Adherence to Otezla

Study Overview
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Brief Summary
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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
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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.

Official Title
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Adherence to Otezla in Patients With Mild Psoriasis

Conditions
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Psoriasis

Intervention / Treatment
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* Drug: Otezla - Standard Care
* Behavioral: Reminder Text Intervention with apremilast
* Behavioral: Extended Consultation for apremilast


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomization 1:1:1
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1 - Standard of Care<br>Participant will be given the medication with an electronic monitoring cap attached and a return appointment for a standard of care regular visit | Drug: Otezla - Standard Care<br>* The participant will be given their medication with the electronic adapter cap on it and asked to return for the follow-up visit<br>* Other names: Apremilast;Behavioral: Reminder Text Intervention with apremilast<br>* 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.<br>* Other names: Otezla;Behavioral: Extended Consultation for apremilast<br>* 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<br>* Other names: Otezla;|
| Experimental: Arm 2 - Reminder text<br>Participant will be given the medication with an electronic monitoring cap attached and receive weekly electronic text/email-based reporting intervention that is designed to promote better adherence to treatment (to help assure that the study have subjects who have excellent adherence. Having patients report their progress on a regular basis promotes better treatment adherence, perhaps by creating the same sense of accountability promoted by regular office visits | Behavioral: Reminder Text Intervention with apremilast<br>* 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.<br>* Other names: Otezla;|
| Experimental: Arm 3 - Initial patient consult<br>Participant will be given the medication with an electronic monitoring cap attached and will receive an initial patient consultation intervention, which will focus on the prescribed medication education and setting expectations of what to anticipate with usage of the medication | Behavioral: Extended Consultation for apremilast<br>* 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<br>* Other names: Otezla;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication Adherence Outlier | 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. | Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference of Efficacy among high adherent subjects | 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. | Month 6 | 
| Difference of Safety among low adherent subjects | 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. | Month 6 |