Improving self-management behaviour through a digital lifestyle intervention: An internal pilot study

IF 1.5 4区医学 Q3 NURSING

Journal of renal care Pub Date : 2024-01-31 DOI:10.1111/jorc.12488

Courtney J. Lightfoot PhD, Thomas J. Wilkinson PhD, Noemi Vadaszy PhD, Matthew P. M. Graham-Brown PhD, Melanie J. Davies MD, Thomas Yates PhD, Alice C. Smith PhD

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Abstract

Background

Self-management is a key component of successful chronic kidney disease (CKD) management. Here, we present the findings from the internal pilot of a multicentre randomised controlled trial (RCT) aimed to test the effect of a digital self-management programme (‘My Kidneys & Me’ (MK&M)).

Methods

Participants (aged ≥18 years and CKD stages 3-4) were recruited from hospital kidney services across England. Study processes were completed virtually. Participants were randomised 2:1 to either intervention (MK&M) or control group. The first 60 participants recruited were included in a 10-week internal pilot which assessed study feasibility and acceptability against pre-specified progression criteria: 1) eligibility and recruitment, acceptability of 2) randomisation and 3) outcomes, 4) MK&M activation, and 5) retention and attrition rates. Semi-structured interviews further explored views on trial participation.

Results

Of the 60 participants recruited, 41 were randomised to MK&M and 19 to control. All participants completed baseline measures and 62% (n=37) completed post-intervention outcome measures. All progression criteria met the minimum thresholds to proceed. Nine participants were interviewed. The themes identified were satisfaction with study recruitment processes (openness to participate, reading and agreeing to “terms and conditions”), acceptability of study design (remote study participation, acceptability of randomisation, completion of online assessment(s)), and methods to improve recruitment and retention (personalised approach, follow-up communication).

Conclusion

This internal pilot demonstrated the feasibility and acceptability of a virtually run RCT. Progression criteria thresholds to proceed to the definitive RCT were met. Areas for improvement were identified and protocol amendments were made to improve trial delivery.

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通过数字化生活方式干预改善自我管理行为：内部试点研究

背景：自我管理是成功控制慢性肾脏病（CKD）的关键因素。在此，我们介绍一项多中心随机对照试验（RCT）的内部试点结果，该试验旨在测试数字自我管理项目（"我的肾脏与我"（MK&M））的效果：方法：从英格兰各地的医院肾脏服务部门招募参与者（年龄≥18 岁，慢性肾脏病分期为 3-4 期）。研究过程以虚拟方式完成。参与者按 2:1 随机分配到干预组（MK&M）或对照组。首批招募的 60 名参与者被纳入为期 10 周的内部试点，根据预先规定的进展标准评估研究的可行性和可接受性：1) 资格和招募，2) 随机化的可接受性，3) 结果，4) MK&M 激活，5) 保留率和流失率。半结构式访谈进一步探讨了对参与试验的看法：在招募的 60 名参与者中，41 人被随机分配到 MK&M 项目，19 人被随机分配到对照项目。所有参与者都完成了基线测量，62%（n=37）的参与者完成了干预后结果测量。所有进展标准都达到了继续进行的最低阈值。九名参与者接受了访谈。确定的主题包括对研究招募过程的满意度（参与的开放性、阅读并同意 "条款和条件"）、研究设计的可接受性（远程研究参与、随机化的可接受性、在线评估的完成）以及改进招募和保留的方法（个性化方法、后续沟通）：此次内部试点证明了虚拟运行 RCT 的可行性和可接受性。达到了进行最终 RCT 的进展标准阈值。确定了需要改进的地方，并对方案进行了修订，以改进试验的实施。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of renal care Nursing-Advanced and Specialized Nursing

CiteScore

3.50

自引率

5.30%

发文量

期刊介绍： The Journal of Renal Care (JORC), formally EDTNA/ERCA Journal, is the official publication of the European Dialysis and Transplant Nursing Association/European Renal Care Association (EDTNA/ERCA). The Journal of Renal Care is an international peer-reviewed journal for the multi-professional health care team caring for people with kidney disease and those who research this specialised area of health care. Kidney disease is a chronic illness with four basic treatments: haemodialysis, peritoneal dialysis conservative management and transplantation, which includes emptive transplantation, living donor & cadavaric transplantation. The continuous world-wide increase of people with chronic kidney disease (CKD) means that research and shared knowledge into the causes and treatment is vital to delay the progression of CKD and to improve treatments and the care given. The Journal of Renal Care is an important journal for all health-care professionals working in this and associated conditions, such as diabetes and cardio-vascular disease amongst others. It covers the trajectory of the disease from the first diagnosis to palliative care and includes acute renal injury. The Journal of Renal Care accepts that kidney disease affects not only the patients but also their families and significant others and provides a forum for both the psycho-social and physiological aspects of the disease.