Long-term Improvement of Psoriasis Patients' Adherence to Topical Drugs: Testing a Patient-supporting Intervention Delivered by Healthcare Professionals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 2
- 主要终点
- Severity of Psoriasis
研究概览
简要总结
Psoriasis affects 2-4% of the Western adult population and is a socio-economic burden for patients and society. Topical drugs are recommended as first-line treatment for mild-to-moderate psoriasis, but low adherence is a barrier for treatment success. There is a need for improved patient support for psoriasis patients, which is suggested to improve long-term use of topical drugs.
The project aims to test whether a patient-supporting intervention delivered by healthcare professionals can improve the use of topical drugs. The intervention design is based on experiences with previous adherence-improving studies consisting of digital support by conducting a systematic literature search and holding focus groups with patients as well as healthcare professionals. The intervention consists of shared decision-making with patients, nurses and doctors, frequent consultations, easy access to healthcare professionals through video or in-office consultations and holding patients accountable for taking the medication.
The intervention will be tested in a randomized controlled trial: during a 48 week period, a group of patients (18-85 years of age) diagnosed with mild-to-moderate psoriasis and treated with topical drugs will be randomized to an intervention (n=40) or non-intervention group (n=40). The primary outcome will be severity of psoriasis and secondary outcomes primary adherence (i.e., rate of filled prescriptions) and quality of life.
If the intervention can reduce the severity of psoriasis in a significant manner, there is a potential for a national implementation of the intervention.
详细描述
Background Psoriasis is a chronic inflammatory skin disease affecting 2-4% of the Western adult population. It is associated with many comorbidities, negatively affects quality of life and is a socioeconomic burden for patients and society. Topical drugs are the recommended first-line treatment for mild-to-moderate psoriasis, but adherence rates are low, which is a barrier for treatment success, resulting in a need for systemic or biological treatments, which are associated with more severe adverse events and are more expensive than topical drugs. However, improved adherence to topical drugs is associated with improved efficacy. That is why there is a need for improving psoriasis patients' adherence to topical drugs.
As a supplement to the introduction of new and advanced technology, there is a need for more studies on how to optimize the available healthcare professionals in dermatology clinics. Since dermatologists are a limited resource, there is a need to study how other healthcare professionals, e.g., hospital nurses and pharmaconomists at the pharmacies, can support psoriasis patients in their use of topical drugs.
Hypothesis
A patient-supporting intervention delivered by dermatologists, dermatology nurses and pharmaconomists significantly reduces psoriasis patients' severity of psoriasis compared to standard patient support.
Aims
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
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
- •Legally competent patients with milder-to-moderate psoriasis
排除标准
- •Incapable patients not diagnosed with psoriasis
结局指标
主要结局
Severity of Psoriasis
时间窗: Change from baseline at week 48
Lattice-System Physician's Global Assessment (LS-PGA) (interval scale). From value 1 (no visible psoriasis) to 8 (severely affected by psoriasis).
次要结局
- Secondary Adherence(Week 48)
- Quality of Life (QOL)(Change from baseline to week 48)
研究者
Mathias Tiedemann Svendsen
Specialist in dermato-venereology, MD, PhD
Odense University Hospital