Effectiveness of a Digital Health Application for Psoriasis

Not Applicable

Active, not recruiting

• Conditions: Psoriasis
• Interventions: Behavioral: Online program for psoriasis (GAIA-PSO-01)

• Registration Number: NCT06027034
• Lead Sponsor: Gaia AG

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-08-31
• Study Start: 2023-09-04
• Study First Submitted QC: 2023-09-06
• Study First Posted: 2023-09-07
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-29
• Last Update Posted: 2025-01-30
• Primary Completion: 2025-03
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 348

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Online program for psoriasis (GAIA-PSO-01) + TAU	Online program for psoriasis (GAIA-PSO-01)	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).

Primary Outcome Measures

Name	Time	Method
Health-Related Quality of Life	3 months	Total score of the Dermatology Life Quality Index (DLQI). Total score ranging from 0-30; higher scores mean a worse outcome.

Secondary Outcome Measures

Name	Time	Method
Psoriasis Severity	3 months, 6 months, 12 months	Total score of the Self-Administered Psoriasis Area Severity Index (PASI). Total score ranging from 0-72; higher scores mean a worse outcome.
Health-Related Quality of Life	6 months, 12 months	Total score of the Dermatology Life Quality Index (DLQI). Total score ranging from 0-30; higher scores mean a worse outcome.
Depressive Symptoms	3 months, 6 months, 12 months	Total score of the Patient Health Questionnaire (PHQ-9). Total score ranging from 0-27; higher scores mean a worse outcome.
Body Surface Area (BSA)	3 months, 6 months, 12 months	Body Surface Area (BSA) is a measure used to determine the extent of skin involvement in psoriasis. Total score ranging from 0-100; higher scores mean a worse outcome.

Trial Locations

Locations (1)

GAIA AG; 🇩🇪 Hamburg, Germany