Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
RECRUITING
Total Enrollment
100 participants
Study Classification
OBSERVATIONAL
Study Start Date
2023-06-20
Study Completion Date
2024-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Research goals:
To explore the views and baseline knowledge of children and young people (CYP) with CKD and their caregivers to develop effective phosphate educational materials (PEM), adapted for age, and acknowledging different learning styles
To explore the views and baseline knowledge of children and young people (CYP) with CKD and their caregivers to develop effective phosphate educational materials (PEM), adapted for age, and acknowledging different learning styles
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Prevention of Renal Failure in Children With Urinary Tract Infections
NCT00316043
Urinary Tract Infections
COMPLETED
NA
Ultrasonographic Versus Renographic Parameters in Prediction of Early Success After Pyeloplasty in Children
NCT03939091
Pyeloplasty
Pediatrics
Renogram
+1 more
UNKNOWN
NA
Impact of Chronic Kidney Disease on Postural Stability in Children
NCT04411927
Chronic Kidney Diseases
COMPLETED
Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics Study of Tolvaptan in Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload
NCT03255226
Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload
COMPLETED
PHASE3
Hypertension in Children and Young People at Risk of Autosomal Dominant Polycystic Kidney Disease
NCT07260071
Autosomal Dominant Polycystic Kidney Disease (ADPKD
RECRUITING
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Background and Rationale
Background:
CKD mineral and bone disorder (CKD-MBD) can lead to debilitating skeletal complications, fractures, poor growth and vascular calcification, and remains one of the most challenging areas of CKD management. Serum phosphate and related measures of MBD, including Fibroblast Growth Factor 23 (FGF23) and parathyroid hormone (PTH), are raised in CKD and causally associated with adverse outcomes including vascular damage and calcification, left ventricular hypertrophy and renal bone disease. Reduction in dietary phosphate intake and regular intake of phosphate binder medications is required for optimal phosphate control but is extremely challenging, leading to poor adherence in a significant number of patients. The International Paediatric Dialysis Network Registry reports that in over 900 children on PD, 45% had high serum phosphate levels, with the prevalence of hyperphosphataemia increasing to 80% in adolescents.
Paediatric renal dietitians are responsible for educating families about dietary phosphate intake: limiting foods high in organic phosphate as well as avoiding the "hidden" inorganic phosphate from food additives, without compromising nutritional adequacy. Phosphate educational material (PEM) have been developed primarily for adults but dietary adherence is less than 50%, and is similarly low in children. Not only must children understand how to reduce their dietary phosphate intake but also how to use phosphate binder medication to reduce phosphate absorption from their foods and drinks. Adherence to binder medication is typically low due to poor palatability and the complexity of administration. Phosphate binder adherence is compounded by issues of access at school and psychological impacts, particularly during adolescence.
Educational interventions have mainly focused on the adult haemodialysis population with short-term follow-up. There are eight randomised controlled trials (RCTs) of using an educational intervention in adults with CKD or on dialysis which conclude that such interventions increased adherence compared to no intervention or routine standard care. A meta-analysis of adult RCTs also reported that educational initiatives can improve serum phosphate levels. Adult data has limited applicability to the management of hyperphosphataemia in CYP, as understanding and compliance with dietary restrictions will often be a joint responsibility between the CYP and their caregivers. There are very few studies assessing the success of educational programmes in paediatrics but, despite some showing an improvement in knowledge scores, interventions seem not to be associated with changes in serum phosphate or PTH. However, these studies had small sample sizes, were of short duration and learning patterns or factors influencing behaviour were not explored. Education strategies to balance dietary phosphate load to binder dose have been developed for children but require a high degree of patient motivation and do not account for the variable presence and bioavailability of inorganic and organic phosphate. The very high prevalence of hyperphosphataemia and its complications makes it clear that current management strategies are not effective and that alternative approaches are required to ensure optimal phosphate control.
Gaining feedback from children and their families about the challenges they face with phosphate control, as well as how they respond to dietary educational tools, is essential to enable meaningful improvements to be made to their health care. Educational psychologists report that adherence to any advice is improved when an individual's learning style (such as visual or auditory) and preferences for learning materials is provided for. Thus, although written or verbal explanations are the most common approaches, pictures and diagrams are more effective with visual learners. Similarly, adolescents report that they want more health-focused communications, presenting data as charts and graphs. In paediatric practice, the understanding of both the child and their parents must be considered and the parent-child interplay can influence the ability to learn. Sharing experiences and strategies between groups of parents and children can motivate long-term dietary changes. Healthcare professionals need to identify age-appropriate, relevant and engaging educational strategies informed by patient preferences, as these are most likely to empower, upskill and ensure optimal long-term adherence.
