Active not recruitingNAINTERVENTIONAL

The smartNTx Trial:Telemedical Management Versus Standard Aftercare in Kidney Transplant Recipients (KTR)

The smartNTx trial is looking at whether using a special smartphone app for extra support after a kidney transplant can lead to better health outcomes. It compares the app-based care with the usual follow-up care that transplant patients receive. Patients using the app will regularly share health information like vital signs and how they're feeling, and their medical team can review this data to offer advice or intervene if needed. The study hopes to find out if this extra remote monitoring can help kidneys last longer, improve patients' quality of life, prevent problems, and even reduce healthcare costs. It's a year-long study taking place in Germany.

At a glance

Status

Active not recruiting

Phase

Sponsor

University of Erlangen-Nürnberg Medical School

Enrolment target

384

Start

15 May 2023

Estimated completion

30 Aug 2026

Kidney Transplant Rejection Kidney Transplant Failure

What is this study about?

When someone has a kidney transplant, it's really important to look after their new kidney to help it last a long time. This study, called `smartNTx`, is designed to find out if giving people extra support through a smartphone app, on top of their usual follow-up care, can make a positive difference. The researchers want to see if this additional remote care helps keep the new kidney working well for longer, improves how patients feel day-to-day, and reduces health problems.

Currently, after a kidney transplant, patients have regular check-ups with their medical team. In this study, some patients will continue with just this standard care. Other patients, however, will also use a special smartphone app. This app lets them regularly share information about their health, such as their blood pressure, how they're generally feeling, and details about their medicines. Their medical team can then look at this information and get in touch if they think something needs attention, offering a kind of continuous support right from the patient's home.

The main goal is to see if this extra support from the app leads to fewer hospital stays, shorter hospital stays if they are needed, better control of blood pressure, and better overall kidney function. It also aims to see if patients are more likely to take their medicines as prescribed and have a better quality of life. The study involves patients in three different German kidney transplant centers, and it will last for one year.

Key takeaways

This study compares standard kidney transplant care with extra support via a smartphone app.
It aims to improve long-term kidney health, reduce complications, and enhance quality of life.
Patients in the app group will regularly share health data with their medical team.
The study takes place in Germany and lasts for one year.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for people who have had a kidney transplant within the last 12 months and are currently taking a specific medicine called tacrolimus. You should be planning to have your regular follow-up care at one of the participating transplant centers.

To join, you'll need to be able to use a smartphone or tablet yourself, or have someone close to you who can help. If you're under 12, your parents would need to manage the smartphone for you. You also need to be able to communicate in either German or English and have good, stable kidney function. Importantly, you must be willing to participate and give your permission to be part of the study.

There are certain reasons why you wouldn't be able to join. These include having mental health issues that might make it hard to follow the study rules, having other major health problems, or a recent history of alcohol or drug abuse. You also can't have participated in another clinical trial recently, had certain types of combined organ transplants, or have some specific kidney conditions or active cancers.

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.

Have I had a kidney transplant within the last 12 months?
Am I currently taking tacrolimus medication?
Can I, or someone close to me, regularly use a smartphone or tablet?
Do I expect to receive my follow-up care at one of the participating transplant centers?
Do I have stable kidney function?
Am I able to communicate in German or English?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it will last for one year. All patients will receive their usual, ongoing care after their kidney transplant. If you are in the group receiving the additional support, you will also be asked to regularly use a special smartphone app. Through this app, you'll share information about your health, such as your vital signs (like blood pressure), how you're feeling, details about your medications, and lab results. This data will be sent automatically and securely to your kidney transplant center.

A special medical team will constantly check this incoming health information. If they notice anything that needs attention, they might get in touch with you or your local kidney doctor to discuss what steps might be needed. The study does not involve new medications, but it focuses on how your care is managed and monitored. You will have your regular clinic appointments as planned, with the app providing an extra layer of remote monitoring and communication.

Potential risks and benefits

Participating in this study might offer some potential benefits, especially for those using the app, as they will receive additional monitoring and communication about their health, which could lead to earlier identification and management of potential issues. Ultimately, the hope is to improve long-term kidney health and quality of life. However, as with any study, there are no guarantees of direct personal benefit. Potential risks are generally low, as the study focuses on how care is managed rather than introducing new treatments. Risks might include the time commitment required for using the app and providing information. It's really important to remember that participating is completely voluntary, and you have the right to withdraw from the study at any time without it affecting your medical care.

Locations (2)

Charité Universitätsmedizin Berlin
Approximate
Berlin, Germany
University Hospital Essen
Verified postcode
Essen, Germany

Common questions

What is `telemedical management`?

It means using technology, like a smartphone app, to monitor your health and communicate with your doctors from a distance, usually from your home.

Will I still have my regular doctor appointments?

Yes, all patients in the study will continue to receive their usual follow-up care and appointments with their medical team.

Do I need to be good with technology?

You need to be able to use a smartphone or tablet, or have someone close to you (like a family member) who can help you use it regularly.

What information will the app collect?

The app will collect health information like your vital signs (e.g., blood pressure), how you're feeling, your medication details, and lab results.

Can I leave the study if I change my mind?

Yes, you are free to leave the study at any time, and it will not affect your kidney care.