Community Access Through Remote Eyesight (CARE) Study

Study Overview
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Brief Summary
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Study is a randomized clinical trial evaluating the efficacy of novel mobile application technologies (including Seeing AI, Aira, and Supervision+) to improve quality of life in older adults with low vision by expanding community access and providing assistance with activities of daily living. Aira provides real-time remote personal assistance through a sighted Aira agent supplying direct feedback to assist with visual tasks. Seeing AI provides optical character recognition allowing any text to be read aloud, color identification, bar code reading, scene description, and facial recognition based on stored photos. Supervision + allows one to use the phone as a magnifier, providing magnification and contrast enhancement using the camera of the mobile phone. This study seeks to understand the potential of these technologies to improve daily activities, community participation, independence, and self-sufficiency in this group by examining a technological approach, which has not yet undergone rigorous investigation in a diverse population of older adults with visual impairment. Project objectives are to evaluate mobile applications in a wide range of visual disability, categorized into three groups: (1) mild to moderate visual acuity loss, (2) severe to profound visual acuity loss, and (3) legal blindness secondary to visual field loss. Participants are randomized to one of three intervention groups: (1) Supervision+ application, (2) Aira application, or (3) Seeing AI application for a period of 6 months. For the Aira intervention group, participants will be assigned either with 'restricted' access (current open access areas plus 30 minutes/month anywhere), or 'unrestricted' access (700 minutes), for a period of 3 months with a 3 month cross-over period. Participants may elect to continue the study for an additional 3 months during which time they have access to all 3 study mobile applications. Outcome measures include assessment of changes at three, six and nine months post-intervention for: visual ability, health state (including depression), self-efficacy, loneliness, life space, distances travelled from the home, and types of services obtained.

Official Title
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Community Access Through Remote Eyesight (CARE) Study

Conditions
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Low Vision

Intervention / Treatment
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* Behavioral: Low Vision Rehabilitation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 55 years + (no upper limit) reside in CA state (for subjects enrolled at UCLA) reside in New England states of MA, NH, CT or RI (for subjects enrolled at NECO) best-corrected visual acuity 20/40 to 20/800 in the better eye or visual field diameter less than 20 degrees in the better eye English speaking Ability to demonstrate proficiency with the smartphone and mobile app at 4 weeks post initial training no previous use of the Aira app, Seeing AI app or Super Vision+ app on a smartphone (<5 uses in lifetime) Exclusion Criteria: out of the country for >2 weeks during study intervention period if cannot use their own international data plan on their own phone unable to successfully complete the initial on-boarding call for Aira service with an agent as documented by the Aira agent's log (if randomized to Aira) schedules not permitting participation in planned study duration (including planning to move or take extended vacation during study period) inability to understand study procedures or communicate responses in a consistent manner (cognitive impairment as per TICS) substance abuse significant hearing loss (unable to hear communication by phone) significant medical condition likely to limit participation or lifespan participating in another clinical trial that involves treatment that could impact visual function during the study period participant in another clinical trial that involves a treatment or intervention that could impact visual functioning begins use of a new vision-related app during the trial period for the study

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Seeing AI Smart Phone App<br>Intervention: Behavioral: Low Vision Rehabilitation | Behavioral: Low Vision Rehabilitation<br>* Smart phone App<br>|
| Experimental: Supervision+ Smart Phone App<br>Intervention: Behavioral: Low Vision Rehabilitation | Behavioral: Low Vision Rehabilitation<br>* Smart phone App<br>|
| Experimental: Aira Smart Phone App<br>Intervention: Behavioral: Low Vision Rehabilitation | Behavioral: Low Vision Rehabilitation<br>* Smart phone App<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual ability change score | The primary outcome measure is the person change score (before and after intervention), from the adaptive Massof Activity Inventory (AI) Questionnaire. The AI has an item bank of 510 items organized into 50 goals and 460 related visually-based tasks. Subscales range from 0 (not important) to 3 (very important). For those goals rated as important, subjects are asked to rate the task difficulty on subscales of 0 (impossible to do without help) to 5 (not difficult). Rasch analysis is employed to estimate visual ability from these difficulty ratings, on an interval scale. With Rasch analysis person measures are estimated, whereby a more positive person measure reflects greater visual ability. In this study, we will explore the the difference in person measures (i.e. change score) after the intervention at 3 and 6 months. A larger, more positive change score indicates greater visual ability since intervention. | AI questionnaire will be administered three times over 6 months: baseline, 3-months post-intervention and 6-months post-intervention, and also 9 months post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related Quality of Life: SF-36 | questionnaire; scale ranges from 1 (excellent) to 5 (poor), with higher values indicating greater difficulty. | will be administered three times over 6 months: baseline, 3-months post-intervention and 6-months post-intervention and also 9 months post-intervention | 
| Beck Depression Inventory | questionnaire; subscales range from 0 to 3, with higher values indicating greater depression. | will be administered three times over 6 months: baseline, 3-months post-intervention and 6-months post-intervention and also 9 months post-intervention | 
| Community Living: Life Space Questionnaire | questionnaire; subscales range from 1 (Yes) to 2 (No), with a higher total value indicating a more restricted life space. | will be administered three times over 6 months: baseline, 3-months post-intervention and 6-months post-intervention and also 9 months post-intervention | 
| 3-item UCLA Loneliness Scale | questionnaire; subscales range from 1 to 3, with a high value indicating increased loneliness. | will be administered three times over 6 months: baseline, 3-months post-intervention and 6-months post-intervention and also 9 months post-intervention | 
| New General Self Efficacy Scale | questionnaire; subscales range from 1 to 5, with a higher value indicating greater self-efficacy. | will be administered three times over 6 months: baseline, 3-months post-intervention and 6-months post-intervention and also 9 months post-intervention | 
| App usage frequency | App usage in minutes. | at 3 months post-intervention and 6 months post intervention and also 9 months post-intervention |