ClinicalTrials.gov record NCT07561957

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

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

A Smart Phone Application to Improve Adoption of the 2024 KDIGO CKD Guidelines

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
Age16 years old and older
SexAll
LocationIreland
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This interventional study evaluates whether use of a KDIGO-aligned smartphone application improves alignment with the KDIGO 2024 Chronic Kidney Disease guidelines. It focuses on transition-age young people with CKD and uses a randomized, modified stepped-wedge/crossover approach so groups begin app exposure at different times. The app provides tailored recommendations, reminders, education, and collects patient-reported measures; the study measures documented guideline-aligned care from clinical records.

What it is studying. The study tests whether using a KDIGO-aligned smartphone application changes documented clinician- and system-level adherence to KDIGO 2024 recommendations. Measured components (from the registry) include proportions of eligible patients receiving recommended care such as indicated prescriptions (e.g., ACE inhibitor/ARB or SGLT2 inhibitor), blood pressure managed to KDIGO targets, lipid-lowering therapy when indicated, lifestyle counselling and smoking advice, annual eGFR and urinary albumin-to-creatinine ratio checks, and cardiovascular risk assessment.

What the researchers hope to learn. Scientific goals are to measure whether a digital application can improve implementation of KDIGO 2024 CKD guideline recommendations, to quantify changes in the proportion of patients receiving guideline-recommended care components, and to evaluate app use and guideline implementation in transition-age young adults and certain high-risk subgroups (for example, people with sickle cell disease or cancer-treatment–related CKD). The findings aim to inform digital implementation and scalability of guideline-aligned care.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Device
  • Use of an electronic digital Application

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will be randomly assigned in a crossover design to receive earlier or later exposure to a KDIGO‑aligned smartphone application. They will use the app (receive tailored recommendations, reminders and educational materials) and complete patient‑reported outcome measures. The study team will collect routine clinical data from medical records—such as prescribed medications, blood pressure measurements, annual eGFR and urinary albumin-to-creatinine ratio, and documentation of cardiovascular risk assessment—to assess adherence to KDIGO guideline recommendations. No additional invasive procedures beyond usual clinical care are described in the registry.

How the study is structured. An interventional, randomized study using a modified stepped-wedge crossover design: participants are assigned at random to start app exposure at different times and are followed with no masking (open label). The primary purpose is prevention and outcomes are assessed from clinical records and patient-reported measures over the study period.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The listed sites are in Ireland. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

More on tuberous sclerosis complex

Important dates

Study start
Jan 14, 2026
Primary completion
Jan 1, 2027 (estimated)
Study completion
Jun 1, 2027 (estimated)
Target enrollment
80 participants (estimated)
Last updated on registry
May 1, 2026
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
St. James's Hospital, Ireland
Principal investigator
Susan McAnallen, Consultant Nephrologist
St. James's Hospital, Ireland
Collaborators
  • University of Dublin, Trinity College

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (2)

  • St. James's HospitalRecruiting

    Dublin · Ireland

  • Trinity College DublinRecruiting

    Dublin · Ireland

Terms used on this page · explanations by MedicalUpdates.ai

cohort
A group of people who share a characteristic, such as a diagnosis, and are studied together. 'Prospective' means they are followed forward from enrolment; 'retrospective' means existing records are reviewed.
outcome measures
Something the study measures to judge its results, such as a symptom score, a blood test or survival. Outcomes are grouped as primary, secondary and sometimes exploratory.
informed consent
The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
bone marrow transplant
A procedure that replaces blood-forming cells after high-dose treatment. 'Autologous' uses the person's own cells collected beforehand; 'allogeneic' uses cells from a donor.
life expectancy
Some studies require that, in the investigator's judgement, a participant is likely to live long enough to complete the study period. It is a study requirement, not a prediction about any individual.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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