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Completed

NCT Number: NCT04926974

Community Access Through Remote Eyesight (CARE) Study

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.

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Key information

Conditions

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

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCLA Stein Eye Institute, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Low Vision Rehabilitation

Behavioral

Smart phone App

Primary outcomes

  1. Visual ability change score

    Time frame: 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

    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.

Secondary outcomes

  1. Health-related Quality of Life: SF-36

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

    questionnaire; scale ranges from 1 (excellent) to 5 (poor), with higher values indicating greater difficulty.

  2. Beck Depression Inventory

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

    questionnaire; subscales range from 0 to 3, with higher values indicating greater depression.

  3. Community Living: Life Space Questionnaire

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

    questionnaire; subscales range from 1 (Yes) to 2 (No), with a higher total value indicating a more restricted life space.

  4. 3-item UCLA Loneliness Scale

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

    questionnaire; subscales range from 1 to 3, with a high value indicating increased loneliness.

  5. New General Self Efficacy Scale

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

    questionnaire; subscales range from 1 to 5, with a higher value indicating greater self-efficacy.

  6. App usage frequency

    Time frame: at 3 months post-intervention and 6 months post intervention and also 9 months post-intervention

    App usage in minutes.

Other outcomes

  1. Telephone Interview of Cognitive Status (TICS)

    Time frame: administered at time of enrollment

    questionnaire; with subscales 0 to 1, with higher scores indicating greater cognitive ability.

  2. Psychosocial Impact of Assistive Devices Scale (PIADS)

    Time frame: administered at 3-months post-intervention and 6-months post-intervention and also 9 months post-intervention

    questionnaire; with subscales from -3 to 3, higher scores indicate greater affinity of a particular factor to assistive technology use.

  3. Aira Explorer Survey post intervention feedback

    Time frame: 6 months and also 9 months post-intervention

    (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.

Sponsors and collaborators

Lead sponsor

New England College of Optometry

Other

Collaborators

  • National Institute on Disability, Independent Living, and Rehabilitation Research
  • University of California, Los Angeles

Registry information

Acronym: CARE

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 15, 2021
Registry last updated
Oct 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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