TY - JOUR
T1 - The development and internal pilot trial of a digital physical activity and emotional well-being intervention (Kidney BEAM) for people with chronic kidney disease
AU - Young, Hannah M.L
AU - Castle, Ellen M.
AU - Briggs, Juliet
AU - Walklin, Christy
AU - Billany, Roseanne E
AU - Asgari, Elham
AU - Bhandari, Sunil
AU - Bishop, Nicolette
AU - Bramham, Kate
AU - Burton, James O
AU - Campbell, Jackie
AU - Chilcot, Joseph
AU - Cooper, Nicola
AU - Deelchand, Vashist
AU - Graham-Brown, Matthew P.M
AU - Haggis, Lynda
AU - Hamilton, Alexander
AU - Jesky, Mark
AU - Kalra, Philip A
AU - Koufaki, Pelagia
AU - Macdonald, Jamie H.
AU - McCafferty, Kieran
AU - Nixon, Andrew C
AU - Noble, Helen
AU - Saynor, Zoe L
AU - Taal, Maarten W
AU - Tollitt, James
AU - Wheeler, David C.
AU - Wilkinson, Thomas J
AU - Greenwood, Sharlene A.
N1 - Funding Information:
This trial was funded by a grant from Kidney Research UK. Funding for Kidney Beam is currently supported by the four major UK charities: Kidney Research UK, Kidney Care UK, National Kidney Federation and the UK Kidney Association. HMLY is funded by the NIHR [NIHR302926]. Part of this research was carried out at the National Institute for Health and Care Research (NIHR) Leicester Biomedical Research Centre (BRC). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. The funders had no role in the design, collection, analysis, interpretation of the data, or writing of this protocol.
Publisher Copyright:
© 2024, The Author(s).
PY - 2024/1/6
Y1 - 2024/1/6
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85181500276&partnerID=8YFLogxK
U2 - 10.1038/s41598-023-50507-4
DO - 10.1038/s41598-023-50507-4
M3 - Article
SN - 2045-2322
VL - 14
JO - Scientific Reports
JF - Scientific Reports
IS - 1
M1 - 700
ER -