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

Manon H J Veldman,Marc Koopmanschap,Ruth M A Van Nispen,Hans Knoop,Edwin Stavleu,Carel T J Hulshof,Ger H M B Van Rens,Christina Bode,Hilde P A Van Der Aa

doi:10.1186/s13063-021-05935-w

Abstract

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.

Highlights

Fatigue is a significant problem in adults with visual impairment that needs to be addressed urgently [1]
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, 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

Summary

Methods

Study design In this RCT we investigate the effectiveness of an eHealth intervention aimed at reducing fatigue severity in adults with visual impairment. It is possible that the intervention could worsen symptoms of fatigue induced by greater awareness of fatigue-related symptoms and an emotional response can be evoked by the content This will be monitored by the social worker and reported to the research team as a study-related (serious) adverse event ((S)AE). Working mechanism outcomes The working mechanism, i.e. the psychological mechanisms that might mediate or explain whether the intervention is effective in subgroups of patients, is based on different hypotheses about participants’ perceptions and beliefs about fatigue, and will be measured with the 7-item Brief Illness Perceptions Questionnaire (BIPQ) [51]; the 6-item Self-efficacy scale (SE-scale) to assess how fatigue is handled [52] and the 10-item Fatigue Catastrophizing Scale (FCS) to assess negative cognitions towards fatigue [53] Patient characteristics, such as gender and severity of vision loss might moderate the effect. Minddistrict, the Internet Portal Supplier, will encrypt and securely store all data of patients, i.e. assignments and communication with social workers

Discussion

Introduction

Findings