Chronic Kidney DiseasesNCT04872933
The Kidney BEAM Trial
A study testing Kidney Beam Online Platform in people with Chronic Kidney Diseases, run by King's College Hospital NHS Trust at 1 site in United Kingdom.
Trial summary
This is a multi-centre single-blind waitlist randomised controlled trial (RCT) that will examine the clinical value and cost-effectiveness of an online physical and emotional wellbeing resource for the improvement of health-related quality of life in people with CKD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- Kidney Beam Online Platform
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Apr 2021to Sep 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals with established CKD
- Adults aged 18yrs+
- Written or virtual informed consent
Who cannot join
- Weight < 50kg
- Self-reported participation in a structured exercise programme or kidney beam digital health intervention platform within previous 3 months
- Active infection
- Uncontrolled arrhythmias
- Unstable angina or heart attack within the 3 months
- Persistent uncontrolled hypertension (systolic blood pressure >180 mm Hg or diastolic blood pressure >110 mm Hg)
Show all 11Show fewer
- Recent (within the last 3 months) stroke or transient ischaemic attack
- Receiving palliative care for advanced terminal cancer
- Patients with peripheral vascular or musculoskeletal disease, who the investigator deems unable to carry out a physical activity intervention.
- Any other health condition considered by the local Principal Investigator in which exercise therapy will be contraindicated.
- Insufficient understanding of the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicentre Prospective Single-blind Wait-list Randomised Controlled Trial, With Nested Pilot, of the Clinical Value and Economic Evaluation of an Online Physical and Emotional Wellbeing Resource for the Improvement of Health-related Quality of Life in People With Chronic Kidney Disease: The Kidney Beam Trial
This is a multi-centre single-blind waitlist randomised controlled trial (RCT) that will examine the clinical value and cost-effectiveness of an online physical and emotional wellbeing resource for the improvement of health-related quality of life in people with CKD.
Physical inactivity and poor mental health are very real concerns for people living with kidney disease, and they report multiple symptoms that impact upon the physical component of health-related quality of life (HRQoL). A decrease in the physical component of HRQoL is independently associated with mortality and morbidity. In people living with end stage kidney disease (ESKD), systematic reviews indicate that a range of exercise training interventions improve physical function and alleviate disability symptoms. The physical component of HRQoL can be targeted with interventions to enhance physical activity, however people living with kidney disease are still not routinely offered specialist physical activity or mental health support in the NHS. Kidney Beam is a new wellbeing digital health intervention platform that was developed, and launched, to help people with kidney disease manage their physical and mental health through the Coronavirus 2019 (COVID-19) pandemic, resulting lockdown and beyond. It involves a digital health intervention platform to support people with health conditions to stay physically active. Patients will have access to live-on demand or recorded physical activity classes that they will use for 12 weeks with 2 sessions per week.
The study aims to recruit 304 patients.
Read the detailed description
Trial Design An investigator-led multicentre single-blind waitlist randomised controlled trial (with nested pilot study) of participants with established chronic kidney disease (CKD). The study will adopt a nested pilot design to preliminarily assess trial and intervention feasibility. To assess this, a traffic light system will be utilised to determine if the study should be halted (red), changes to the design or intervention considered (amber) or is considered feasible and progress to the full trial (green). These criteria will be reviewed and set by the investigators prior to start of study.
Selection of Participants and Procedure
Three hundred and thirty patients aged 18 years or over with established CKD will be enrolled. Potential study trial patients will be identified in outpatient clinic list or approached during their routine hospital visit for an informal chat.
The study team and PI will confirm patient's eligibility. When patient agrees to participate, patient will be asked to sign a consent form. Patient will be scheduled for baseline visit and will be randomised using a secure web-based service. Only by the unblinded member of the study team will be able to randomise patient. Blinded member of the team (research Assistant) will perform the assessment of outcome measures at Baseline and 12 week visit.
