Improving Phosphate Control in Children With CKD (IMPACT)

November 13, 2023 updated by: Rukshana Shroff1, Great Ormond Street Hospital for Children NHS Foundation Trust

Development of Effective Resources for Phosphate Education for Children and Families With Chronic Kidney Disease: Hearing the Patient Voice

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

50 caregiver-child dyads with CKD stage 4-5 and on dialysis

Description

Inclusion Criteria:

  • Patients with CKD4-5D between 8-18 years of age.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CKD aged 8-<13 years
8-<13 years n = 25
Other: Knowledge questionnaire
Completion of a questionnaire at baseline
Other: Focus groups
structured interviews
CKD aged 13-18 years
13-18 years n = 25
Other: Knowledge questionnaire
Completion of a questionnaire at baseline
Other: Focus groups
structured interviews
Parents/caregivers
Parent/caregivers of children and young people with CKD 4-5D n=50
Other: Knowledge questionnaire
Completion of a questionnaire at baseline
Other: Focus groups
structured interviews

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characterise the facilitators and barriers to adherence to reduced dietary phosphate advice and phosphate binder medication administration in children and young people with CKD and their caregivers.
Time Frame: 2 years
Qualitative - questionnaire and focus groups
2 years
Identify the preferred format and content of phosphate educational material of children and young people with CKD
Time Frame: 2 years
Questionnaire and focus groups
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Great Ormond Street Hospital for Children NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2023

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

November 30, 2024

Study Registration Dates

First Submitted

June 27, 2022

First Submitted That Met QC Criteria

June 27, 2022

First Posted (Actual)

June 30, 2022

Study Record Updates

Last Update Posted (Actual)

November 15, 2023

Last Update Submitted That Met QC Criteria

November 13, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21BO24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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