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

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ClinicalTrials.gov Identifier: NCT05453656
Recruitment Status : Recruiting
First Posted : July 12, 2022
Last Update Posted : November 18, 2023
Sponsor:
Collaborators:
Sheffield Hallam University
King's College Hospital NHS Trust
Keele University
Great Ormond Street Hospital for Children NHS Foundation Trust
University Hospital Southampton NHS Foundation Trust
Glasgow Royal Hospital for children
Information provided by (Responsible Party):
Pelagia Koufaki, PhD, Queen Margaret University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Kidney Transplantation Behavioral: exercise Not Applicable

Detailed Description:

Kidney transplantation (KT) is the preferred and most prevalent treatment in CYP with CKD but is associated with increased risk of cardiovascular complications, insulin resistance, and diabetes, with likely contributors being visceral obesity and low lean body mass. In general paediatric populations, all of the above are favourably modified by regular/varied PA. The benefits and risks of PA for CYP with CKD are, however, less well established and available data are mainly from cross-sectional studies. Kidney-BEAM is a digital health platform for adults with CKD, which provides live and on-demand exercise classes. The investigators propose to adapt the kidney BEAM platform to kidney BEAM-KIDS for CYP with CKD to access activities adapted to their needs and document benefits on outcomes that matter to them.

Aims and methods: A single-arm, multi-centre, feasibility study, with a mixed-method design using an effectiveness and theory-based perspective. Investigators will examine the feasibility and acceptability of (a) Kidney BEAM-KIDS as the intervention and delivery setting in CYP following KT, and (b) the evaluation design for addressing all recommended core elements (context, engaging stakeholders, identifying key uncertainties, refining the intervention, economic considerations) to inform the development of a clinical evaluation trial The team will aim to recruit about 30 participants between 6-17 years of age. Research questions:

  1. What are participants' experiences of Kidney BEAM-KIDS and views on its feasibility, acceptability and benefits?
  2. What type and quantity of adverse events (if any) are experienced over an observation period of 7-12 months?
  3. What are the study recruitment and retention rates?
  4. What is the acceptability of data collection methods and rate of outcome measure completion?
  5. What are the variability and patterns of change in outcomes to determine a primary outcome measure and calculate sample size for a future study?
  6. What is the feasibility of a future health economic evaluation?

Outcomes: Quantitive data: demographic, clinical and physical characteristics, adverse events and hospitalisations, 4-7 day dietary intake diaries, at 3 time points: before and after KT and after 12 weeks exposure to Kidney BEAM-KIDS. Selection of outcomes was based on i) the potential impact on outcomes that matter to CYP (multidimensional PedsQLv4, self perception profile, Physical activity questionnaire, BEAM-KIDS platform use metrics), (ii) participants' wide age range (6-17 years), and iii) the need to minimise face-to-face assessments where possible due to the wide geographical spread of recruiting centres. Physical function outcomes (strength and cardiorespitatory fitness) will be collected in person if possible. Qualitative data: via remote semi-structured individual interviews and focus groups using a process evaluation approach to explore experiences, attitudes, preferences, suggestions to inform future directions.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Co-design, Development and Evaluation of the KIDNEY BEAM-KIDS Platform for Paediatric Kidney Transplant Recipients: a Feasibility Study
Actual Study Start Date : August 18, 2023
Estimated Primary Completion Date : October 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
exercise
live and on demand exercise sessions on the Kidney BEAM-KIDS platform
 Behavioral: exercise
physical activity promotion and engagement following kidney transplantation
Other Name: kidney transplantation


Outcome Measures
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Primary Outcome Measures :
  1. Quality of Life score [ Time Frame: change from baseline to 12 and 24 weeks post kidney transplantation and exercise ]
    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


Secondary Outcome Measures :
  1. Frequency and type of physical activity [ Time Frame: change from baseline to 12 and 24 weeks post kidney transplantation and exercise ]
    the self-reported Physical Activity Questionnaire - PAQ for CYP will be used to capture data on PA patterns

  2. type and quantity of food groups consumed [ Time Frame: change from baseline to 12 and 24 weeks post kidney transplantation and exercise ]
    4-7 day diaries will be used to capture and analyse nutritional intake information

  3. adverse events [ Time Frame: change from baseline to 12 and 24 weeks post kidney transplantation and exercise ]
    episodes of hospitalisations and other infection events will be captured via medical records

  4. kidney BEAM-KIDS platform metrics [ Time Frame: change from 12 weeks post kidney transplantation to 12 weeks post exercise ]
    minutes spent on physical activity and engagement with the digital health platform

  5. qualitative exploration of trial acceptability and participant experience [ Time Frame: at 12 weeks post kidney transplantation ]
    focus groups and semi structured interviews with participants and families will be used to capture qualitative data

  6. qualitative exploration of trial acceptability and participant experience [ Time Frame: at 12 weeks post exercise ]
    focus groups and semi structured interviews with participants and families will be used to capture qualitative data


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   self reported
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05453656


Contacts
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Contact: Pelagia Koufaki, PhD 01314740000 pkoufaki@qmu.ac.uk
Contact: Sharlene Greenwood, PhD 0131 474 0000 sharlene.greenwood@nhs.net

Locations
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United Kingdom
Glasgow Royal Hospital for Children Recruiting
Glasgow, United Kingdom
Contact: REYNOLDS         
Sponsors and Collaborators
Queen Margaret University
Sheffield Hallam University
King's College Hospital NHS Trust
Keele University
Great Ormond Street Hospital for Children NHS Foundation Trust
University Hospital Southampton NHS Foundation Trust
Glasgow Royal Hospital for children
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Pelagia Koufaki, PhD, Reader, Exercise Physiology and Rehabilitation Sciences, Queen Margaret University
ClinicalTrials.gov Identifier: NCT05453656    
Other Study ID Numbers: P2008QMU
First Posted: July 12, 2022    Key Record Dates
Last Update Posted: November 18, 2023
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no plan yet

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pelagia Koufaki, PhD, Queen Margaret University:
exercise
child
adolescent
quality of life