The development and internal pilot trial of a digital physical activity and emotional well-being intervention (Kidney BEAM) for people with chronic kidney disease.


Journal

Scientific reports
ISSN: 2045-2322
Titre abrégé: Sci Rep
Pays: England
ID NLM: 101563288

Informations de publication

Date de publication:
06 Jan 2024
Historique:
received: 15 09 2023
accepted: 20 12 2023
medline: 7 1 2024
pubmed: 7 1 2024
entrez: 6 1 2024
Statut: epublish

Résumé

This trial assessed the feasibility and acceptability of Kidney BEAM, a physical activity and emotional well-being self-management digital health intervention (DHI) for people with chronic kidney disease (CKD), which offers live and on-demand physical activity sessions, educational blogs and videos, and peer support. In this mixed-methods, multicentre randomised waitlist-controlled internal pilot, adults with established CKD were recruited from five NHS hospitals and randomised 1:1 to Kidney BEAM or waitlist control. Feasibility outcomes were based upon a priori progression criteria. Acceptability was primarily explored via individual semi-structured interviews (n = 15). Of 763 individuals screened, n = 519 (68%, 95% CI 65 to 71%) were eligible. Of those eligible, n = 303 (58%, 95% CI 54-63%) did not respond to an invitation to participate by the end of the pilot period. Of the 216 responders, 50 (23%, 95% CI 18-29%) consented. Of the 42 randomised, n = 22 (10 (45%) male; 49 ± 16 years; 14 (64%) White British) were allocated to Kidney BEAM and n = 20 (12 (55%) male; 56 ± 11 years; 15 (68%) White British) to the waitlist control group. Overall, n = 15 (30%, 95% CI 18-45%) withdrew during the pilot phase. Participants completed a median of 14 (IQR 5-21) sessions. At baseline, 90-100% of outcome data (patient reported outcome measures and a remotely conducted physical function test) were completed and 62-83% completed at 12 weeks follow-up. Interview data revealed that remote trial procedures were acceptable. Participants' reported that Kidney BEAM increased their opportunity and motivation to be physically active, however, lack of time remained an ongoing barrier to engagement with the DHI. An randomised controlled trial of Kidney BEAM is feasible and acceptable, with adaptations to increase recruitment, retention and engagement.Trial registration NCT04872933. Date of first registration 05/05/2021.

Identifiants

pubmed: 38184737
doi: 10.1038/s41598-023-50507-4
pii: 10.1038/s41598-023-50507-4
doi:

Banques de données

ClinicalTrials.gov
['NCT04872933']

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

700

Informations de copyright

© 2024. The Author(s).

