Older Kidney Patient Optimisation Pretransplant (OK-POP)

Optimising Access to and Outcomes From Transplantation in Older Potential Kidney Transplant Recipients: Pilot Feasibility Study on Kidney Transplant-specific Comprehensive Geriatric Assessment (KT-CGA)

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)

Study Overview

• Status: Not yet recruiting
• Conditions: Cognitive Impairment; Frailty; Kidney Failure; Multimorbidity; Kidney Disease; Kidney Transplant; End Stage Kidney Disease (ESRD); Health Inequity
• Intervention / Treatment: Other: Kidney transplant-specific comprehensive geriatric assessment

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: John A Holland, MB BCh BAO; Phone Number: +447307073144; Email: john.holland9@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Kidney transplant-specific CGA; This arm will receive KT-CGA (single clinic visit lasting 45-60 minutes with multidimensional assessment of frailty, multimorbidity, cognition, renal disease/treatment and function).	Other: Kidney 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.
No Intervention: Standard pre-transplant care; This arm will receive usual pre-transplant evaluation and care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From first eligible patient approached through completion of recruitment (anticipated 12 months)
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).	At intervention visit (single study visit following randomisation, within 4 weeks of allocation)
Duration of KT-CGA visit	Mean duration of the KT-CGA intervention visit, measured in minutes from start to completion of assessment.	At intervention visit (single study visit following randomisation, within 4 weeks of allocation)
Reach of KT-CGA	Proportion of eligible participants who received KT-CGA among those randomised to the intervention arm.	From first intervention delivered through completion of recruitment (anticipated 12 months)
Fidelity of KT-CGA delivery	Proportion of predefined KT-CGA protocol components delivered per participant, assessed using a structured fidelity checklist.	At intervention visit (single study visit following randomisation, within 4 weeks of allocation)
Participant acceptability of randomisation and KT-CGA	Participant-reported acceptability measured using Likert-scale responses (e.g., 1-5 scale) assessing views on randomisation, intervention experience, and follow-up procedures.	Immediately post-intervention visit (same day as KT-CGA visit)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	180 days from index date (date of KT-CGA for intervention group; equivalent index clinic date for control group)
Kidney transplant waitlisting status	Proportion of participants placed on the kidney transplant waiting list (absolute number and expressed as percentage).	6 months, 12 months, and 24 months after index study visit
Kidney transplantation status	Proportion of participants who receive a kidney transplant during follow-up (absolute number and expressed as percentage).	12 months and 24 months after index study visit
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.	From transplant admission through hospital discharge (hospital stay, up to 30 days post-transplant)
Number of investigations requested	Total number of diagnostic investigations requested per participant during pre-transplant evaluation and follow-up (count).	Up to 24 months after index study visit
Kidney graft survival	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).	12 months and 24 months after transplantation
Overall survival	Survival status of participants during follow-up (Time-to-event (months) / Proportion surviving).	12 months and 24 months after index study visit
Days Alive and Out of Hospital at 365 days (DAOH-365)	Number of days participants are alive and not hospitalised during the 365-day follow-up period.	365 days after index study visit
Days Alive and Out of Hospital at 730 days (DAOH-730)	Number of days participants are alive and not hospitalised during the 730-day follow-up period.	730 days after index study visit
New diagnoses or clinical findings following KT-CGA	Number of new diagnoses or previously unrecognised clinical findings identified following completion of KT-CGA (Count).	Up to 6 months after KT-CGA
Medication changes prompted by KT-CGA	Number of medication changes initiated following KT-CGA, including new prescriptions, dose adjustments, and deprescribing (Count).	Up to 6 months after KT-CGA
Therapy referrals initiated following 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).	Up to 6 months after KT-CGA
Lifestyle advice provided following 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).	Up to 6 months after KT-CGA
Multispecialty referrals or investigations prompted by KT-CGA	Number of multispecialty referrals or additional investigations initiated following KT-CGA, beyond standard pre-transplant assessment (Count).	Up to 6 months after KT-CGA
Shared decision-making discussions following 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).	Up to 6 months after KT-CGA
Long-term condition management actions following 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).	Up to 6 months after KT-CGA
Advance care planning actions following 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).	Up to 6 months after KT-CGA
Opportunity cost measured by healthcare utilisation	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).	Up to 24 months after index study visit
Change in health-related quality of life (EQ-5D-5L) at 12 months	Change in health-related quality of life measured using the EQ-5D-5L questionnaire.	Baseline and 12 months after index study visit
Change in Clinical Frailty Scale (CFS) score at 12 months	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.	Baseline and 12 months after randomisation
Change in Edmonton Frail Scale (EFS) score at 12 months	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.	Baseline and 12 months after randomisation
Change in Montreal Cognitive Assessment (MoCA) score at 12 months	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.	Baseline and 12 months after randomisation
Change in Rowland Universal Dementia Assessment Scale (RUDAS) score at 12 months	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.	Baseline and 12 months after randomisation

Collaborators and Investigators

• Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Collaborators: King's College London
• Investigators: Principal Investigator: Antonia J Cronin, MBBS MA PhD, Guy's and St Thomas' NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Estimated): February 2, 2026
• Primary Completion (Estimated): February 2, 2027
• Study Completion (Estimated): February 2, 2028

Study Registration Dates

• First Submitted: January 7, 2026
• First Submitted That Met QC Criteria: February 12, 2026
• First Posted (Actual): February 19, 2026

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: frailty; kidney transplant; multimorbidity; cognitive impairment; end stage kidney disease; health inequality
• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Pathologic Processes; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Neurocognitive Disorders; Cognition Disorders; Renal Insufficiency, Chronic; Pathological Conditions, Signs and Symptoms; Frailty; Cognitive Dysfunction; Renal Insufficiency; Kidney Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: 358879

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No