Assessing Patient Confidence in Biologic Medications

Not Applicable

Active, not recruiting

• Conditions: Psoriasis
• Interventions: Behavioral: Anecdotal + Research Study Evidence; Behavioral: Research Study Evidence; Behavioral: Anecdotal Evidence; Behavioral: No Evidence

• Registration Number: NCT03168347
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-24
• Study First Submitted QC: 2017-05-24
• Study First Posted: 2017-05-30
• Study Start: 2017-06-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-30
• Last Update Posted: 2025-01-01
• Primary Completion: 2025-05
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anecdotal + Research Study Evidence	Anecdotal + Research Study Evidence	Scenario describes a medication's (biologic's) therapeutic effect results based on research study evidence and anecdotal evidence.
Research Study Evidence	Research Study Evidence	Scenario describes a medication's (biologic's) therapeutic effect results based on research study evidence.
Anecdotal Evidence	Anecdotal Evidence	Scenario describes a medication's (biologic's) therapeutic effect results based on anecdotal evidence.
No Evidence	No Evidence	Scenario describes a medication's (biologic's) therapeutic effect with no mention on anecdotal nor research study evidence.

Primary Outcome Measures

Name	Time	Method
Oral survey responses	1 day	Oral survey response from 1 (not willing) to 10 (completely willing) scale to take a treatment

Trial Locations

Locations (1)

Wake Forest University Health Sciences Department of Dermatology; 🇺🇸 Winston-Salem, North Carolina, United States