ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03465696
Recruitment Status : Recruiting
First Posted : March 14, 2018
Last Update Posted : June 1, 2018
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

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 Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

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?

  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)





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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03465696


Contacts
Contact: Leah A Cardwell, MD 336-716-1773 lcardwe@wakehealth.edu

Locations
United States, North Carolina
Wake Forest University Baptist Health Recruiting
Winston-Salem, North Carolina, United States, 27104
Contact: Leah A Cardwell, MD    336-716-1773    lcardwe@wakehealth.edu   
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
Principal Investigator: Steven R Feldman Wake Forest University

Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03465696     History of Changes
Other Study ID Numbers: IRB00049576
First Posted: March 14, 2018    Key Record Dates
Last Update Posted: June 1, 2018
Last Verified: May 2018
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
Ustekinumab
Dermatologic Agents