Références

Bikbov, B. et al. Global, regional, and national burden of chronic kidney disease, 1990–2017: A systematic analysis for the Global Burden of Disease Study 2017. Lancet 395(10225), 709–733 (2020).
doi: 10.1016/S0140-6736(20)30045-3
Fletcher, B. R. et al. Symptom burden and health-related quality of life in chronic kidney disease: A global systematic review and meta-analysis. PLoS Med. 19(4), e1003954 (2022).
pubmed: 35385471 pmcid: 8985967 doi: 10.1371/journal.pmed.1003954
Zhang, F. et al. Therapeutic effects of exercise interventions for patients with chronic kidney disease: An umbrella review of systematic reviews and meta-analyses. BMJ Open 12(9), e054887 (2022).
pubmed: 36123085 pmcid: 9486234 doi: 10.1136/bmjopen-2021-054887
Jeddi, F. R., Nabovati, E. & Amirazodi, S. Features and effects of information technology-based interventions to improve self-management in chronic kidney disease patients: A systematic review of the literature. J. Med. Syst. 41, 1–13 (2017).
doi: 10.1007/s10916-017-0820-6
Greenwood, S. A. et al. Exercise counselling practices for patients with chronic kidney disease in the UK: A renal multidisciplinary team perspective. Nephron Clin. Pract. 128(1–2), 67–72 (2014).
pubmed: 25358965 doi: 10.1159/000363453
Kyaw, T. L. et al. Cost-effectiveness of digital tools for behavior change interventions among people with chronic diseases: Systematic review. Interact. J. Med. Res. 12(1), e42396 (2023).
pubmed: 36795470 pmcid: 9982716 doi: 10.2196/42396
Mayes, J. et al. The rapid development of a novel kidney-specific digital intervention for self-management of physical activity and emotional well-being during the COVID-19 pandemic and beyond: Kidney Beam. Clin. Kidney J. 15(3), 571–573 (2022).
pubmed: 35198162 doi: 10.1093/ckj/sfab239
Taylor, M. L. et al. Digital health experiences reported in chronic disease management: An umbrella review of qualitative studies. J. Telemed. Telecare 28(10), 705–717 (2022).
pubmed: 36346938 doi: 10.1177/1357633X221119620
Stevenson, J. K. et al. eHealth interventions for people with chronic kidney disease. Cochrane Database Syst. Rev. https://doi.org/10.1002/14651858.CD012379.pub2 (2019).
doi: 10.1002/14651858.CD012379.pub2 pubmed: 31425608 pmcid: 6699665
O’connor, S. et al. Understanding factors affecting patient and public engagement and recruitment to digital health interventions: A systematic review of qualitative studies. BMC Med. Inform. Decis. Mak. 16, 1–15 (2016).
doi: 10.1186/s12911-016-0359-3
Antoun, J. et al. Understanding the impact of initial COVID-19 restrictions on physical activity, wellbeing and quality of life in shielding adults with end-stage renal disease in the United Kingdom dialysing at home versus in-centre and their experiences with telemedicine. Int. J. Environ. Res. Public Health 18(6), 3144 (2021).
pubmed: 33803708 pmcid: 8002886 doi: 10.3390/ijerph18063144
Walklin, C. et al. 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. 24(1), 122 (2023).
pubmed: 37131125 pmcid: 10152439 doi: 10.1186/s12882-023-03173-7
Eldridge, S. M. et al. CONSORT 2010 statement: Extension to randomised pilot and feasibility trials. BMJ 355, i5239 (2016).
pubmed: 27777223 pmcid: 5076380 doi: 10.1136/bmj.i5239
Boutron, I. et al. CONSORT statement for randomized trials of nonpharmacologic treatments: A 2017 update and a CONSORT extension for nonpharmacologic trial abstracts. Ann. Internal med. 167(1), 40–47 (2017).
doi: 10.7326/M17-0046
Eysenbach G, Group C-E. CONSORT-EHEALTH: Improving and standardizing evaluation reports of Web-based and mobile health interventions. J. Med. Internet Res. 13(4), e1923 (2011).
doi: 10.2196/jmir.1923
Research NIoH. Remote trial delivery 2022. https://sites.google.com/nihr.ac.uk/remotetrialdelivery/home (Accessed December 2022).
Tong, A., Sainsbury, P. & Craig, J. Consolidated criteria for reporting qualitative research (COREQ): A 32-item checklist for interviews and focus groups. Int. J. Qual. Health Care 19(6), 349–357 (2007).
pubmed: 17872937 doi: 10.1093/intqhc/mzm042
Herbert, E., Julious, S. A. & Goodacre, S. Progression criteria in trials with an internal pilot: An audit of publicly funded randomised controlled trials. Trials 20(1), 1–9 (2019).
doi: 10.1186/s13063-019-3578-y
Levey, A. S. et al. Definition and classification of chronic kidney disease: A position statement from kidney disease: Improving global outcomes (KDIGO). Kidney Int. 67(6), 2089–2100 (2005).
pubmed: 15882252 doi: 10.1111/j.1523-1755.2005.00365.x
