评估世界卫生组织在线干预 "iSupport "对减少痴呆症照护者抑郁和痛苦的影响：在英国进行的为期六个月的多中心随机对照试验

IF 13.6 Q1 HEALTH CARE SCIENCES & SERVICES

Lancet Regional Health-Europe Pub Date : 2024-11-20 DOI:10.1016/j.lanepe.2024.101125

Gill Windle , Greg Flynn , Zoe Hoare , Nia Goulden , Rhiannon Tudor Edwards , Bethany Anthony , Patricia Masterson Algar , Suman Kurana , Aimee Spector , Gwenllian Hughes , Ryan Innes , John Connaghan , Danielle Proctor , Fatene Abakar Ismail , Kiara Jackson , Kieren Egan , Joshua Stott

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引用次数: 0

摘要

背景提高痴呆症照护者的能力是全球的当务之急。iSupport "是世界卫生组织（WHO）为减少痴呆症照护者的心理健康问题而设计的一种自我指导在线干预措施。本研究测试了 iSupport 在减少痴呆症照护者的痛苦和抑郁方面的有效性。在英格兰、威尔士和苏格兰招募了居住在社区的成年照护者（18 岁以上），并通过网络系统将他们随机分配（1:1）到 iSupport 或常规照护中。结果评估者不参与分配。主要结果是评估基线和 6 个月后痛苦和抑郁程度的差异。目标样本量为 350 个，以达到 90% 的有效率，显著性为 2.5%，包括 25% 的自然减员（262 名完成者）。分析遵循意向治疗（ITT）原则。研究结果在 2021 年 11 月 12 日至 2023 年 3 月 31 日期间，177 名护理者（50.3%）被随机分配到常规护理中，175 名护理者（49.7%）被随机分配到 iSupport 中。263人（74.7%）完成了试验。所有护理人员都纳入了 ITT 分析。6个月后，常规护理的平均痛苦评分为20.0（标准差=8.3），iSupport的平均痛苦评分为20.6（标准差=8.6）。调整协变量后，平均差异为 0.16（95% CI -1.17 至 1.49，P = 0.29）。在六个月的平均抑郁评分中，常规护理为 9.5（标准差 = 7.0）分，iSupport 为 9.8（标准差 = 6.5）分。六个月时的平均差异为-0.54（95% CI = -1.70 至 0.62，P = 0.44）。据我们所知，这是评估英国痴呆症照护者自我指导在线干预的最大规模试验，也是首次成功评估 iSupport 效果的试验。鉴于世界卫生组织正在全球范围内实施iSupport，而且作为数字健康转型的一部分，自我指导干预措施已被纳入主流护理服务，因此这一无效研究结果具有重要意义。

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Evaluating the effects of the World Health Organization's online intervention ‘iSupport’ to reduce depression and distress in dementia carers: a multi-centre six-month randomised controlled trial in the UK

Background

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.

Methods

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).

Findings

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.

Interpretation

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.

Funding

NIHR.

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来源期刊

Lancet Regional Health-Europe Multiple-

CiteScore

19.90

自引率

1.40%

发文量

260

审稿时长

9 weeks

期刊介绍： The Lancet Regional Health – Europe, a gold open access journal, is part of The Lancet's global effort to promote healthcare quality and accessibility worldwide. It focuses on advancing clinical practice and health policy in the European region to enhance health outcomes. The journal publishes high-quality original research advocating changes in clinical practice and health policy. It also includes reviews, commentaries, and opinion pieces on regional health topics, such as infection and disease prevention, healthy aging, and reducing health disparities.