After randomisation, patient will be assigned either to waiting list or non-waiting list. If patient is assigned to nonwaiting list group, patient will be asked to attend a total of 3 virtual assessments (baseline, 6M and 12M) and will offered online Kidney BEAM intervention straight away for 12 weeks. If patient is assigned to waiting list group, they will still be asked to complete the 3 virtual assessments but will only start online Kidney BEAM intervention after 12 weeks of being on study. Baseline and 12 week visit will include a review of patient's up to date blood test results, functional capacity (Sit-to stand 60), completion of questionnaire sets and adverse event assessment. After completing the intervention, a highly trained physiotherapist will also conduct qualitative interview to explore patient's experience of the study. For the pilot interviews , up to 15 participants from the intervention arm will be recruited. For the final interviews, up to 30 participants will be recruited in total, from each arm of the trial. Again, data collection will cease at the point where information power is achieved. Interviews are expected to last approximately 60 minutes. At the end of each interview, participants will be given another opportunity to ask questions, or seek clarification and the voluntary nature of their participation will be re-iterated. Should any participant request further information or highlight any concerns during the interview then these will be discussed with the Principal Investigator at their recruiting site, for appropriate onward referral as required.
COVID-19 Sub-study The Kidney Beam trial will contain an exploratory sub-study for any patients with CKD who had COVID-19 or who have been left with CKD following AKI-related to COVID-19 infection. Only patients with history of COVID prior to consent will be assessed using COVID functional status tool at baseline and 12 week visit. Patients who develop COVID while on study will be assessed the same tool on their follow up visit.
For those who had a positive test, an assessment of the severity of their COVID will be made in the following way:
- COVID positive, managed at home not requiring hospital admission
- COVID positive, required hospital admission but no oxygen therapy
- COVID positive, required hospital admission and oxygen therapy
- COVID positive, required hospital admission and non-invasive ventilation
- COVID positive, required hospital admission and admission to intensive care Additional details of the admission, including length of stay and time since discharge will be recorded. Subjects will continue in the study in the same way but will complete the post-COVID functional status tool questionnaire at baseline and follow-up in addition to other outcome measures.
- Conditions
- Chronic Kidney Diseases
- Being tested
- Kidney Beam Online Platform
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kidney Beam Online PlatformOther
Kidney Beam is a wellbeing digital health intervention platform that offers patients living with kidney disease a way to improve their physical activity and boost their mental health through live and on demand movement classes and expert educational videos, while remaining in their own home. Kidney Beam is led by specialist kidney professionals, including renal physiotherapists and renal counsellors, from a number of different NHS Trusts and backgrounds, as well as people living with kidney disease.
| Study group | Role | What they receive |
|---|---|---|
| Non-Waitlist | Other | Patient will attend a total of 3 virtual assessments whilst in the study: at baseline, at 12 weeks then at 6 months. The online intervention will commence straight after completing the baseline visit. Receives: Other: Kidney Beam Online Platform |
| Waitlist | Other | Patient will be complete assessments at baseline and 12 weeks but will only start the online intervention after the 12-week assessment. Receives: Other: Kidney Beam Online Platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental Composite Score (MCS) of KDQOL-36 quality of life questionnaire at 12 weeks.
To assess the clinical value of the Kidney Beam digital health intervention platform
Measured: Week 12
Secondary outcomes (10)
Patient activation measure (PAM-13)
The PAM-13 is a validated tool of 13 questions which assesses a patient's knowledge, skills and confidence in managing their own health.
Measured: Week 12
Chalder Fatigue Questionnaire -- physical and mental fatigue
The Chalder Fatigue Questionnaire is an 11-item questionnaire measuring the severity of physical and mental fatigue on two separate subscales
Measured: Baseline and week 12
Patient Health Questionnaire-4 (PHQ-4)
The Patient-Health Questionnaire-4 (PHQ-4) is an ultra-brief screener for depression and anxiety
Measured: Baseline
Functional capacity
STS60 (Sit-to-Stand 60 second) to provide a measure of muscle endurance, another aspect of physical performance
Measured: Baseline and Week12
Quality of life score
To assess the quality of life of patients with kidney disease using KDQOL-36 physical component score (PCS), energy/fatigue, burden of kidney disease, role physical, physical functioning, mental health, bodily pain, role emotional, social functioning, general health)
Measured: Baseline, Week12 and 6 month follow up
Global Physical Activity Questionnaire
It collects information on physical activity participation in three settings (or domains) as well as sedentary behaviour, comprising 16 questions (P1-P16). The domains are:
- Activity at work
- Travel to and from places
- Recreational activities
It collects information on physical activity participation in three settings (or domains) as well as sedentary behaviour, comprising 16 questions (P1-P16). The domains are:
- Activity at work
- Travel to and from places
- Recreational activities
Measured: Baseline and Week 12
Clinical Frailty Score
The Clinical Frailty Scale (CFS), a risk stratification tool which grades frailty level from 1 (very fit) to 9 (terminally ill) using the standardised qualifiers, and has been validated for use in a range of CKD populations, will be used to identify the frailty status of participants at baseline
Measured: Baseline and Week 12
Qualitative exploration of intervention and trial acceptability and participant experience
Semi-structured interviews will be used to gather qualitative data as they offer an open and flexible method for exploring the participants' individual experiences in-depth.
