Community Access Through Remote Eyesight (CARE) Study (CARE)

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.

Study Overview

• Status: Completed
• Conditions: Low Vision
• Intervention / Treatment: Behavioral: Low Vision Rehabilitation

• Study Type: Interventional
• Enrollment (Actual): 145
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA Stein Eye Institute
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • New England College of Optometry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Seeing AI Smart Phone App; Intervention: Behavioral: Low Vision Rehabilitation	Behavioral: Low Vision Rehabilitation; Smart phone App
Experimental: Supervision+ Smart Phone App; Intervention: Behavioral: Low Vision Rehabilitation	Behavioral: Low Vision Rehabilitation; Smart phone App
Experimental: Aira Smart Phone App; Intervention: Behavioral: Low Vision Rehabilitation	Behavioral: Low Vision Rehabilitation; Smart phone App

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Telephone Interview of Cognitive Status (TICS)	questionnaire; with subscales 0 to 1, with higher scores indicating greater cognitive ability.	administered at time of enrollment
Psychosocial Impact of Assistive Devices Scale (PIADS)	questionnaire; with subscales from -3 to 3, higher scores indicate greater affinity of a particular factor to assistive technology use.	administered at 3-months post-intervention and 6-months post-intervention and also 9 months post-intervention
Aira Explorer Survey post intervention feedback	(specific to those participants randomized to Aira); questionnaire, with subscales ranging from 0 to 10, higher scores indicate stronger agreement or helpfulness of the Aira App.	6 months and also 9 months post-intervention

Collaborators and Investigators

• Sponsor: New England College of Optometry
• Collaborators: University of California, Los Angeles; National Institute on Disability, Independent Living, and Rehabilitation Research

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2021
• Primary Completion (Actual): September 29, 2023
• Study Completion (Actual): September 29, 2023

Study Registration Dates

• First Submitted: June 2, 2021
• First Submitted That Met QC Criteria: June 8, 2021
• First Posted (Actual): June 15, 2021

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: October 4, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Sensation Disorders; Vision Disorders; Vision, Low
• Other Study ID Numbers: CARE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be shared according to the protocols stipulated by NIDILRR and the IRB at NECO and UCLA.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No