A Priming Intervention to Increase Patient Willingness to Use Injectables for the Management of Psoriasis

NCT03465696 | Completed

• 1 other identifier: IRB00049576
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Biologic medications have revolutionized the treatment of inflammatory diseases such as moderate-to-severe psoriasis. Though very effective with an excellent safety profile, patients may be apprehensive about choosing a biologic medication for a variety of reasons. The purpose of this research study is to learn more about patient's perception of certain psoriasis treatment options.

Conditions

Psoriasis

Keywords

psoriasis; biologics; treatment decision-making

Outcome Measures

Primary Outcomes (1)

• Oral Survey Responses

  Oral survey responses, on a (1 = definitely willing, 2 = probably willing, 3 = probably not willing, 4 = definitely not willing) scale to take a treatment.

  12 months

Study Arms (3)

Group #1 (Control)

NO INTERVENTION

Group #1 (Control) Oral survey 1 will be administered and patients will be asked: Stelara® inhibits interleukin 23, one of the immune signaling molecules involved in psoriasis. How willing would you be to take Stelara® to treat your psoriasis, on a scale of (1 = definitely willing, 2 = probably willing, 3 = probably not willing, 4 = definitely not willing)

Group #2 (Intervention)

EXPERIMENTAL

Group #2 (Intervention) Survey 2 will be administered, and patients will be asked the following primer: Stelara® inhibits interleukin 23, one of the immune signaling molecules involved in psoriasis. People who are born with a genetic deficiency in the immune signal interleukin-23 are generally healthy, but also have a LOWER risk of getting immune diseases like psoriasis. How willing would you be to take Stelara® to treat your psoriasis, on a scale of (1 = definitely willing, 2 = probably willing, 3 = probably not willing, 4 = definitely not willing)

Behavioral: Group #2 (Intervention)

Group #3 (Intervention)

EXPERIMENTAL

Group #3 (Intervention) Survey 3 will be administered, and patients will be asked the following primer: Stelara® inhibits interleukin 23, one of the immune signaling molecules involved in psoriasis. People who are born with a genetic deficiency in the immune signal interleukin-23 are generally healthy, but also have a LOWER risk of getting immune diseases like psoriasis. What do you think would be the best way to describe this to a patient? 1. Stelara® acts in an almost all-natural way to help control psoriasis. 2. Stelara® blocks one of the genetic causes of psoriasis. 3. Stelara® makes psoriasis better by blocking the overactive signal that gets the immune system out of balance 4. Stelara® blocks interleukin-23, an important immune system signaling molecule involved in psoriasis How willing would you be to take Stelara® to treat your psoriasis, on a scale of (1 = definitely willing, 2 = probably willing, 3 = probably not willing, 4 = definitely not willing)

Behavioral: Group #3 (Intervention)

Interventions

Group #2 (Intervention) BEHAVIORAL

Group #2 (Intervention) Survey 2 will be administered, and patients will be asked the following primer: Stelara® inhibits interleukin 23, one of the immune signaling molecules involved in psoriasis. People who are born with a genetic deficiency in the immune signal interleukin-23 are generally healthy, but also have a LOWER risk of getting immune diseases like psoriasis. How willing would you be to take Stelara® to treat your psoriasis, on a scale of (1 = definitely willing, 2 = probably willing, 3 = probably not willing, 4 = definitely not willing)

Group #2 (Intervention)

Group #3 (Intervention) BEHAVIORAL

Group #3 (Intervention) Survey 3 will be administered, and patients will be asked the following primer: Stelara® inhibits interleukin 23, one of the immune signaling molecules involved in psoriasis. People who are born with a genetic deficiency in the immune signal interleukin-23 are generally healthy, but also have a LOWER risk of getting immune diseases like psoriasis. What do you think would be the best way to describe this to a patient? 1. Stelara® acts in an almost all-natural way to help control psoriasis. 2. Stelara® blocks one of the genetic causes of psoriasis. 3. Stelara® makes psoriasis better by blocking the overactive signal that gets the immune system out of balance 4. Stelara® blocks interleukin-23, an important immune system signaling molecule involved in psoriasis How willing would you be to take Stelara® to treat your psoriasis, on a scale of (1 = definitely willing, 2 = probably willing, 3 = probably not willing, 4 = definitely not willing)

Group #3 (Intervention)

Eligibility Criteria

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

You may qualify if:

• Either diagnosed with psoriasis (ICD-9: 696.1) or a parent/caregiver of an individual diagnosed with psoriasis (ICD-9: 696.1).
• Subjects with a working knowledge of English.

You may not qualify if:

• Already on or previously failed management attempts with an IL-23 inhibitor including ustekinumab, guselkumab, risankizumab, or Tildrakizumab, amongst others.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Baptist Health

Winston-Salem, North Carolina, 27104, United States

Location

MeSH Terms

Conditions

Psoriasis

Interventions

Methods

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Steven R Feldman

  Wake Forest University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2018
• First Posted: March 14, 2018
• Study Start: May 14, 2018
• Primary Completion: June 5, 2019
• Study Completion: June 21, 2019
• Last Updated: April 24, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)