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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-30
SponsorSt. James's Hospital, Ireland

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged ≥16 years.

Diagnosed with CKD stages 1-5.

Owns a smartphone and is capable of using mobile applications.

Provides informed consent.

Disqualifiers

Inability to provide informed consent due to a neurocognitive impairment.

Age 30 years or older

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: First exposure to digital applicationExperimental treatment 1 intervention
Group B: second exposure to appActive comparator 1 intervention

Trial outcomes

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 (%).

Time frame
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.

Secondary outcomes

Other outcomes

Sponsors and contacts

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St. James's Hospital, Ireland

Lead sponsor

University of Dublin, Trinity College

Collaborator