Rationale:
An international panel of paediatric renal dietitians and nephrologists from the Paediatric Renal Nutritional Taskforce (PRNT) have collaborated to develop a questionnaire (PUKA) to assess the baseline phosphate knowledge and understanding of CYP with CKD and their caregivers. A literature review was conducted to analyse existing instruments to evaluate phosphate knowledge. This showed that there was a lack of existing tools with proven validity and reliability that were suitable for use in paediatrics. However, this proved a useful guide for constructing a questionnaire and the questions chosen, format and design of the questionnaire was informed by those used in other studies, but expanded to gather background information on teaching preferences and problems experienced in relation to dietary changes or adherence to phosphate binder medication. This has been piloted on 10 CYP and their families to ensure face validity. The PUKA questionnaire will be completed by a purposive sample of CYP with CKD and caregivers in the 4 UK and 5 European nephrology units. The questionnaires will analysed to generate a phosphate knowledge score. Questions relating to personal opinions (such as preferred phosphate education approaches, perceived problems associated with implementing the reduced phosphate diet or taking phosphate binder medication) will be categorised and calculated as frequencies to represent the distribution of views. Correlation analysis will be used to measure the degree of association between any two variables (for example age, dialysis status, baseline biochemistry and knowledge score).
Current national and international PEM will be collated, evaluated and a representative sample selected. Focus groups of 5-6 children with CKD or caregivers will be run across these sites to gain feedback on these selected PEM and to further explore their perceived barriers and facilitators to adherence. The PUKA questionnaire and focus group data will be used to inform the development of PEM that address knowledge gaps and utilise the preferred education techniques. This novel approach will address adherence issues, empowering families to take ownership of phosphate management by personalising their child's care and offering patient choice, thereby optimising phosphate control and long-term bone and cardiovascular outcomes.
Benefits of research:
The investigators hope to find the real knowledge gaps and practical challenges experienced by CYP from diverse backgrounds, as represented across the partner sites to inform the co-design of PEM. Harnessing the expertise of an international team of dietitians and nephrologists is a unique strength of this proposal, including input from a clinical psychologist and 5 patient representatives. Patient-led resources will enable CYP to take control of their health, improve phosphate control and reduce long term adverse bone and cardiovascular outcomes. In addition, this project may also serve as a template to inform the development of future educational materials produced for children with kidney diseases.
Background:
CKD mineral and bone disorder (CKD-MBD) can lead to debilitating skeletal complications, fractures, poor growth and vascular calcification, and remains one of the most challenging areas of CKD management. Serum phosphate and related measures of MBD, including Fibroblast Growth Factor 23 (FGF23) and parathyroid hormone (PTH), are raised in CKD and causally associated with adverse outcomes including vascular damage and calcification, left ventricular hypertrophy and renal bone disease. Reduction in dietary phosphate intake and regular intake of phosphate binder medications is required for optimal phosphate control but is extremely challenging, leading to poor adherence in a significant number of patients. The International Paediatric Dialysis Network Registry reports that in over 900 children on PD, 45% had high serum phosphate levels, with the prevalence of hyperphosphataemia increasing to 80% in adolescents.
Paediatric renal dietitians are responsible for educating families about dietary phosphate intake: limiting foods high in organic phosphate as well as avoiding the "hidden" inorganic phosphate from food additives, without compromising nutritional adequacy. Phosphate educational material (PEM) have been developed primarily for adults but dietary adherence is less than 50%, and is similarly low in children. Not only must children understand how to reduce their dietary phosphate intake but also how to use phosphate binder medication to reduce phosphate absorption from their foods and drinks. Adherence to binder medication is typically low due to poor palatability and the complexity of administration. Phosphate binder adherence is compounded by issues of access at school and psychological impacts, particularly during adolescence.
