Kidney TransplantationBEAM-KIDsNCT05453656
Development and Testing of the Kidney BEAM-KIDS Digital Platform for Children After Kidney Transplantation
A study testing exercise in people with Kidney Transplantation, run by Queen Margaret University at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Aug 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Glasgow Royal Hospital for Children
Glasgow
REYNOLDS
About this study
Official title: Co-design, Development and Evaluation of the KIDNEY BEAM-KIDS Platform for Paediatric Kidney Transplant Recipients: a Feasibility Study
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.
Read the 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:
- What are participants' experiences of Kidney BEAM-KIDS and views on its feasibility, acceptability and benefits?
- What type and quantity of adverse events (if any) are experienced over an observation period of 7-12 months?
- What are the study recruitment and retention rates?
- What is the acceptability of data collection methods and rate of outcome measure completion?
- What are the variability and patterns of change in outcomes to determine a primary outcome measure and calculate sample size for a future study?
- 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.
- Conditions
- Kidney Transplantation
- Being tested
- exercise
- Keywords
- exercise, child, adolescent, quality of life
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exerciseBehavioural
Also called kidney transplantation
physical activity promotion and engagement following kidney transplantation
| Study group | Role | What they receive |
|---|---|---|
| exercise | Other | live and on demand exercise sessions on the Kidney BEAM-KIDS platform Receives: Behavioral: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: change from baseline to 12 and 24 weeks post kidney transplantation and exercise
Secondary outcomes (6)
Frequency and type of physical activity
the self-reported Physical Activity Questionnaire - PAQ for CYP will be used to capture data on PA patterns
Measured: change from baseline to 12 and 24 weeks post kidney transplantation and exercise
type and quantity of food groups consumed
4-7 day diaries will be used to capture and analyse nutritional intake information
Measured: change from baseline to 12 and 24 weeks post kidney transplantation and exercise
adverse events
episodes of hospitalisations and other infection events will be captured via medical records
Measured: change from baseline to 12 and 24 weeks post kidney transplantation and exercise
kidney BEAM-KIDS platform metrics
minutes spent on physical activity and engagement with the digital health platform
Measured: change from 12 weeks post kidney transplantation to 12 weeks post exercise
qualitative exploration of trial acceptability and participant experience
focus groups and semi structured interviews with participants and families will be used to capture qualitative data
Measured: at 12 weeks post kidney transplantation
qualitative exploration of trial acceptability and participant experience
focus groups and semi structured interviews with participants and families will be used to capture qualitative data
Measured: at 12 weeks post exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start18 Aug 2023
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Margaret University
- Sponsor type
- University, hospital or other
- 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, Royal Hospital for Sick Children
- Responsible party
- Principal investigator, Pelagia Koufaki, PhD, Queen Margaret University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05453656
- Sponsor's protocol ID
- P2008QMU
- Acronym
- BEAM-KIDs
- Status last verified
- Nov 2023
- First submitted
- 20 Jun 2022
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan yet
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Co-design, Development and Evaluation of the KIDNEY BEAM-KIDS Platform for Paediatric Kidney Transplant Recipients: a Feasibility Study
- ClinicalTrials.gov ID
- NCT05453656
- Acronym / sponsor ID
- BEAM-KIDs / P2008QMU
- Conditions
- Kidney Transplantation
- Keywords
- exercise, child, adolescent, quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Queen Margaret UniversityUniversity, hospital or other
- 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, Royal Hospital for Sick Children
- Study start
- 18 Aug 2023 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 12 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- What are participants' experiences of Kidney BEAM-KIDS and views on its feasibility, acceptability and benefits?
- What type and quantity of adverse events (if any) are experienced over an observation period of 7-12 months?
- What are the study recruitment and retention rates?
- What is the acceptability of data collection methods and rate of outcome measure completion?
- What are the variability and patterns of change in outcomes to determine a primary outcome measure and calculate sample size for a future study?
- 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
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| exercise | Other | Behavioral: exerciselive and on demand exercise sessions on the Kidney BEAM-KIDS platform |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exerciseAlso: kidney transplantationphysical activity promotion and engagement following kidney transplantation | Behavioural | exercise |
Primary outcome
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
6 secondary outcomes
Frequency and type of physical activity
Time frame: change from baseline to 12 and 24 weeks post kidney transplantation and exercise
type and quantity of food groups consumed
Time frame: change from baseline to 12 and 24 weeks post kidney transplantation and exercise
adverse events
Time frame: change from baseline to 12 and 24 weeks post kidney transplantation and exercise
kidney BEAM-KIDS platform metrics
Time frame: change from 12 weeks post kidney transplantation to 12 weeks post exercise
qualitative exploration of trial acceptability and participant experience
Time frame: at 12 weeks post kidney transplantation
qualitative exploration of trial acceptability and participant experience
Time frame: at 12 weeks post exercise
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No. no plan yet
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise in people with Kidney Transplantation, run by Queen Margaret University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pelagia Koufaki, PhD (01314740000, pkoufaki@qmu.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life score (time frame: change from baseline to 12 and 24 weeks post kidney transplantation and exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.