Kidney Transplant Failure
Conditions
Keywords
Kidney Transplantation, Graft Loss, Kidney Transplant Failure, Riks Prediction System
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 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.
Interventions
OTHERAI-based risk prediction for kidney graft loss
Implementation of AI-based risk prediction tool for the 1-year risk of kidney graft loss.
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Conversation about kidney replacement therapy after graft loss | 12 months | Proportion of patients, with whom the necessity of kidney replacement therapy after kidney allograft loss is discussed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CollaboRATE mean score after 12 months | 12 months | CollaboRATE mean score of all study visits from study inclusion until month 12 (values 0 - 9, higher values indicating better outcome) |
| Control Preferences Scale mean after 12 months | 12 months | Mean Control Preferences Scale of all study visits from study inclusion until month 12 (values 1 - 5, higher values indicating better outcome) |
| Kidney replacement therapy 12 months | 12 months | Frequency of kidney replacement therapy after graft loss 12 months |
| Emergency dialysis 12 months | 12 months | Frequency of emergency dialysis after graft loss 12 months |
| Dialysis initiation via AV-shunt 12 months | 12 months | Frequency of dialysis initiation via AV-shunt after graft loss 12 months |
| Dialysis initiation via permanent catheter 12 months | 12 months | Frequency of dialysis initiation via permanent catheter after graft loss 12 months |
| Retransplantation 12 months | 12 months | Frequency of retransplantation after graft loss 12 months |
Countries
Germany
Contacts
PRINCIPAL_INVESTIGATORKlemens Budde, MD
Charite University, Berlin, Germany
Outcome results
None listed