Cognitive Impairment, End Stage Kidney Disease (ESRD), Frailty, Health Inequity, Kidney Disease, Kidney Failure, Kidney Transplant, Multimorbidity
Conditions
Keywords
kidney transplant, frailty, multimorbidity, cognitive impairment, end stage kidney disease, health inequality
Brief summary
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)
Detailed description
Older adults with advanced chronic kidney disease (CKD) are increasingly being assessed for kidney transplantation. However, multimorbidity, frailty, and cognitive impairment are highly prevalent in this population and may influence transplant eligibility, perioperative risk, recovery trajectories, and longer-term outcomes. Current transplant assessment pathways are not routinely designed to systematically identify or address these geriatric syndromes. Comprehensive Geriatric Assessment (CGA) is a structured, multidimensional process that evaluates medical, functional, cognitive, psychological, and social domains, with the aim of informing personalised care planning and optimisation. CGA has demonstrated benefit in older surgical and oncological populations, but its feasibility and impact within kidney transplant assessment pathways remain uncertain. The OK-POP study is a single-centre, randomised controlled feasibility trial evaluating the integration of a kidney transplant-specific CGA (KT-CGA) into routine outpatient transplant assessment at Guy's and St Thomas' NHS Foundation Trust. Participants undergoing transplant assessment are randomised in a 1:1 ratio to either usual transplant assessment care or usual care supplemented by KT-CGA delivered by a clinician trained in geriatric principles. The primary focus of the study is to assess the feasibility and acceptability of delivering KT-CGA within an established transplant assessment pathway. This includes evaluation of recruitment and retention processes, completeness of study assessments, fidelity of KT-CGA delivery, and acceptability to both patients and clinical staff. Secondary objectives explore the clinical, service-level, and patient-centred consequences of KT-CGA, including its influence on transplant assessment processes, optimisation actions triggered by assessment findings, healthcare utilisation, and longer-term clinical and patient-reported outcomes. Outcomes are collected longitudinally over a two-year follow-up period to characterise trajectories before and after transplant listing and, where applicable, transplantation. The study also incorporates a preliminary health economic evaluation to explore the feasibility of estimating costs and outcomes associated with KT-CGA. Pseudonymised data are securely shared with King's College London to support exploratory analyses of healthcare utilisation and quality-adjusted life years, informing the design of a future definitive economic evaluation. Findings from this feasibility trial will inform the refinement of the KT-CGA intervention, outcome selection, and trial procedures, and will be used to support the design of a future multicentre randomised controlled trial evaluating the effectiveness and cost-effectiveness of KT-CGA in older kidney transplant candidates.
Interventions
OTHERKidney transplant-specific comprehensive geriatric assessment
KT-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.
Sponsors
Guy's and St Thomas' NHS Foundation Trust
King's College London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a feasibility study examining KT-CGA in patients aged over 60 being worked up for kidney transplantation. It is a single-centre, unblinded randomised control trial.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged 60 years or older * Attending Guy's and St Thomas' (GSTT) Nephrology services * Diagnosed with Chronic Kidney Disease (CKD) Stage 5 Either: * Pre-dialysis, or * Receiving dialysis (in-centre haemodialysis, peritoneal dialysis, or home haemodialysis) * Referred to the kidney transplant surgical clinic for assessment of suitability for kidney transplantation (pre-transplant evaluation)
Exclusion criteria
* Adults aged under 60 years * Patients currently attending the Nephrology Supportive Care service at GSTT
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of eligible patients who consented and were randomised | From first eligible patient approached through completion of recruitment (anticipated 12 months) | 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 | At intervention visit (single study visit following randomisation, within 4 weeks of allocation) | 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 | At intervention visit (single study visit following randomisation, within 4 weeks of allocation) | Mean duration of the KT-CGA intervention visit, measured in minutes from start to completion of assessment. |
| Reach of KT-CGA | From first intervention delivered through completion of recruitment (anticipated 12 months) | Proportion of eligible participants who received KT-CGA among those randomised to the intervention arm. |
| Fidelity of KT-CGA delivery | At intervention visit (single study visit following randomisation, within 4 weeks of allocation) | Proportion of predefined KT-CGA protocol components delivered per participant, assessed using a structured fidelity checklist. |
| Participant acceptability of randomisation and KT-CGA | Immediately post-intervention visit (same day as KT-CGA visit) | Participant-reported acceptability measured using Likert-scale responses (e.g., 1-5 scale) assessing views on randomisation, intervention experience, and follow-up procedures. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Days Alive and Out of Hospital at 180 days (DAOH-180) | 180 days from index date (date of KT-CGA for intervention group; equivalent index clinic date for control group) | 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 | 6 months, 12 months, and 24 months after index study visit | Proportion of participants placed on the kidney transplant waiting list (absolute number and expressed as percentage). |
