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Assessing Patient Confidence in Biologic Medications

Primary Purpose

Psoriasis

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Anecdotal Evidence
Research Study Evidence
Anecdotal + Research Study Evidence
No Evidence
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 Decision making

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wake Forest University Health Sciences Department of Dermatology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Anecdotal Evidence

Research Study Evidence

Anecdotal + Research Study Evidence

No Evidence

Arm Description

Scenario describes a medication's (biologic's) therapeutic effect results based on anecdotal evidence.

Scenario describes a medication's (biologic's) therapeutic effect results based on research study evidence.

Scenario describes a medication's (biologic's) therapeutic effect results based on research study evidence and anecdotal evidence.

Scenario describes a medication's (biologic's) therapeutic effect with no mention on anecdotal nor research study evidence.

Outcomes

Primary Outcome Measures

Oral survey responses
Oral survey response from 1 (not willing) to 10 (completely willing) scale to take a treatment

Secondary Outcome Measures

Full Information

First Posted
May 24, 2017
Last Updated
July 31, 2023
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03168347
Brief Title
Assessing Patient Confidence in Biologic Medications
Official Title
Assessing Patient Confidence in Biologic Medications
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
April 2024 (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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis
Keywords
Decision making

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anecdotal Evidence
Arm Type
Active Comparator
Arm Description
Scenario describes a medication's (biologic's) therapeutic effect results based on anecdotal evidence.
Arm Title
Research Study Evidence
Arm Type
Active Comparator
Arm Description
Scenario describes a medication's (biologic's) therapeutic effect results based on research study evidence.
Arm Title
Anecdotal + Research Study Evidence
Arm Type
Active Comparator
Arm Description
Scenario describes a medication's (biologic's) therapeutic effect results based on research study evidence and anecdotal evidence.
Arm Title
No Evidence
Arm Type
Placebo Comparator
Arm Description
Scenario describes a medication's (biologic's) therapeutic effect with no mention on anecdotal nor research study evidence.
Intervention Type
Behavioral
Intervention Name(s)
Anecdotal Evidence
Intervention Description
Communicate basic information on the therapeutic effect of a drug using only anecdotal evidence.
Intervention Type
Behavioral
Intervention Name(s)
Research Study Evidence
Intervention Description
Communicate basic information on the therapeutic effect of a drug using only research study evidence.
Intervention Type
Behavioral
Intervention Name(s)
Anecdotal + Research Study Evidence
Intervention Description
Communicate basic information on the therapeutic effect of a drug using only anecdotal and research study evidence.
Intervention Type
Behavioral
Intervention Name(s)
No Evidence
Intervention Description
Communicate basic information on the therapeutic effect of a drug using neither anecdotal evidence nor research study evidence.
Primary Outcome Measure Information:
Title
Oral survey responses
Description
Oral survey response from 1 (not willing) to 10 (completely willing) scale to take a treatment
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steve R Feldman, MD, PhD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences Department of Dermatology
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Assessing Patient Confidence in Biologic Medications

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