Effectiveness of a Multi-disciplinary Vision Rehabilitation Programme in Improving Function and Quality of Life of Visually Impaired Patients: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- General-health related quality of life
研究概览
简要总结
This trial compares multidisciplinary vision rehabilitation and vision rehabilitation services to determine which service works better at improving overall quality of life for adults with visual impairment. Before receiving the intervention, participants will complete baseline measurements, including an eye examination, cognitive and hearing screenings, mobility and balance assessments, questionnaires on basic demographics and health, and a home environment assessment. This randomised controlled trial includes three arms: 1) control-waitlist (wait for 3 months before joining either intervention arm), 2) vision rehabilitation with low vision training only, and 3) multidisciplinary vision rehabilitation arm.
The intervention period lasts for eight weeks, comprising of four on-site training sessions.
- During the intervention period, all participants will receive low-vision training on the use of advanced assistive technology.
- Those in the multidisciplinary group will also receive counselling, exercise training, and home assessment with home modifications (if needed).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 and 80 years
- •Community-dwelling in Hong Kong
- •Cantonese Speaker
- •Clinical diagnosis of low vision (best-corrected visual acuity <6/18; and/or field loss of < 20 degree)
- •Stable ocular condition for ≥ 3 months
- •Owns a smartphone
- •Not currently participating in any vision rehabilitation programme
- •Willing to participate and commit for at least 6 months to 12 months
- •Provides informed consent
排除标准
- •Living in a nursing home/ institutionalized
- •Self-reported severe cognitive impairment or HK-MoCA-VI cut off score of 12
- •Self-reported severe hearing impairment
- •Uncontrolled systemic ocular diseases/ neurological or psychiatric conditions
- •Immobility caused by physical impairment
- •Refuse to provide written informed consent
- •Participating in another vision rehabilitation programme during the trial period
研究组 & 干预措施
Control waitlist
Participants will wait for 3 months before receiving intervention
Vision rehabilitation arm
Participants assigned to the Vision rehabilitation arm will only receive the low vision training on the use of advanced assistive technology. Group-based training will be provided.
干预措施: Vision rehabilitation incorporating low vision training only (Other)
Multidisciplinary vision rehabilitation
Multidisciplinary vision rehabilitation includes group-based low-vision training, group-based solution-focused therapy, group-based exercise training, and home assessment with home modification (if needed).
干预措施: Multidisciplinary vision rehabilitaion (Other)
结局指标
主要结局
General-health related quality of life
时间窗: Changes in the measurement at Baseline and within one month after the completion of an eight-week intervention.
General health related quality of life will be measured using the Hong Kong version of the EuroQoL 5-Dimension instrument 5-level (EQ-5D-5L-HK). Five aspects will be meausred including mobility, self-care, usual activities, pain/discomport, anxiety/depression. A scale of 1 to 5 will be rated. The participant will also be asked to give an overall score for their health at the time of measurement, which is out of 100, 0 means poorest
Vision-related quality of life
时间窗: Changes in the measurement at Baseline and within one month after the completion of an eight-week intervention.
Vision-related quality of life will be measured by the Low Vision Visual Functioning Questionnaire 48 (LV VFQ-48). The LV VFQ48 was translated into Traditional Chinese. LV VFQ-48 measures the difficulties in performing daily activities.
次要结局
- Visual function(Changes in the measurement at Baseline and within one month after the completion of an eight-week intervention.)
- Level of hope (psychological wellbeing)(Changes from baseline and within one month after the completion of an eight-week intervention.)
- Depression severity (psychological wellbeing)(Changes in the measurement at Baseline and within one month after the completion of an eight-week intervention.)
- Anxiety severity (Psychological wellbeing)(Changes in the measurement at Baseline and within one month after the completion of an eight-week intervention.)
- Balance and mobility functions(Changes in measurement from Baseline to within one month after the completion of an eight-week intervention programme.)
- Mobility(Changes in the measurement at Baseline and within one month after the completion of an eight-week intervention.)
- Lower body functioning(Changes in measurement from Baseline to within one month after completion of an eight-week intervention)
- Fear of fall(Changes in measurement from baseline to within one month after the completion of an eight-week intervention.)
- Awareness of fall protective behaviour(Changes in measurement from baseline to within one month after the completion of an eight-week intervention.)
- Environmental fall hazards (home environement)(Changes in measurement from baseline to within one month after the completion of an eight-week intervention)
研究者
Allen MY Cheong
Professor
The Hong Kong Polytechnic University