Investigating the Impact of AI on Shared Decision Making in Post-kidney Transplant Care (PRIMA-AI)

May 13, 2026 updated by: Klemens Budde, Charite University, Berlin, Germany

Prospective, Randomized Controlled Trial to Investigate the Impact of AI on Shared Decision Making in Post-kidney Transplant Care

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • State of Berlin
      • Berlin, State of Berlin, Germany, 10117
        • Charité - Universitätsmedizin Berlin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Routine Care
Patients in the "Routine Care" arm are will undergo regular follow-up at the kidney transplant center.
Experimental: AI-supported Care
Patients in the "AI-supported Care" arm will undergo regular follow-up at the kidney transplant center. Treating physicians will be provided an AI-based risk prediction tool that predict 1-year risk of graft loss for patients in this group based on routine parameters.
Other: AI-based risk prediction for kidney graft loss
Implementation of AI-based risk prediction tool for the 1-year risk of kidney graft loss.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Conversation about kidney replacement therapy after graft loss
Time Frame: 12 months
Proportion of patients, with whom the necessity of kidney replacement therapy after kidney allograft loss is discussed
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CollaboRATE mean score after 12 months
Time Frame: 12 months
CollaboRATE mean score of all study visits from study inclusion until month 12 (values 0 - 9, higher values indicating better outcome)
12 months
Control Preferences Scale mean after 12 months
Time Frame: 12 months
Mean Control Preferences Scale of all study visits from study inclusion until month 12 (values 1 - 5, higher values indicating better outcome)
12 months
Kidney replacement therapy 12 months
Time Frame: 12 months
Frequency of kidney replacement therapy after graft loss 12 months
12 months
Emergency dialysis 12 months
Time Frame: 12 months
Frequency of emergency dialysis after graft loss 12 months
12 months
Dialysis initiation via AV-shunt 12 months
Time Frame: 12 months
Frequency of dialysis initiation via AV-shunt after graft loss 12 months
12 months
Dialysis initiation via permanent catheter 12 months
Time Frame: 12 months
Frequency of dialysis initiation via permanent catheter after graft loss 12 months
12 months
Retransplantation 12 months
Time Frame: 12 months
Frequency of retransplantation after graft loss 12 months
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Qualitative analysis of semistructured interviews
Time Frame: 24 months
Qualitative analysis of semistructured interviews after 24 months
24 months
Qualitative analysis of physician-patient conversations
Time Frame: 24 months
Qualitative analysis of physician-patient conversations after 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charite University, Berlin, Germany

Investigators

  • Principal Investigator: Klemens Budde, MD, Charite University, Berlin, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 19, 2024

Primary Completion (Actual)

October 21, 2025

Study Completion (Actual)

October 21, 2025

Study Registration Dates

First Submitted

September 21, 2023

First Submitted That Met QC Criteria

September 21, 2023

First Posted (Actual)

September 28, 2023

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CHA-PRIMA-AI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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