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Low VisionCARENCT04926974

Community Access Through Remote Eyesight (CARE) Study

A study testing Low Vision Rehabilitation in people with Low Vision, run by New England College of Optometry at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 55 years and olderHealthy volunteers can take part
Conditions the study is for
Low Vision
What is being tested?
Low Vision Rehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
145 participants
Where
2 sitesUnited States
Study dates
2 Jun 2021to 29 Sep 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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)
Show all 10Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • New England College of Optometry

    Boston, Massachusetts, 02115

  • UCLA Stein Eye Institute

    Los Angeles, California, 90095

Other trials in United States

About this 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.

Conditions
Low Vision
Being tested
Low Vision Rehabilitation
Medical subject headings
Vision, Low

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low Vision RehabilitationBehavioural

    Smart phone App

Study groups in NCT04926974
Study groupRoleWhat they receive
Seeing AI Smart Phone AppExperimentalIntervention: Behavioral: Low Vision Rehabilitation
Receives: Behavioral: Low Vision Rehabilitation
Supervision+ Smart Phone AppExperimentalIntervention: Behavioral: Low Vision Rehabilitation
Receives: Behavioral: Low Vision Rehabilitation
Aira Smart Phone AppExperimentalIntervention: Behavioral: Low Vision Rehabilitation
Receives: Behavioral: Low Vision Rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

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

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

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

  2. Beck Depression Inventory

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

    Measured: 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. 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.

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

  4. 3-item UCLA Loneliness Scale

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

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

  5. New General Self Efficacy Scale

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

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

  6. App usage frequency

    App usage in minutes.

    Measured: at 3 months post-intervention and 6 months post intervention and also 9 months post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2021
  2. Study start2 Jun 2021
  3. Primary completion29 Sep 2023
  4. Study completion29 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
145 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04926974
Sponsor's protocol ID
CARE
Acronym
CARE
Status last verified
Oct 2023
First submitted
2 Jun 2021
Last updated
5 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data will be shared according to the protocols stipulated by NIDILRR and the IRB at NECO and UCLA.

Publications

  • 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.

    PubMed 39443965

  • 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.

    PubMed 38990234

  • 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.

    PubMed 38820379

Questions about this trial

What is this clinical trial studying?

A study testing Low Vision Rehabilitation in people with Low Vision, run by New England College of Optometry at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04926974, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2023.

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