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)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Proportion of eligible patients who consented and were randomised
研究概览
简要总结
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)
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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)
排除标准
- •Adults aged under 60 years
- •Patients currently attending the Nephrology Supportive Care service at GSTT
研究组 & 干预措施
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).
干预措施: Kidney transplant-specific comprehensive geriatric assessment (Other)
Standard pre-transplant care
This arm will receive usual pre-transplant evaluation and care.
结局指标
主要结局
Proportion of eligible patients who consented and were randomised
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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))
- Kidney transplant waitlisting status(6 months, 12 months, and 24 months after index study visit)
- Kidney transplantation status(12 months and 24 months after index study visit)
- Length of hospital stay associated with kidney transplantation(From transplant admission through hospital discharge (hospital stay, up to 30 days post-transplant))
- Number of investigations requested(Up to 24 months after index study visit)
- Kidney graft survival(12 months and 24 months after transplantation)
- Overall survival(12 months and 24 months after index study visit)
- Days Alive and Out of Hospital at 365 days (DAOH-365)(365 days after index study visit)
- Days Alive and Out of Hospital at 730 days (DAOH-730)(730 days after index study visit)
- New diagnoses or clinical findings following KT-CGA(Up to 6 months after KT-CGA)
- Medication changes prompted by KT-CGA(Up to 6 months after KT-CGA)
- Therapy referrals initiated following KT-CGA(Up to 6 months after KT-CGA)
- Lifestyle advice provided following KT-CGA(Up to 6 months after KT-CGA)
- Multispecialty referrals or investigations prompted by KT-CGA(Up to 6 months after KT-CGA)
- Shared decision-making discussions following KT-CGA(Up to 6 months after KT-CGA)
- Long-term condition management actions following KT-CGA(Up to 6 months after KT-CGA)
- Advance care planning actions following KT-CGA(Up to 6 months after KT-CGA)
- Opportunity cost measured by healthcare utilisation(Up to 24 months after index study visit)
- Change in health-related quality of life (EQ-5D-5L) at 12 months(Baseline and 12 months after index study visit)
- Change in Clinical Frailty Scale (CFS) score at 12 months(Baseline and 12 months after randomisation)
- Change in Edmonton Frail Scale (EFS) score at 12 months(Baseline and 12 months after randomisation)
- Change in Montreal Cognitive Assessment (MoCA) score at 12 months(Baseline and 12 months after randomisation)
- Change in Rowland Universal Dementia Assessment Scale (RUDAS) score at 12 months(Baseline and 12 months after randomisation)