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

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

Detailed Description
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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.

Official Title
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Low-vision Rehabilitation Program for Low-vision Patients and Care Givers: A Single Blind Longitudinal Randomized Controlled Trial

Conditions
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Low Vision Aids, Low Vision, One Eye, Unspecified Eye, Low Vision Blindness

Intervention / Treatment
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* Other: Low-vision rehabilitation program
* Other: No Intervention


Participation Criteria
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Eligibility Criteria
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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. 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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low-vision rehabilitation program<br>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. | Other: Low-vision rehabilitation program<br>* Low Vision Rehabilitation Program 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 CNIB including demonstration of visual aids as well as training on proper use of visual aids.<br>|
| Placebo Comparator: No Intervention<br>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. | Other: No Intervention<br>* Participants will continue to receive treatment as usual<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Health related Quality of Life (HRQoL) | HRQoL is measured using time trade-off (TTO) method | Change from baseline up to 24 weeks | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Low-vision, health related quality of life, visual aids, randomized controlled trial