Socially Assistive Robots to Enhance Magnification Device Use for Reading
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04190134 |
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Recruitment Status :
Recruiting
First Posted : December 9, 2019
Last Update Posted : May 19, 2023
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Sponsor:
University of California, Los Angeles
Collaborator:
University of Southern California
Information provided by (Responsible Party):
Ava K. Bittner, OD, PhD, University of California, Los Angeles
| Tracking Information | |||||||||
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| First Submitted Date ICMJE | December 3, 2019 | ||||||||
| First Posted Date ICMJE | December 9, 2019 | ||||||||
| Last Update Posted Date | May 19, 2023 | ||||||||
| Actual Study Start Date ICMJE | April 22, 2022 | ||||||||
| Estimated Primary Completion Date | February 2024 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Activity Inventory [ Time Frame: change from 1 month post-enrollment to 2-3 months after receiving the socially assistive robot ] questionnaire; scores will be Rasch analyzed in logic units with higher or positive scores indicating less difficulty (i.e., improvement)
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Socially Assistive Robots to Enhance Magnification Device Use for Reading | ||||||||
| Official Title ICMJE | Development of a Behavioral Intervention With Socially Assistive Robots to Enhance Magnification Device Use for Reading | ||||||||
| 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. | ||||||||
| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Phase 1 | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Outcomes Assessor) Primary Purpose: Supportive Care |
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| Condition ICMJE | Low Vision | ||||||||
| Intervention ICMJE | Behavioral: Socially Assistive Robot for Low Vision Rehabilitation
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.
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
20 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | February 2024 | ||||||||
| Estimated Primary Completion Date | February 2024 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT04190134 | ||||||||
| Other Study ID Numbers ICMJE | 19-001429 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||||||
| Current Responsible Party | Ava K. Bittner, OD, PhD, University of California, Los Angeles | ||||||||
| Original Responsible Party | Same as current | ||||||||
| Current Study Sponsor ICMJE | University of California, Los Angeles | ||||||||
| Original Study Sponsor ICMJE | Same as current | ||||||||
| Collaborators ICMJE | University of Southern California | ||||||||
| Investigators ICMJE |
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| PRS Account | University of California, Los Angeles | ||||||||
| Verification Date | May 2023 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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