Chronic Kidney DiseaseNCT07561957
A Smart Phone Application to Improve Adoption of the 2024 Kidney Disease Improving Global Outcomes (KDIGO) Chronic Kidney Disease (CKD) Guidelines
A study testing Use of an electronic digital Application in people with Chronic Kidney Disease and Proteinuria, run by St. James's Hospital, Ireland at 2 sites in Ireland.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 30 years
- Conditions the study is for
- Chronic Kidney Disease, Proteinuria, Blood Pressure Control
- What is being tested?
- Use of an electronic digital Application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesIreland
- Study dates
- 14 Jan 2026to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adults aged ≥16 years.
- Diagnosed with CKD stages 1-5.
- Owns a smartphone and is capable of using mobile applications.
- Provides informed consent.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Ireland2 sites, 2 recruiting
- Recruiting
St. James's Hospital
Dublin
- Recruiting
Trinity College Dublin
Dublin
About this study
Official title: A Smart Phone Application to Improve Adoption of the 2024 KDIGO CKD Guidelines
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.
Read more
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.
Read the detailed description
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.
The proposed research aims to address this implementation gap by leveraging digital technology to promote concordance with Kidney Disease: Improving Global Outcomes (KDIGO) guidelines. Through adaptation of the existing St. James's Hospital (SJH) Renal App into a KDIGO-aligned young adult platform, the project seeks to improve engagement, support self-management by empowering young adults, and enhance clinical outcomes. This review situates this proposal within the existing body of evidence, highlighting current knowledge, theoretical frameworks, empirical gaps, and the potential contribution of technology-enabled transitional nephrology.
Challenges in Transitional Nephrology for Young Adults As outlined, transition from paediatric to adult nephrology care is a well known period of clinical risk. Adolescents and young adults (AYA) often experience a lack of continuity of care, reduced clinic attendance, and diminished adherence to medication regimens8,9 with many young adults not appreciating long term health consequences of their decisions during this vulnerable time. The causes of these behaviours are multifactorial, encompassing developmental immaturity, competing psychosocial interests, and a lack of autonomy in healthcare management7.
Physiological factors also contribute to poorer renal outcomes during young adulthood. Puberty and early adulthood are associated with metabolic and haemodynamic changes that can accelerate CKD progression10. Mortality among young adults with ESKD doubles between the ages of 20 and 30 compared with earlier life1, largely attributable to cardiovascular complications2. These findings highlight that transition is not merely a logistical transfer of care but a critical period requiring structured, developmentally appropriate intervention.
International frameworks such as the "Ready, Steady, Go and Hello" transition model7 emphasise a gradual preparation for adult care, beginning early in adolescence and focusing on education, self-efficacy, and continuity. Despite the availability of such frameworks, implementation remains inconsistent, and many services lack resources or training to implement transition effectively.
The establishment of a dedicated Young Adult Clinic at SJH in 2023 exemplifies local recognition of this gap. Early clinical data - 70 attendances within the first year are reflective of an increasing demand and underscore the importance of structured transitional pathways to give young adults living with CKD the best chance.
UNICEF's seminal report The Adolescent Brain: A Second Window of Opportunity13 reinforces that adolescence and early adulthood represent periods of heightened neuroplasticity and receptivity to behavioural change. This developmental insight supports the potential of technology-based, interactive interventions to enhance engagement and self-management in chronic disease.
Evidence-Based Management and the KDIGO Framework The Kidney Disease: Improving Global Outcomes (KDIGO) guidelines are the international benchmark for evidence-based management of CKD. The 2024 update provides detailed recommendations on blood pressure control, lipid management, proteinuria reduction, and newer pharmacological therapies, including sodium-glucose co-transporter-2 (SGLT2) inhibitors14. Implementation of these strategies is known to slow disease progression and improve cardiovascular outcomes, however, adherence to these recommendations in real-world clinical practice remains suboptimal, particularly among younger adults.
KDIGO itself recognises individuals under 25 years as a unique subgroup at high risk for adverse outcomes (Figure 1), partly due to incomplete brain maturation, psychosocial vulnerability, and treatment non-adherence14. The guidelines advocate for patient-centred care and shared decision-making, principles that align closely with the aims of digital self-management interventions. Despite the strong evidence base supporting these clinical strategies, translation into routine practice is inconsistent. Barriers include fragmented care transitions, limited patient understanding, and insufficient integration of behavioural supports into traditional care models.
