Assessing Patient Confidence in Biologic Medications

NCT ID: NCT03168347

Last Updated: 2025-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2021-06-03

Brief Summary

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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

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Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Anecdotal Evidence

Scenario describes a medication's (biologic's) therapeutic effect results based on anecdotal evidence.

Group Type ACTIVE_COMPARATOR

Anecdotal Evidence

Intervention Type BEHAVIORAL

Communicate basic information on the therapeutic effect of a drug using only anecdotal evidence.

Research Study Evidence

Scenario describes a medication's (biologic's) therapeutic effect results based on research study evidence.

Group Type ACTIVE_COMPARATOR

Research Study Evidence

Intervention Type BEHAVIORAL

Communicate basic information on the therapeutic effect of a drug using only 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.

Group Type ACTIVE_COMPARATOR

Anecdotal + Research Study Evidence

Intervention Type BEHAVIORAL

Communicate basic information on the therapeutic effect of a drug using only anecdotal and research study evidence.

No Evidence

Scenario describes a medication's (biologic's) therapeutic effect with no mention on anecdotal nor research study evidence.

Group Type PLACEBO_COMPARATOR

No Evidence

Intervention Type BEHAVIORAL

Communicate basic information on the therapeutic effect of a drug using neither anecdotal evidence nor research study evidence.

Interventions

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Anecdotal Evidence

Communicate basic information on the therapeutic effect of a drug using only anecdotal evidence.

Intervention Type BEHAVIORAL

Research Study Evidence

Communicate basic information on the therapeutic effect of a drug using only research study evidence.

Intervention Type BEHAVIORAL

Anecdotal + Research Study Evidence

Communicate basic information on the therapeutic effect of a drug using only anecdotal and research study evidence.

Intervention Type BEHAVIORAL

No Evidence

Communicate basic information on the therapeutic effect of a drug using neither anecdotal evidence nor research study evidence.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steve R Feldman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Wake Forest University Health Sciences Department of Dermatology

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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IRB00043948

Identifier Type: -

Identifier Source: org_study_id

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