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一项针对慢性肾脏病患者的数字身体活动和情绪健康干预(Kidney BEAM)的开发和内部试点试验。

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

机构信息

Leicester Diabetes Centre, University Hospitals of Leicester NHS Trust, Leicester, UK.

Diabetes Research Centre, University of Leicester, Leicester, UK.

出版信息

Sci Rep. 2024 Jan 6;14(1):700. doi: 10.1038/s41598-023-50507-4.

Abstract

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.

摘要

这项试验评估了 Kidney BEAM 的可行性和可接受性,这是一种针对慢性肾脏病 (CKD) 患者的身体活动和情绪健康自我管理数字健康干预 (DHI),提供现场和按需的身体活动课程、教育博客和视频以及同伴支持。在这项混合方法、多中心随机等待名单对照内部试验中,从五家 NHS 医院招募了已确诊 CKD 的成年人,并按 1:1 随机分配到 Kidney BEAM 组或等待名单对照组。可行性结果基于事先规定的进展标准。可接受性主要通过个人半结构化访谈(n=15)进行探索。在筛选出的 763 人中,n=519 人(68%,95%CI 65-71%)符合条件。在符合条件的人中,n=303 人(58%,95%CI 54-63%)在试验期间结束前未回复参与邀请。在 216 名应答者中,n=50 人(23%,95%CI 18-29%)同意。在 42 名随机分组的人中,n=22 人(10 名(45%)男性;49±16 岁;14 名(64%)白种英国人)被分配到 Kidney BEAM 组,n=20 人(12 名(55%)男性;56±11 岁;15 名(68%)白种英国人)被分配到等待名单对照组。总体而言,n=15 人(30%,95%CI 18-45%)在试验阶段退出。参与者完成了中位数为 14 次(IQR 5-21 次)的课程。在基线时,90-100%的结果数据(患者报告的结果测量和远程进行的身体功能测试)已完成,62-83%在 12 周随访时完成。访谈数据显示,远程试验程序是可以接受的。参与者报告说,Kidney BEAM 增加了他们进行身体活动的机会和动力,然而,缺乏时间仍然是参与 DHI 的一个持续障碍。Kidney BEAM 的随机对照试验是可行和可接受的,需要进行调整以增加招募、保留和参与。试验注册 NCT04872933。首次注册日期 2021 年 5 月 5 日。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4bca/10771473/95c1d65491fc/41598_2023_50507_Fig1_HTML.jpg

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