The Standardised Outcomes in Nephrology-Children and Adolescents (SONG-Kids) initiative15, 16 highlights a further dimension of this challenge: misalignment between clinician and patient priorities. Young people and families often emphasise psychosocial wellbeing, fatigue, and treatment burden, while clinicians can prioritise laboratory outcomes. The development of digital platforms that can simultaneously deliver education, monitor clinical metrics, and support wellbeing may bridge this divide, aligning KDIGO's biomedical focus with the lived experiences of young patients.
Digital Health Interventions in Chronic Kidney Disease Digital health technologies have rapidly evolved as adjuncts to chronic disease management. Evidence indicates that smartphone-based interventions can enhance self-efficacy, improve adherence, and facilitate timely clinical engagement across multiple conditions, including diabetes and hypertension. Within nephrology, the integration of telehealth and mobile applications remains comparatively underexplored, though early studies suggest potential benefits in patient empowerment and clinical outcomes.
The UNICEF13 framework identifies digital engagement as particularly effective for adolescents, who are more receptive to interactive and visual content. This demographic alignment positions mobile health (mHealth) tools as uniquely suited to address behavioural barriers in young adults with CKD.
Studies evaluating digital nephrology interventions are promising, but limited. Pilot trials have demonstrated improved dietary adherence, blood pressure monitoring, and patient knowledge12. However, many interventions remain generic and do not incorporate evidence-based frameworks such as KDIGO. In addition, few are tailored to the developmental and psychosocial needs of transitioning young adults. This represents a significant gap in current nephrology practice and research - a gap the proposed KDIGO-aligned SJH App seeks to fill.
The St. James's Hospital Renal App: A Model for KDIGO Implementation The SJH Nephrology Department has an established digital infrastructure, with an existing Renal App currently supporting over 3,000 patients. Initially developed in 2015 through multidisciplinary collaboration and patient co-design, the App provides access to educational materials, clinical communication, and self-monitoring tools.
A pilot evaluation demonstrated high patient satisfaction: 89% of users reported improved understanding of their condition, and over 80% reported positive behavioural changes, such as healthier diets and increased physical activity. These findings highlight the potential of digital tools to enhance patient engagement and promote lifestyle modification - both central in KDIGO recommendations16.
Recent funding from the Department of Health's, 'Seedling' project within the eHealth Telehealth Programme and the HSE Spark Innovation Programme has enabled integration of KDIGO-based clinical decision support. The App has the capacity to select cohorts, apply KDIGO criteria, identify patients eligible for interventions such as SGLT2 inhibitors, and flag gaps in guideline implementation.
Integration with the Cerner Electronic Health Record and the national renal IT system (eMed) enables real-time data linkage, positioning the platform as a scalable, evidence-based digital solution.
For young adults, the App offers several advantages: electronic appointment management, medication reminders, and tailored educational resources. It aligns closely with Sláintecare objectives by promoting telehealth access, reducing unnecessary hospital visits, and improving system efficiency. It also can provide an infrastructure through which transition-specific content - such as "Ready, Steady, Go and Hello" assessments can be embedded and evaluated.
Subpopulation Considerations and Health Equity The SJH Young Adult Clinic serves a complex patient population, including individuals with rare and treatment-related kidney diseases. These subgroups - such as post-bone marrow transplant survivors, oncology survivors, patients living with sickle cell disease (SCD), and those with tuberous sclerosis complex (TSC) are faced with distinct challenges in disease management and transition. For example, up to 25% of bone marrow transplant survivors develop CKD within a decade of treatment17,18 while renal complications are a leading cause of mortality in adults with TSC21, 22. CKD is also a not uncommon sequelae of childhood cancer, both due to treatment and disease itself19 and with increased use of more personalised tumour treatment (such as checkpoint inhibitors) and improved survival the incidence of CKD and AKI is likely to further increase. Similarly, CKD in patients with SCD reduces life expectancy by 25 - 30 years20.