O’Cathain, A. et al. Guidance on how to develop complex interventions to improve health and healthcare. BMJ Open 9(8), e029954 (2019).
pubmed: 31420394 pmcid: 6701588 doi: 10.1136/bmjopen-2019-029954
West, R. & Michie, S. A Guide to Development and Evaluation of Digital Behaviour Interventions in Healthcare (Silverback Publishing, 2016).
NIHR. Guidance on co-producing a research project. https://www.learningforinvolvement.org.uk/?opportunity=nihr-guidance-on-co-producing-a-research-project (2021).
Clemensen, J. et al. Participatory design in health sciences: Using cooperative experimental methods in developing health services and computer technology. Qual. Health Res. 17(1), 122–130 (2007).
pubmed: 17170250 doi: 10.1177/1049732306293664
Zeng, J. et al. The exercise perceptions of people treated with peritoneal dialysis. J. Renal Care 46(2), 106–114 (2020).
doi: 10.1111/jorc.12313
Barriers and facilitators for engagement and implementation of exercise in end‐stage kidney disease: Future theory‐based interventions using the behavior change wheel. Seminars in dialysis (Wiley Online Library, 2019).
Clarke, A. L. et al. Motivations and barriers to exercise in chronic kidney disease: A qualitative study. Nephrol. Dial. Transplant. 30(11), 1885–1892 (2015).
pubmed: 26056174 doi: 10.1093/ndt/gfv208
Castle, E. M. et al. Usability and experience testing to refine an online intervention to prevent weight gain in new kidney transplant recipients. Br. J. Health Psychol. 26(1), 232–255 (2021).
pubmed: 32931645 doi: 10.1111/bjhp.12471
Billany, R. E. et al. Perceived barriers and facilitators to exercise in kidney transplant recipients: A qualitative study. Health Expect. 25(2), 764–774 (2022).
pubmed: 35014114 pmcid: 8957725 doi: 10.1111/hex.13423
Michie, S., Atkins, L. & West, R. The Behaviour Change Wheel. A Guide to Designing Interventions 1st edn, 1003–1010 (Silverback Publishing, 2014).
Michie, S., Van Stralen, M. M. & West, R. The behaviour change wheel: A new method for characterising and designing behaviour change interventions. Implement. sci. 6(1), 1–12 (2011).
doi: 10.1186/1748-5908-6-42
Michie, S. et al. The behavior change technique taxonomy (v1) of 93 hierarchically clustered techniques: Building an international consensus for the reporting of behavior change interventions. Ann. Behav. Med. 46(1), 81–95 (2013).
pubmed: 23512568 doi: 10.1007/s12160-013-9486-6
Brhel, M. et al. Exploring principles of user-centered agile software development: A literature review. Inf. Softw. Technol. 61, 163–181 (2015).
doi: 10.1016/j.infsof.2015.01.004
Hoffmann, T. C. et al. Better reporting of interventions: Template for intervention description and replication (TIDieR) checklist and guide. BMJ https://doi.org/10.1136/bmj.g1687 (2014).
doi: 10.1136/bmj.g1687 pubmed: 24609605 pmcid: 3898420
Sim, J. & Lewis, M. The size of a pilot study for a clinical trial should be calculated in relation to considerations of precision and efficiency. J. Clin. Epidemiol. 65(3), 301–308 (2012).
pubmed: 22169081 doi: 10.1016/j.jclinepi.2011.07.011
Ritchie, J. et al. Qualitative Research Practice: A Guide for Social Science Students and Researchers (Sage, 2013).
Malterud, K., Siersma, V. D. & Guassora, A. D. Sample size in qualitative interview studies: Guided by information power. Qual. Health Res. 26(13), 1753–1760 (2016).
pubmed: 26613970 doi: 10.1177/1049732315617444
Ozalevli, S. et al. Comparison of the Sit-to-Stand Test with 6 min walk test in patients with chronic obstructive pulmonary disease. Respir. Med. 101(2), 286–293 (2007).
pubmed: 16806873 doi: 10.1016/j.rmed.2006.05.007
Avery, K. N. et al. Informing efficient randomised controlled trials: Exploration of challenges in developing progression criteria for internal pilot studies. BMJ Open 7(2), e013537 (2017).
pubmed: 28213598 pmcid: 5318608 doi: 10.1136/bmjopen-2016-013537
Gale, N. K. et al. Using the framework method for the analysis of qualitative data in multi-disciplinary health research. BMC Med. Res. Methodol. 13(1), 1–8 (2013).
doi: 10.1186/1471-2288-13-117
Tracy, S. J. Qualitative quality: Eight “big-tent” criteria for excellent qualitative research. Qual. Inquiry 16(10), 837–851 (2010).
doi: 10.1177/1077800410383121
Creswell, J. W. & Clark, V. L. P. Designing and Conducting Mixed Methods Research (Sage publications, 2017).
Anding-Rost, K. et al. Exercise during hemodialysis in patients with chronic kidney failure. NEJM Evid. https://doi.org/10.1056/EVIDoa2300057 (2023).
