Effectiveness of a Digital Health Application for Psoriasis

Gaia AG

Status: Active, not recruiting

Conditions: Psoriasis

Treatments: Behavioral: Online program for psoriasis (GAIA-PSO-01)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06027034

Psoriasis RCT 2023

Details and patient eligibility

About

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.

Enrollment: 348 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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348 participants in 2 patient groups

Online program for psoriasis (GAIA-PSO-01) + TAU

Experimental group

Description:

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).

Treatment:

Behavioral: Online program for psoriasis (GAIA-PSO-01)

TAU

No Intervention group

Description:

Participants allocated to the control group will receive access to treatment as usual (TAU).