Clinical trial NCT04872933: The Kidney BEAM 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Kidney Diseases
Lead sponsor: King's College Hospital NHS Trust
Sponsor class: OTHER
Collaborators: name: Bangor University
name: University of Portsmouth
name: University of Leicester
name: Manchester University NHS Foundation Trust
name: University Hospitals Bristol and Weston NHS Foundation Trust
name: Belfast Health and Social Care Trust
First posted: 2021-05-05
Enrollment: 304
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mental Composite Score (MCS) of KDQOL-36 quality of life questionnaire at 12 weeks.
timeFrame: Week 12
Secondary outcomes:
measure: Patient activation measure (PAM-13)
timeFrame: Week 12
measure: Chalder Fatigue Questionnaire -- physical and mental fatigue
timeFrame: Baseline and week 12
measure: Patient Health Questionnaire-4 (PHQ-4)
timeFrame: Baseline
measure: Functional capacity
timeFrame: Baseline and Week12
measure: Quality of life score
timeFrame: Baseline, Week12 and 6 month follow up
measure: Global Physical Activity Questionnaire
timeFrame: Baseline and Week 12
measure: Clinical Frailty Score
timeFrame: Baseline and Week 12
measure: Qualitative exploration of intervention and trial acceptability and participant experience
timeFrame: End of 12 week pilot phase and Week 12
measure: Adverse events
timeFrame: Baseline and Week 12
measure: Kidney Beam platform metrics
timeFrame: Week 12
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Kings College Hospital
Study officials:
affiliation: Kings College Hospital NHS Trust
name: Sharlene Greenwood, Dr
role: PRINCIPAL_INVESTIGATOR
References: