NCT03026153

Brief Summary

Biologics are used to treat conditions such as moderate-to-severe psoriasis, a chronic condition that impairs quality of life as much or more than other major medical conditions. Biopharmaceuticals are medications which are are isolated from biological sources including microorganisms, animals or humans. These medications generally function to decrease inflammation or disrupt the inflammatory cycle. Patients are often apprehensive about choosing a biologic medication over other options due to anxiety regarding the need for regular injections, leaving the patient undertreated and continuing to suffer with psoriasis. Reducing fears of injections may improve adherence to treatment and may improve treatment outcomes. Fear of injection is inherently subjective and may be easily modified. Anchoring is the tendency for humans to rely on a specific value when making decisions and to make judgments relative to that value. Patients who have never taken an injection will subjectively view the idea of taking an injection relative to the "not taking any injection" baseline. This comparison is scary and represents a considerable hurdle to taking a new injectable medication that may be otherwise optimal for their treatment. Resetting the anchor may be all that is needed to help patients overcome fear of injection. The objective is to assess whether patients offered a once monthly injectable biologic would be more likely to accept that biologic medication if they are first counseled about a daily injection.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 13, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 20, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

June 11, 2018

Status Verified

June 1, 2018

Enrollment Period

6 months

First QC Date

January 13, 2017

Last Update Submit

June 7, 2018

Conditions

Moderate-to-severe Psoriasis

Outcome Measures

Primary Outcomes (1)

  • Oral survey responses Oral Survey Outcomes

    1 day

Study Arms (2)

Control group - Oral Survey 1

OTHER

Oral survey 1 will be administered as control intervention: patients will be asked how willing they would be to take an injectable medication to control their psoriasis which required once-monthly injections

Behavioral: Control Group Oral Survey 1

Intervention Group - Oral Survey 2

OTHER

Oral Survey 2 will be administered as the intervention : patients will be asked how willing they would be to take an injectable medication to control their psoriasis which required once-daily injections, then surveyor would ask how willing they would be to take an injectable medication which required only once-monthly injections

Behavioral: Intervention Group Oral Survey 2

Interventions

Control Group Oral Survey 1BEHAVIORAL

Oral survey 1 will be administered as control intervention: patients will be asked how willing they would be to take an injectable medication to control their psoriasis which required once-monthly injections

Control group - Oral Survey 1
Intervention Group Oral Survey 2BEHAVIORAL

Oral Survey 2 will be administered as the intervention: patients will be asked how willing they would be to take an injectable medication to control their psoriasis which required once-daily injections, then surveyor would ask how willing they would be to take an injectable medication which required only once-monthly injections

Intervention Group - Oral Survey 2

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • moderate-to-severe psoriasis
  • not currently managed with biologic or other injectable medication

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Dermatology, WFUHS

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (2)

  • Chandler D, Bewley A. Biologics in dermatology. Pharmaceuticals (Basel). 2013 Apr 17;6(4):557-78. doi: 10.3390/ph6040557.

    PMID: 24276125BACKGROUND

  • Wilson TD, Houston CE, Etling KM, Brekke N. A new look at anchoring effects: basic anchoring and its antecedents. J Exp Psychol Gen. 1996 Dec;125(4):387-402. doi: 10.1037//0096-3445.125.4.387.

    PMID: 8945789BACKGROUND

Study Officials

  • Steve R Feldman, MD,PhD

    Wake Forest University Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2017

First Posted

January 20, 2017

Study Start

October 1, 2016

Primary Completion

March 16, 2017

Study Completion

July 1, 2017

Last Updated

June 11, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)