Completed

NCT Number: NCT03026153

Biologics Anchoring Study

Biologics are used to treat conditions such as moderate-to-severe psoriasis, a chronic condition that impairs quality of life as much or more than other major medical conditions. Biopharmaceuticals are medications which are are isolated from biological sources including microorganisms, animals or humans. These medications generally function to decrease inflammation or disrupt the inflammatory cycle. Patients are often apprehensive about choosing a biologic medication over other options due to anxiety regarding the need for regular injections, leaving the patient undertreated and continuing to suffer with psoriasis. Reducing fears of injections may improve adherence to treatment and may improve treatment outcomes. Fear of injection is inherently subjective and may be easily modified. Anchoring is the tendency for humans to rely on a specific value when making decisions and to make judgments relative to that value. Patients who have never taken an injection will subjectively view the idea of taking an injection relative to the "not taking any injection" baseline. This comparison is scary and represents a considerable hurdle to taking a new injectable medication that may be otherwise optimal for their treatment. Resetting the anchor may be all that is needed to help patients overcome fear of injection. The objective is to assess whether patients offered a once monthly injectable biologic would be more likely to accept that biologic medication if they are first counseled about a daily injection.

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Key information

Conditions

Moderate-to-severe Psoriasis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept of Dermatology, WFUHS

Winston-Salem, North Carolina, 27157, United States

About this study

Biologics are used to treat a variety of medical conditions across multiple medical specialties. In the Dermatology specialty, biologics are used to treat conditions such as moderate-to-severe psoriasis, a chronic condition that impairs quality of life as much or more than other major medical conditions. Biopharmaceuticals are medications which are are isolated from biological sources including microorganisms, animals or humans. 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).

These medications generally function to decrease inflammation or disrupt the inflammatory cycle. Biologic medications are administered via injection by the patient or a healthcare provider. Most of the medications require periodic injections approximately once per month. Patients may undergo periodic lab monitoring to assess for side effects. Biologic medications have revolutionized dermatology and the general medical field. Patients are often apprehensive about choosing a biologic medication over other option due to anxiety regarding the need for regular injections, leaving the patient undertreated and continuing to suffer with psoriasis. Reducing fears of injections may improve adherence to treatment and may improve treatment outcomes. Fear of injection is inherently subjective and may be easily modified.

Anchoring is the tendency for humans to rely on a specific value when making decisions and to make judgments relative to that value. Patients who have never taken an injection will subjectively view the idea of taking an injection relative to the "not taking any injection" baseline. This comparison is scary and represents a considerable hurdle to taking a new injectable medication that may be otherwise optimal for their treatment.

Resetting the anchor may be all that is needed to help patients overcome fear of injection. The investigators hypothesize that if a patient were first counseled about the possibility of taking an injectable biologic medication daily, they would be much less hesitant to take a monthly injection.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

moderate-to-severe psoriasis
not currently managed with biologic or other injectable medication

Exclusion criteria

Individuals younger than 18 (line of questioning necessary for the study may be beyond understanding in this age group)
Currently managed with biologic medication or other injectable medication

Treatment and study plan

Control Group Oral Survey 1

Behavioral

Oral survey 1 will be administered as control intervention: patients will be asked how willing they would be to take an injectable medication to control their psoriasis which required once-monthly injections

Intervention Group Oral Survey 2

Behavioral

Oral Survey 2 will be administered as the intervention: patients will be asked how willing they would be to take an injectable medication to control their psoriasis which required once-daily injections, then surveyor would ask how willing they would be to take an injectable medication which required only once-monthly injections

Primary outcomes

Oral survey responses Oral Survey Outcomes

Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Jan 20, 2017
Registry last updated: Jun 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.