Assessing Patient Confidence in Biologic Medications

In dermatology, biologic medications are used to treat conditions such as moderate-to-severe psoriasis. These medications generally function to decrease inflammation or disrupt the inflammatory cycle. 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).

Due to biologic medication's efficacy and safety profiles, they have revolutionized dermatology and the general medical field. However, patients may be apprehensive about choosing a biologic medication for a variety of reasons. These include hearing negative information about the drug from friends or family, being nervous about injection, or seeing the drug or its side effects negatively portrayed in the media. Many patients are not aware that clinical trial evidence for biologics exist, and instead may rely on anecdotal evidence in choosing to take these medications.

Because fear of the drug is inherently subjective, it can be modified with appropriate reassurance and presentation of evidence. Physicians must be able to ascertain from where the fear originates and how it can be countered. By understanding what kind of information will allow patients to be confident in their decision to take a biologic, dermatologists can improve outcomes and initiate use of this drug. Furthermore, reducing fear of side effects or adverse events may improve adherence to treatment and may improve treatment outcomes. The investigators propose this study with the goal of learning whether patients are more confident in the potential success of biologic medications in treating their psoriasis after being presented with clinical trial evidence, anecdotal evidence, or both.

Study Overview

• Status: Active, not recruiting
• Conditions: Psoriasis
• Intervention / Treatment: Behavioral: Anecdotal Evidence; Behavioral: Research Study Evidence; Behavioral: Anecdotal + Research Study Evidence; Behavioral: No Evidence

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences Department of Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosed with psoriasis (ICD-9: 696.1)
• Age 18-80

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Anecdotal Evidence; Scenario describes a medication's (biologic's) therapeutic effect results based on anecdotal evidence.	Behavioral: Anecdotal Evidence; Communicate basic information on the therapeutic effect of a drug using only anecdotal evidence.
Active Comparator: Research Study Evidence; Scenario describes a medication's (biologic's) therapeutic effect results based on research study evidence.	Behavioral: Research Study Evidence; Communicate basic information on the therapeutic effect of a drug using only research study evidence.
Active Comparator: Anecdotal + Research Study Evidence; Scenario describes a medication's (biologic's) therapeutic effect results based on research study evidence and anecdotal evidence.	Behavioral: Anecdotal + Research Study Evidence; Communicate basic information on the therapeutic effect of a drug using only anecdotal and research study evidence.
Placebo Comparator: No Evidence; Scenario describes a medication's (biologic's) therapeutic effect with no mention on anecdotal nor research study evidence.	Behavioral: No Evidence; Communicate basic information on the therapeutic effect of a drug using neither anecdotal evidence nor research study evidence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral survey responses	Oral survey response from 1 (not willing) to 10 (completely willing) scale to take a treatment	1 day

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Steve R Feldman, MD, PhD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: May 24, 2017
• First Submitted That Met QC Criteria: May 24, 2017
• First Posted (Actual): May 30, 2017

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: January 2, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Decision making
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: IRB00043948

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No