E-nergEYEze，一种基于认知行为疗法和自我管理的视觉特异性电子健康干预措施，用于减少视力障碍成年人的疲劳：一项随机对照试验的研究方案。
E-nergEYEze, a vision-specific eHealth intervention based on cognitive behavioral therapy and self-management to reduce fatigue in adults with visual impairment: study protocol for a randomized controlled trial.
机构信息
Amsterdam UMC, Vrije Universiteit Amsterdam, Ophthalmology, Amsterdam Public Health Research Institute, De Boelelaan, 1117, Amsterdam, The Netherlands.
Department of Psychology, Health and Technology, University of Twente, Enschede, The Netherlands.
出版信息
Trials. 2021 Dec 28;22(1):966. doi: 10.1186/s13063-021-05935-w.
BACKGROUND
More than half of the adults with visual impairment experience severe symptoms of fatigue, with a negative impact on daily life. Since there is no evidence-based treatment to reduce fatigue in adults with visual impairment, we developed E-nergEYEze, an eHealth intervention based on cognitive behavioral therapy and self-management tailored to the needs of visually impaired adults. The aim is to describe the study protocol of a randomized controlled trial testing E-nergEYEze.
METHODS
A randomized controlled trial will be conducted to investigate the cost-effectiveness and cost-utility of E-nergEYEze to reduce fatigue severity compared to care as usual from a healthcare and societal perspective. A total of 172 severely fatigued adults with visual impairment will be recruited and randomized to either the E-nergEYEze intervention plus care as usual or to care as usual only (ratio 1:1). Inclusion criteria are having a visual impairment, experiencing severe fatigue (Checklist Individual Strength - subscale Fatigue Severity: CIS-FS > 35), being 18 years or older, understanding the Dutch language, and having access to the internet. The intervention consists of one face-to-face session and a computer training followed by internet-based modules with information and assignments on coping with fatigue. During this 5-month intervention, participants will be digitally supported by a social worker. All measurements will be administered at baseline, after 6 and 12 months, and additionally, those related to cost-effectiveness at 3 and 9 months. The primary outcome is fatigue severity (CIS-FS).
DISCUSSION
Severe fatigue on top of visual impairment compromises quality of life and is associated with incremental societal costs that largely determine the economic burden of low vision or blindness. E-nergEYEze contributes to the evidence base of potentially feasible interventions to reduce the important health-related consequences of vision loss and could fulfill the gap in knowledge, skills and treatment options for low vision services.
TRIAL REGISTRATION
Dutch Trial Register NTR7764 . Registered on 28 May 2019.
背景
超过一半的视力障碍成年人经历严重的疲劳症状，对日常生活产生负面影响。由于没有基于证据的治疗方法可以减轻视力障碍成年人的疲劳，我们开发了 E-nergEYEze，这是一种基于认知行为疗法和自我管理的电子健康干预措施，专门针对视力障碍成年人的需求。目的是描述一项随机对照试验的研究方案，该试验测试 E-nergEYEze 以减轻疲劳严重程度。
方法
将进行一项随机对照试验，从医疗保健和社会角度调查 E-nergEYEze 与常规护理相比降低疲劳严重程度的成本效益和成本效用。总共将招募 172 名严重疲劳的视力障碍成年人，并将他们随机分为 E-nergEYEze 干预加常规护理组或仅常规护理组（比例为 1:1）。纳入标准是视力障碍、经历严重疲劳（Checklist Individual Strength-疲劳严重程度亚量表：CIS-FS > 35）、年龄在 18 岁或以上、懂荷兰语并能上网。干预措施包括一次面对面会议和计算机培训，然后是基于互联网的模块，提供关于应对疲劳的信息和任务。在这 5 个月的干预期间，参与者将由一名社会工作者进行数字支持。所有测量将在基线、6 个月和 12 个月后进行，并且还将在 3 个月和 9 个月时进行成本效益相关的测量。主要结局是疲劳严重程度（CIS-FS）。
讨论
视力障碍加上严重疲劳会降低生活质量，并与增量社会成本相关，这些成本在很大程度上决定了低视力或失明的经济负担。E-nergEYEze 为减轻视力丧失的重要健康后果提供了潜在可行干预措施的证据基础，并可能填补低视力服务在知识、技能和治疗选择方面的空白。
试验注册
荷兰试验注册 NTR7764。于 2019 年 5 月 28 日注册。
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