Despite these high-risk profiles, few studies have examined transitional or digital interventions specifically tailored to these groups and this research has the potential to do so.
Incorporating subgroup-specific educational modules within a digital platform could address this gap, enhancing understanding of disease mechanisms and evidence-based care.
The SJH catchment area's linguistic and cultural diversity necessitates inclusive design, such as multilingual interfaces and accessibility adaptations. These considerations align with global calls for equity, diversity, and inclusion in digital health, ensuring that innovations reduce rather than exacerbate disparities evident in care access and outcomes.
Gaps in Knowledge and Rationale for the Proposed Research Despite a growing recognition of the vulnerabilities inherent in transitional nephrology, several gaps persist in both the literature and clinical practice.
First, there is limited evidence on the effectiveness of structured transition interventions in improving long-term renal outcomes. While models such as "Ready, Steady, Go \& Hello" demonstrate feasibility, robust longitudinal data remain sparse7.
Second, there is a persistent implementation gap between KDIGO guideline recommendations and their uptake in daily practice, particularly in younger patients. Barriers include limited awareness, therapeutic inertia, patient reluctance related to perceived side effects or complexity of regimens as well as prescriber reluctance at a pivotal transition point.
Third, although digital health interventions show potential, few have been co-designed with young adults, grounded in behavioural theory, or evaluated within a KDIGO-aligned framework. Most existing digital Health studies in CKD are descriptive or short-term, focusing on feasibility rather than measurable clinical endpoints such as blood pressure control, proteinuria reduction, or hospitalisation rates.
The proposed research directly addresses these gaps by integrating guideline-driven management, developmental psychology, and digital health innovation into a single intervention. By embedding validated transition tools, readiness assessments, and more accessible education tools within the existing SJH App, the study will evaluate both clinical outcomes and patient-reported measures of engagement and empowerment.
If successful, the App could provide a scalable model for national implementation, enhancing the quality, consistency, and cost-effectiveness of CKD care.
Conclusion The transition from paediatric to adult nephrology care remains one of the most vulnerable periods in the continuum of CKD management, highlighted by KDIGO's recent consensus statement.
Despite clear international guidelines and growing awareness of the psychosocial challenges of young adulthood, clinical outcomes continue to fall short of potential. Evidence suggests that digital health technologies - when appropriately designed, evidence-based, and user-centred, can address many of the barriers to adherence, education, and engagement that undermine successful transition.
The KDIGO 2024 guidelines provide a comprehensive, evidence-based foundation for optimal CKD management, but their implementation in everyday clinical settings remains inconsistent and variable.
The existing SJH Renal App provides a unique opportunity to ensure implementation of KDIGO recommendations through a platform already embedded in clinical practice. By expanding to meet the specific developmental and psychosocial needs of young adults, this project aims to improve self-management, enhance treatment adherence, and ultimately reduce disease progression.
Critically, this research addresses a key gap at the intersection of nephrology, behavioural science, and digital health. It aligns international best practice with local clinical innovation and holds potential for national scalability. If effective, a KDIGO-aligned, smartphone-based intervention could redefine how young adults with CKD transition to adult care, transforming a period of risk into an opportunity for empowerment, prevention, and sustained health.
- Conditions
- Chronic Kidney Disease, Proteinuria, Blood Pressure Control, Congenital Anomalies of the Kidneys and Urinary Tract, Nephrotic Syndrome, Sickle-Cell Nephropathy
- Being tested
- Use of an electronic digital Application
- Keywords
- Digital Interventions, Kidney Disease, Paediatric Nephrology, Transitional Nephrology
- Medical subject headings
- Renal Insufficiency, Chronic, Proteinuria, Nephrotic Syndrome, Tuberous Sclerosis, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of an electronic digital ApplicationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| First exposure to digital application | Experimental | These patients will receive first exposure to the digital application Receives: Device: Use of an electronic digital Application |
| second exposure to app | Active comparator | Not described Receives: Device: Use of an electronic digital Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (%).
