Active not recruitingNAINTERVENTIONAL

Effectiveness of a Digital Health Application for Psoriasis

This study is investigating how effective an online self-help program called GAIA-PSO-01 is for adults living with psoriasis. Psoriasis is a common skin condition. We know that living with psoriasis can sometimes affect day-to-day life and wellbeing. This study will involve 348 people with psoriasis. Half of the participants will use the online program for 12 months, in addition to their regular medical care from their GP or specialists. The other half will continue with only their regular medical care. By comparing these two groups, researchers hope to understand if the online program can help people manage their condition better and improve their quality of life. The study aims to make sure that any new treatments are well-tested and safe for patients.

At a glance

Status

Active not recruiting

Phase

Sponsor

Gaia AG

Enrolment target

348

Start

04 Sep 2023

Estimated completion

01 Dec 2026

Psoriasis

What is this study about?

This study is about a new online program designed to help adults with psoriasis. Psoriasis is a common skin condition where people develop red, flaky patches of skin that can sometimes be itchy. It can also affect joints, which is called psoriatic arthritis. Even though there are many treatments available, psoriasis can sometimes really impact how people feel and their everyday lives. This online program, called GAIA-PSO-01, is a self-guided tool, meaning you can use it on your own.

The main goal of this study is to see if using this online program, alongside the usual care you receive from your doctor or specialists, can make a difference. Things like creams, light therapy, medicines, or mental health support are all part of 'usual care.' The study wants to find out if adding this online program improves things for people over a year, compared to just sticking with their usual care alone.

By carefully studying these two groups, the researchers hope to learn if this digital tool can offer a helpful new way for people to manage their psoriasis and feel better about their health and lives. It's an important step to explore how technology can support long-term conditions like psoriasis.

Key takeaways

This study tests an online program for adults with psoriasis.
It aims to see if the program improves quality of life when used alongside usual care.
Participants will be randomly assigned to either use the program or continue with usual care only.
The study lasts for 12 months.
A good understanding of German and basic computer skills are needed.
This study is currently recruiting in Germany.

Who may be eligible?

To join this study, participants must be at least 18 years old and have a diagnosis of psoriasis or a type of arthritis linked to psoriasis (called psoriatic arthritis). It's also important that your psoriasis has significantly affected your quality of life, which means it has bothered you quite a bit in your daily activities and wellbeing.

You also need to be able to understand German well enough for the program and have a good grasp of how to use a computer or other digital devices.

However, some people won't be able to join. This includes those with other specific types of psoriasis (like pustular or guttate psoriasis), certain serious illnesses like cancer, or other long-lasting health problems that severely impact their quality of life. If you are currently getting treatment for a serious mental health condition or have trouble with technology, you also wouldn't be able to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have typical psoriasis (psoriasis vulgaris) or psoriatic arthritis, confirmed by a specialist?
Has your psoriasis significantly affected your quality of life?
Do you have a good understanding of German and feel comfortable using computers or digital tools?
Do you NOT have specific types of psoriasis (like pustular or guttate), cancer, or a serious mental health condition?
Are you able to get a medical certificate from a specialist confirming your diagnosis?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be randomly put into one of two groups, like flipping a coin. You won't get to choose which group you're in. One group will get a year's access to the online program for psoriasis, in addition to all the regular treatments and care you already receive from your doctor or specialists. This 'usual care' can include anything your medical team prescribes or recommends, such as creams, light therapy, medicines, or talking therapies. The other group will simply continue with their usual medical care, without access to the online program. The study will likely involve some assessments to measure your general health and how psoriasis affects your daily life at the start and end of the 12-month period. There are no study medications involved beyond your regular prescribed treatments, and the total duration of active participation for using the program or being monitored will be 12 months.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is that if you are in the group using the online program, it might help you manage your psoriasis better and improve your quality of life. For everyone taking part, your contribution helps researchers learn more about how to support people with psoriasis, which could benefit others in the future. There are no physical risks associated with this study, as it primarily involves an online program and your usual medical care. The main risk is that the online program might not be as effective as hoped. Remember, you have the right to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

GAIA AG
Verified postcode
Hamburg, Germany

Common questions

What is the online program (GAIA-PSO-01)?

It's a digital tool designed to help people with psoriasis manage their condition on their own, by providing information and support online.

Will I still see my regular doctor if I join?

Yes, absolutely. This study is about adding the online program to your existing care, not replacing it. You will continue to receive all your usual treatment from your GP and specialists.

Why can't people with other types of psoriasis join?

The study is specifically looking at 'psoriasis vulgaris' and a linked form of arthritis. Other types of psoriasis might respond differently, so they aren't included to keep the study focused.

What does 'impaired quality of life' mean for this study?

It means your psoriasis has affected your daily life and wellbeing significantly, as measured by a specific health questionnaire doctors use.

Do I have to speak German to join?

Yes, a good understanding of the German language is required to participate in this study, as the online program will be in German.