About this trial
The goal of this clinical trial is to learn if a kidney transplant-specific comprehensive geriatric assessment (KT-CGA) can improve the way older adults are assessed for kidney transplantation. The main questions it aims to answer are:
Is it feasible and acceptable to deliver a KT-CGA alongside routine transplant assessment in older adults with advanced kidney disease?
What is the effect of KT-CGA on decision-making about transplant listing and on patient-reported outcomes such as quality of life and frailty?
Researchers will compare participants who receive the KT-CGA plus usual care to those who receive usual care alone.
Participants will:
Continue with their usual transplant assessment process
If randomised to the intervention group, also complete the KT-CGA (a structured set of questionnaires, short memory and function tests, and discussions about wellbeing and support needs, taking about 45-60 minutes)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 60 years or older
Attending Guy's and St Thomas' (GSTT) Nephrology services
Diagnosed with Chronic Kidney Disease (CKD) Stage 5
Pre-dialysis, or
Disqualifiers
Adults aged under 60 years
Patients currently attending the Nephrology Supportive Care service at GSTT
Trial design
Parallel
Treatments tested in this trial
Kidney transplant-specific comprehensive geriatric assessment
Other interventionKT-CGA is an adaptation of the standard Comprehensive Geriatric Assessment (CGA), a multidimensional, interdisciplinary evaluation designed to identify and address medical, functional, psychological, and social factors that influence outcomes in older adults. Like conventional CGA, KT-CGA includes structured assessments of frailty, cognition, mood, mobility, activities of daily living, comorbidity, and social support. KT-CGA incorporates elements specific to advanced kidney disease and transplantation, including review of renal history, dialysis modality, and suitability for renal replacement therapies. It emphasises optimisation: medication reconciliation, health promotion, and onward referral to relevant specialties or allied health professionals as indicated. It is delivered in the outpatient setting by an experienced renal clinician with oversight from a consultant geriatrician trained in perioperative CGA and a consultant nephrologist.
Treatment groups
Trial outcomes
Primary outcomes
Proportion of eligible patients who consented and were randomised
Proportion of eligible patients approached for participation who provided written informed consent and were subsequently randomised.
Proportion of participants allocated to KT-CGA who completed the full assessment
Proportion of participants randomised to the intervention arm who completed all predefined components of the kidney transplant-specific comprehensive geriatric assessment (KT-CGA).
Duration of KT-CGA visit
Mean duration of the KT-CGA intervention visit, measured in minutes from start to completion of assessment.
Reach of KT-CGA
Proportion of eligible participants who received KT-CGA among those randomised to the intervention arm.
Secondary outcomes
Days Alive and Out of Hospital at 180 days (DAOH-180)
DAOH-180 will be calculated as the number of days alive and not spent in hospital during the 180-day follow-up period.
Kidney transplant waitlisting status
Proportion of participants placed on the kidney transplant waiting list (absolute number and expressed as percentage).
Kidney transplantation status
Proportion of participants who receive a kidney transplant during follow-up (absolute number and expressed as percentage).
Length of hospital stay associated with kidney transplantation
Total length of inpatient hospital stay associated with kidney transplantation, measured in days from date of transplant admission to date of hospital discharge, among participants who undergo transplantation during the study period.
Locations
Sponsors and contacts
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Guy's and St Thomas' NHS Foundation Trust
Lead sponsor
King's College London
Collaborator
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