Adherence to Otezla

Wake Forest University (WFU)

Status and phase: Withdrawn; Early Phase 1

Conditions: Psoriasis

Treatments: Behavioral: Reminder Text Intervention with apremilast; Drug: Otezla - Standard Care; Behavioral: Extended Consultation for apremilast

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05601492

IRB00088889

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 3 patient groups

Arm 1 - Standard of Care

Active Comparator group

Description:

Participant will be given the medication with an electronic monitoring cap attached and a return appointment for a standard of care regular visit

Treatment:

Behavioral: Extended Consultation for apremilast

Drug: Otezla - Standard Care

Behavioral: Reminder Text Intervention with apremilast

Arm 2 - Reminder text

Experimental group

Description:

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

Treatment:

Behavioral: Reminder Text Intervention with apremilast

Arm 3 - Initial patient consult

Experimental group

Description:

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

Treatment:

Behavioral: Extended Consultation for apremilast