doi: 10.1056/EVIDoa2300057
Manfredini, F. et al. Exercise in patients on dialysis: A multicenter, randomized clinical trial. J. Am. Soc. Nephrol. JASN 28(4), 1259 (2017).
pubmed: 27909047 doi: 10.1681/ASN.2016030378
Hellberg, M. et al. Randomized controlled trial of exercise in CKD—The RENEXC study. Kidney Int. Rep. 4(7), 963–976 (2019).
pubmed: 31312771 pmcid: 6609793 doi: 10.1016/j.ekir.2019.04.001
Ancliffe, L. C. E., Wilkinson, T. & Young, H. M. L. The Stark Landscape of Kidney Rehabilitation Services in the UK: Is the kidney Therapy Workforce Really a Priority? (UK Kidney Week, 2023).
Gorst, S. L. et al. Home telehealth uptake and continued use among heart failure and chronic obstructive pulmonary disease patients: A systematic review. Ann. Behav. Med. 48(3), 323–336 (2014).
pubmed: 24763972 doi: 10.1007/s12160-014-9607-x
Masoli, J. A. et al. A report from the NIHR UK working group on remote trial delivery for the COVID-19 pandemic and beyond. Trials 22(1), 1–10 (2021).
doi: 10.1186/s13063-021-05880-8
McDermott, M. M. & Newman, A. B. Remote research and clinical trial integrity during and after the coronavirus pandemic. JAMA 325(19), 1935–1936 (2021).
pubmed: 33885728 doi: 10.1001/jama.2021.4609
Brøgger-Mikkelsen, M. et al. Online patient recruitment in clinical trials: Systematic review and meta-analysis. J. Med. Internet Res. 22(11), e22179 (2020).
pubmed: 33146627 pmcid: 7673977 doi: 10.2196/22179
Daniore, P., Nittas, V. & von Wyl, V. Enrollment and retention of participants in remote digital health studies: Scoping review and framework proposal. J. Med. Internet Res. 24(9), e39910 (2022).
pubmed: 36083626 pmcid: 9508669 doi: 10.2196/39910
Pratap, A. et al. Indicators of retention in remote digital health studies: A cross-study evaluation of 100,000 participants. NPJ Digit. Med. 3(1), 21 (2020).
pubmed: 32128451 pmcid: 7026051 doi: 10.1038/s41746-020-0224-8
Registry UR. UK Renal Registry 24th Annual Report—Data to. https://ukkidney.org/audit-research/annual-report (Accessed 31 December 2020) (2022).
Wilkinson, T. J. et al. Associations between frailty trajectories and cardiovascular, renal, and mortality outcomes in chronic kidney disease. J. Cachexia Sarcopenia Muscle 13(5), 2426–2435 (2022).
pubmed: 35851589 pmcid: 9530530 doi: 10.1002/jcsm.13047
Silva, R. et al. The effect of physical exercise on frail older persons: A systematic review. J. Frailty Aging 6(2), 91–96 (2017).
pubmed: 28555710
Solis-Navarro, L. et al. Effectiveness of home-based exercise delivered by digital health in older adults: A systematic review and meta-analysis. Age Ageing 51(11), afac243 (2022).
pubmed: 36346736 pmcid: 9642810
Jakob, R. et al. Factors influencing adherence to mHealth apps for prevention or management of noncommunicable diseases: Systematic review. J. Med. Internet Res. 24(5), e35371 (2022).
pubmed: 35612886 pmcid: 9178451 doi: 10.2196/35371
Greenwood, S. A. et al. Evaluation of a pragmatic exercise rehabilitation programme in chronic kidney disease. Nephrol. Dial. Transplant. 27(suppl_3), iii126–iii34 (2012).
pubmed: 22785111
Shen, H. et al. Electronic health self-management interventions for patients with chronic kidney disease: Systematic review of quantitative and qualitative evidence. J. Med. Internet Res. 21(11), e12384 (2019).
pubmed: 31687937 pmcid: 6864489 doi: 10.2196/12384
Stauss, M. et al. Opportunities in the cloud or pie in the sky? Current status and future perspectives of telemedicine in nephrology. Clin. Kidney J. 14(2), 492–506 (2021).
pubmed: 33619442 doi: 10.1093/ckj/sfaa103
Unit TS. Improving Digital Health Inclusion: evidence scan 2020. https://www.strategyunitwm.nhs.uk/sites/default/files/2021-04/Digital%20Inclusion%20evidence%20scan.pdf (Accessed 29th March 2023).
Herrera, S., Salazar, A. & Nazar, G. Barriers and supports in eHealth implementation among people with chronic cardiovascular ailments: Integrative review. Int. J. Environ. Res. Public Health 19(14), 8296 (2022).
pubmed: 35886149 pmcid: 9318125 doi: 10.3390/ijerph19148296
Linn, N. et al. Digital health interventions among people living with frailty: A scoping review. J. Am. Med. Dir. Assoc. 22(9), 1802–1812 (2021).
pubmed: 34000266 doi: 10.1016/j.jamda.2021.04.012
Mitchell, U. A., Chebli, P. G., Ruggiero, L. & Muramatsu, N. The digital divide in health-related technology use: The significance of race/ethnicity. Gerontologist 59(1), 6–14 (2019).
pubmed: 30452660 doi: 10.1093/geront/gny138

