RecruitingNAINTERVENTIONAL

Impact of Enhanced Information on Subjective Information Level and PROMs in Patients with Aortic Stenosis

This study is for people who have a serious heart condition called aortic stenosis, where the main valve in your heart doesn't open properly. If you're planning to have a procedure called TAVI to fix this, you might be interested. Researchers want to see if using a special mobile app to give you more information about your condition and treatment can make a difference. They'll be checking if the app helps you feel more informed and if it improves how you feel and your quality of life after your procedure. The aim is to find better ways to support patients through their treatment journey.

At a glance

Status

Recruiting

Phase

Sponsor

Heart and Diabetes Center North-Rhine Westfalia

Enrolment target

250

Start

21 Aug 2024

Estimated completion

01 Dec 2025

Aortic Stenosis Disease

What is this study about?

This research study is about helping people who have a serious heart problem called aortic stenosis. This is when the main valve in your heart (the aortic valve) becomes stiff and narrow, making it harder for your heart to pump blood around your body. When it's severe, doctors often recommend a procedure to replace this valve, sometimes using a method called TAVI (Transcatheter Aortic Valve Implantation).

The main idea behind this study is to see if giving patients more detailed and easy-to-understand information through a special mobile phone app can make a positive difference. We all know that understanding your health condition and treatment options can be a bit overwhelming, and this study wants to explore if a well-designed app can help you feel more informed and confident.

The researchers will be comparing how patients feel and their well-being, both with and without the extra app-based information. They want to find out if being better informed helps improve things like your quality of life and how you cope with your condition and treatment. This research could help doctors and nurses find better ways to support patients like you in the future.

Key takeaways

This study is for adults with severe aortic stenosis having TAVI.
It tests if a mobile app providing extra information helps patients.
The goal is to see if better information improves how patients feel and cope.
You won't receive new medicines; it's about information delivery.
Your participation could help improve care for future patients.

Who may be eligible?

This study is looking for adults aged 18 and over who have a severe blockage of their aortic valve (severe aortic stenosis) and are scheduled to have a specific heart procedure called TAVI to replace it.

To join, you would need to be able to fill out surveys in German and give your written permission (consent) to take part. The study needs participants who can understand and respond to the questions asked.

If you have a language barrier that prevents you from completing surveys in German, unfortunately, this study wouldn't be suitable for you.

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?
Have you been diagnosed with severe aortic stenosis?
Are you scheduled to have a TAVI procedure?
Can you understand and complete surveys in German?
Are you able to use a mobile app on a smartphone?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you won't be given any new medication or different treatments for your heart condition. The study focuses purely on comparing how different amounts of information affect patients. You would be asked to use a specific mobile app that provides enhanced information about your condition and treatment. Throughout your participation, you would likely be asked to complete surveys at different times. These surveys would ask about your understanding of your condition and how you're feeling. The exact number of surveys and how long you'd be involved would be explained fully by the study team, but it would revolve around your planned TAVI procedure and recovery.

Potential risks and benefits

Taking part in this study specifically focuses on how information is given, and it does not involve any changes to your medical treatment. This means there are no direct medical risks from participating. A potential benefit is that using the app might help you feel more informed and confident about your condition and treatment, which could improve your experience. Your answers to the surveys will also help improve care for future patients. You are always free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Clinic for General and Interventional Cardiology/Angiology, Herz- und Diabeteszentrum NRW
Verified postcode
Bad Oeynhausen, Germany· Recruiting

Common questions

What is TAVI?

TAVI stands for Transcatheter Aortic Valve Implantation. It's a keyhole procedure to replace a narrowed aortic valve in your heart.

Do I have to use a smartphone to join?

Yes, this study involves using a mobile app on a smartphone to receive information and complete surveys.

Will my doctors know if I join the study?

Yes, your medical team will be aware if you choose to participate, as it's linked to your planned TAVI procedure.

Does this study involve any new medicines?

No, this study does not involve any new medicines or changes to your prescribed treatment.

What do they mean by 'subjective information level'?

This basically means how much you feel you understand about your condition and treatment, from your own point of view.

How to find out more

Astrid Kleemeyer

akleemeyer@hdz-nrw.de 49 5731 971258 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.