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Assessing Patient Confidence in Biologic Medications

Assessing Patient Confidence in Biologic Medications

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03168347
Enrollment
400
Registered
2017-05-30
Start date
2017-06-01
Completion date
2021-06-03
Last updated
2025-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

Keywords

Decision making

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.

Interventions

BEHAVIORALAnecdotal Evidence

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

BEHAVIORALResearch Study Evidence

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

BEHAVIORALAnecdotal + Research Study Evidence

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

BEHAVIORALNo Evidence

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

Sponsors

Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Oral survey responses1 dayOral survey response from 1 (not willing) to 10 (completely willing) scale to take a treatment

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026