Effectiveness of a Multi-disciplinary Vision Rehabilitation Programme in Improving the Overall Quality of Life of Visually Impaired Adults

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorThe Hong Kong Polytechnic University

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Multidisciplinary vision rehabilitaion

    Other intervention

    A holistic approach to provide vision rehabilitation services, including low vision training incorporating advanced assistive technology, home-based exercise training, counselling and home assessment with home modification. The intervention lasts for eight weeks. On-site, group-based training sessions are provided for low vision training (1 hour), exercise training (1 hour), and solution-focused therapy (1.5 hours). Low vision training components are identical to the components received in the vision rehabilitation (low vision component) arm. Exercise training focuses on strengthening lower-limb muscles designed to reduce risk of falls. Solution-focused therapy focuses on helping participants build solutions to visual impairment problems and facilitate their development of preferred futures. Participants will receive minor home modifications, if needed, after the home assessment.

  • Vision rehabilitation incorporating low vision training only

    Other intervention

    This intervention includes providing vision rehabilitation that incorporates advanced assistive technology to support daily living. The intervention lasts for eight weeks, which includes four on-site training sessions (1 hour each). The group-based training includes an introduction to operating smart glasses and AI assistant applications on mobile devices, and offers scenario-based training on utilising these advanced assistive technologies to perform daily activities.

Treatment groups

1,000 Participants
are divided into 3 treatment groups
Group A: Control waitlistNo intervention 0 interventions
Group B: Vision rehabilitation armExperimental treatment 1 intervention
Group C: Multidisciplinary vision rehabilitationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

General-health related quality of life

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

Time frame
Changes in the measurement at Baseline and within one month after the completion of an eight-week intervention.
2

Vision-related quality of life

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.

Time frame
Changes in the measurement at Baseline and within one month after the completion of an eight-week intervention.

Secondary outcomes

1

Visual function

Visual function will be measured using the Melbourne Low-Vision ADL Index (MLVAI). It includes 17 functional performance measures and 9 self-reported questions related to real-world daily activities. The original 17-item functional tasks in MLVAI were modified to align with the local context. Item descriptions were translated into Traditional Chinese. The scoring system has been revised to include quantifiable completion time to improve the reliability of performance scoring between assessors. Baseline assessment will collect two types of data: the original performance using habitual glasses and the performance score using a mobile phone (with any assistive functions enabled). The post-intervention assessment will collect performance scores using the advanced assistive technology prescribed to the participants during the intervention (i.e., smart glasses and/or an AI assistant on their mobile phone).

Time frame
Changes in the measurement at Baseline and within one month after the completion of an eight-week intervention.
2

Level of hope (psychological wellbeing)

The level of hope is measured by the Herth Hope Index (HHI). This index includes 12 self-reported items, covering three subscales "Sense of temporality and future", "Positive readiness and expectancy", and "Interconnectedness with self and others". Each item is rated on a 4-point Likert scale, where 1 indicates strongly disagree, and 4 indicates strongly agree. The total score can range from 12 to 48. The higher the score, the greater the level of hope.

Time frame
Changes from baseline and within one month after the completion of an eight-week intervention.
3

Depression severity (psychological wellbeing)

Depression severity is measured using the Patient Health Questionnaire (PHQ-9) . The PHQ-9 comprises nine questions, along with an impact question measuring the extent to which depressive symptoms affect daily functioning. Depression severity is measured over a two-week period. The frequency of the symptoms is rated on a four-point scale, where 0 = "Not at all", 1 = "several days", 2 = "More than half of the days", and 3 = "Nearly every day". The total score can range from 0 to 27. A higher PHQ-9 score indicates higher depressive severity. A cutoff score of 20 or above indicates severe depression.

Time frame
Changes in the measurement at Baseline and within one month after the completion of an eight-week intervention.
4

Anxiety severity (Psychological wellbeing)

Severity of anxiety is assessed using the Generalised Anxiety Disorder-7 (GAD-7). GAD-7 includes seven questions along with one impact question. On a four-level scale, GAD-7 captures the frequency of anxiety symptoms experienced over the past two-week period. Each question is rated on a four-point scale, where 0 = "Not at all", 1 = "Several days", 2 = "More than half the days", 3 = "Nearly every day". The total score can range from 0 to 21. The higher the GAD-7 score, the higher the level of anxiety. A cutoff score of 15 or above indicates a severe level of anxiety.

Time frame
Changes in the measurement at Baseline and within one month after the completion of an eight-week intervention.

Other outcomes

1

fall incidence

The number of falls in the past 12 months, fall characteristics and consquences will be collected

Time frame
This outcome will be collected at baseline, within one month after completion of intervention, 3-month post intervention, 6-month post intervention, 9-month post intervention and 12-month post intervention.
2

advanced assistive technology adoption rate

The adoption rate is the proportion of people who are introduced to an advanced assistive device and agree to use the device during the intervention period. A binary outcome will be collected, i.e. yes/ no.

Time frame
The measurement will be taken at baseline.
3

advanced assistive technology continuation rate

The continuation rate of the intervention components will be recorded as a binary outcome, i.e. yes or no. We collect whether the participant continue to engage in execise training, use of AI glassess/ smartphone accessibility, after intervention period.

Time frame
Outcome measurement collected at 3 months post intervention, 6 month post intervention, and 12 month post intervention.
4

User satisfaction of assistive tehcnology

This will be assessed using the Chinese version of the Quebec User Evaluation of Satisfaction with Assistive Technology (C-QUEST). This survey has 12 statements focusing on the device domain (Dimension, weight, adjustment, safety, durability, simplicity of use, comfort, and effectiveness) and the service domain (delivery service, repair/servicing, professional service, and follow-up service). Each statement is rated on a scale from 1 to 5, with 1 = "not satisfied at all" to 5 = "very satisfied". The questionnaire will yield three scores: the sub-scores for the device and service domains, and the total C-QUEST score. The CQUEST score can range from 12 to 60. The higher the CQUEST score, the higher the satisfaction towards the prescribed assistive technology. Each participant is also required to identify the three most important items out of the 12 items.

Time frame
The outcome will be collected in the 4th week of the intervention period and within one month after the completion of the eight-week intervention.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Hong Kong Polytechnic University

Lead sponsor

Wu Jieh Yee Charitable Foundation

Collaborator