Assessing Patient Confidence in Biologic Medications

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03168347
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Wake Forest University Health Sciences
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Steve R Feldman, MD, PhD
Principal Investigator Affiliation Wake Forest University Health Sciences
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis
Arms & Interventions

Arms

Active Comparator: Anecdotal Evidence

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

Active Comparator: Research Study Evidence

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

Placebo Comparator: No Evidence

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

Interventions

Behavioral: - Anecdotal Evidence

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

Behavioral: - Research Study Evidence

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

Behavioral: - Anecdotal + Research Study Evidence

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

Behavioral: - No Evidence

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Winston-Salem, North Carolina

Status

Recruiting

Address

Wake Forest University Health Sciences Department of Dermatology

Winston-Salem, North Carolina, 27157

Site Contact

Irma M Richardson, MHA

[email protected]

336-716-2903

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