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

Low Vision Aids Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03166072
• Other study ID #: 10016927
• Status: Not yet recruiting
• Phase: N/A
• First received: May 23, 2017
• Last updated: August 22, 2017
• Start date: September 1, 2018
• Est. completion date: December 1, 2019

Study information

• Verified date: August 2017
• Source: Lawson Health Research Institute
• Contact: Monali Malvankar, PhD
• Phone: 5196858500
• Email: monali.malvankar[@]sjhc.london.on.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: December 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Low-vision rehabilitation program
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.
• No Intervention
Participants will continue to receive treatment as usual

Locations

Country	Name	City	State
Canada	St. Joseph's Hospital, Ivey Eye Institute	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Depression Score	Depression measured using the Patient Health Questionnaire (PHQ-9)	Change from baseline up to 24 weeks
Secondary	Change in Anxiety Score	Anxiety measured using the Generalized Anxiety Disorder (GAD-7)	Change from baseline up to 24 weeks
Secondary	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