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

Primary Purpose

Low Vision

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low Vision Rehabilitation
Sponsored by
New England College of Optometry
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Vision

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UCLA Stein Eye Institute
  • New England College of Optometry

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Seeing AI Smart Phone App

Supervision+ Smart Phone App

Aira Smart Phone App

Arm Description

Intervention: Behavioral: Low Vision Rehabilitation

Intervention: Behavioral: Low Vision Rehabilitation

Intervention: Behavioral: Low Vision Rehabilitation

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Health-related Quality of Life: SF-36
questionnaire; scale ranges from 1 (excellent) to 5 (poor), with higher values indicating greater difficulty.
Beck Depression Inventory
questionnaire; subscales range from 0 to 3, with higher values indicating greater depression.
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.
3-item UCLA Loneliness Scale
questionnaire; subscales range from 1 to 3, with a high value indicating increased loneliness.
New General Self Efficacy Scale
questionnaire; subscales range from 1 to 5, with a higher value indicating greater self-efficacy.
App usage frequency
App usage in minutes.

Full Information

First Posted
June 2, 2021
Last Updated
October 4, 2023
Sponsor
New England College of Optometry
Collaborators
National Institute on Disability, Independent Living, and Rehabilitation Research, University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT04926974
Brief Title
Community Access Through Remote Eyesight (CARE) Study
Acronym
CARE
Official Title
Community Access Through Remote Eyesight (CARE) Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
June 2, 2021 (Actual)
Primary Completion Date
September 29, 2023 (Actual)
Study Completion Date
September 29, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New England College of Optometry
Collaborators
National Institute on Disability, Independent Living, and Rehabilitation Research, University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Vision

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
145 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Seeing AI Smart Phone App
Arm Type
Experimental
Arm Description
Intervention: Behavioral: Low Vision Rehabilitation
Arm Title
Supervision+ Smart Phone App
Arm Type
Experimental
Arm Description
Intervention: Behavioral: Low Vision Rehabilitation
Arm Title
Aira Smart Phone App
Arm Type
Experimental
Arm Description
Intervention: Behavioral: Low Vision Rehabilitation
Intervention Type
Behavioral
Intervention Name(s)
Low Vision Rehabilitation
Intervention Description
Smart phone App
Primary Outcome Measure Information:
Title
Visual ability change score
Description
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.
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
Secondary Outcome Measure Information:
Title
Health-related Quality of Life: SF-36
Description
questionnaire; scale ranges from 1 (excellent) to 5 (poor), with higher values indicating greater difficulty.
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
Title
Beck Depression Inventory
Description
questionnaire; subscales range from 0 to 3, with higher values indicating greater depression.
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
Title
Community Living: Life Space Questionnaire
Description
questionnaire; subscales range from 1 (Yes) to 2 (No), with a higher total value indicating a more restricted life space.
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
Title
3-item UCLA Loneliness Scale
Description
questionnaire; subscales range from 1 to 3, with a high value indicating increased loneliness.
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
Title
New General Self Efficacy Scale
Description
questionnaire; subscales range from 1 to 5, with a higher value indicating greater self-efficacy.
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
Title
App usage frequency
Description
App usage in minutes.
Time Frame
at 3 months post-intervention and 6 months post intervention and also 9 months post-intervention
Other Pre-specified Outcome Measures:
Title
Telephone Interview of Cognitive Status (TICS)
Description
questionnaire; with subscales 0 to 1, with higher scores indicating greater cognitive ability.
Time Frame
administered at time of enrollment
Title
Psychosocial Impact of Assistive Devices Scale (PIADS)
Description
questionnaire; with subscales from -3 to 3, higher scores indicate greater affinity of a particular factor to assistive technology use.
Time Frame
administered at 3-months post-intervention and 6-months post-intervention and also 9 months post-intervention
Title
Aira Explorer Survey post intervention feedback
Description
(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.
Time Frame
6 months and also 9 months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
UCLA Stein Eye Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
New England College of Optometry
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be shared according to the protocols stipulated by NIDILRR and the IRB at NECO and UCLA.

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Community Access Through Remote Eyesight (CARE) Study

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