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start14 Jan 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. James's Hospital, Ireland
- Sponsor type
- University, hospital or other
- Collaborators
- University of Dublin, Trinity College
- Responsible party
- Principal investigator, Susan McAnallen, St. James's Hospital, Ireland
- Investigators
- Donal Sexton, MB BCh BAO BSc, MRCPI, MD, PhD, Study director, St. James's Hospital, IrelandSusan McAnallen, MB BCh BAO, MRCPI, ESENeph, Principal investigator, St. James's Hospital, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07561957
- Sponsor's protocol ID
- SJHJREC4528no226
- Status last verified
- Dec 2025
- First submitted
- 31 Dec 2025
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual data will be maintained within our research team. This includes a senior nephrology nurse specialist and medical staff, which may include medical students. Within this core research group, patient demographics - name, email, telephone number, Address, Gender, Date of Birth may be reviewed. The data will be pseudonymized within our department and no personal data will be shared beyond our research group. Pseudonymized data may be shared with researchers within Trinity College Dublin to help with the analysis. This would be in conjunction with our approved Data Protection Impact Assessment and General Data Protection Regulation.
Publications
Jandoc 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.
PubMed 25890805Murray 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.
PubMed 27745684Hemming 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.
PubMed 25662947Sandys 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.
PubMed 36176647Sexton 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.
PubMed 40206527Tuberous Sclerosis Association. Kidneys and Tuberous Sclerosis. 2024. Available from: https://tuberous-sclerosis.org/tsc_affects_the_body/kidneys/
Kingswood 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.
PubMed 27504842Aeddula YNR, Bardhan M, Baradhi KM. Renal manifestations of sickle cell disease. StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 [updated 2022 Sep 12]. Available from: https://www.ncbi.nlm.nih.gov/books/NBK526017/
Skinner R. Late renal toxicity of treatment for childhood malignancy: risk factors, long-term outcomes, and surveillance. Pediatr Nephrol. 2018 Feb;33(2):215-225. doi: 10.1007/s00467-017-3662-z. Epub 2017 Apr 22.
PubMed 28434047Detaille T, Anslot C, de Clety SC. Acute kidney injury in paediatric bone marrow patients. Acta Clin Belg. 2007;62 Suppl 2:401-4. doi: 10.1179/acb.2007.090.
PubMed 18284009Jo T, Arai Y, Kondo T, Kitano T, Hishizawa M, Yamashita K, Takaori-Kondo A. Chronic Kidney Disease in Long-Term Survivors after Allogeneic Hematopoietic Stem Cell Transplantation: Retrospective Analysis at a Single Institute. Biol Blood Marrow Transplant. 2017 Dec;23(12):2159-2165. doi: 10.1016/j.bbmt.2017.08.016. Epub 2017 Aug 16.
PubMed 28822830Hanson CS, Craig JC, Logeman C, Sinha A, Dart A, Eddy AA, Guha C, Gipson DS, Bockenhauer D, Yap HK, Groothoff J, Zappitelli M, Webb NJA, Alexander SI, Furth SL, Samuel S, Neu A, Viecelli AK, Ju A, Sharma A, Au EH, Desmond H, Shen JI, Manera KE, Azukaitis K, Dunn L, Carter SA, Gutman T, Cho Y, Walker A, Francis A, Sanchez-Kazi C, Kausman J, Pearl M, Benador N, Sahney S, Tong A; SONG-Kids consensus workshops investigators. Establishing core outcome domains in pediatric kidney disease: report of the Standardized Outcomes in Nephrology-Children and Adolescents (SONG-KIDS) consensus workshops. Kidney Int. 2020 Sep;98(3):553-565. doi: 10.1016/j.kint.2020.05.054. Epub 2020 Jul 4.
PubMed 32628942Tong A, Samuel S, Zappitelli M, Dart A, Furth S, Eddy A, Groothoff J, Webb NJ, Yap HK, Bockenhauer D, Sinha A, Alexander SI, Goldstein SL, Gipson DS, Hanson CS, Evangelidis N, Crowe S, Harris T, Hemmelgarn BR, Manns B, Gill J, Tugwell P, Van Biesen W, Wheeler DC, Winkelmayer WC, Craig JC; SONG-Kids Investigators. Standardised Outcomes in Nephrology-Children and Adolescents (SONG-Kids): a protocol for establishing a core outcome set for children with chronic kidney disease. Trials. 2016 Aug 12;17:401. doi: 10.1186/s13063-016-1528-5.
