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

• ClinicalTrials.gov Identifier: NCT03465696
• Recruitment Status: Active, not recruiting
• First Posted: March 14, 2018
• Last Update Posted: December 21, 2021
• Sponsor: Wake Forest University Health Sciences
• Information provided by (Responsible Party): Wake Forest University Health Sciences

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Psoriasis	Behavioral: Group #2 (Intervention); Behavioral: Group #3 (Intervention)	Not Applicable

Detailed Description:

The study will be conducted at the Wake Forest University Dermatology Clinic and on Amazon Mechanical Turk. Patients meeting the following characteristics will be eligible to participate: individuals diagnosed with psoriasis (ICD-9: 696.1) or a parent/caregiver of an individual diagnosed with psoriasis (ICD-9: 696.1). The study team will recruit 180 subjects for the study. Patients will be randomized to three survey groups.

Amazon Mechanical Turk, https://www.mturk.com/mturk/welcome, Amazon Mechanical Turk is an online crowdsourcing platform. The purpose of Mechanical Turk (MTurk) is to help people (participants) find paid tasks. In recent years MTurk had been extensively used in social science research.3 MTurk enables researchers to recruit participants to perform tasks such as filling out surveys, opinion polls, & cognitive psychological studies. Researchers advertise their studies on MTurk, and participants chose only those studies that interest them.

Amazon Turk had been extensively used by psychologists in the last few years for participant recruitment. Participants on Amazon Turk see a list of potential jobs (referred to as HITs) when they log into their MTurk account. The price is provided next to the name of the HIT along with the approximate length of time that the HIT will take. Participants are free to choose the HITs that they are interested in taking, from a long list of thousands of tasks. The name of our HIT will be "Treatment of Psoriasis - the patient's perspective". The survey takes approximately one minute to complete. Once participants click on the HIT, they will be taken directly to the survey (attached as supporting document) which provides further information about the study. The survey/study will be hosted on "Google forms, Survey monkey, Qualtrics or other survey form". MTurk rules state that participants can terminate the study by returning the HIT at any time, without any penalty.

Subjects will be randomized using SPSS version 24.0 or later into three groups and administered surveys querying willingness to use a biologic medication.

The surveyor will record patient responses in the study log if patient is recruited at the Wake Forest Dermatology Clinic. If recruited via MTurk, patient responses will be recorded through the MTurk log.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 180 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: A Priming Intervention to Increase Patient Willingness to Use Injectables for the Management of Psoriasis
• Actual Study Start Date: May 14, 2018
• Actual Primary Completion Date: June 5, 2019
• Estimated Study Completion Date: June 2022

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Group #1 (Control); 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)
Experimental: Group #2 (Intervention); 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 #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)
Experimental: Group #3 (Intervention); 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?; Stelara® acts in an almost all-natural way to help control psoriasis.; Stelara® blocks one of the genetic causes of psoriasis.; Stelara® makes psoriasis better by blocking the overactive signal that gets the immune system out of balance; 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); 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?; Stelara® acts in an almost all-natural way to help control psoriasis.; Stelara® blocks one of the genetic causes of psoriasis.; Stelara® makes psoriasis better by blocking the overactive signal that gets the immune system out of balance; 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)

Outcome Measures

Primary Outcome Measures :

1. Oral Survey Responses [ Time Frame: 12 months ]
   Oral survey responses, on a (1 = definitely willing, 2 = probably willing, 3 = probably not willing, 4 = definitely not willing) scale to take a treatment.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Contacts and Locations

Locations

United States, North Carolina

Wake Forest University Baptist Health

Winston-Salem, North Carolina, United States, 27104

Sponsors and Collaborators

Wake Forest University Health Sciences

Investigators

• Principal Investigator: Steven R Feldman; Wake Forest University

More Information

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT03465696
• Other Study ID Numbers: IRB00049576
• First Posted: March 14, 2018
• Last Update Posted: December 21, 2021
• Last Verified: December 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wake Forest University Health Sciences:

psoriasis; biologics; treatment decision-making

Additional relevant MeSH terms:

Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases