Older Kidney Patient Optimisation Pretransplant
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Kidney transplant-specific comprehensive geriatric assessment.
- Кому может быть актуально
- Состояния в реестре: Kidney Disease, Kidney Failure, Frailty, Cognitive Impairment. Базовые параметры: от 60 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Список центров уточняется — проверьте первичный протокол.
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
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)
Обзор
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)
Подробное описание
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.
Вмешательства
- Другое 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 transpla
Первичные конечные точки
- Proportion of eligible patients who consented and were randomised [Срок оценки: From first eligible patient approached through completion of recruitment (anticipated 12 months)]
- Proportion of participants allocated to KT-CGA who completed the full assessment [Срок оценки: At intervention visit (single study visit following randomisation, within 4 weeks of allocation)]
- Duration of KT-CGA visit [Срок оценки: At intervention visit (single study visit following randomisation, within 4 weeks of allocation)]
- Reach of KT-CGA [Срок оценки: From first intervention delivered through completion of recruitment (anticipated 12 months)]
- Fidelity of KT-CGA delivery [Срок оценки: At intervention visit (single study visit following randomisation, within 4 weeks of allocation)]
- Participant acceptability of randomisation and KT-CGA [Срок оценки: Immediately post-intervention visit (same day as KT-CGA visit)]
Вторичные конечные точки (12)
- Days Alive and Out of Hospital at 180 days (DAOH-180) [Срок оценки: 180 days from index date (date of KT-CGA for intervention group; equivalent index clinic date for control group)]
- Kidney transplant waitlisting status [Срок оценки: 6 months, 12 months, and 24 months after index study visit]
- Kidney transplantation status [Срок оценки: 12 months and 24 months after index study visit]
- Length of hospital stay associated with kidney transplantation [Срок оценки: From transplant admission through hospital discharge (hospital stay, up to 30 days post-transplant)]
- Number of investigations requested [Срок оценки: Up to 24 months after index study visit]
- Kidney graft survival [Срок оценки: 12 months and 24 months after transplantation]
- Overall survival [Срок оценки: 12 months and 24 months after index study visit]
- Days Alive and Out of Hospital at 365 days (DAOH-365) [Срок оценки: 365 days after index study visit]
- Days Alive and Out of Hospital at 730 days (DAOH-730) [Срок оценки: 730 days after index study visit]
- New diagnoses or clinical findings following KT-CGA [Срок оценки: Up to 6 months after KT-CGA]
- Medication changes prompted by KT-CGA [Срок оценки: Up to 6 months after KT-CGA]
- Therapy referrals initiated following KT-CGA [Срок оценки: Up to 6 months after KT-CGA]
Критерии участия
Критерии включения
- 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)
Критерии исключения
- Adults aged under 60 years
- Patients currently attending the Nephrology Supportive Care service at GSTT
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Идентификаторы
NCT: NCT07419945 · 358879