PubMed 27519274Levin A, Ahmed SB, Carrero JJ, Foster B, Francis A, Hall RK, Herrington WG, Hill G, Inker LA, Kazancioglu R, Lamb E, Lin P, Madero M, McIntyre N, Morrow K, Roberts G, Sabanayagam D, Schaeffner E, Shlipak M, Shroff R, Tangri N, Thanachayanont T, Ulasi I, Wong G, Yang CW, Zhang L, Robinson KA, Wilson L, Wilson RF, Kasiske BL, Cheung M, Earley A, Stevens PE. Executive summary of the KDIGO 2024 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease: known knowns and known unknowns. Kidney Int. 2024 Apr;105(4):684-701. doi: 10.1016/j.kint.2023.10.016.
PubMed 38519239Balvin N, Banati P. The Adolescent Brain: A Second Window of Opportunity - A Compendium. Florence: UNICEF Office of Research - Innocenti; 2017. Available from: https://www.unicef-irc.org/publications/993-the-adolescent-brain-a-second-window-of-opportunity-a-compendium.html
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Smart Phone Application to Improve Adoption of the 2024 KDIGO CKD Guidelines
- ClinicalTrials.gov ID
- NCT07561957
- Acronym / sponsor ID
- SJHJREC4528no226
- Conditions
- Chronic Kidney Disease, Proteinuria, Blood Pressure Control, Congenital Anomalies of the Kidneys and Urinary Tract, Nephrotic Syndrome, Sickle-Cell Nephropathy
- Keywords
- Digital Interventions, Kidney Disease, Paediatric Nephrology, Transitional Nephrology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- St. James's Hospital, IrelandUniversity, hospital or other
- Collaborators
- University of Dublin, Trinity College
- Study start
- 14 Jan 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 1 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
The proposed research aims to address this implementation gap by leveraging digital technology to promote concordance with Kidney Disease: Improving Global Outcomes (KDIGO) guidelines. Through adaptation of the existing St. James's Hospital (SJH) Renal App into a KDIGO-aligned young adult platform, the project seeks to improve engagement, support self-management by empowering young adults, and enhance clinical outcomes. This review situates this proposal within the existing body of evidence, highlighting current knowledge, theoretical frameworks, empirical gaps, and the potential contribution of technology-enabled transitional nephrology.
Challenges in Transitional Nephrology for Young Adults As outlined, transition from paediatric to adult nephrology care is a well known period of clinical risk. Adolescents and young adults (AYA) often experience a lack of continuity of care, reduced clinic attendance, and diminished adherence to medication regimens8,9 with many young adults not appreciating long term health consequences of their decisions during this vulnerable time. The causes of these behaviours are multifactorial, encompassing developmental immaturity, competing psychosocial interests, and a lack of autonomy in healthcare management7.
Physiological factors also contribute to poorer renal outcomes during young adulthood. Puberty and early adulthood are associated with metabolic and haemodynamic changes that can accelerate CKD progression10. Mortality among young adults with ESKD doubles between the ages of 20 and 30 compared with earlier life1, largely attributable to cardiovascular complications2. These findings highlight that transition is not merely a logistical transfer of care but a critical period requiring structured, developmentally appropriate intervention.
International frameworks such as the "Ready, Steady, Go and Hello" transition model7 emphasise a gradual preparation for adult care, beginning early in adolescence and focusing on education, self-efficacy, and continuity. Despite the availability of such frameworks, implementation remains inconsistent, and many services lack resources or training to implement transition effectively.
The establishment of a dedicated Young Adult Clinic at SJH in 2023 exemplifies local recognition of this gap. Early clinical data - 70 attendances within the first year are reflective of an increasing demand and underscore the importance of structured transitional pathways to give young adults living with CKD the best chance.
UNICEF's seminal report The Adolescent Brain: A Second Window of Opportunity13 reinforces that adolescence and early adulthood represent periods of heightened neuroplasticity and receptivity to behavioural change. This developmental insight supports the potential of technology-based, interactive interventions to enhance engagement and self-management in chronic disease.
