Back to results

Socially Assistive Robots to Enhance Magnification Device Use for Reading

Primary Purpose

Low Vision

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Socially Assistive Robot for Low Vision Rehabilitation

About this trial

This is an interventional supportive care trial for Low Vision focused on measuring robot

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Individuals with any level of vision loss due to any ocular disease,
age 18 and older,
received a magnification device(s) (i.e., hand-held optical magnifiers, portable electronic video magnifiers, some stand magnifiers and CCTVs) from the UCLA Vision Rehabilitation Center.

Exclusion Criteria:

schedules not permitting participation in planned study sessions or visits (including planning to move or take extended vacation during study period),
inability to understand study procedures or communicate responses to visual stimuli in a consistent manner (cognitive impairment as per TICS),
substance abuse,
significant hearing loss (unable to hear communication by phone or from robot),
significant medical condition likely to limit participation or lifespan,
their magnifier device has features that would not work in conjunction with the beacon sensors: (1) hands-free and do not have a place where the patient's hand is holding the device during use (therefore, they would not register a significant change in temperature), and/or (2) no surface area of at least 1"x1" to which the beacon sensor could be attached without interfering with the device.

Sites / Locations

UCLA Stein Eye InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Immediate Robot

Delayed/Waitlist Robot

Arm Description

One month after study entry, participants will receive the robot at home for two months, followed by a three month observation period without the robot.

Three months after study entry, participants will receive the robot at home for three months.

Outcomes

Primary Outcome Measures

Activity Inventory

questionnaire; scores will be Rasch analyzed in logic units with higher or positive scores indicating less difficulty (i.e., improvement)

Secondary Outcome Measures

MNread

reading test

Sustained Silent Reading Test

reading test

Geriatric Depression Scale (GDS)

questionnaire; scale ranges from 0 to 15 with higher values indicating greater depression

PANAS

questionnaire; scale ranges from 10 to 50 with higher values indicating greater positive moods

Perceived Stress Scale

questionnaire; scale ranges from 0 to 56 with higher values indicating greater perceived stress

3-item UCLA Loneliness Scale

questionnaire; scale ranges from 3 to 9 with higher values indicating greater loneliness

Duke Social Support Index

questionnaire; scale ranges from 10 to 30 with higher values indicating greater social support

Almere

questionnaire; scale ranges from 41 to 205 with higher values indicating greater acceptance of robots

Full Information

NCT ID

NCT04190134

First Posted

December 3, 2019

Last Updated

May 17, 2023

Sponsor

University of California, Los Angeles

Collaborators

University of Southern California

1. Study Identification

Unique Protocol Identification Number

NCT04190134

Brief Title

Socially Assistive Robots to Enhance Magnification Device Use for Reading

Official Title

Development of a Behavioral Intervention With Socially Assistive Robots to Enhance Magnification Device Use for Reading

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 22, 2022 (Actual)

Primary Completion Date

February 2024 (Anticipated)

Study Completion Date

February 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of California, Los Angeles

Collaborators

University of Southern California

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

The aims of this exploratory research project are to customize, deploy and evaluate the preliminary efficacy of a socially assistive robot as a novel approach to motivate and encourage optimal, long-term use of new magnification devices for reading in individuals with vision loss. The goals are to promote patient acceptance, adherence and skills reinforcement to achieve proficiency in the use of the magnifier, in order to attempt to reduce visual disability while performing important daily activities, such as reading tasks. This is a high priority given the increasing prevalence of low vision, paucity of low vision rehabilitation providers, and barriers related to access to care, such as transportation and geography, all of which motivate the development of this complementary approach for the provision of additional support at home by the socially assistive robot.

6. Conditions and Keywords

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

Low Vision

Keywords

robot

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Immediate Robot

Arm Type

Experimental

Arm Description

One month after study entry, participants will receive the robot at home for two months, followed by a three month observation period without the robot.

Arm Title

Delayed/Waitlist Robot

Arm Type

Active Comparator

Arm Description

Three months after study entry, participants will receive the robot at home for three months.

Intervention Type

Behavioral

Intervention Name(s)

Socially Assistive Robot for Low Vision Rehabilitation

Intervention Description

A socially assistive robot will be customized to engage in dialog and conversations to motivate and encourage optimal use of new magnification devices for reading at home by individuals with vision loss.

Primary Outcome Measure Information:

Title

Activity Inventory

Description

questionnaire; scores will be Rasch analyzed in logic units with higher or positive scores indicating less difficulty (i.e., improvement)

Time Frame

change from 1 month post-enrollment to 2-3 months after receiving the socially assistive robot

Secondary Outcome Measure Information:

Title

MNread

Description

reading test

Time Frame

For Immediate robot: baseline, 1 month, 3 months, 6 months. For Delayed/Waitlist robot: baseline, 3 months, 6 months.

Title

Sustained Silent Reading Test

Description

reading test

Time Frame