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Assessing Patient Confidence in Biologic Medications

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: NCT03168347
Recruitment Status : Recruiting
First Posted : May 30, 2017
Last Update Posted : August 25, 2020
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:

In dermatology, biologic medications are used to treat conditions such as moderate-to-severe psoriasis. These medications generally function to decrease inflammation or disrupt the inflammatory cycle. Examples of biologic medications commonly used in dermatology include tumor necrosis factor-alpha (TNF-alpha), blockers/inhibitors (etanercept, infliximab, certolizumab pegol, golimumab), interleukin 12/23 blockers (ustekinumab) and interleukin 17A blockers (secukinumab, ixekizumab).

Due to biologic medication's efficacy and safety profiles, they have revolutionized dermatology and the general medical field. However, patients may be apprehensive about choosing a biologic medication for a variety of reasons. These include hearing negative information about the drug from friends or family, being nervous about injection, or seeing the drug or its side effects negatively portrayed in the media. Many patients are not aware that clinical trial evidence for biologics exist, and instead may rely on anecdotal evidence in choosing to take these medications.

Because fear of the drug is inherently subjective, it can be modified with appropriate reassurance and presentation of evidence. Physicians must be able to ascertain from where the fear originates and how it can be countered. By understanding what kind of information will allow patients to be confident in their decision to take a biologic, dermatologists can improve outcomes and initiate use of this drug. Furthermore, reducing fear of side effects or adverse events may improve adherence to treatment and may improve treatment outcomes. The investigators propose this study with the goal of learning whether patients are more confident in the potential success of biologic medications in treating their psoriasis after being presented with clinical trial evidence, anecdotal evidence, or both.


Condition or disease Intervention/treatment Phase
Psoriasis Behavioral: Anecdotal Evidence Behavioral: Research Study Evidence Behavioral: Anecdotal + Research Study Evidence Behavioral: No Evidence Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Health Services Research
Official Title: Assessing Patient Confidence in Biologic Medications
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis

Arm Intervention/treatment
Active Comparator: Anecdotal Evidence
Scenario describes a medication's (biologic's) therapeutic effect results based on anecdotal evidence.
Behavioral: Anecdotal Evidence
Communicate basic information on the therapeutic effect of a drug using only anecdotal evidence.

Active Comparator: Research Study Evidence
Scenario describes a medication's (biologic's) therapeutic effect results based on research study evidence.
Behavioral: Research Study Evidence
Communicate basic information on the therapeutic effect of a drug using only research study evidence.

Active Comparator: Anecdotal + Research Study Evidence
Scenario describes a medication's (biologic's) therapeutic effect results based on research study evidence and anecdotal evidence.
Behavioral: Anecdotal + Research Study Evidence
Communicate basic information on the therapeutic effect of a drug using only anecdotal and research study evidence.

Placebo Comparator: No Evidence
Scenario describes a medication's (biologic's) therapeutic effect with no mention on anecdotal nor research study evidence.
Behavioral: No Evidence
Communicate basic information on the therapeutic effect of a drug using neither anecdotal evidence nor research study evidence.




Primary Outcome Measures :
  1. Oral survey responses [ Time Frame: 1 day ]
    Oral survey response from 1 (not willing) to 10 (completely 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.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with psoriasis (ICD-9: 696.1)
  • Age 18-80

Exclusion Criteria:

  • Individuals younger than 18 (line of questioning necessary for the study may be beyond understanding in this age group)
  • Currently or previously managed with a biologic medication

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): NCT03168347


Contacts
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Contact: Irma M Richardson, MHA 336-716-2903 irichard@wakehealth.edu

Locations
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United States, North Carolina
Wake Forest University Health Sciences Department of Dermatology Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Irma M Richardson, MHA    336-716-2903    irichard@wakehealth.edu   
Contact: Adele Clark, PA-C    336-716-7465    adclark@wakehealth.edu   
Principal Investigator: Steven Feldman, MD, PhD         
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Steve R Feldman, MD, PhD Wake Forest University Health Sciences
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03168347    
Other Study ID Numbers: IRB00043948
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: August 25, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
Decision making
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases