Effectiveness of a Digital Health Application for Psoriasis: Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Psoriasis
- Sponsor
- Gaia AG
- Enrollment
- 348
- Locations
- 1
- Primary Endpoint
- Health-Related Quality of Life
- Status
- Active, not recruiting
- Last Updated
- 8 months ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Health-Related Quality of Life
Time Frame: 3 months
Total score of the Dermatology Life Quality Index (DLQI). Total score ranging from 0-30; higher scores mean a worse outcome.
Secondary Outcomes
- 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)