NCT06056518

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Jan 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Jan 2024Sep 2026

First Submitted

Initial submission to the registry

September 21, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

January 19, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Expected
Last Updated

January 20, 2025

Status Verified

January 1, 2025

Enrollment Period

1.6 years

First QC Date

September 21, 2023

Last Update Submit

January 17, 2025

Conditions

Kidney Transplant Failure

Keywords

Kidney TransplantationGraft LossKidney Transplant FailureRiks Prediction System

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (15)

  • CollaboRATE mean score after 12 months

    12 months

  • CollaboRATE mean score after 24 months

    24 months

  • Control Preferences Scale mean after 12 months

    12 months

  • Control Preferences Scale mean after 24 months

    24 months

  • Kidney replacement therapy 12 months

    12 months

  • +10 more secondary outcomes

Other Outcomes (2)

  • Qualitative analysis of semistructured interviews

    24 months

  • Qualitative analysis of physician-patient conversations

    24 months

Study Arms (2)

Routine Care

NO INTERVENTION

Patients in the "Routine Care" arm are will undergo regular follow-up at the kidney transplant center.

AI-supported Care

EXPERIMENTAL

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

Interventions

AI-based risk prediction for kidney graft lossOTHER

Implementation of AI-based risk prediction tool for the 1-year risk of kidney graft loss.

AI-supported Care

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsAll genders (male, female, and others) are eligible for this study.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité - Universitätsmedizin Berlin

Berlin, State of Berlin, 10117, Germany

Location

Related Publications (1)

  • Osmanodja B, Sassi Z, Eickmann S, Hansen CM, Roller R, Burchardt A, Samhammer D, Dabrock P, Moller S, Budde K, Herrmann A. Investigating the Impact of AI on Shared Decision-Making in Post-Kidney Transplant Care (PRIMA-AI): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Apr 1;13:e54857. doi: 10.2196/54857.

    PMID: 38557315DERIVED

Study Officials

  • Klemens Budde, MD

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 21, 2023

First Posted

September 28, 2023

Study Start

January 19, 2024

Primary Completion

September 1, 2025

Study Completion (Estimated)

September 1, 2026

Last Updated

January 20, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)