Assessing Patient Confidence in Biologic Medications

NCT03168347 | Completed

• 1 other identifier: IRB00043948
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Psoriasis

Keywords

Decision making

Outcome Measures

Primary Outcomes (1)

• Oral survey responses

  Oral survey response from 1 (not willing) to 10 (completely willing) scale to take a treatment

  1 day

Study Arms (4)

Anecdotal Evidence

ACTIVE COMPARATOR

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

Behavioral: Anecdotal Evidence

Research Study Evidence

ACTIVE COMPARATOR

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

Behavioral: Research Study Evidence

Anecdotal + Research Study Evidence

ACTIVE COMPARATOR

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

Behavioral: Anecdotal + Research Study Evidence

No Evidence

PLACEBO COMPARATOR

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

Behavioral: No Evidence

Interventions

Anecdotal Evidence BEHAVIORAL

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

Anecdotal Evidence

Research Study Evidence BEHAVIORAL

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

Research Study Evidence

Anecdotal + Research Study Evidence BEHAVIORAL

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

Anecdotal + Research Study Evidence

No Evidence BEHAVIORAL

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

No Evidence

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences Department of Dermatology

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Steve R Feldman, MD, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2017
• First Posted: May 30, 2017
• Study Start: June 1, 2017
• Primary Completion: June 3, 2021
• Study Completion: June 3, 2021
• Last Updated: July 2, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)