Effectiveness of a Digital Health Application for Psoriasis: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Gaia AG
- 入组人数
- 348
- 试验地点
- 2
- 主要终点
- Health-Related Quality of Life
研究概览
简要总结
This clinical trial with 348 patients with psoriasis aims to investigate the effectiveness of a self-guided online program for patients with psoriasis.
Patients will be randomized and allocated in a 1:1 ratio to either an intervention group, in which they will receive 12-month-access to an online program for psoriasis in addition to treatment as usual (TAU, n = 174), or to a control group, in which they will receive only TAU (n = 174). TAU is defined as any therapy prescribed or recommended by the GP or specialists (e.g. dermatologist, psychiatrist), which may include topical therapy, phototherapy, pharmacotherapy, psychosocial therapy, etc.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Presence of psoriasis vulgaris or psoriatic arthritis
- •Submission of a specialist medical certificate attesting to the presence of at least one of the following ICD-10-GM diagnoses: Psoriasis vulgaris (L 40.0, L 40.7), Psoriatic arthritis (L40.5, M07.x)
- •Impaired health-related quality of life (DLQI > 10)
- •Consent to participate
- •Sufficient understanding of the German language
排除标准
- •Presence of another subtype of psoriasis (pustular psoriasis, guttate psoriasis, inverse psoriasis, erythrodermic psoriasis, or drug-induced psoriasis) or psoriatic arthritis without skin involvement
- •Presence of malignancies
- •Presence of other chronic diseases with strong negative influence on quality of life
- •Currently undergoing psychiatric treatment / current presence of a severe psychiatric diagnosis
- •Insufficient language and/or IT skills
研究组 & 干预措施
Online program for psoriasis (GAIA-PSO-01) + TAU
Participants allocated to the intervention group will receive access to an online program for psoriasis (GAIA-PSO-01) in addition to treatment as usual (TAU).
干预措施: Online program for psoriasis (GAIA-PSO-01) (Behavioral)
TAU
Participants allocated to the control group will receive access to treatment as usual (TAU).
结局指标
主要结局
Health-Related Quality of Life
时间窗: 3 months
Total score of the Dermatology Life Quality Index (DLQI). Total score ranging from 0-30; higher scores mean a worse outcome.
次要结局
- Psoriasis Severity(3 months, 6 months, 12 months)
- Health-Related Quality of Life(6 months, 12 months)
- Depressive Symptoms(3 months, 6 months, 12 months)
- Body Surface Area (BSA)(3 months, 6 months, 12 months)