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

April 23, 2025 updated by: Wake Forest University Health Sciences
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27104
        • Wake Forest University Baptist Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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?

  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)

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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wake Forest University Health Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Steven R Feldman, Wake Forest University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 14, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 5, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 21, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 7, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 14, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00049576

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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