A Smart Phone Application to Improve Adoption of the 2024 KDIGO CKD Guidelines
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change in KDIGO Guideline Adherence Following Exposure to a KDIGO-Aligned Smartphone Application
研究概览
简要总结
The goal of this study is to establish whether use of a digital intervention can improve adherence and alignment with the Kidney Disease: Improving Global Outcomes (KDIGO) Chronic Kidney Disease (CKD) 2024 Guidelines.
A subset of the study will focus on whether the intervention improves outcomes for young adults living with CKD, in the context of the imminent co-location of Children's Health Ireland on the St. James's Hospital campus.
Young adults with CKD transitioning to adult services are recognised as a high-risk and vulnerable cohort, with many individuals unaware of increased cardiovascular risk and mortality¹². In response, and in the context of the co-location of Children's Health Ireland on the St. James's Hospital site, a young adult nephrology clinic has been established.
The KDIGO CKD 2024 Guidelines identify transition as a period of increased risk and include recommendations regarding cardiovascular risk factor targets and the use of therapies known to delay CKD progression³.
Electronic communication is a preferred method for accessing health information among many young adults⁴⁵ and aligns with Sláintecare digital health strategies⁶. A recently established, award-winning St. James's Hospital renal smartphone application is currently used by over 3,000 individuals living with CKD.
The study aims to determine whether use of the application improves adherence to KDIGO guideline recommendations, with the objective of delaying CKD progression and associated complications. The application will support optimisation of care by signposting opportunities for evidence-based interventions (e.g., SGLT2 inhibitors, renin-angiotensin system inhibition) to healthcare providers. The application will also provide participants with tailored recommendations, reminders, educational materials, and collection of patient-reported outcome measures.
Due to the diverse population and range of specialties at St. James's Hospital, the young adult clinic serves distinct subgroups, including individuals with sickle cell anaemia and survivors of cancer and haematological malignancies. These populations will be examined in the context of KDIGO guideline implementation, contributing to a limited international evidence base.
This research evaluates an intervention designed to improve care for adults living with chronic kidney disease.
详细描述
Introduction
The transition from paediatric to adult nephrology care represents a critical period of vulnerability for young people living with chronic kidney disease (CKD). Despite advances in renal replacement therapy and multidisciplinary care (including roll out of tools such as Ready, Steady, Go & Hello7"), morbidity and mortality remain disproportionately high in this population compared with healthy peers1,2. The transition phase is characterised by physiological, psychological, and social changes that challenge consistent engagement with care, resulting in poor treatment adherence, accelerated kidney function decline, and preventable graft loss8,9,10.
Internationally, up to one third of young adults lose a functioning renal transplant within three years of transfer to adult services, regardless of their socioeconomic circumstances8,9.
While end-stage kidney disease (ESKD) thankfully remains rare in young adulthood11, its impact is profound - both for patients, families and for healthcare systems.
Annual cost of haemodialysis in Ireland has been estimated at approximately €80,000 per patient12, underscoring the need for early intervention and adherence to evidence-based management strategies to delay disease progression. Despite this, there remains a persistent gap between established guideline recommendations and real-world implementation, particularly among younger adults transitioning to independent care8,9.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged ≥16 years.
- •Diagnosed with CKD stages 1-
- •Owns a smartphone and is capable of using mobile applications.
- •Provides informed consent.
排除标准
- •Inability to provide informed consent due to a neurocognitive impairment.
- •Age 30 years or older
- •The study will be conducted in the already established SJH Young Adult Clinic, with anticipated expansion coinciding with the co-location Children's Health Ireland (CHI) on site.
研究组 & 干预措施
First exposure to digital application
These patients will receive first exposure to the digital application
干预措施: Use of an electronic digital Application (Device)
second exposure to app
干预措施: Use of an electronic digital Application (Device)
结局指标
主要结局
Change in KDIGO Guideline Adherence Following Exposure to a KDIGO-Aligned Smartphone Application
时间窗: Recruitment is anticipated to occur over the first 6 months of the project. A modified stepped wedge design is anticipated. The entirety of the research is anticipated to be completed within 18 months.
Adherence to KDIGO 2024 Chronic Kidney Disease guideline recommendations will be assessed using documented clinical data. For each component, the proportion of eligible participants receiving recommended care will be assessed and include: ACE inhibitor or ARB prescribed (if indicated) SGLT2 inhibitor prescribed (if indicated) Blood pressure managed to KDIGO targets Lipid-lowering therapy prescribed (if indicated) Lifestyle counselling documented Smoking status assessed and cessation advice provided (if applicable) Annual eGFR measurement Annual urinary albumin-to-creatinine ratio (uACR) measurement Cardiovascular risk assessment documented Each component will be reported as a proportion (%).
次要结局
未报告次要终点
研究者
Susan McAnallen
Consultant Nephrologist
St. James's Hospital, Ireland