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

Low-vision Rehabilitation Program for Low-vision Patients and Care Givers: A 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).

Study Overview

• Status: Unknown
• Conditions: Low Vision Aids; Low Vision, One Eye, Unspecified Eye; Low Vision Blindness
• Intervention / Treatment: Other: Low-vision rehabilitation program; Other: No Intervention

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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6G0H8
      • St. Joseph's Hospital, Ivey Eye Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 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.	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.
PLACEBO_COMPARATOR: 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.	Other: No Intervention; Participants will continue to receive treatment as usual

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2018
• Primary Completion (ANTICIPATED): July 1, 2019
• Study Completion (ANTICIPATED): December 1, 2019

Study Registration Dates

• First Submitted: May 23, 2017
• First Submitted That Met QC Criteria: May 23, 2017
• First Posted (ACTUAL): May 24, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 24, 2017
• Last Update Submitted That Met QC Criteria: August 22, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: randomized controlled trial; health related quality of life; Low-vision; visual aids
• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Sensation Disorders; Vision Disorders; Blindness; Vision, Low
• Other Study ID Numbers: 10016927

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be available to other researchers since the current research team has the necessary expertise to conduct data analysis.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No