Windle Gill, Flynn Greg, Hoare Zoe, Goulden Nia, Tudor Edwards Rhiannon, Anthony Bethany, Algar Patricia Masterson, Kurana Suman, Spector Aimee, Hughes Gwenllian, Innes Ryan, Connaghan John, Proctor Danielle, Ismail Fatene Abakar, Jackson Kiara, Egan Kieren, Stott Joshua
Dementia Services Development Centre Wales (DSDC Wales), School of Health Sciences, Bangor University, Wales, UK.
North Wales Organisation for Randomised Trials in Health (NWORTH), North Wales Medical School, Bangor University, Wales, UK.
Lancet Reg Health Eur. 2024 Nov 20;48:101125. doi: 10.1016/j.lanepe.2024.101125. eCollection 2025 Jan.
Sustaining the capabilities of dementia carers is a global priority. 'iSupport' is a self-guided online intervention designed by the World Health Organization (WHO) to reduce mental health problems in dementia carers. iSupport is undergoing global implementation, however there is an absence of effectiveness evidence. This study tested the effectiveness of iSupport to reduce distress and depression in dementia carers.
A pragmatic randomised controlled trial was conducted in three centres. Adult carers (18+) living in the community were recruited in England, Wales and Scotland and randomly assigned (1:1) through a web-based system to iSupport or usual care. Outcome assessors were masked to allocation. The primary outcomes assessed the difference in distress and depression between baseline and six-months. The target sample size was 350 to enable 90% power, significance at 2.5% including 25% attrition (262 completers) on either outcome. Analysis followed the intention-to-treat (ITT) principle. The trial was registered with ISRCTN registry (17420703).
Between 12th November 2021 and 31st March 2023,177 carers (50.3%) were randomised to usual care and 175 (49.7%) to iSupport. 263 (74.7%) completed the trial. All were included in the ITT analysis. Mean distress scores at six-months were 20.0 (SD = 8.3) for usual care and 20.6 (SD = 8.6) for iSupport. The mean difference was 0.16 (95% CI -1.17 to 1.49, p = 0.29) after adjusting for covariates. Mean depression scores at six-months were 9.5 (SD = 7.0) for usual care and 9.8 (SD = 6.5) for iSupport. The mean difference at six-months was -0.54 (95% CI = -1.70 to 0.62, p = 0.44). No serious adverse events were linked to the trial.
To our knowledge this is the largest trial evaluating a self-guided online intervention in UK dementia carers, and the first to successfully evaluate the effectiveness of iSupport. The null findings are significant given the ongoing global implementation of iSupport by the WHO and the adoption of self-guided interventions into mainstream care delivery as part of digital health transformations.
NIHR.
维持痴呆症护理人员的能力是全球优先事项。“iSupport”是世界卫生组织（WHO）设计的一种自我引导式在线干预措施，旨在减少痴呆症护理人员的心理健康问题。iSupport正在全球范围内实施，但缺乏有效性证据。本研究测试了iSupport在减轻痴呆症护理人员的痛苦和抑郁方面的有效性。
在三个中心进行了一项实用的随机对照试验。在英格兰、威尔士和苏格兰招募了居住在社区的成年护理人员（18岁以上），并通过基于网络的系统将其随机分配（1:1）到iSupport组或常规护理组。结果评估人员对分配情况不知情。主要结果评估了基线和六个月时痛苦和抑郁的差异。目标样本量为350，以实现90%的检验效能，显著性水平为2.5%，包括25%的损耗率（262名完成者）在任何一个结果上。分析遵循意向性分析（ITT）原则。该试验已在ISRCTN注册库（17420703）注册。
在2021年11月12日至2023年3月31日期间，177名护理人员（50.3%）被随机分配到常规护理组，175名（49.7%）被随机分配到iSupport组。263名（74.7%）完成了试验。所有人员均纳入ITT分析。常规护理组六个月时的平均痛苦评分为20.0（标准差=8.3），iSupport组为20.6（标准差=8.6）。调整协变量后，平均差异为0.16（95%置信区间-1.17至1.49，p=0.29）。常规护理组六个月时的平均抑郁评分为9.5（标准差=7.0），iSupport组为9.8（标准差=6.5）。六个月时的平均差异为-0.54（95%置信区间=-1.70至0.62，p=0.44）。没有严重不良事件与该试验相关。
据我们所知，这是评估英国痴呆症护理人员自我引导式在线干预措施的最大规模试验，也是首次成功评估iSupport有效性的试验。鉴于WHO正在全球范围内实施iSupport，并将自我引导式干预措施纳入主流护理服务作为数字健康转型的一部分，这些阴性结果具有重要意义。
英国国家卫生研究院。
