A Smart Phone Application to Improve Adoption of the 2024 Kidney Disease Improving Global Outcomes (KDIGO) Chronic Kidney Disease (CKD) Guidelines

NCT07561957 | Recruiting DMC

• 1 other identifier: SJHJREC4528no226
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Nephrotic Syndrome; Sickle-Cell Nephropathy; Tuberous Sclerosis Complex; Cancer Survivors; Chronic Kidney Disease; Proteinuria; Blood Pressure Control; Congenital Anomalies of the Kidneys and Urinary Tract

Keywords

Digital Interventions; Kidney Disease; Paediatric Nephrology; Transitional Nephrology

Outcome Measures

Primary Outcomes (1)

• Change in KDIGO Guideline Adherence Following Exposure to a KDIGO-Aligned Smartphone Application

  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 (%).

  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.

Study Arms (2)

First exposure to digital application

EXPERIMENTAL

These patients will receive first exposure to the digital application

Device: Use of an electronic digital Application

second exposure to app

ACTIVE COMPARATOR

Device: Use of an electronic digital Application

Interventions

Use of an electronic digital Application DEVICE

This intervention will plans to use a modified step wedge approach to ascertain if engagement with a digital application can improve alignment with the Kidney Disease Improving Global Outcomes (KDIGO) Guidelines or not. It is unique in that our hospital has recently established a dedicated Young Adult Clinic in the context of imminent colocation of Children's Health Ireland on site.

First exposure to digital application; second exposure to app

Eligibility Criteria

• Age: 16 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Adults aged ≥16 years.
• Diagnosed with CKD stages 1-5.
• Owns a smartphone and is capable of using mobile applications.
• Provides informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Dublin, Trinity College: collaborator
• St. James's Hospital, Ireland: lead

Study Sites (2)

St. James's Hospital

Dublin, Ireland

RECRUITING

Trinity College Dublin

Dublin, Ireland

RECRUITING

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MeSH Terms

Conditions

Renal Insufficiency, Chronic; Proteinuria; Nephrotic Syndrome; Tuberous Sclerosis; Kidney Diseases

Condition Hierarchy (Ancestors)

Renal Insufficiency; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urological Manifestations; Signs and Symptoms; Nephrosis; Hamartoma; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Malformations of Cortical Development, Group I; Malformations of Cortical Development; Nervous System Malformations; Nervous System Diseases; Neurocutaneous Syndromes; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Study Officials

• Donal Sexton, MB BCh BAO BSc, MRCPI, MD, PhD

  St. James's Hospital, Ireland

  STUDY DIRECTOR

• Susan McAnallen, MB BCh BAO, MRCPI, ESENeph

  St. James's Hospital, Ireland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Susan M McAnallen, MB BCh BAO

CONTACT

014103000; sumcanallen@stjames.ie

Prof Donal J Sexton, MB BCh BAO BSc, MRCPI, MD, PhD

CONTACT

014103000; dsexton@stjames.ie

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Nephrologist

Model Details: On consideration and discussion with the wider team and colleagues in the institute of Population Health and the Department of Biostatistics at the School of Medicine, Trinity College Dublin, we aim to adopt a modified stepped wedged randomisation approach as a pilot scale study and blind the data analysis. Participants will be randomised to vary the duration prior to and after exposure to the App at different time points throughout the study period.

Study Record Dates

• First Submitted: December 31, 2025
• First Posted: May 1, 2026
• Study Start: January 14, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: No data will be shared until recruitment begins (hoped to be early 2026). The research is intended to be completed within 18months - 2 years and it is not anticipated that data would be kept beyond this point.
• Access Criteria: Only the core research group - including consultants, specialist nurses and potentially one or two supervised medical students will be able to access the personal data for the purposes of this study. Pseudonymized data may be shared with statistics colleagues within Trinity College Dublin.

Locations

IE (2)