Clinical trial NCT03166072: Low-vision Rehabilitation Program for Low-vision Patients and Care Givers
Official title: Low-vision Rehabilitation Program for Low-vision Patients and Care Givers: A Single Blind Longitudinal Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Vision, One Eye, Unspecified Eye
Low Vision Blindness
Low Vision Aids
Keywords: Low-vision
health related quality of life
visual aids
randomized controlled trial
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2017-05-24
Enrollment: 150
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Health related Quality of Life (HRQoL)
timeFrame: Change from baseline up to 24 weeks
Secondary outcomes:
measure: Change in Depression Score
timeFrame: Change from baseline up to 24 weeks
measure: Change in Anxiety Score
timeFrame: Change from baseline up to 24 weeks
measure: Change in Low vision Score
timeFrame: Change from baseline up to 24 weeks
Other outcomes:
Locations:
city: London
country: Canada
facility: St. Joseph's Hospital, Ivey Eye Institute
state: Ontario
Study officials:
affiliation: Western University, Canada
name: Monali Malvankar
role: PRINCIPAL_INVESTIGATOR
References: