Oral Psoriasis Treatment Adherence and Intervention Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Patterns of Misuse
研究概览
简要总结
Response to psoriasis treatment is variable in large part because of poor adherence treatments. Studies using electronic monitors have assessed adherence to topical and injectable psoriasis treatments and to biologics, yielding critically important insights. Adherence to oral psoriasis treatments is not as well characterized but is also critical, as the therapeutic windows for these treatments are narrower than for other psoriasis treatment options.
The proposed study will assess patients' adherence to oral psoriasis treatment (primarily methotrexate) and will also collect pilot data on an intervention to improve adherence. The primary hypothesis of the investigators study is that adherence to oral psoriasis treatment is poor and that a reporting intervention may improve adherence to oral psoriasis treatment. In the investigator-blinded, 6-month prospective study, patients will be randomized to standard-of-care treatment or standard-of-care supplemented with the weekly online reporting intervention. Adherence will be assessed using electronic monitors. This randomized trial will permit the investigators to determine adherence to oral psoriasis treatment, assess the relationship between adherence and psoriasis outcomes, identify factors that are associated with adherence to oral psoriasis treatment (including physician trust, confidence in the treatment plan, and depression), and obtain preliminary data on the impact of an Internet-reporting measure on patients' adherence to oral psoriasis treatment
.
详细描述
Psoriasis is a common, chronic inflammatory disease that has a major impact on patients' quality of life. Patients' response to treatment is variable. Poor adherence to topical, oral and biologic psoriasis treatments is common and may account for poor responses.1, 2 Many psoriasis patients do not even fill their prescriptions.3 Electronic monitoring of adherence provides the most detailed and accurate way to assess adherence. While studies using electronic monitors have assessed adherence to topical psoriasis treatments and to biologics, adherence to oral psoriasis treatments is not as well characterized. Understanding adherence to oral psoriasis treatments is critical, as the therapeutic windows for these treatments are narrower than for other psoriasis treatment options, making adherence to recommended dosing all the more critical.
Developing methods to improve psoriasis patients' adherence has the potential to provide an immediate, practical means to improve patients' treatment outcomes. Return visits improve patients' use of medication & treatment outcomes but are not practical and add additional costs to the patient and medical system. Having patients report on their treatment experience without an office visit offers promise for improving adherence but has not been tested in a psoriasis population.
The primary hypothesis of the investigators study is that adherence to oral psoriasis treatment is poor and that a reporting intervention may improve adherence to oral psoriasis treatment.
The Specific Aims of this study are:
- To determine adherence to oral psoriasis treatments (methotrexate) with electronic monitors.
- To assess the relationship between adherence and psoriasis outcomes (measured by body surface area [BSA], Physician Global Assessment [PGA] and [BSA]x[PGA]).
- To identify factors that are associated with adherence to oral psoriasis treatment, including physician trust, confidence in the treatment plan, and depression which will be measured with the Wake Forest University Physician Trust Scale (WFUPTS),4-6 the Treatment Satisfaction Questionnaire for Medication (TSQM),7 and the Hamilton Depression Rating Scale (HAM-D).
- To test obtain preliminary data on the impact of an Internet-reporting measure on patients' adherence to oral psoriasis treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any male or female 12 years or older of age with a diagnosis of psoriasis who is prescribed methotrexate by a dermatologist will be eligible for participation.
- •Greater than 10% of body surface involvement for psoriasis.
- •Subject is capable of understanding and willing to provide a signed and dated written voluntary informed consent before any protocol specific procedures are performed.
- •The subject is able to complete the study and comply with study instructions, including attending all study visits.
排除标准
- •Individuals younger than 12 years of age.
- •Known allergy or sensitivity to methotrexate.
- •Inability to complete all study-related visits, or inability to complete the Internet survey due to inadequate Internet access.
- •Introduction of any other prescription medication, topical or systemic, for psoriasis while participating in the study.
结局指标
主要结局
Patterns of Misuse
时间窗: 6 months
Self-report of not taking the medication as prescribed;
Adherence to prescribed oral Methotrexate treatment
时间窗: 6 months
Determined by intervention of weekly internet survey compared to no survey
Psoriasis severity outcomes
时间窗: 6 months
The relationship between body surface area, Physician Global Assessment outcomes will be assessed.
次要结局
- Relationship to Adherence(6 months)
- Relationship to Satisfaction(6 months)