Adherence to Otezla
- Conditions
- Psoriasis
- Interventions
- Behavioral: Reminder Text Intervention with apremilastBehavioral: Extended Consultation for apremilast
- Registration Number
- NCT05601492
- Lead Sponsor
- Wake Forest University Health Sciences
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 84
- Adult 18 years or older
- Diagnosis of mild psoriasis with Otezla recommendation
- Non-pregnant
- English speaking
- Under 18 years of age
- Not diagnosis of mild psoriasis
- Pregnant
- Non-English speaking
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 - Standard of Care Otezla - Standard Care Participant will be given the medication with an electronic monitoring cap attached and a return appointment for a standard of care regular visit Arm 1 - Standard of Care Reminder Text Intervention with apremilast Participant will be given the medication with an electronic monitoring cap attached and a return appointment for a standard of care regular visit Arm 1 - Standard of Care Extended Consultation for apremilast Participant will be given the medication with an electronic monitoring cap attached and a return appointment for a standard of care regular visit Arm 2 - Reminder text Reminder Text Intervention with apremilast 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 Arm 3 - Initial patient consult Extended Consultation for apremilast 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
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States