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

Trials

Carel T. J. Hulshof¹  Hans Knoop²  Manon H. J. Veldman³  Hilde P. A. van der Aa³  Ruth M. A. van Nispen³  Ger H. M. B. van Rens⁴  Christina Bode⁵  Marc Koopmanschap⁶  Edwin Stavleu⁷ 

[1] Amsterdam UMC, University of Amsterdam, Coronel Institute of Occupational Health, Amsterdam Public Health Research Institute, Meibergdreef 9, Amsterdam, The Netherlands;Amsterdam UMC, University of Amsterdam, Medical Psychology, Amsterdam Public Health Research Institute, Meibergdreef 9, Amsterdam, The Netherlands;Amsterdam UMC, Vrije Universiteit Amsterdam, Ophthalmology, Amsterdam Public Health Research Institute, De Boelelaan, 1117, Amsterdam, The Netherlands;Amsterdam UMC, Vrije Universiteit Amsterdam, Ophthalmology, Amsterdam Public Health Research Institute, De Boelelaan, 1117, Amsterdam, The Netherlands;Elkerliek Hospital, Ophthalmology, Helmond, The Netherlands;Department of Psychology, Health and Technology, University of Twente, Enschede, The Netherlands;Institute of Health Policy and Management, Erasmus University, Rotterdam, The Netherlands;Royal Dutch Visio, Centre of Expertise for Visually Impaired and Blind People, Huizen, The Netherlands;

关键词: Fatigue;    Visual impairment;    Cognitive behavioral therapy;    Self-management;    eHealth;    Randomized controlled trial;   

DOI  :  10.1186/s13063-021-05935-w

来源: Springer

【 摘 要 】

BackgroundMore 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.MethodsA 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).DiscussionSevere 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 registrationDutch Trial Register NTR7764. Registered on 28 May 2019.

【 授权许可】

CC BY