Development and Testing of the Kidney BEAM-KIDS Digital Platform for Children After Kidney Transplantation

NCT05453656 | Unknown

• 1 other identifier: P2008QMU
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Children and young people (CYP) with chronic kidney disease (CKD) say that physical activity, school, social activities and tiredness are the main issues they want to improve. Kidney-BEAM, a digital health platform designed for adults with CKD, provides a combination of live and on-demand exercise classes to encourage physical activity and movement but is currently not available to CYP with CKD. Therefore, investigators will work with CYP with CKD, parents/carers and healthcare professionals to find out if a CYP-related version (Kidney BEAM-KIDS), could be developed to encourage exercise options that are enjoyable, safe and sustainable. In this project, CYP who have received a KT will be invited by their local clinical teams to try out Kidney BEAM-KIDS; this will include exercise-based classes delivered in age-appropriate groups where CYP will be able to get peer support. Kidney BEAM-KIDS will include features to help motivation such as badges and celebrations when reaching targets. The CYP will be asked to participate in discussions and complete several questionnaires at three time-points over 12 months to explore how CYP feel about themselves and aspects of their lives such as friendships and school, how physically active they are, their preferred types of foods, activities they do, and their health. This will help the investigators a) understand how acceptable Kidney BEAM-KIDS is to CYP, b) determine whether it needs any changes/improvements, and c) identify key issues around how best to gather data and answer research questions about physical activity benefits in CYP with CKD.

Conditions

Kidney Transplantation

Keywords

exercise; child; adolescent; quality of life

Outcome Measures

Primary Outcomes (1)

• Quality of Life score

  the multidimensional PedsQLv4 questionnaire and relevant sub-module questionnaires on fatigue and transplantation will be used to estimate scores that reflect the domains of physical functioning, emotional functioning, social functioning, school functioning, general fatigue, sleep/rest fatigue and cognitive fatigue, treatment anxiety

  change from baseline to 12 and 24 weeks post kidney transplantation and exercise

Secondary Outcomes (6)

• Frequency and type of physical activity

  change from baseline to 12 and 24 weeks post kidney transplantation and exercise

• type and quantity of food groups consumed

  change from baseline to 12 and 24 weeks post kidney transplantation and exercise

• adverse events

  change from baseline to 12 and 24 weeks post kidney transplantation and exercise

• kidney BEAM-KIDS platform metrics

  change from 12 weeks post kidney transplantation to 12 weeks post exercise

• qualitative exploration of trial acceptability and participant experience

  at 12 weeks post kidney transplantation

Study Arms (1)

exercise

OTHER

live and on demand exercise sessions on the Kidney BEAM-KIDS platform

Behavioral: exercise

Interventions

exercise BEHAVIORAL

physical activity promotion and engagement following kidney transplantation

Also known as: kidney transplantation

exercise

Eligibility Criteria

• Age: 6 Years - 17 Years
• Gender Eligibility Details: self reported
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• CYP of school age between 6 and 17 years attending a paediatric transplant centre
• Likely to require a KT within 12 months
• No intended date of transition to adult services within 12 months

You may not qualify if:

• Inability or absolute contraindications to engaging in PA
• Severe bone disease
• Cancer/leukaemia or HIV treatment within the 12 months before enrolment
• Enrolment in other clinical trials in which treatment is masked.

Sponsors & Collaborators

• Queen Margaret University: lead
• Sheffield Hallam University: collaborator
• King's College Hospital NHS Trust: collaborator
• Keele University: collaborator
• Great Ormond Street Hospital for Children NHS Foundation Trust: collaborator
• University Hospital Southampton NHS Foundation Trust: collaborator
• Glasgow Royal Hospital for children: collaborator

Study Sites (1)

Glasgow Royal Hospital for Children

Glasgow, United Kingdom

RECRUITING

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise; Kidney Transplantation

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Renal Replacement Therapy; Therapeutics; Organ Transplantation; Transplantation; Surgical Procedures, Operative; Urologic Surgical Procedures; Urogenital Surgical Procedures

Central Study Contacts

Pelagia Koufaki, PhD

CONTACT

01314740000; pkoufaki@qmu.ac.uk

Sharlene Greenwood, PhD

CONTACT

0131 474 0000; sharlene.greenwood@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reader, Exercise Physiology and Rehabilitation Sciences

Study Record Dates

• First Submitted: June 20, 2022
• First Posted: July 12, 2022
• Study Start: August 18, 2023
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)