Measured: End of 12 week pilot phase and Week 12
Adverse events
Episodes of hospitalisation and other infection episodes will be documented and analysed descriptively.
Measured: Baseline and Week 12
Kidney Beam platform metrics
To assess physical activity and engagement on the Kidney BEAM platform
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start21 Apr 2021
- Primary completionSep 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies 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
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 304 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Bangor University, University of Portsmouth, University of Leicester, Manchester University NHS Foundation Trust, University Hospitals Bristol and Weston NHS Foundation Trust, Belfast Health and Social Care Trust
- Responsible party
- Sponsor
- Investigators
- Sharlene Greenwood, Dr, Principal investigator, Kings College Hospital NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04872933
- Sponsor's protocol ID
- KCH21-043
- Status last verified
- Apr 2021
- First submitted
- 23 Apr 2021
- Last updated
- 5 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Walklin C, Briggs J, Freeman S, Mangahis E, Dias C, Bhandari S, Bramham K, Burton JO, Campbell J, Kalra PA, Macdonald J, Taal MW, Wheeler DC, Greenwood SA, Young HML. A Digital Inclusion Intervention to Improve Access to a Digital Health Intervention Among Digitally Excluded Adults: Mixed Methods Pilot Randomized Controlled Trial. JMIR Form Res. 2026 Apr 16;10:e91438. doi: 10.2196/91438.
PubMed 41989885Greenwood SA, Briggs J, Walklin C, Mangahis E, Young HML, Castle EM, Billany RE, Asgari E, Bhandari S, Bishop N, Bramham K, Burton JO, Campbell J, Chilcot J, Cooper N, Deelchand V, Graham-Brown MPM, Haggis L, Hamilton A, Jesky M, Kalra PA, Koufaki P, McCafferty K, Nixon AC, Noble H, Saynor ZL, Taal MW, Tollitt J, Wheeler DC, Wilkinson TJ, Worboys H, Macdonald J. Kidney Beam-A Cost-Effective Digital Intervention to Improve Mental Health. Kidney Int Rep. 2024 Sep 2;9(11):3204-3217. doi: 10.1016/j.ekir.2024.08.030. eCollection 2024 Nov.
PubMed 39534205Young HML, Castle EM, Briggs J, Walklin C, Billany RE, Asgari E, Bhandari S, Bishop N, Bramham K, Burton JO, Campbell J, Chilcot J, Cooper N, Deelchand V, Graham-Brown MPM, Haggis L, Hamilton A, Jesky M, Kalra PA, Koufaki P, Macdonald J, McCafferty K, Nixon AC, Noble H, Saynor ZL, Taal MW, Tollitt J, Wheeler DC, Wilkinson TJ, Greenwood SA. The development and internal pilot trial of a digital physical activity and emotional well-being intervention (Kidney BEAM) for people with chronic kidney disease. Sci Rep. 2024 Jan 6;14(1):700. doi: 10.1038/s41598-023-50507-4.
PubMed 38184737Greenwood SA, Young HML, Briggs J, Castle EM, Walklin C, Haggis L, Balkin C, Asgari E, Bhandari S, Burton JO, Billany RE, Bishop NC, Bramham K, Campbell J, Chilcot J, Cooper NJ, Deelchand V, Graham-Brown MPM, Hamilton A, Jesky M, Kalra PA, Koufaki P, McCafferty K, Nixon AC, Noble H, Saynor Z, Taal MW, Tollit J, Wheeler DC, Wilkinson TJ, Worboys H, Macdonald JH. Evaluating the effect of a digital health intervention to enhance physical activity in people with chronic kidney disease (Kidney BEAM): a multicentre, randomised controlled trial in the UK. Lancet Digit Health. 2024 Jan;6(1):e23-e32. doi: 10.1016/S2589-7500(23)00204-2. Epub 2023 Nov 14.
