search
Back to results

Effectiveness of a Digital Health Application for Psoriasis

Primary Purpose

Psoriasis

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Online program for psoriasis (GAIA-PSO-01)
Sponsored by
Gaia AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • GAIA AGRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

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

TAU

Arm 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).

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Depressive Symptoms
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)
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.
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.

Full Information

First Posted
August 31, 2023
Last Updated
October 16, 2023
Sponsor
Gaia AG
Collaborators
University of Giessen, Universitätsklinikum Hamburg-Eppendorf
search

1. Study Identification

Unique Protocol Identification Number
NCT06027034
Brief Title
Effectiveness of a Digital Health Application for Psoriasis
Official Title
Effectiveness of a Digital Health Application for Psoriasis: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 4, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gaia AG
Collaborators
University of Giessen, Universitätsklinikum Hamburg-Eppendorf

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
348 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Online program for psoriasis (GAIA-PSO-01) + TAU
Arm Type
Experimental
Arm 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).
Arm Title
TAU
Arm Type
No Intervention
Arm Description
Participants allocated to the control group will receive access to treatment as usual (TAU).
Intervention Type
Behavioral
Intervention Name(s)
Online program for psoriasis (GAIA-PSO-01)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Health-Related Quality of Life
Description
Total score of the Dermatology Life Quality Index (DLQI). Total score ranging from 0-30; higher scores mean a worse outcome.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Psoriasis Severity
Description
Total score of the Self-Administered Psoriasis Area Severity Index (PASI). Total score ranging from 0-72; higher scores mean a worse outcome.
Time Frame
3 months, 6 months, 12 months
Title
Depressive Symptoms
Description
Total score of the Patient Health Questionnaire (PHQ-9). Total score ranging from 0-27; higher scores mean a worse outcome.
Time Frame
3 months, 6 months, 12 months
Title
Body Surface Area (BSA)
Description
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.
Time Frame
3 months, 6 months, 12 months
Title
Health-Related Quality of Life
Description
Total score of the Dermatology Life Quality Index (DLQI). Total score ranging from 0-30; higher scores mean a worse outcome.
Time Frame
6 months, 12 months
Other Pre-specified Outcome Measures:
Title
Patient Activation
Description
Total score of the Patient Activation Measure-13 (PAM-13). Total score ranging from 0-100; higher scores mean a better outcome.
Time Frame
3 months, 6 months, 12 months
Title
Self-Esteem
Description
Total score of the Rosenberg Self-Esteem Scale (RSE). Total score ranging from 0-30; higher scores mean a better outcome.
Time Frame
3 months, 6 months, 12 months
Title
Body Mass Index
Description
Body mass index (BMI) is a simple measure of body fat based on height and weight. Higher values mean a worse outcome.
Time Frame
3 months, 6 months, 12 months
Title
Alcohol Consumption
Description
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.
Time Frame
3 months, 6 months, 12 months
Title
Cigarette Smoking
Description
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.
Time Frame
3 months, 6 months, 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gitta Jacob, PD Dr.
Phone
+49.40.349930-374
Email
gitta.jacob@gaia-group.com
First Name & Middle Initial & Last Name or Official Title & Degree
Linda Betz, Dr.
Email
linda.betz@gaia-group.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Uwe Gieler, Prof. Dr.
Organizational Affiliation
University of Giessen
Official's Role
Principal Investigator
Facility Information:
Facility Name
GAIA AG
City
Hamburg
ZIP/Postal Code
22085
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gitta Jacob, PD Dr.
Email
gitta.jacob@gaia-group.com
First Name & Middle Initial & Last Name & Degree
Linda Betz, Dr.
Email
linda.betz@gaia-group.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effectiveness of a Digital Health Application for Psoriasis

We'll reach out to this number within 24 hrs