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

Primary Purpose

Psoriasis

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group #2 (Intervention)
Group #3 (Intervention)
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Psoriasis focused on measuring psoriasis, biologics, treatment decision-making

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Wake Forest University Baptist Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Group #1 (Control)

Group #2 (Intervention)

Group #3 (Intervention)

Arm Description

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) 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 #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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 7, 2018
Last Updated
September 21, 2023
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03465696
Brief Title
A Priming Intervention to Increase Patient Willingness to Use Injectables for the Management of Psoriasis
Official Title
A Priming Intervention to Increase Patient Willingness to Use Injectables for the Management of Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 14, 2018 (Actual)
Primary Completion Date
June 5, 2019 (Actual)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
psoriasis, biologics, treatment decision-making

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group #1 (Control)
Arm Type
No Intervention
Arm Description
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)
Arm Title
Group #2 (Intervention)
Arm Type
Experimental
Arm Description
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)
Arm Title
Group #3 (Intervention)
Arm Type
Experimental
Arm Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Group #2 (Intervention)
Intervention Description
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)
Intervention Type
Behavioral
Intervention Name(s)
Group #3 (Intervention)
Intervention Description
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)
Primary Outcome Measure Information:
Title
Oral Survey Responses
Description
Oral survey responses, on a (1 = definitely willing, 2 = probably willing, 3 = probably not willing, 4 = definitely not willing) scale to take a treatment.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven R Feldman
Organizational Affiliation
Wake Forest University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Baptist Health
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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