PubMed 37968170Walklin CG, Young HML, Asghari E, Bhandari S, Billany RE, Bishop N, Bramham K, Briggs J, Burton JO, Campbell J, Castle EM, Chilcot J, Cooper N, Deelchand V, Graham-Brown MPM, Hamilton A, Jesky M, Kalra PA, Koufaki P, McCafferty K, Nixon AC, Noble H, Saynor ZL, Sothinathan C, Taal MW, Tollitt J, Wheeler DC, Wilkinson TJ, Macdonald JH, Greenwood SA. The effect of a novel, digital physical activity and emotional well-being intervention on health-related quality of life in people with chronic kidney disease: trial design and baseline data from a multicentre prospective, wait-list randomised controlled trial (kidney BEAM). BMC Nephrol. 2023 May 2;24(1):122. doi: 10.1186/s12882-023-03173-7.
PubMed 37131125
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Prospective Single-blind Wait-list Randomised Controlled Trial, With Nested Pilot, of the Clinical Value and Economic Evaluation of an Online Physical and Emotional Wellbeing Resource for the Improvement of Health-related Quality of Life in People With Chronic Kidney Disease: The Kidney Beam Trial
- ClinicalTrials.gov ID
- NCT04872933
- Acronym / sponsor ID
- KCH21-043
- Conditions
- Chronic Kidney Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 304 participants (estimated)
- Lead sponsor
- King's College Hospital NHS TrustUniversity, hospital or other
- Collaborators
- Bangor University, University of Portsmouth, University of Leicester, Manchester University NHS Foundation Trust, University Hospitals Bristol and Weston NHS Foundation Trust, Belfast Health and Social Care Trust
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 5 May 2021 (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.
This is a multi-centre single-blind waitlist randomised controlled trial (RCT) that will examine the clinical value and cost-effectiveness of an online physical and emotional wellbeing resource for the improvement of health-related quality of life in people with CKD.
Physical inactivity and poor mental health are very real concerns for people living with kidney disease, and they report multiple symptoms that impact upon the physical component of health-related quality of life (HRQoL). A decrease in the physical component of HRQoL is independently associated with mortality and morbidity. In people living with end stage kidney disease (ESKD), systematic reviews indicate that a range of exercise training interventions improve physical function and alleviate disability symptoms. The physical component of HRQoL can be targeted with interventions to enhance physical activity, however people living with kidney disease are still not routinely offered specialist physical activity or mental health support in the NHS. Kidney Beam is a new wellbeing digital health intervention platform that was developed, and launched, to help people with kidney disease manage their physical and mental health through the Coronavirus 2019 (COVID-19) pandemic, resulting lockdown and beyond. It involves a digital health intervention platform to support people with health conditions to stay physically active. Patients will have access to live-on demand or recorded physical activity classes that they will use for 12 weeks with 2 sessions per week.
The study aims to recruit 304 patients.
Detailed description
Trial Design An investigator-led multicentre single-blind waitlist randomised controlled trial (with nested pilot study) of participants with established chronic kidney disease (CKD). The study will adopt a nested pilot design to preliminarily assess trial and intervention feasibility. To assess this, a traffic light system will be utilised to determine if the study should be halted (red), changes to the design or intervention considered (amber) or is considered feasible and progress to the full trial (green). These criteria will be reviewed and set by the investigators prior to start of study.
Selection of Participants and Procedure
Three hundred and thirty patients aged 18 years or over with established CKD will be enrolled. Potential study trial patients will be identified in outpatient clinic list or approached during their routine hospital visit for an informal chat.
The study team and PI will confirm patient's eligibility. When patient agrees to participate, patient will be asked to sign a consent form. Patient will be scheduled for baseline visit and will be randomised using a secure web-based service. Only by the unblinded member of the study team will be able to randomise patient. Blinded member of the team (research Assistant) will perform the assessment of outcome measures at Baseline and 12 week visit.
