Cost-effectiveness of basic vision rehabilitation (The basic VRS-effect study): study protocol for a randomised controlled trial

Purpose: To investigate the cost-effectiveness of a basic vision rehabilitation service (basic-VRS) in Portugal. We designed a parallel group, randomised controlled trial whose aim is to compare the effects and costs of ‘usual low vision care’ with a ‘basic-VRS intervention’ on self-reported visual ability and other psychosocial and health-related quality-of-life outcomes. Methods: The trial will recruit participants that meet the following inclusion criteria: (1) visual acuity between 0.4–1.0 logMAR in the better-seeing eye, (2) cause of vision loss is diabetic retinopathy or age-related macular degeneration, (3) 18 years or older and iv) live in the community (not in nursing homes or other type of institution). Participants will be randomised to one of the study arms consisting of immediate intervention and delayed intervention. The delayed intervention group will receive ‘usual care’ or no intervention in the first 12 weeks. Visual acuity, contrast sensitivity and retinal structure will be assessed during the study. Results: The primary outcome measure is visual ability, which will be evaluated with the Massof Activity Inventory, we expect that the intervention will raise the overall person measure or visual ability. Reading, health-related quality-of-life, anxiety and depression and social support will be also assessed. The analysis will be undertaken on an intention-to-treat basis. A cost-effectiveness analysis will be performed to provide information about the cost per unit of utility. To evaluate the cost-effectiveness of the intervention we will adopt the perspective of the healthcare system. Conclusion: This study will provide additional evidence about the effects of basic-VRS on self-reported visual ability. Findings from this study should also contribute to better planning of low vision provision and, consequently, may contribute to reduce barriers to basic-VRS.