Effectiveness of a Digital Health Application for Psoriasis

Psoriasis Clinical Trial

Official title:

Effectiveness of a Digital Health Application for Psoriasis: Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06027034
• Other study ID #: Psoriasis RCT 2023
• Status: Recruiting
• Phase: N/A
• Start date: September 4, 2023
• Est. completion date: March 2025

Study information

• Verified date: October 2023
• Source: Gaia AG
• Contact: Gitta Jacob, PD Dr.
• Phone: +49.40.349930-374
• Email: gitta.jacob[@]gaia-group.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 348
• Est. completion date: March 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Psoriasis

Intervention

Behavioral:
• Online program for psoriasis (GAIA-PSO-01)
The program to-be-tested (GAIA-PSO-01) is an interactive online program for independent use by users with psoriasis. It focuses on recognized treatment elements of cognitive behavioral therapy (CBT) and behavior change techniques.

Locations

Country	Name	City	State
Germany	GAIA AG	Hamburg

Sponsors (3)

Lead Sponsor	Collaborator
Gaia AG	Universitätsklinikum Hamburg-Eppendorf, University of Giessen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient Activation	Total score of the Patient Activation Measure-13 (PAM-13). Total score ranging from 0-100; higher scores mean a better outcome.	3 months, 6 months, 12 months
Other	Self-Esteem	Total score of the Rosenberg Self-Esteem Scale (RSE). Total score ranging from 0-30; higher scores mean a better outcome.	3 months, 6 months, 12 months
Other	Body Mass Index	Body mass index (BMI) is a simple measure of body fat based on height and weight. Higher values mean a worse outcome.	3 months, 6 months, 12 months
Other	Alcohol Consumption	Total score of the Alcohol use Disorders Identification Test - Consumption Items (AUDIT-C). Total score ranging from 0-12; higher scores mean a worse outcome.	3 months, 6 months, 12 months
Other	Cigarette Smoking	Cigarette smoking will be assessed with a single question 'How often do you smoke cigarettes?', with response options 'Never/rarely/sometimes/often/very often', coded from 0-4. Higher scores mean a worse outcome.	3 months, 6 months, 12 months
Primary	Health-Related Quality of Life	Total score of the Dermatology Life Quality Index (DLQI). Total score ranging from 0-30; higher scores mean a worse outcome.	3 months
Secondary	Psoriasis Severity	Total score of the Self-Administered Psoriasis Area Severity Index (PASI). Total score ranging from 0-72; higher scores mean a worse outcome.	3 months, 6 months, 12 months
Secondary	Depressive Symptoms	Total score of the Patient Health Questionnaire (PHQ-9). Total score ranging from 0-27; higher scores mean a worse outcome.	3 months, 6 months, 12 months
Secondary	Body Surface Area (BSA)	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.	3 months, 6 months, 12 months
Secondary	Health-Related Quality of Life	Total score of the Dermatology Life Quality Index (DLQI). Total score ranging from 0-30; higher scores mean a worse outcome.	6 months, 12 months