After randomisation, patient will be assigned either to waiting list or non-waiting list. If patient is assigned to nonwaiting list group, patient will be asked to attend a total of 3 virtual assessments (baseline, 6M and 12M) and will offered online Kidney BEAM intervention straight away for 12 weeks. If patient is assigned to waiting list group, they will still be asked to complete the 3 virtual assessments but will only start online Kidney BEAM intervention after 12 weeks of being on study. Baseline and 12 week visit will include a review of patient's up to date blood test results, functional capacity (Sit-to stand 60), completion of questionnaire sets and adverse event assessment. After completing the intervention, a highly trained physiotherapist will also conduct qualitative interview to explore patient's experience of the study. For the pilot interviews , up to 15 participants from the intervention arm will be recruited. For the final interviews, up to 30 participants will be recruited in total, from each arm of the trial. Again, data collection will cease at the point where information power is achieved. Interviews are expected to last approximately 60 minutes. At the end of each interview, participants will be given another opportunity to ask questions, or seek clarification and the voluntary nature of their participation will be re-iterated. Should any participant request further information or highlight any concerns during the interview then these will be discussed with the Principal Investigator at their recruiting site, for appropriate onward referral as required.
COVID-19 Sub-study The Kidney Beam trial will contain an exploratory sub-study for any patients with CKD who had COVID-19 or who have been left with CKD following AKI-related to COVID-19 infection. Only patients with history of COVID prior to consent will be assessed using COVID functional status tool at baseline and 12 week visit. Patients who develop COVID while on study will be assessed the same tool on their follow up visit.
For those who had a positive test, an assessment of the severity of their COVID will be made in the following way:
- COVID positive, managed at home not requiring hospital admission
- COVID positive, required hospital admission but no oxygen therapy
- COVID positive, required hospital admission and oxygen therapy
- COVID positive, required hospital admission and non-invasive ventilation
- COVID positive, required hospital admission and admission to intensive care Additional details of the admission, including length of stay and time since discharge will be recorded. Subjects will continue in the study in the same way but will complete the post-COVID functional status tool questionnaire at baseline and follow-up in addition to other outcome measures.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-Waitlist | Other | Other: Kidney Beam Online PlatformPatient will attend a total of 3 virtual assessments whilst in the study: at baseline, at 12 weeks then at 6 months. The online intervention will commence straight after completing the baseline visit. |
| Waitlist | Other | Other: Kidney Beam Online PlatformPatient will be complete assessments at baseline and 12 weeks but will only start the online intervention after the 12-week assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals with established CKD
- Adults aged 18yrs+
- Written or virtual informed consent
Key exclusion criteria (11 listed)
- Weight < 50kg
- Self-reported participation in a structured exercise programme or kidney beam digital health intervention platform within previous 3 months
- Active infection
- Uncontrolled arrhythmias
- Unstable angina or heart attack within the 3 months
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 |
|---|---|---|
| Kidney Beam Online PlatformKidney Beam is a wellbeing digital health intervention platform that offers patients living with kidney disease a way to improve their physical activity and boost their mental health through live and on demand movement classes and expert educational videos, while remaining in their own home. Kidney Beam is led by specialist kidney professionals, including renal physiotherapists and renal counsellors, from a number of different NHS Trusts and backgrounds, as well as people living with kidney disease. | Other | Non-Waitlist, Waitlist |
Primary outcome
Mental Composite Score (MCS) of KDQOL-36 quality of life questionnaire at 12 weeks.
Time frame: Week 12
To assess the clinical value of the Kidney Beam digital health intervention platform
10 secondary outcomes
Patient activation measure (PAM-13)
Time frame: Week 12
Chalder Fatigue Questionnaire -- physical and mental fatigue
Time frame: Baseline and week 12
Patient Health Questionnaire-4 (PHQ-4)
Time frame: Baseline
Functional capacity
Time frame: Baseline and Week12
Quality of life score
Time frame: Baseline, Week12 and 6 month follow up
Global Physical Activity Questionnaire
Time frame: Baseline and Week 12
Clinical Frailty Score
Time frame: Baseline and Week 12
Qualitative exploration of intervention and trial acceptability and participant experience
Time frame: End of 12 week pilot phase and Week 12
Adverse events
Time frame: Baseline and Week 12
Kidney Beam platform metrics
Time frame: Week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
- Derived from this study: PubMed 41989885Walklin C, Briggs J, Freeman S, Mangahis E, Dias C, Bhandari S, Bramham K, Burton JO, Campbell J, Kalra PA, Macdonald J, Taal MW, Wheeler DC, Greenwood SA, Young HML. A Digital Inclusion Intervention to Improve Access to a Digital Health Intervention Among Digitally Excluded Adults: Mixed Methods Pilot Randomized Controlled Trial. JMIR Form Res. 2026 Apr 16;10:e91438. doi: 10.2196/91438.
