Clinical trial · Interventional
A Smart Phone Application to Improve Adoption of the 2024 Kidney Disease Improving Global Outcomes (KDIGO) Chronic Kidney Disease (CKD) Guidelines
A Smart Phone Application to Improve Adoption of the 2024 KDIGO CKD Guidelines
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Blood Pressure Control | — | UNRESOLVED | — |
| Cancer Survivors | — | UNRESOLVED | — |
| Chronic Kidney Disease | — | UNRESOLVED | — |
| Congenital Anomalies of the Kidneys and Urinary Tract | — | UNRESOLVED | — |
| Nephrotic Syndrome | — | UNRESOLVED | — |
| Proteinuria | — | UNRESOLVED | — |
| Sickle-Cell Nephropathy | — | UNRESOLVED | — |
| Tuberous Sclerosis Complex | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Use of an electronic digital Application | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- First exposure to digital application
- description
- These patients will receive first exposure to the digital application
- interventionNames
- Device: Use of an electronic digital Application
- type
- ACTIVE_COMPARATOR
- label
- second exposure to app
- interventionNames
- Device: Use of an electronic digital Application
Primary outcomes (1)
- measure
- Change in KDIGO Guideline Adherence Following Exposure to a KDIGO-Aligned Smartphone Application
- timeFrame
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria: * Adults aged ≥16 years. * Diagnosed with CKD stages 1-5. * Owns a smartphone and is capable of using mobile applications. * Provides informed consent. Exclusion Criteria: * 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.
References
Publications (27)
- BACKGROUNDJandoc R, Burden AM, Mamdani M, Levesque LE, Cadarette SM. Interrupted time series analysis in drug utilization research is increasing: systematic review and recommendations. J Clin Epidemiol. 2015 Aug;68(8):950-6. doi: 10.1016/j.jclinepi.2014.12.018. Epub 2015 Mar 11. PMID 25890805
- BACKGROUNDMurray E, Hekler EB, Andersson G, Collins LM, Doherty A, Hollis C, Rivera DE, West R, Wyatt JC. Evaluating Digital Health Interventions: Key Questions and Approaches. Am J Prev Med. 2016 Nov;51(5):843-851. doi: 10.1016/j.amepre.2016.06.008. PMID 27745684
- BACKGROUNDHemming K, Haines TP, Chilton PJ, Girling AJ, Lilford RJ. The stepped wedge cluster randomised trial: rationale, design, analysis, and reporting. BMJ. 2015 Feb 6;350:h391. doi: 10.1136/bmj.h391. No abstract available. PMID 25662947
- BACKGROUNDSandys V, Sexton DJ. Learning Methodological Lessons from Exemplar Studies in Nephrology: PEXIVAS and Sample Size Calculation. Kidney360. 2022 May 20;3(8):1427-1430. doi: 10.34067/KID.0005052021. eCollection 2022 Aug 25. PMID 36176647
- BACKGROUNDSexton DJ, Judge C. Assessments of Generative Artificial Intelligence as Clinical Decision Support Ought to be Incorporated Into Randomized Controlled Trials of Electronic Alerts for Acute Kidney Injury. Mayo Clin Proc Digit Health. 2024 Oct 10;2(4):606-610. doi: 10.1016/j.mcpdig.2024.09.004. eCollection 2024 Dec. No abstract available. PMID 40206527
- BACKGROUNDTuberous Sclerosis Association. Kidneys and Tuberous Sclerosis. 2024. Available from: https://tuberous-sclerosis.org/tsc_affects_the_body/kidneys/
- BACKGROUNDKingswood JC, Bissler JJ, Budde K, Hulbert J, Guay-Woodford L, Sampson JR, Sauter M, Cox J, Patel U, Elmslie F, Anderson C, Zonnenberg BA. Review of the Tuberous Sclerosis Renal Guidelines from the 2012 Consensus Conference: Current Data and Future Study. Nephron. 2016;134(2):51-58. doi: 10.1159/000448293. Epub 2016 Aug 10.