics Anchoring Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
March 16, 2017 (Actual)
Study Completion Date
July 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Moderate-to-severe Psoriasis

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group - Oral Survey 1
Arm Type
Other
Arm 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 Title
Intervention Group - Oral Survey 2
Arm Type
Other
Arm 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(s)
Control Group Oral Survey 1
Intervention 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
Intervention Type
Behavioral
Intervention Name(s)
Intervention Group Oral Survey 2
Intervention 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
Primary Outcome Measure Information:
Title
Oral survey responses Oral Survey Outcomes
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: moderate-to-severe psoriasis not currently managed with biologic or other injectable medication Exclusion Criteria: Individuals younger than 18 (line of questioning necessary for the study may be beyond understanding in this age group) Currently managed with biologic medication or other injectable medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steve R Feldman, MD,PhD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept of Dermatology, WFUHS
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24276125
Citation
Chandler D, Bewley A. Biologics in dermatology. Pharmaceuticals (Basel). 2013 Apr 17;6(4):557-78. doi: 10.3390/ph6040557.
Results Reference
background
PubMed Identifier
8945789
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.
Results Reference
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Biologics Anchoring Study

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