- Derived from this study: PubMed 39534205Greenwood SA, Briggs J, Walklin C, Mangahis E, Young HML, Castle EM, Billany RE, Asgari E, Bhandari S, Bishop N, Bramham K, Burton JO, Campbell J, Chilcot J, Cooper N, Deelchand V, Graham-Brown MPM, Haggis L, Hamilton A, Jesky M, Kalra PA, Koufaki P, McCafferty K, Nixon AC, Noble H, Saynor ZL, Taal MW, Tollitt J, Wheeler DC, Wilkinson TJ, Worboys H, Macdonald J. Kidney Beam-A Cost-Effective Digital Intervention to Improve Mental Health. Kidney Int Rep. 2024 Sep 2;9(11):3204-3217. doi: 10.1016/j.ekir.2024.08.030. eCollection 2024 Nov.
- Derived from this study: PubMed 38184737Young HML, Castle EM, Briggs J, Walklin C, Billany RE, Asgari E, Bhandari S, Bishop N, Bramham K, Burton JO, Campbell J, Chilcot J, Cooper N, Deelchand V, Graham-Brown MPM, Haggis L, Hamilton A, Jesky M, Kalra PA, Koufaki P, Macdonald J, McCafferty K, Nixon AC, Noble H, Saynor ZL, Taal MW, Tollitt J, Wheeler DC, Wilkinson TJ, Greenwood SA. The development and internal pilot trial of a digital physical activity and emotional well-being intervention (Kidney BEAM) for people with chronic kidney disease. Sci Rep. 2024 Jan 6;14(1):700. doi: 10.1038/s41598-023-50507-4.
- Derived from this study: PubMed 37968170Greenwood SA, Young HML, Briggs J, Castle EM, Walklin C, Haggis L, Balkin C, Asgari E, Bhandari S, Burton JO, Billany RE, Bishop NC, Bramham K, Campbell J, Chilcot J, Cooper NJ, Deelchand V, Graham-Brown MPM, Hamilton A, Jesky M, Kalra PA, Koufaki P, McCafferty K, Nixon AC, Noble H, Saynor Z, Taal MW, Tollit J, Wheeler DC, Wilkinson TJ, Worboys H, Macdonald JH. Evaluating the effect of a digital health intervention to enhance physical activity in people with chronic kidney disease (Kidney BEAM): a multicentre, randomised controlled trial in the UK. Lancet Digit Health. 2024 Jan;6(1):e23-e32. doi: 10.1016/S2589-7500(23)00204-2. Epub 2023 Nov 14.
- Derived from this study: PubMed 37131125Walklin CG, Young HML, Asghari E, Bhandari S, Billany RE, Bishop N, Bramham K, Briggs J, Burton JO, Campbell J, Castle EM, Chilcot J, Cooper N, Deelchand V, Graham-Brown MPM, Hamilton A, Jesky M, Kalra PA, Koufaki P, McCafferty K, Nixon AC, Noble H, Saynor ZL, Sothinathan C, Taal MW, Tollitt J, Wheeler DC, Wilkinson TJ, Macdonald JH, Greenwood SA. The effect of a novel, digital physical activity and emotional well-being intervention on health-related quality of life in people with chronic kidney disease: trial design and baseline data from a multicentre prospective, wait-list randomised controlled trial (kidney BEAM). BMC Nephrol. 2023 May 2;24(1):122. doi: 10.1186/s12882-023-03173-7.
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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.
Sharlene Greenwood, Dr principal investigator
Kings College Hospital NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kidney Beam Online Platform in people with Chronic Kidney Diseases, run by King's College Hospital NHS Trust 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 11 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 5 May 2021. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental Composite Score (MCS) of KDQOL-36 quality of life questionnaire at 12 weeks. (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04872933, which also lists 5 linked publications.
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 5 May 2021.