Kidney Transplant Failure Clinical Trial
— PRIMA-AIOfficial title:
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 and 24 months follow-up. Implementation barriers and enablers will also be assessed.
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 |
Country | Name | City | State |
---|---|---|---|
Germany | Charité - Universitätsmedizin Berlin | Berlin |
Lead Sponsor | Collaborator |
---|---|
Charite University, Berlin, Germany |
Germany,
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 |
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