Effectiveness of a Digital Health Application for Psoriasis

October 16, 2023 updated by: Gaia AG

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

348

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: TAU
Participants allocated to the control group will receive access to treatment as usual (TAU).
Experimental: 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).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Psoriasis Severity
Time Frame: 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.
3 months, 6 months, 12 months
Depressive Symptoms
Time Frame: 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.
3 months, 6 months, 12 months
Body Surface Area (BSA)
Time Frame: 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.
3 months, 6 months, 12 months
Health-Related Quality of Life
Time Frame: 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.
6 months, 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Activation
Time Frame: 3 months, 6 months, 12 months
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
Self-Esteem
Time Frame: 3 months, 6 months, 12 months
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
Body Mass Index
Time Frame: 3 months, 6 months, 12 months
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
Alcohol Consumption
Time Frame: 3 months, 6 months, 12 months
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
Cigarette Smoking
Time Frame: 3 months, 6 months, 12 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gaia AG

Collaborators

University of Giessen
Universitätsklinikum Hamburg-Eppendorf

Investigators

  • Principal Investigator: Uwe Gieler, Prof. Dr., University of Gießen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2023

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

March 1, 2025

Study Registration Dates

First Submitted

August 31, 2023

First Submitted That Met QC Criteria

September 6, 2023

First Posted (Actual)

September 7, 2023

Study Record Updates

Last Update Posted (Actual)

October 17, 2023

Last Update Submitted That Met QC Criteria

October 16, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Psoriasis RCT 2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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