A randomized controlled trial assessing the effectiveness of strategies delivering low vision rehabilitation: design and baseline characteristics of study participants

Abstract

Purpose: To design a randomized controlled trial (RCT) to compare the effectiveness of four different strategies to deliver low vision rehabilitation services. Methods: The four arms of the RCT comprised-center based rehabilitation, home based rehabilitation, a mix of center based and home based rehabilitation, and center based rehabilitation with home based non interventional supplementary visits by rehabilitation workers. Outcomes were assessed 9 months after baseline and included measuring changes in adaptation to age-related vision loss, quality of life, impact of vision impairment and effectiveness of low vision rehabilitation training. The socio-demographic and vision characteristics of the sample in each of the 4 arms were compared to ensure that outcomes are not associated with differences between the groups. Results: Four hundred and thirty six individuals were enrolled in the study; 393 individuals completed the study. One-fifth of participants were children aged 8 to 16 years. At baseline, socio-demographic and clinical characteristics were similar between individuals in the four arms of the trial. Socio-demographic and clinical characteristics did not differ significantly, except for age, between the 393 individuals who completed the trial and the 43 individuals who dropped out of the study. Twenty six (60.46%) of the forty three drop outs were from the center based arm of the trial. Conclusions: Information from this trial has the potential to shape policy and practice pertaining to low vision rehabilitation services.