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

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.

Study Overview

• Status: Recruiting
• Conditions: Proteinuria; Chronic Kidney Disease; Tuberous Sclerosis Complex; Nephrotic Syndrome; Cancer Survivors; Blood Pressure Control; Congenital Anomalies of the Kidneys and Urinary Tract; Sickle-Cell Nephropathy
• Intervention / Treatment: Device: Use of an electronic digital Application

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 Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr Susan M McAnallen, MB BCh BAO; Phone Number: 014103000; Email: sumcanallen@stjames.ie
• Study Contact Backup: Name: Prof Donal J Sexton, MB BCh BAO BSc, MRCPI, MD, PhD; Phone Number: 014103000; Email: dsexton@stjames.ie

Study Locations

• Ireland
  • Dublin, Ireland
    • Recruiting
    • St. James's Hospital
  • Dublin, Ireland
    • Recruiting
    • Trinity College Dublin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: First exposure to digital application; These patients will receive first exposure to the digital application	Device: Use of an electronic digital Application; 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.
Active Comparator: second exposure to app	Device: Use of an electronic digital Application; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in KDIGO Guideline Adherence Following Exposure to a KDIGO-Aligned Smartphone Application	Adherence to KDIGO 2024 Chronic Kidney Disease guideline recommendations will be assessed using documented clinical data. For each component, the proportion of eligible participants receiving recommended care will be assessed and include: ACE inhibitor or ARB prescribed (if indicated) SGLT2 inhibitor prescribed (if indicated) Blood pressure managed to KDIGO targets Lipid-lowering therapy prescribed (if indicated) Lifestyle counselling documented Smoking status assessed and cessation advice provided (if applicable) Annual eGFR measurement Annual urinary albumin-to-creatinine ratio (uACR) measurement Cardiovascular risk assessment documented Each component will be reported as a proportion (%).	Recruitment is anticipated to occur over the first 6 months of the project. A modified stepped wedge design is anticipated. The entirety of the research is anticipated to be completed within 18 months.

Collaborators and Investigators

• Sponsor: St. James's Hospital, Ireland
• Collaborators: University of Dublin, Trinity College
• Investigators: Study Director: Donal Sexton, MB BCh BAO BSc, MRCPI, MD, PhD, St. James's Hospital, Ireland; Principal Investigator: Susan McAnallen, MB BCh BAO, MRCPI, ESENeph, St. James's Hospital, Ireland

