Low-vision Rehabilitation Program for Low-vision Patients and Care Givers

Not Applicable

• Conditions: Low Vision, One Eye, Unspecified Eye; Low Vision Aids; Low Vision Blindness
• Interventions: Other: Low-vision rehabilitation program; Other: No Intervention

• Registration Number: NCT03166072
• Lead Sponsor: Lawson Health Research Institute

Brief Summary

To evaluate health related quality of life (HRQoL) of low-vision patients and their care givers undergoing low-vision rehabilitation program (LVRP).

Detailed Description

To conduct a pilot single-center, single blind longitudinal randomized controlled trial to evaluate health related quality of life (HRQoL) of low-vision patients and their care givers undergoing low-vision rehabilitation program (LVRP). LVRP includes functional vision assessments (low-vision refraction), prescription of a variety of visual aids including microscopes, magnifiers, telescopes, absorptive filters and electronic spectacle eyewear, large print books, and automatic self-transcending meditation plus essential skills for daily living and mobility training offered by Canadian National Institute for the Blind (CNIB) including demonstration of visual aids as well as training on proper use of visual aids.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-05-23
• Study First Submitted QC: 2017-05-23
• Study First Posted: 2017-05-24
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-22
• Last Update Posted: 2017-08-24
• Study Start: 2018-09-01
• Primary Completion: 2019-07-01
• Study Completion: 2019-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• at least 50 years of age
• has low-vision,
• deemed competent such as no language issues or communication barriers, no self-reported or physician diagnosed mental health disorder besides having depressive and anxiety symptoms,
• have sufficient hearing to be able to follow verbal instructions and able to sit without physical discomfort for 30 minutes
• willing and able to attend 4 initial ASTM training sessions and at least 75% of weekly, bi-weekly and monthly follow up sessions,
• willing to dedicate 20 minutes twice per day to ASTM practice at their own home.

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Exclusion Criteria

• actively suicidal as per self-report (scoring 2 or more on item 9 of the Patient Health Questionnaire (PHQ-9) or on assessment by the physician,
• currently participating in other similar studies
• currently practicing any type of formal meditation regularly

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low-vision rehabilitation program	Low-vision rehabilitation program	Participants and their care givers in Low-vision rehabilitation program will undergo a standardized interview to measure HRQoL using the time trade-off method (TTO), depression using the Patient Health Questionnaire (PHQ-9), anxiety using Generalized Anxiety Disorder (GAD-7) and Veterans Affairs Low Vision Visual Functioning Questionnaire (VA LV VFQ-48) at the first study visit and after Low-vision rehabilitation program.
No Intervention	No Intervention	Participants and their care givers will undergo a standardized interview to measure HRQoL using the time trade-off method (TTO), depression using the Patient Health Questionnaire (PHQ-9), anxiety using Generalized Anxiety Disorder (GAD-7) and Veterans Affairs Low Vision Visual Functioning Questionnaire (VA LV VFQ-48) at the first study visit and will continue to receive treatment as usual.

Primary Outcome Measures

Name	Time	Method
Change in Health related Quality of Life (HRQoL)	Change from baseline up to 24 weeks	HRQoL is measured using time trade-off (TTO) method

Secondary Outcome Measures

Name	Time	Method
Change in Low vision Score	Change from baseline up to 24 weeks	Low visual function measured using the Veterans Affairs Low Vision Visual Functioning Questionnaire (VA LV VFQ-48)
Change in Anxiety Score	Change from baseline up to 24 weeks	Anxiety measured using the Generalized Anxiety Disorder (GAD-7)
Change in Depression Score	Change from baseline up to 24 weeks	Depression measured using the Patient Health Questionnaire (PHQ-9)

Trial Locations

Locations (1)

St. Joseph's Hospital, Ivey Eye Institute; 🇨🇦 London, Ontario, Canada