| Kidney transplantation status | 12 months and 24 months after index study visit | 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 | From transplant admission through hospital discharge (hospital stay, up to 30 days post-transplant) | 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. |
| Number of investigations requested | Up to 24 months after index study visit | Total number of diagnostic investigations requested per participant during pre-transplant evaluation and follow-up (count). |
| Kidney graft survival | 12 months and 24 months after transplantation | Graft survival defined as absence of graft failure requiring return to dialysis or death due to kidney failure among transplanted participants (Time-to-event (months) / Proportion surviving). |
| Overall survival | 12 months and 24 months after index study visit | Survival status of participants during follow-up (Time-to-event (months) / Proportion surviving). |
| Days Alive and Out of Hospital at 365 days (DAOH-365) | 365 days after index study visit | Number of days participants are alive and not hospitalised during the 365-day follow-up period. |
| Days Alive and Out of Hospital at 730 days (DAOH-730) | 730 days after index study visit | Number of days participants are alive and not hospitalised during the 730-day follow-up period. |
| New diagnoses or clinical findings following KT-CGA | Up to 6 months after KT-CGA | Number of new diagnoses or previously unrecognised clinical findings identified following completion of KT-CGA (Count). |
| Medication changes prompted by KT-CGA | Up to 6 months after KT-CGA | Number of medication changes initiated following KT-CGA, including new prescriptions, dose adjustments, and deprescribing (Count). |
| Therapy referrals initiated following KT-CGA | Up to 6 months after KT-CGA | Number of referrals to allied health professionals (e.g., physiotherapy, occupational therapy, dietetics, speech and language therapy, or social work) initiated following KT-CGA (Count). |
| Lifestyle advice provided following KT-CGA | Up to 6 months after KT-CGA | Number of instances in which lifestyle advice (e.g., smoking cessation, alcohol reduction, weight management, sleep hygiene, continence advice) is documented following KT-CGA (Count). |
| Multispecialty referrals or investigations prompted by KT-CGA | Up to 6 months after KT-CGA | Number of multispecialty referrals or additional investigations initiated following KT-CGA, beyond standard pre-transplant assessment (Count). |
| Shared decision-making discussions following KT-CGA | Up to 6 months after KT-CGA | Number of documented shared decision-making discussions following KT-CGA, including assessment of decision-making capacity and discussion of benefits, risks, alternatives, and non-transplant options (Count). |
| Long-term condition management actions following KT-CGA | Up to 6 months after KT-CGA | Number of management actions for long-term conditions initiated following KT-CGA, including new outpatient referrals and documented advice to primary or specialty care teams (Count). |
| Advance care planning actions following KT-CGA | Up to 6 months after KT-CGA | Number of advance care planning actions documented following KT-CGA, including treatment escalation planning, cardiopulmonary resuscitation decisions, or discussion of lasting power of attorney (Count). |
| Opportunity cost measured by healthcare utilisation | Up to 24 months after index study visit | Healthcare utilisation associated with pre-transplant and post-transplant care, measured by the number of investigation requests and specialty referrals initiated, including referrals made pre-emptively following KT-CGA compared with referrals made during unplanned inpatient admissions (Counts). |
| Change in health-related quality of life (EQ-5D-5L) at 12 months | Baseline and 12 months after index study visit | Change in health-related quality of life measured using the EQ-5D-5L questionnaire. |
| Change in Clinical Frailty Scale (CFS) score at 12 months | Baseline and 12 months after randomisation | Change in frailty score from baseline to 12 months, measured using the Clinical Frailty Scale (CFS). The CFS is a 9-point ordinal scale, with higher scores indicating greater frailty. |
| Change in Edmonton Frail Scale (EFS) score at 12 months | Baseline and 12 months after randomisation | Change in frailty score from baseline to 12 months, measured using the Edmonton Frail Scale (EFS). The EFS is a multidimensional frailty assessment tool with scores ranging from 0 to 17, with higher scores indicating greater frailty. |
| Change in Montreal Cognitive Assessment (MoCA) score at 12 months | Baseline and 12 months after randomisation | Change in cognitive assessment score from baseline to 12 months, measured using the Montreal Cognitive Assessment (MoCA). The MoCA is a 30-point screening tool, with lower scores indicating greater cognitive impairment. |
| Change in Rowland Universal Dementia Assessment Scale (RUDAS) score at 12 months | Baseline and 12 months after randomisation | Change in cognitive assessment score from baseline to 12 months, measured using the Rowland Universal Dementia Assessment Scale (RUDAS). The RUDAS is a 30-point cognitive screening tool, with lower scores indicating greater cognitive impairment. |
Contacts
CONTACTJohn A Holland, MB BCh BAO
PRINCIPAL_INVESTIGATORAntonia J Cronin, MBBS MA PhD
Guy's and St Thomas' NHS Foundation Trust
Outcome results
None listed