Assessing Patient Confidence in Biologic Medications
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|ClinicalTrials.gov Identifier: NCT03168347|
Recruitment Status : Recruiting
First Posted : May 30, 2017
Last Update Posted : August 25, 2020
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|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|
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.
- Oral survey responses [ Time Frame: 1 day ]Oral survey response from 1 (not willing) to 10 (completely willing) scale to take a treatment
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
|Contact: Irma M Richardson, MHAfirstname.lastname@example.org|
|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 email@example.com|
|Contact: Adele Clark, PA-C 336-716-7465 firstname.lastname@example.org|
|Principal Investigator: Steven Feldman, MD, PhD|
|Principal Investigator:||Steve R Feldman, MD, PhD||Wake Forest University Health Sciences|