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Completed

NCT Number: NCT06056518

Investigating 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.

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Key information

Conditions

Kidney Transplant Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Charité - Universitätsmedizin Berlin

Berlin, State of Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AI-based risk prediction for kidney graft loss

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. 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)

  3. Kidney replacement therapy 12 months

    Time frame: 12 months

    Frequency of kidney replacement therapy after graft loss 12 months

  4. Emergency dialysis 12 months

    Time frame: 12 months

    Frequency of emergency dialysis after graft loss 12 months

  5. Dialysis initiation via AV-shunt 12 months

    Time frame: 12 months

    Frequency of dialysis initiation via AV-shunt after graft loss 12 months

  6. Dialysis initiation via permanent catheter 12 months

    Time frame: 12 months

    Frequency of dialysis initiation via permanent catheter after graft loss 12 months

  7. Retransplantation 12 months

    Time frame: 12 months

    Frequency of retransplantation after graft loss 12 months

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

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

Acronym: PRIMA-AI

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 28, 2023
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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