Evidence-Based Management and the KDIGO Framework The Kidney Disease: Improving Global Outcomes (KDIGO) guidelines are the international benchmark for evidence-based management of CKD. The 2024 update provides detailed recommendations on blood pressure control, lipid management, proteinuria reduction, and newer pharmacological therapies, including sodium-glucose co-transporter-2 (SGLT2) inhibitors14. Implementation of these strategies is known to slow disease progression and improve cardiovascular outcomes, however, adherence to these recommendations in real-world clinical practice remains suboptimal, particularly among younger adults.
KDIGO itself recognises individuals under 25 years as a unique subgroup at high risk for adverse outcomes (Figure 1), partly due to incomplete brain maturation, psychosocial vulnerability, and treatment non-adherence14. The guidelines advocate for patient-centred care and shared decision-making, principles that align closely with the aims of digital self-management interventions. Despite the strong evidence base supporting these clinical strategies, translation into routine practice is inconsistent. Barriers include fragmented care transitions, limited patient understanding, and insufficient integration of behavioural supports into traditional care models.
The Standardised Outcomes in Nephrology-Children and Adolescents (SONG-Kids) initiative15, 16 highlights a further dimension of this challenge: misalignment between clinician and patient priorities. Young people and families often emphasise psychosocial wellbeing, fatigue, and treatment burden, while clinicians can prioritise laboratory outcomes. The development of digital platforms that can simultaneously deliver education, monitor clinical metrics, and support wellbeing may bridge this divide, aligning KDIGO's biomedical focus with the lived experiences of young patients.
Digital Health Interventions in Chronic Kidney Disease Digital health technologies have rapidly evolved as adjuncts to chronic disease management. Evidence indicates that smartphone-based interventions can enhance self-efficacy, improve adherence, and facilitate timely clinical engagement across multiple conditions, including diabetes and hypertension. Within nephrology, the integration of telehealth and mobile applications remains comparatively underexplored, though early studies suggest potential benefits in patient empowerment and clinical outcomes.
The UNICEF13 framework identifies digital engagement as particularly effective for adolescents, who are more receptive to interactive and visual content. This demographic alignment positions mobile health (mHealth) tools as uniquely suited to address behavioural barriers in young adults with CKD.
Studies evaluating digital nephrology interventions are promising, but limited. Pilot trials have demonstrated improved dietary adherence, blood pressure monitoring, and patient knowledge12. However, many interventions remain generic and do not incorporate evidence-based frameworks such as KDIGO. In addition, few are tailored to the developmental and psychosocial needs of transitioning young adults. This represents a significant gap in current nephrology practice and research - a gap the proposed KDIGO-aligned SJH App seeks to fill.
The St. James's Hospital Renal App: A Model for KDIGO Implementation The SJH Nephrology Department has an established digital infrastructure, with an existing Renal App currently supporting over 3,000 patients. Initially developed in 2015 through multidisciplinary collaboration and patient co-design, the App provides access to educational materials, clinical communication, and self-monitoring tools.
A pilot evaluation demonstrated high patient satisfaction: 89% of users reported improved understanding of their condition, and over 80% reported positive behavioural changes, such as healthier diets and increased physical activity. These findings highlight the potential of digital tools to enhance patient engagement and promote lifestyle modification - both central in KDIGO recommendations16.
Recent funding from the Department of Health's, 'Seedling' project within the eHealth Telehealth Programme and the HSE Spark Innovation Programme has enabled integration of KDIGO-based clinical decision support. The App has the capacity to select cohorts, apply KDIGO criteria, identify patients eligible for interventions such as SGLT2 inhibitors, and flag gaps in guideline implementation.
Integration with the Cerner Electronic Health Record and the national renal IT system (eMed) enables real-time data linkage, positioning the platform as a scalable, evidence-based digital solution.
For young adults, the App offers several advantages: electronic appointment management, medication reminders, and tailored educational resources. It aligns closely with Sláintecare objectives by promoting telehealth access, reducing unnecessary hospital visits, and improving system efficiency. It also can provide an infrastructure through which transition-specific content - such as "Ready, Steady, Go and Hello" assessments can be embedded and evaluated.
