NCT04872933

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
304

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 21, 2021

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 23, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 5, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2023

Completed
Last Updated

May 5, 2021

Status Verified

April 1, 2021

Enrollment Period

2.4 years

First QC Date

April 23, 2021

Last Update Submit

April 29, 2021

Conditions

Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Patient activation measure (PAM-13)

    Week 12

  • Chalder Fatigue Questionnaire -- physical and mental fatigue

    Baseline and week 12

  • Patient Health Questionnaire-4 (PHQ-4)

    Baseline

  • Functional capacity

    Baseline and Week12

  • Quality of life score

    Baseline, Week12 and 6 month follow up

  • +5 more secondary outcomes

Study Arms (2)

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.

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.

Other: Kidney Beam Online Platform

Interventions

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.

Non-WaitlistWaitlist

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals with established CKD
  • Adults aged 18yrs+
  • Written or virtual informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kings College Hospital

London, SE5 9RS, United Kingdom

Location

Related Publications (4)

  • Greenwood 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.

    PMID: 39534205DERIVED

  • Young 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.

    PMID: 38184737DERIVED

  • Greenwood 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.

    PMID: 37968170DERIVED

  • Walklin 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.

    PMID: 37131125DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sharlene Greenwood, Dr

    Kings College Hospital NHS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2021

First Posted

May 5, 2021

Study Start

April 21, 2021

Primary Completion

September 1, 2023

Study Completion

September 1, 2023

Last Updated

May 5, 2021

Record last verified: 2021-04

Locations

GB(1)