Acton Jennifer H, Molik Bablin, Binns Alison, Court Helen, Margrain Tom H
School of Optometry & Vision Sciences, College of Biomedical and Life Sciences, Cardiff University, Maindy Road, Cardiff, CF24 4HQ, Wales, UK.
Division of Optometry, School of Health Sciences, City University London, Northampton Square, London, EC1V 0HB, England, UK.
Trials. 2016 Feb 24;17(1):105. doi: 10.1186/s13063-016-1235-2.
Visual Rehabilitation Officers help people with a visual impairment maintain their independence. This intervention adopts a flexible, goal-centred approach, which may include training in mobility, use of optical and non-optical aids, and performance of activities of daily living. Although Visual Rehabilitation Officers are an integral part of the low vision service in the United Kingdom, evidence that they are effective is lacking. The purpose of this exploratory trial is to estimate the impact of a Visual Rehabilitation Officer on self-reported visual function, psychosocial and quality-of-life outcomes in individuals with low vision.
METHODS/DESIGN: In this exploratory, assessor-masked, parallel group, randomised controlled trial, participants will be allocated either to receive home visits from a Visual Rehabilitation Officer (n = 30) or to a waiting list control group (n = 30) in a 1:1 ratio. Adult volunteers with a visual impairment, who have been identified as needing rehabilitation officer input by a social worker, will take part. Those with an urgent need for a Visual Rehabilitation Officer or who have a cognitive impairment will be excluded. The primary outcome measure will be self-reported visual function (48-item Veterans Affairs Low Vision Visual Functioning Questionnaire). Secondary outcome measures will include psychological and quality-of-life metrics: the Patient Health Questionnaire (PHQ-9), the Warwick-Edinburgh Mental Well-being Scale (WEMWBS), the Adjustment to Age-related Visual Loss Scale (AVL-12), the Standardised Health-related Quality of Life Questionnaire (EQ-5D) and the UCLA Loneliness Scale. The interviewer collecting the outcomes will be masked to the group allocations. The analysis will be undertaken on a complete case and intention-to-treat basis. Analysis of covariance (ANCOVA) will be applied to follow-up questionnaire scores, with the baseline score as a covariate.
This trial is expected to provide robust effect size estimates of the intervention effect. The data will be used to design a large-scale randomised controlled trial to evaluate fully the Visual Rehabilitation Officer intervention. A rigorous evaluation of Rehabilitation Officer input is vital to direct a future low vision rehabilitation strategy and to help direct government resources.
The trial was registered with ( ISRCTN44807874 ) on 9 March 2015.
视觉康复官帮助视力受损者维持其独立性。该干预措施采用灵活的、以目标为中心的方法，可能包括行动能力训练、光学和非光学辅助器具的使用以及日常生活活动的执行。尽管视觉康复官是英国低视力服务的一个组成部分，但缺乏其有效性的证据。这项探索性试验的目的是评估视觉康复官对低视力个体自我报告的视觉功能、心理社会和生活质量结果的影响。
方法/设计：在这项探索性、评估者盲法、平行组随机对照试验中，参与者将按1:1的比例被分配接受视觉康复官的家访（n = 30）或进入等候名单对照组（n = 30）。由社会工作者确定需要康复官介入的成年视力受损志愿者将参与。急需视觉康复官或有认知障碍的人将被排除。主要结局指标将是自我报告的视觉功能（48项退伍军人事务部低视力视觉功能问卷）。次要结局指标将包括心理和生活质量指标：患者健康问卷（PHQ - 9）、沃里克 - 爱丁堡心理健康量表（WEMWBS）、与年龄相关视力丧失调整量表（AVL - 12）、标准化健康相关生活质量问卷（EQ - 5D）和加州大学洛杉矶分校孤独感量表。收集结局的访谈者将对分组情况保持盲态。分析将基于完整病例和意向性分析进行。协方差分析（ANCOVA）将应用于随访问卷得分，以基线得分作为协变量。
预计该试验将提供干预效果的可靠效应量估计。这些数据将用于设计一项大规模随机对照试验，以全面评估视觉康复官干预措施。对康复官介入进行严格评估对于指导未来的低视力康复策略和帮助指导政府资源至关重要。
该试验于2015年3月9日在（ISRCTN44807874）注册。
