Psoriasis
Conditions
Brief summary
Most people with psoriasis have very limited disease, yet that disease may still have a large impact on their lives. While limited psoriasis may be amenable to topical treatment, patients are exceptionally poorly adherent to topical treatment, especially over the long run.
Detailed description
Psoriasis patients prefer oral treatments and are more adherent to orals than to topicals, but adherence to oral treatment of psoriasis may still be limited, compromising treatment outcomes. How well the medication works in the patients who take treatment regularly is not well characterized.
Interventions
DRUGOtezla - Standard Care
The participant will be given their medication with the electronic adapter cap on it and asked to return for the follow-up visit
BEHAVIORALReminder Text Intervention with apremilast
Participants will receive a weekly electronic text/email-based intervention that is designed to promote better adherence to treatment in addition to receiving their medication with the electronic adapter cap on it.
BEHAVIORALExtended Consultation for apremilast
Participants will be given their medication with the electronic adapter cap on it and will receive an initial patient consult intervention, which will focus on medication education and setting expectations of what to anticipate with usage of the prescribed medication
Sponsors
Amgen
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
The participant will not know that the electronic cap adapter is actually recording the opening of the medication bottle.
Intervention model description
Randomization 1:1:1
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Adult 18 years or older * Diagnosis of mild psoriasis with Otezla recommendation * Non-pregnant * English speaking
Exclusion criteria
* Under 18 years of age * Not diagnosis of mild psoriasis * Pregnant * Non-English speaking
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medication Adherence Outlier | Month 6 | Identify adherence outliers (high and low adherence). Adherence will be determined by the data retrieved from the electronic monitor that is placed on the medication bottle to provide the days and times the bottle is opened to take the medication. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference of Efficacy among high adherent subjects | Month 6 | As a secondary outcome, we will compare psoriasis treatment outcomes (efficacy) between the most and least adherent patients. Measures for comparing efficacy between high vs low adherence subjects will be percent of subjects with Investigator Global Assessment (IGA) of clear/almost clear - The IGA is a five-point scale that provides a global clinical assessment of Atopic Dermatitis (AD) severity ranging from 0 to 4, where 0 indicates clear, 2 is mild, 3 is moderate, and 4 indicates severe Atopic Dermatitis (AD). A decrease in score relates to an improvement in signs and symptoms. |
| Difference of Safety among low adherent subjects | Month 6 | As a secondary outcome, we will compare psoriasis treatment outcomes (safety) between the most and least adherent patients. Measures for comparing safety between high vs low adherence subjects will be percent of subjects with Investigator Global Assessment (IGA) of clear/almost clear - The IGA is a five-point scale that provides a global clinical assessment of Atopic Dermatitis (AD) severity ranging from 0 to 4, where 0 indicates clear, 2 is mild, 3 is moderate, and 4 indicates severe Atopic Dermatitis (AD). A decrease in score relates to an improvement in signs and symptoms. |
Countries
United States
Outcome results
None listed