Adherence to Otezla in Patients With Mild Psoriasis
试验速览
- 阶段
- 早期 1 期
- 状态
- 撤回
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Medication Adherence Outlier
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
The participant will not know that the electronic cap adapter is actually recording the opening of the medication bottle.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult 18 years or older
- •Diagnosis of mild psoriasis with Otezla recommendation
- •Non-pregnant
- •English speaking
排除标准
- •Under 18 years of age
- •Not diagnosis of mild psoriasis
- •Non-English speaking
研究组 & 干预措施
Arm 1 - Standard of Care
Participant will be given the medication with an electronic monitoring cap attached and a return appointment for a standard of care regular visit
干预措施: Otezla - Standard Care (Drug)
Arm 1 - Standard of Care
Participant will be given the medication with an electronic monitoring cap attached and a return appointment for a standard of care regular visit
干预措施: Reminder Text Intervention with apremilast (Behavioral)
Arm 1 - Standard of Care
Participant will be given the medication with an electronic monitoring cap attached and a return appointment for a standard of care regular visit
干预措施: Extended Consultation for apremilast (Behavioral)
Arm 2 - Reminder text
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
干预措施: Reminder Text Intervention with apremilast (Behavioral)
Arm 3 - Initial patient consult
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
干预措施: Extended Consultation for apremilast (Behavioral)
结局指标
主要结局
Medication Adherence Outlier
时间窗: 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.
次要结局
- Difference of Efficacy among high adherent subjects(Month 6)
- Difference of Safety among low adherent subjects(Month 6)