The Kidney BEAM Trial

Chronic Kidney Diseases Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04872933
• Other study ID #: KCH21-043
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 21, 2021
• Est. completion date: September 2023

Study information

• Verified date: April 2021
• Source: King's College Hospital NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 304
• Est. completion date: September 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Individuals with established CKD

• Adults aged 18yrs+

• Written or virtual informed consent

Exclusion Criteria:

• 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)

• 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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• Kidney Beam Online Platform
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.

Locations

Country	Name	City	State
United Kingdom	Kings College Hospital	London

Sponsors (7)

Lead Sponsor	Collaborator
King's College Hospital NHS Trust	Bangor University, Belfast Health and Social Care Trust, Manchester University NHS Foundation Trust, University Hospitals Bristol and Weston NHS Foundation Trust, University of Leicester, University of Portsmouth

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Week 12
Secondary	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.	Week 12
Secondary	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	Baseline and week 12
Secondary	Patient Health Questionnaire-4 (PHQ-4)	The Patient-Health Questionnaire-4 (PHQ-4) is an ultra-brief screener for depression and anxiety	Baseline
Secondary	Functional capacity	STS60 (Sit-to-Stand 60 second) to provide a measure of muscle endurance, another aspect of physical performance	Baseline and Week12
Secondary	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)	Baseline, Week12 and 6 month follow up
Secondary	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	Baseline and Week 12
Secondary	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	Baseline and Week 12
Secondary	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.	End of 12 week pilot phase and Week 12
Secondary	Adverse events	Episodes of hospitalisation and other infection episodes will be documented and analysed descriptively.	Baseline and Week 12
Secondary	Kidney Beam platform metrics	To assess physical activity and engagement on the Kidney BEAM platform	Week 12