About this trial
The investigators aim to conduct a mixed-method study in which a randomised controlled trial (RCT) and a descriptive qualitative study will be conducted. The RCT aims to determine whether free near and distance glasses provided to residents in Hyderabad, India, aged ≥ 60 years, with under- or un- corrected refractive error and normal baseline hearing and cognition (HMSE \> 18), can improve quality of life, reduce falls, reduce depression, improve social interaction and physical activity cost-effectively over 36 months. The primary qualitative research aim is to a) contextualize the RCT with information on the milieu and culture in which the trial will be conducted; b) provide data on the lived experiences of older adults with reduced vision in the study area, and c) conduct a process evaluation of the trial.
The primary outcome measure is the three-year change in cognition measured by LASI- DAD (Longitudinal Aging Study in India(LASI)- Diagnostic Assessment of Dementia(DAD) global cognitive score.
Secondary Outcome Measures: Three year change in Quality of Life score measured by WHO QOL-BREF; Visual functioning from the RASCH-scaled version of INDVFQ(Indian Visual Functioning(INDVFQ);self-reported physical activity score measured using IPAQ questionnaire; PHQ9 score; domain specific cognitive score (orientation, executive function, language/fluency, memory) measured by HMSE; Total cost of care including direct and indirect costs; Quality adjusted life years; Incremental Cost Effectiveness Ratio; Number of falls measured by Quick Screen score over the three years; Social network density at 3 years (SNI 1-3 represents a "limited" social network, 4-5 is a "medium" social network, and SNI ≥6 is a "diverse" social network) measured by the SNI score; An additional secondary outcome will be LASI-DAD global cognitive score analysed by excluding any tests determined pre-hoc to depend on visual acuity.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Community dwelling
Residency
Presenting vision in the better eye due to uncorrected refractive error
Impaired distance vision less than 6/18
Disqualifiers
Impaired baseline cognition
Non-refractive causes of vision impairment
Severely impaired mobility
immobile
Trial design
Parallel
Treatments tested in this trial
Free near and Distance Vision glasses
DeviceIntervention Description: All participants randomised to the intervention group will be provided with free near and/or distance spectacles based on the results of refraction.Glasses will be provided at the time of enrolment in the study.
Treatment groups
Trial outcomes
Primary outcomes
Change in cognitive score
The metric or method of measurement to be used: LASI-DAD global cognitive score. The best possible score is 360 and the worst possible score is 0.
Secondary outcomes
26-Item Quality of Life
The metric or method of measurement to be used: Quality of Life using WHO BREF questionnaire. Higher scores (for 4 domains) indicate higher quality of life and vice versa (it is a continuum)
Cost effectiveness
The metric or method of measurement to be used: Cost-effectiveness using Client Service Receipt Inventory
Social interaction/isolation
The metric or method of measurement to be used: Social Networking Index. The best possible score is 12 and the worst possible score is 0
Self-reported physical activity.
The metric or method of measurement to be used: International Physical Activity Questionnaire Self-reported physical activity: International Physical Activity Questionnaire (IPAQ).
Sponsors and contacts
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Queen's University, Belfast
Lead sponsor
L.V. Prasad Eye Institute
Collaborator
National Institute of Mental Health and Neuro Sciences, India
Collaborator
The George Institute
Collaborator
Johns Hopkins University
Collaborator
University of Michigan
Collaborator
Clearly
Collaborator
Belfast Health and Social Care Trust
Collaborator