Educational interventions have mainly focused on the adult haemodialysis population with short-term follow-up. There are eight randomised controlled trials (RCTs) of using an educational intervention in adults with CKD or on dialysis which conclude that such interventions increased adherence compared to no intervention or routine standard care. A meta-analysis of adult RCTs also reported that educational initiatives can improve serum phosphate levels. Adult data has limited applicability to the management of hyperphosphataemia in CYP, as understanding and compliance with dietary restrictions will often be a joint responsibility between the CYP and their caregivers. There are very few studies assessing the success of educational programmes in paediatrics but, despite some showing an improvement in knowledge scores, interventions seem not to be associated with changes in serum phosphate or PTH. However, these studies had small sample sizes, were of short duration and learning patterns or factors influencing behaviour were not explored. Education strategies to balance dietary phosphate load to binder dose have been developed for children but require a high degree of patient motivation and do not account for the variable presence and bioavailability of inorganic and organic phosphate. The very high prevalence of hyperphosphataemia and its complications makes it clear that current management strategies are not effective and that alternative approaches are required to ensure optimal phosphate control.
Gaining feedback from children and their families about the challenges they face with phosphate control, as well as how they respond to dietary educational tools, is essential to enable meaningful improvements to be made to their health care. Educational psychologists report that adherence to any advice is improved when an individual's learning style (such as visual or auditory) and preferences for learning materials is provided for. Thus, although written or verbal explanations are the most common approaches, pictures and diagrams are more effective with visual learners. Similarly, adolescents report that they want more health-focused communications, presenting data as charts and graphs. In paediatric practice, the understanding of both the child and their parents must be considered and the parent-child interplay can influence the ability to learn. Sharing experiences and strategies between groups of parents and children can motivate long-term dietary changes. Healthcare professionals need to identify age-appropriate, relevant and engaging educational strategies informed by patient preferences, as these are most likely to empower, upskill and ensure optimal long-term adherence.
Rationale:
An international panel of paediatric renal dietitians and nephrologists from the Paediatric Renal Nutritional Taskforce (PRNT) have collaborated to develop a questionnaire (PUKA) to assess the baseline phosphate knowledge and understanding of CYP with CKD and their caregivers. A literature review was conducted to analyse existing instruments to evaluate phosphate knowledge. This showed that there was a lack of existing tools with proven validity and reliability that were suitable for use in paediatrics. However, this proved a useful guide for constructing a questionnaire and the questions chosen, format and design of the questionnaire was informed by those used in other studies, but expanded to gather background information on teaching preferences and problems experienced in relation to dietary changes or adherence to phosphate binder medication. This has been piloted on 10 CYP and their families to ensure face validity. The PUKA questionnaire will be completed by a purposive sample of CYP with CKD and caregivers in the 4 UK and 5 European nephrology units. The questionnaires will analysed to generate a phosphate knowledge score. Questions relating to personal opinions (such as preferred phosphate education approaches, perceived problems associated with implementing the reduced phosphate diet or taking phosphate binder medication) will be categorised and calculated as frequencies to represent the distribution of views. Correlation analysis will be used to measure the degree of association between any two variables (for example age, dialysis status, baseline biochemistry and knowledge score).
Current national and international PEM will be collated, evaluated and a representative sample selected. Focus groups of 5-6 children with CKD or caregivers will be run across these sites to gain feedback on these selected PEM and to further explore their perceived barriers and facilitators to adherence. The PUKA questionnaire and focus group data will be used to inform the development of PEM that address knowledge gaps and utilise the preferred education techniques. This novel approach will address adherence issues, empowering families to take ownership of phosphate management by personalising their child's care and offering patient choice, thereby optimising phosphate control and long-term bone and cardiovascular outcomes.
Benefits of research:
The investigators hope to find the real knowledge gaps and practical challenges experienced by CYP from diverse backgrounds, as represented across the partner sites to inform the co-design of PEM. Harnessing the expertise of an international team of dietitians and nephrologists is a unique strength of this proposal, including input from a clinical psychologist and 5 patient representatives. Patient-led resources will enable CYP to take control of their health, improve phosphate control and reduce long term adverse bone and cardiovascular outcomes. In addition, this project may also serve as a template to inform the development of future educational materials produced for children with kidney diseases.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Chronic Kidney Diseases
Hyperphosphatemia
Pediatric Kidney Disease
CKD-MBD
Chronic Kidney Disease-Mineral and Bone Disorder
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Observational Model Type
OTHER
Study Time Perspective
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CKD aged 8-<13 years
8-\<13 years n = 25
Knowledge questionnaire
Intervention Type
OTHER
Completion of a questionnaire at baseline
Focus groups
Intervention Type
OTHER
structured interviews
CKD aged 13-18 years
13-18 years n = 25
Knowledge questionnaire
Intervention Type
OTHER
Completion of a questionnaire at baseline
Focus groups
Intervention Type
OTHER
structured interviews
Parents/caregivers
Parent/caregivers of children and young people with CKD 4-5D n=50
Knowledge questionnaire
Intervention Type
OTHER
Completion of a questionnaire at baseline
Focus groups
Intervention Type
OTHER
structured interviews
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Knowledge questionnaire
Completion of a questionnaire at baseline
Intervention Type
OTHER
Focus groups
structured interviews
Intervention Type
OTHER
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients with CKD4-5D between 8-18 years of age.
* One caregiver per patient.
* Consenting to study.
* One caregiver per patient.
* Consenting to study.
Exclusion Criteria
* Children with neurodevelopmental or cognitive disorders.
* Children with an underlying phosphate-losing disease.
* Children on intensive dialysis regimens such as home haemodialysis or frequent daily in-centre HD.
* Children who are fully enterally tube fed.
* Children or caregivers with limited spoken or written language skills.
* Children with an underlying phosphate-losing disease.
* Children on intensive dialysis regimens such as home haemodialysis or frequent daily in-centre HD.
* Children who are fully enterally tube fed.
* Children or caregivers with limited spoken or written language skills.
Minimum Eligible Age
8 Years
Maximum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Great Ormond Street Hospital for Children NHS Foundation Trust
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Rukshana Shroff1
Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Great Ormond Street Hospital for Children
London, , United Kingdom
Site Status
RECRUITING
Countries
Review the countries where the study has at least one active or historical site.
United Kingdom
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Palmer SC, Hayen A, Macaskill P, Pellegrini F, Craig JC, Elder GJ, Strippoli GF. Serum levels of phosphorus, parathyroid hormone, and calcium and risks of death and cardiovascular disease in individuals with chronic kidney disease: a systematic review and meta-analysis. JAMA. 2011 Mar 16;305(11):1119-27. doi: 10.1001/jama.2011.308.
Reference Type
BACKGROUND
Shroff R, Long DA, Shanahan C. Mechanistic insights into vascular calcification in CKD. J Am Soc Nephrol. 2013 Feb;24(2):179-89. doi: 10.1681/ASN.2011121191. Epub 2012 Nov 8.
Reference Type
BACKGROUND
Bertram JF, Goldstein SL, Pape L, Schaefer F, Shroff RC, Warady BA. Kidney disease in children: latest advances and remaining challenges. Nat Rev Nephrol. 2016 Mar;12(3):182-91. doi: 10.1038/nrneph.2015.219. Epub 2016 Feb 1.
Reference Type
BACKGROUND
Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Update Work Group. KDIGO 2017 Clinical Practice Guideline Update for the Diagnosis, Evaluation, Prevention, and Treatment of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD). Kidney Int Suppl (2011). 2017 Jul;7(1):1-59. doi: 10.1016/j.kisu.2017.04.001. Epub 2017 Jun 21. No abstract available.
Reference Type
BACKGROUND
McAlister L, Pugh P, Greenbaum L, Haffner D, Rees L, Anderson C, Desloovere A, Nelms C, Oosterveld M, Paglialonga F, Polderman N, Qizalbash L, Renken-Terhaerdt J, Tuokkola J, Warady B, Walle JV, Shaw V, Shroff R. The dietary management of calcium and phosphate in children with CKD stages 2-5 and on dialysis-clinical practice recommendation from the Pediatric Renal Nutrition Taskforce. Pediatr Nephrol. 2020 Mar;35(3):501-518. doi: 10.1007/s00467-019-04370-z. Epub 2019 Oct 30.
Reference Type
BACKGROUND
Farfan-Ruiz AC, Czikk D, Leidecker J, Ramsay T, McCormick B, Wilson K, Zimmerman D. Multidisciplinary Team versus a "Phosphate-Counting" App for Serum Phosphate Control: A Randomized Controlled Trial. Kidney360. 2020 Dec 15;2(2):290-297. doi: 10.34067/KID.0007132020. eCollection 2021 Feb 25.
Reference Type
BACKGROUND
Karamanidou C, Clatworthy J, Weinman J, Horne R. A systematic review of the prevalence and determinants of nonadherence to phosphate binding medication in patients with end-stage renal disease. BMC Nephrol. 2008 Jan 31;9:2. doi: 10.1186/1471-2369-9-2.
Reference Type
BACKGROUND
Hyperphosphataemia in chronic kidney disease: Evidence Update December 2014: A summary of selected new evidence relevant to NICE clinical guideline 157 'Management of hyperphosphataemia in patients with stage 4 or 5 chronic kidney disease' (2013) [Internet]. London: National Institute for Health and Care Excellence (NICE); 2014. No abstract available. Available from http://www.ncbi.nlm.nih.gov/books/NBK552051/
Reference Type
BACKGROUND
Abercrombie EL, Greenbaum LA, Baxter DH, Hopkins B. Effect of intensified diet education on serum phosphorus and knowledge of pediatric peritoneal dialysis patients. J Ren Nutr. 2010 May;20(3):193-8. doi: 10.1053/j.jrn.2009.10.011. Epub 2010 Mar 19.
Reference Type
BACKGROUND
Ahlenstiel T, Pape L, Ehrich JH, Kuhlmann MK. Self-adjustment of phosphate binder dose to meal phosphorus content improves management of hyperphosphataemia in children with chronic kidney disease. Nephrol Dial Transplant. 2010 Oct;25(10):3241-9. doi: 10.1093/ndt/gfq161. Epub 2010 Mar 22.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
21BO24
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Prospective Evaluation of Blunt Renal Injury in Children
NCT00855036
TERMINATED
Hemostatic Profiles in Pediatric CKD
NCT05064267
COMPLETED
Comparison of Stent-Related Symptoms Between Anti-Reflux Stents and Standard DJ Stents in Children With Urolithiasis
NCT06569173
RECRUITING
NA
Central Blood Pressure and Pulse Wave Velocity in Kidney Transplant Recipients
NCT04212143
ACTIVE_NOT_RECRUITING
Ureteropelvic Junction Obstruction in Early Childhood: Comparison of Surgical Therapy and Surveillance. A Prospective, Randomized, Controlled Multi-Center Study
NCT00444431
UNKNOWN
NA
The Correlation Between Renal Injury and Biomarkers in Pediatric Ureteropelvic Junction Obstruction Patients
NCT01711996
WITHDRAWN
Estimation of Kidney Function Through Combination of Renal Biomarkers in Blood and Urine of Healthy Infants and Children.
NCT03751397
COMPLETED
Pediatric Appendicitis Pathway Study
NCT01192620
COMPLETED
Normal Reference Ranges for Urinary Metabolites and Supersaturation Indices in Pediatric Populations
NCT00591097
COMPLETED
Feasibility of Magnetic-end Double-J Ureteral Stent Use in Children
NCT04384939
COMPLETED
NA
Outcomes and Health Care Resource Utilization in Pediatric Congenital Heart Disease Patients Undergoing Non-Cardiac Procedures
NCT04604418
RECRUITING
Acute Kidney Injury in Children Operated for Congenital Heart Disease
NCT01316497
COMPLETED
NA
Outcomes in Patients and Their Closest Relatives Treated for Congenital Heart Disease With Catheter Based or Surgical Techniques
NCT01421030
UNKNOWN
EARLY_PHASE1
High Risk Screen of Childhood Late-onset Pompe Disease in Pediatric Outpatient Clinics
NCT04981210
UNKNOWN
Stone Disease of the Urinary Tract in Children
NCT06032364
RECRUITING
Phase III Study of Chondrocyte Alginate Gel Suspension in Pediatric Patients With Vesicoureteral Reflux
NCT00004487
UNKNOWN
PHASE3
Clinical Significance of Supranormal Differential Renal Function in the Recovery of Hydronephrosis
NCT01839006
COMPLETED
Cardiac Catheterization in the Management of Pediatric Cardiac Patients at A.U.C.H.
NCT03398187
UNKNOWN
Ultrasound Measurements of Hepatic Vasculatures and Hepatic Doppler Assessment of Healthy Children
NCT04619966
RECRUITING
Validation of Low Dose CT for Diagnosis of Urolithiasis
NCT03656913
TERMINATED
NA
Examination of Trunk and Lower Extremity Biomechanics in Children With LUTD.
NCT05299827
COMPLETED
Management of Grades 3-5 Renal Trauma in Pediatrics
NCT04572204
COMPLETED
Radiation Dose of Pediatric Patients During Ureteroscopy
NCT02895711
COMPLETED
Antiseptic-coated Intermittent Urinary Catheter
NCT02697162
WITHDRAWN
PHASE2/PHASE3
Pediatric ACL: Understanding Treatment Options
NCT02772770
ACTIVE_NOT_RECRUITING