Subpopulation Considerations and Health Equity The SJH Young Adult Clinic serves a complex patient population, including individuals with rare and treatment-related kidney diseases. These subgroups - such as post-bone marrow transplant survivors, oncology survivors, patients living with sickle cell disease (SCD), and those with tuberous sclerosis complex (TSC) are faced with distinct challenges in disease management and transition. For example, up to 25% of bone marrow transplant survivors develop CKD within a decade of treatment17,18 while renal complications are a leading cause of mortality in adults with TSC21, 22. CKD is also a not uncommon sequelae of childhood cancer, both due to treatment and disease itself19 and with increased use of more personalised tumour treatment (such as checkpoint inhibitors) and improved survival the incidence of CKD and AKI is likely to further increase. Similarly, CKD in patients with SCD reduces life expectancy by 25 - 30 years20.
Despite these high-risk profiles, few studies have examined transitional or digital interventions specifically tailored to these groups and this research has the potential to do so.
Incorporating subgroup-specific educational modules within a digital platform could address this gap, enhancing understanding of disease mechanisms and evidence-based care.
The SJH catchment area's linguistic and cultural diversity necessitates inclusive design, such as multilingual interfaces and accessibility adaptations. These considerations align with global calls for equity, diversity, and inclusion in digital health, ensuring that innovations reduce rather than exacerbate disparities evident in care access and outcomes.
Gaps in Knowledge and Rationale for the Proposed Research Despite a growing recognition of the vulnerabilities inherent in transitional nephrology, several gaps persist in both the literature and clinical practice.
First, there is limited evidence on the effectiveness of structured transition interventions in improving long-term renal outcomes. While models such as "Ready, Steady, Go \& Hello" demonstrate feasibility, robust longitudinal data remain sparse7.
Second, there is a persistent implementation gap between KDIGO guideline recommendations and their uptake in daily practice, particularly in younger patients. Barriers include limited awareness, therapeutic inertia, patient reluctance related to perceived side effects or complexity of regimens as well as prescriber reluctance at a pivotal transition point.
Third, although digital health interventions show potential, few have been co-designed with young adults, grounded in behavioural theory, or evaluated within a KDIGO-aligned framework. Most existing digital Health studies in CKD are descriptive or short-term, focusing on feasibility rather than measurable clinical endpoints such as blood pressure control, proteinuria reduction, or hospitalisation rates.
The proposed research directly addresses these gaps by integrating guideline-driven management, developmental psychology, and digital health innovation into a single intervention. By embedding validated transition tools, readiness assessments, and more accessible education tools within the existing SJH App, the study will evaluate both clinical outcomes and patient-reported measures of engagement and empowerment.
If successful, the App could provide a scalable model for national implementation, enhancing the quality, consistency, and cost-effectiveness of CKD care.
Conclusion The transition from paediatric to adult nephrology care remains one of the most vulnerable periods in the continuum of CKD management, highlighted by KDIGO's recent consensus statement.
Despite clear international guidelines and growing awareness of the psychosocial challenges of young adulthood, clinical outcomes continue to fall short of potential. Evidence suggests that digital health technologies - when appropriately designed, evidence-based, and user-centred, can address many of the barriers to adherence, education, and engagement that undermine successful transition.
The KDIGO 2024 guidelines provide a comprehensive, evidence-based foundation for optimal CKD management, but their implementation in everyday clinical settings remains inconsistent and variable.
The existing SJH Renal App provides a unique opportunity to ensure implementation of KDIGO recommendations through a platform already embedded in clinical practice. By expanding to meet the specific developmental and psychosocial needs of young adults, this project aims to improve self-management, enhance treatment adherence, and ultimately reduce disease progression.
Critically, this research addresses a key gap at the intersection of nephrology, behavioural science, and digital health. It aligns international best practice with local clinical innovation and holds potential for national scalability. If effective, a KDIGO-aligned, smartphone-based intervention could redefine how young adults with CKD transition to adult care, transforming a period of risk into an opportunity for empowerment, prevention, and sustained health.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| First exposure to digital application | Experimental | Device: Use of an electronic digital ApplicationThese patients will receive first exposure to the digital application |
| second exposure to app | Active comparator | Device: Use of an electronic digital Application |
Who may qualify
- Ages
- 16 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Adults aged ≥16 years.
- Diagnosed with CKD stages 1-5.
