Investigating the Impact of AI on Shared Decision Making in Post-kidney Transplant Care (NCT06056518) | Clinical Trial Compass
CompletedNot Applicable
Investigating the Impact of AI on Shared Decision Making in Post-kidney Transplant Care
Germany76 participantsStarted 2024-01-19
Plain-language summary
This study aims to analyze the effects of AI-based risk prediction for graft loss on the frequency of conversations about the treatment after graft loss, as well as the associated shared decision making process in post-kidney transplant care in a German kidney transplant center (KTC), as perceived by the patient, their support person and the clinician/physician. Second, it aims to explore changes in patient and support person recall at 12 months follow-up. Implementation barriers and enablers will also be assessed. The protocol was amended so that the initially planned 24 months observation timeframe was removed from the study and it ended after 12 months due to high attrition and funding restrictions.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* written informed consent
* patients with functioning kidney allograft
* \> 12 months after transplantation
* eGFR \< 30 ml/min/1.73m2 according to CKD-EPI 2021 formula
* at least 18 years of age
* ability to communicate in German
* regular follow-up at kidney transplant center
Exclusion Criteria:
* multi-organ transplantation
* eGFR \> 30 ml/min/1.73m2 according to CKD-EPI 2021 formula
* \<= 12 months after transplantation
* less than 18 years of age
* not able to communicate in German
* no regular follow-up at kidney transplant center
* enrollment in another interventional study less than 1 month before participation in this study
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Conversation about kidney replacement therapy after graft loss