Trials (Dec 2021)

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,
  • Hilde P. A. van der Aa,
  • Christina Bode,
  • Hans Knoop,
  • Carel T. J. Hulshof,
  • Marc Koopmanschap,
  • Edwin Stavleu,
  • Ger H. M. B. van Rens,
  • Ruth M. A. van Nispen

DOI
https://doi.org/10.1186/s13063-021-05935-w
Journal volume & issue
Vol. 22, no. 1
pp. 1 – 11

Abstract

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Abstract 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.

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