- Owns a smartphone and is capable of using mobile applications.
- Provides informed consent.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of an electronic digital ApplicationThis 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. | Device | First exposure to digital application, second exposure to app |
Primary outcome
Change in KDIGO Guideline Adherence Following Exposure to a KDIGO-Aligned Smartphone Application
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.
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 (%).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Background: PubMed 25890805Jandoc 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.
- Background: PubMed 27745684Murray 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.
- Background: PubMed 25662947Hemming 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.
- Background: PubMed 36176647Sandys 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.
- Background: PubMed 40206527Sexton 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.
- BackgroundTuberous Sclerosis Association. Kidneys and Tuberous Sclerosis. 2024. Available from: https://tuberous-sclerosis.org/tsc_affects_the_body/kidneys/
- Background: PubMed 27504842Kingswood 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.
- BackgroundAeddula YNR, Bardhan M, Baradhi KM. Renal manifestations of sickle cell disease. StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 [updated 2022 Sep 12]. Available from: https://www.ncbi.nlm.nih.gov/books/NBK526017/
- Background: PubMed 28434047Skinner R. Late renal toxicity of treatment for childhood malignancy: risk factors, long-term outcomes, and surveillance. Pediatr Nephrol. 2018 Feb;33(2):215-225. doi: 10.1007/s00467-017-3662-z. Epub 2017 Apr 22.
- Background: PubMed 18284009Detaille T, Anslot C, de Clety SC. Acute kidney injury in paediatric bone marrow patients. Acta Clin Belg. 2007;62 Suppl 2:401-4. doi: 10.1179/acb.2007.090.
- Background: PubMed 28822830Jo T, Arai Y, Kondo T, Kitano T, Hishizawa M, Yamashita K, Takaori-Kondo A. Chronic Kidney Disease in Long-Term Survivors after Allogeneic Hematopoietic Stem Cell Transplantation: Retrospective Analysis at a Single Institute. Biol Blood Marrow Transplant. 2017 Dec;23(12):2159-2165. doi: 10.1016/j.bbmt.2017.08.016. Epub 2017 Aug 16.
- Background: PubMed 32628942Hanson CS, Craig JC, Logeman C, Sinha A, Dart A, Eddy AA, Guha C, Gipson DS, Bockenhauer D, Yap HK, Groothoff J, Zappitelli M, Webb NJA, Alexander SI, Furth SL, Samuel S, Neu A, Viecelli AK, Ju A, Sharma A, Au EH, Desmond H, Shen JI, Manera KE, Azukaitis K, Dunn L, Carter SA, Gutman T, Cho Y, Walker A, Francis A, Sanchez-Kazi C, Kausman J, Pearl M, Benador N, Sahney S, Tong A; SONG-Kids consensus workshops investigators. Establishing core outcome domains in pediatric kidney disease: report of the Standardized Outcomes in Nephrology-Children and Adolescents (SONG-KIDS) consensus workshops. Kidney Int. 2020 Sep;98(3):553-565. doi: 10.1016/j.kint.2020.05.054. Epub 2020 Jul 4.
- Individual participant dataSharing planned: Yes. Individual data will be maintained within our research team. This includes a senior nephrology nurse specialist and medical staff, which may include medical students. Within this core research group, patient demographics - name, email, telephone number, Address, Gender, Date of Birth may be reviewed. The data will be pseudonymized within our department and no personal data will be shared beyond our research group. Pseudonymized data may be shared with researchers within Trinity College Dublin to help with the analysis. This would be in conjunction with our approved Data Protection Impact Assessment and General Data Protection Regulation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Donal Sexton, MB BCh BAO BSc, MRCPI, MD, PhD study director
St. James's Hospital, Ireland
Susan McAnallen, MB BCh BAO, MRCPI, ESENeph principal investigator
St. James's Hospital, Ireland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of an electronic digital Application in people with Chronic Kidney Disease and Proteinuria, run by St. James's Hospital, Ireland at 2 sites in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Susan M McAnallen, MB BCh BAO (014103000, sumcanallen@stjames.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in KDIGO Guideline Adherence Following Exposure to a KDIGO-Aligned Smartphone Application (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07561957, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.