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

Kidney Transplant Failure Clinical Trial

— PRIMA-AI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06056518
• Other study ID #: CHA-PRIMA-AI
• Status: Recruiting
• Phase: N/A
• Start date: January 19, 2024
• Est. completion date: July 2026

Study information

• Verified date: February 2024
• Source: Charite University, Berlin, Germany
• Contact: Klemens Budde, MD
• Phone: 0049 30 450 614 086
• Email: klemens.budde[@]charite.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 and 24 months follow-up. Implementation barriers and enablers will also be assessed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 122
• Est. completion date: July 2026
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Transplant Failure

Intervention

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.

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Qualitative analysis of semistructured interviews	Qualitative analysis of semistructured interviews after 24 months	24 months
Other	Qualitative analysis of physician-patient conversations	Qualitative analysis of physician-patient conversations after 24 months	24 months
Primary	Conversation about kidney replacement therapy after graft loss	Proportion of patients, with whom the necessity of kidney replacement therapy after kidney allograft loss is discussed	12 months
Secondary	CollaboRATE mean score after 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
Secondary	CollaboRATE mean score after 24 months	CollaboRATE mean score of all study visits from study inclusion until month 24 (values 0 - 9, higher values indicating better outcome)	24 months
Secondary	Control Preferences Scale mean after 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
Secondary	Control Preferences Scale mean after 24 months	Mean Control Preferences Scale of all study visits from study inclusion until month 24 (values 1 - 5, higher values indicating better outcome)	24 months
Secondary	Kidney replacement therapy 12 months	Frequency of kidney replacement therapy after graft loss 12 months	12 months
Secondary	Kidney replacement therapy 24 months	Frequency of kidney replacement therapy after graft loss 24 months	24 months
Secondary	Emergency dialysis 12 months	Frequency of emergency dialysis after graft loss 12 months	12 months
Secondary	Emergency dialysis 24 months	Frequency of emergency dialysis after graft loss 24 months	24 months
Secondary	Dialysis initiation via AV-shunt 12 months	Frequency of dialysis initiation via AV-shunt after graft loss 12 months	12 months
Secondary	Dialysis initiation via AV-shunt 24 months	Frequency of dialysis initiation via AV-shunt after graft loss 24 months	24 months
Secondary	Dialysis initiation via permanent catheter 12 months	Frequency of dialysis initiation via permanent catheter after graft loss 12 months	12 months
Secondary	Dialysis initiation via permanent catheter 24 months	Frequency of dialysis initiation via permanent catheter after graft loss 24 months	24 months
Secondary	Retransplantation 12 months	Frequency of retransplantation after graft loss 12 months	12 months
Secondary	Retransplantation 24 months	Frequency of retransplantation after graft loss 24 months	24 months
Secondary	Conversation about kidney replacement therapy after graft loss	Proportion of patients, with whom the necessity of kidney replacement therapy after kidney allograft loss is discussed	24 months