Biologics Anchoring Study

Moderate-to-severe Psoriasis Clinical Trial

Official title:

Biologics Anchoring Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03026153
• Other study ID #: IRB00040495
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: July 1, 2017

Study information

• Verified date: June 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 1, 2017
• Est. primary completion date: March 16, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Moderate-to-severe Psoriasis
• Psoriasis

Intervention

Behavioral:
• Control Group Oral Survey 1
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
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

Locations

Country	Name	City	State
United States	Dept of Dermatology, WFUHS	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (2)

Chandler D, Bewley A. Biologics in dermatology. Pharmaceuticals (Basel). 2013 Apr 17;6(4):557-78. doi: 10.3390/ph6040557. — View Citation

Wilson TD, Houston CE, Etling KM, Brekke N. A new look at anchoring effects: basic anchoring and its antecedents. J Exp Psychol Gen. 1996 Dec;125(4):387-402. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral survey responses Oral Survey Outcomes		1 day