Cognitive Level Enhancement Through Vision Exams and Refraction

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorQueen's University, Belfast

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Free near and Distance Vision glasses

    Device

    Intervention 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

820 Participants
are divided into 2 treatment groups
Group A: Free near and distance glassesExperimental treatment 1 intervention
Group B: Control-No treatmentNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Time point(s) of primary interest: 36 months collected at 12, 24 and 36 months

Secondary outcomes

1

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)

Time frame
Time point(s) of primary interest: 36 months collected every 12 months - ie at 12, 24 and 36 months
2

Cost effectiveness

The metric or method of measurement to be used: Cost-effectiveness using Client Service Receipt Inventory

Time frame
Time point(s) of primary interest: 36 months collected every 12 months - ie at 12, 24 and 36 months
3

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

Time frame
Time point(s) of primary interest: 36 months collected every 12 months - ie at 12, 24 and 36 months
4

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).

Time frame
Time point(s) of primary interest: 36 months collected every 12 months - ie at 12, 24 and 36 months

Other outcomes

Sponsors and contacts

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

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