Publications and helpful links

General Publications

• Jandoc R, Burden AM, Mamdani M, Lévesque LE, Cadarette SM. Interrupted time series analysis in drug utilization research is increasing: Systematic review and recommendations. J Clin Epidemiol. 2015;68(8):950-956
• Murray E, Hekler EB, Andersson G, et al. Evaluating Digital Health Interventions: Key Questions and Approaches. Am J Prev Med. 2016;51(5):843-851
• Hemming K, Haines TP, Chilton PJ, Girling AJ, Lilford RJ. The stepped wedge cluster randomised trial: rationale, design, analysis, and reporting. BMJ. 2015;350:h391
• Sexton DJ, Sandys V. Learning Methodological Lessons from Exemplar Studies in Nephrology: PEXIVAS and Sample Size Calculation.
• Sexton 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 Clinic Proceedings: Digital Health, Volume 2, Issue 4, 2024, Pages 606-610
• Tuberous 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, et al. Review of the tuberous sclerosis renal guidelines from the 2012 consensus conference: current data and future study. Nephron. 2016;134(2):51-8.
• Aeddula 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. 2017;33(2):215-25.
• Detaille T, Anslot C, de Cléty SC. Acute kidney injury in paediatric bone marrow patients. Acta Clin Belg. 2007;62 Suppl 2:401-4.
• Jo TX, Arai Y, Kondo T, et al. Chronic kidney disease in long-term survivors after allogeneic hematopoietic stem cell transplantation: retrospective analysis at a single institute. Biol Blood Marrow Transplant. 2017;23(12):2159-65.
• Hanson CS, Craig JC, Logeman C, et al. Establishing core outcome domains in paediatric kidney disease: report of the Standardized Outcomes in Nephrology-Children and Adolescents (SONG-Kids) consensus workshops. Kidney Int. 2020;98(3):553-65.
• Tong A, Samuel S, Zappitelli M, et al. 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;17:401.
• Levin A, Ahmed SB, Carrero JJ, et al. 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;105(4):684-701.
• Balvin 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
• European Kidney Health Alliance. European Recommendations for Sustainable Kidney Care. Brussels: EKHA; 2015.
• UK Renal Registry. UK Renal Registry 23rd Annual Report - Data to 31/12/2019. Bristol (UK): Renal Association; 2021.
• Ardissino G, Testa S, Daccò V, et al. Puberty is associated with increased deterioration of renal function in patients with CKD: data from the ItalKid Project. Arch Dis Child. 2012;97(10):885-8
• O'Donoghue DJ. Mind the gap: Transitioning from child to adult kidney services. The Lancet Kidney Campaign. 2022 Jun
• Harden PN, Walsh G, Bandler N, Bradley S, Lonsdale D, Taylor J, et al. Bridging the gap: an integrated paediatric to adult clinical service for young adults with kidney failure. BMJ. 2012;344:e3718.
• Nagra A, McGinnity PM, Davis N, Salmon AP. Implementing transition: Ready Steady Go. Arch Dis Child Educ Pract Ed. 2015;100(6):313-20.
• Department of Health. Sláintecare Action Plan 2023. 2023 Mar 28. Available from: https://www.gov.ie/en/publication/49c5c-slaintecare-action-plan-2023/
• Taba M, Allen TB, Caldwell PHY, et al. Adolescents' self-efficacy and digital health literacy: a cross-sectional mixed methods study. BMC Public Health. 2022;22(1):1223. 6. Department of Health. Sláintecare Action Plan 2023. 2023 Mar 28. Available from: https://www.gov.ie/en/publication/49c5c-slaintecare-action-plan-2023/
• Radovic A, McCarty CA, Katzman K, Richardson LP. Adolescents' perspectives on using technology for health: qualitative study. JMIR Pediatr Parent. 2018;1(1):e2.
• Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. KDIGO 2024 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease. Kidney Int Suppl. 2024;105(4S):S117-314.
• Gotta V, Tancev G, Marsenic O, Vogt J, Pfister M. Identifying key predictors of mortality in young patients on chronic haemodialysis-a machine learning approach. Nephrol Dial Transplant. 2020;36(3):519-28.
• McDonald SP, Craig JC. Long-term survival of children with end-stage renal disease. N Engl J Med. 2004;350(26):2654-62.

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: December 31, 2025
• First Submitted That Met QC Criteria: April 24, 2026
• First Posted (Actual): May 1, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 24, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Kidney Disease; Digital Interventions; Paediatric Nephrology; Transitional Nephrology
• Additional Relevant MeSH Terms: Urogenital Diseases; Nervous System Diseases; Pathologic Processes; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Genetic Diseases, Inborn; Urination Disorders; Urological Manifestations; Neurodegenerative Diseases; Renal Insufficiency; Congenital Abnormalities; Heredodegenerative Disorders, Nervous System; Neoplastic Syndromes, Hereditary; Neurocutaneous Syndromes; Hamartoma; Neoplasms, Multiple Primary; Malformations of Cortical Development, Group I; Malformations of Cortical Development; Nervous System Malformations; Nephrosis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Tuberous Sclerosis; Kidney Diseases; Renal Insufficiency, Chronic; Proteinuria; Nephrotic Syndrome
• Other Study ID Numbers: SJHJREC4528no226

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

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.

• IPD Sharing Time Frame: No data will be shared until recruitment begins (hoped to be early 2026). The research is intended to be completed within 18months - 2 years and it is not anticipated that data would be kept beyond this point.

IPD Sharing Access Criteria

Only the core research group - including consultants, specialist nurses and potentially one or two supervised medical students will be able to access the personal data for the purposes of this study.

Pseudonymized data may be shared with statistics colleagues within Trinity College Dublin.

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No