Auteurs

Hannah M L Young (HML)

Leicester Diabetes Centre, University Hospitals of Leicester NHS Trust, Leicester, UK. hy162@le.ac.uk.
Diabetes Research Centre, University of Leicester, Leicester, UK. hy162@le.ac.uk.
National Institute of Health Research Leicester Biomedical Research Centre, Leicester, UK. hy162@le.ac.uk.

Ellen M Castle (EM)

School of Physiotherapy, Department of Health Sciences, Brunel University, London, UK.

Juliet Briggs (J)

Renal Department, King's College Hospital, London, UK.

Christy Walklin (C)

Renal Department, King's College Hospital, London, UK.

Roseanne E Billany (RE)

Department of Cardiovascular Sciences, University of Leicester, Leicester, UK.

Elham Asgari (E)

Department of Nephrology, Guys and St Thomas's Hospital, London, UK.

Sunil Bhandari (S)

Department of Nephrology, Hull University Teaching Hospitals NHS Trust, Hull, UK.

Nicolette Bishop (N)

School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK.

Kate Bramham (K)

Renal Department, King's College Hospital, London, UK.

James O Burton (JO)

Department of Cardiovascular Sciences, University of Leicester, Leicester, UK.

Jackie Campbell (J)

Faculty of Health, Education and Society, University of Northampton, Northampton, UK.

Joseph Chilcot (J)

Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, UK.

Nicola Cooper (N)

Department of Population Health Science, University of Leicester, Leicester, UK.

Vashist Deelchand (V)

Department of Nephrology Royal Free Hospital, London, UK.

Matthew P M Graham-Brown (MPM)

Department of Cardiovascular Sciences, University of Leicester, Leicester, UK.

Lynda Haggis (L)

Renal Department, King's College Hospital, London, UK.

Alexander Hamilton (A)

Department of Nephrology, Royal Devon and Exeter NHS Foundation Trust, Exeter, UK.

Mark Jesky (M)

Department of Nephrology, Nottingham NHS Trust, Nottingham, UK.

Philip A Kalra (PA)

Department of Nephrology Royal Hospital, Northern Care Alliance NHS Foundation Trust, Salford, UK.

Pelagia Koufaki (P)

Dietetics, Nutrition & Biological Sciences, Physiotherapy, Podiatry & Radiography Division, Queen Margaret University, Edinburgh, UK.

Jamie Macdonald (J)

Institute for Applied Human Physiology, Bangor University, Bangor, UK.

Kieran McCafferty (K)

Department of Nephrology, Barts Health NHS Trust, London, UK.

Andrew C Nixon (AC)

Department of Renal Medicine, Lancashire Teaching Hospitals NHS Foundation Trust, Preston, UK.
Division of Cardiovascular Sciences, The University of Manchester, Manchester, UK.

Helen Noble (H)

School of Nursing and Midwifery, Queen's University Belfast, Belfast, UK.

Zoe L Saynor (ZL)

School of Sport, Health and Exercise Science, University of Portsmouth, Portsmouth, UK.

Maarten W Taal (MW)

Centre for Kidney Research and Innovation, University of Nottingham, Nottingham, UK.

James Tollitt (J)

Department of Nephrology Royal Hospital, Northern Care Alliance NHS Foundation Trust, Salford, UK.

David C Wheeler (DC)

Department of Renal Medicine, University College London, London, UK.

Thomas J Wilkinson (TJ)

National Institute of Health Research Leicester Biomedical Research Centre, Leicester, UK.

Sharlene A Greenwood (SA)

Renal Department, King's College Hospital, London, UK.

Classifications MeSH