Community Access Through Remote Eyesight (CARE) Study

NCT04926974 | Completed

• 1 other identifier: CARE
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Low Vision

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Health-related Quality of Life: SF-36

  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

  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

  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

  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

  will be administered three times over 6 months: baseline, 3-months post-intervention and 6-months post-intervention and also 9 months post-intervention

Other Outcomes (3)

• Telephone Interview of Cognitive Status (TICS)

  administered at time of enrollment

• Psychosocial Impact of Assistive Devices Scale (PIADS)

  administered at 3-months post-intervention and 6-months post-intervention and also 9 months post-intervention

• Aira Explorer Survey post intervention feedback

  6 months and also 9 months post-intervention

Study Arms (3)

Seeing AI Smart Phone App

EXPERIMENTAL

Intervention: Behavioral: Low Vision Rehabilitation

Behavioral: Low Vision Rehabilitation

Supervision+ Smart Phone App

EXPERIMENTAL

Intervention: Behavioral: Low Vision Rehabilitation

Behavioral: Low Vision Rehabilitation

Aira Smart Phone App

EXPERIMENTAL

Intervention: Behavioral: Low Vision Rehabilitation

Behavioral: Low Vision Rehabilitation

Interventions

Low Vision Rehabilitation BEHAVIORAL

Smart phone App

Aira Smart Phone App; Seeing AI Smart Phone App; Supervision+ Smart Phone App

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (2)

UCLA Stein Eye Institute

Los Angeles, California, 90095, United States

Location

New England College of Optometry

Boston, Massachusetts, 02115, United States

Location

Related Publications (3)

• Gobeille M, Bittner AK, Malkin AG, Ho J, Idman-Rait C, Estabrook M, Ross NC; CARE Study Team. Rasch analysis of the new general self efficacy scale: an evaluation of its psychometric properties in older adults with low vision. Health Qual Life Outcomes. 2024 Oct 23;22(1):90. doi: 10.1186/s12955-024-02306-2.

  PMID: 39443965 DERIVED

• Bittner AK, Gobeille M, Malkin AG, Ho J, Idman-Rait C, Estabrook M, Ross NC; CARE Study Team. Life space limitations in visually impaired older adults. Optom Vis Sci. 2024 Jun 1;101(6):321-328. doi: 10.1097/OPX.0000000000002150.

  PMID: 38990234 DERIVED

• Malkin AG, Bittner AK, Ho J, Idman-Rait C, Estabrook M, Ross NC; CARE Study Team. Factors related to training time and achieving proficiency with visual-assistive mobile applications in visually impaired older adults. Optom Vis Sci. 2024 Jun 1;101(6):351-357. doi: 10.1097/OPX.0000000000002135. Epub 2024 May 31.

  PMID: 38820379 DERIVED

MeSH Terms

Conditions

Vision, Low

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: June 15, 2021
• Study Start: June 2, 2021
• Primary Completion: September 29, 2023
• Study Completion: September 29, 2023
• Last Updated: October 5, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will share

Locations

US (2)