Clinical trial NCT04926974: Community Access Through Remote Eyesight (CARE) Study
Official title: Community Access Through Remote Eyesight (CARE) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Vision
Lead sponsor: New England College of Optometry
Sponsor class: OTHER
Collaborators: name: National Institute on Disability, Independent Living, and Rehabilitation Research
name: University of California, Los Angeles
First posted: 2021-06-15
Enrollment: 145
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Visual ability change score
timeFrame: 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:
measure: Health-related Quality of Life: SF-36
timeFrame: will be administered three times over 6 months: baseline, 3-months post-intervention and 6-months post-intervention and also 9 months post-intervention
measure: Beck Depression Inventory
timeFrame: will be administered three times over 6 months: baseline, 3-months post-intervention and 6-months post-intervention and also 9 months post-intervention
measure: Community Living: Life Space Questionnaire
timeFrame: will be administered three times over 6 months: baseline, 3-months post-intervention and 6-months post-intervention and also 9 months post-intervention
measure: 3-item UCLA Loneliness Scale
timeFrame: will be administered three times over 6 months: baseline, 3-months post-intervention and 6-months post-intervention and also 9 months post-intervention
measure: New General Self Efficacy Scale
timeFrame: will be administered three times over 6 months: baseline, 3-months post-intervention and 6-months post-intervention and also 9 months post-intervention
measure: App usage frequency
timeFrame: at 3 months post-intervention and 6 months post intervention and also 9 months post-intervention
Other outcomes:
measure: Telephone Interview of Cognitive Status (TICS)
timeFrame: administered at time of enrollment
measure: Psychosocial Impact of Assistive Devices Scale (PIADS)
timeFrame: administered at 3-months post-intervention and 6-months post-intervention and also 9 months post-intervention
measure: Aira Explorer Survey post intervention feedback
timeFrame: 6 months and also 9 months post-intervention
Locations:
city: Los Angeles
country: United States
facility: UCLA Stein Eye Institute
state: California
city: Boston
country: United States
facility: New England College of Optometry
state: Massachusetts
Study officials:
References: