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

• Sponsor: Lawson Health Research Institute (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03166072
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 15
• Patients Per Site Per Month: 10

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Low Vision, One Eye, Unspecified Eye; Low Vision Blindness; Low Vision Aids	Other: Low-vision rehabilitation program; Other: No Intervention	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Low-vision Rehabilitation Program for Low-vision Patients and Care Givers: A Single Blind Longitudinal Randomized Controlled Trial
• Anticipated Study Start Date: Sep 1, 2018
• Anticipated Primary Completion Date: Jul 1, 2019
• Anticipated Study Completion Date: Dec 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. Change in Depression Score [Change from baseline up to 24 weeks]

   Depression measured using the Patient Health Questionnaire (PHQ-9)

2. Change in Anxiety Score [Change from baseline up to 24 weeks]

   Anxiety measured using the Generalized Anxiety Disorder (GAD-7)

3. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St. Joseph's Hospital, Ivey Eye Institute	London	Ontario	Canada	N6G0H8

Sponsors and Collaborators

• Lawson Health Research Institute

Investigators

• Principal Investigator: Monali Malvankar, University of Western Ontario, Canada

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Monali Malvankar, Assistant Professor, Lawson Health Research Institute
• ClinicalTrials.gov Identifier: NCT03166072
• Other Study ID Numbers: 10016927
• First Posted: May 24, 2017
• Last Update Posted: Aug 24, 2017
• Last Verified: Aug 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Monali Malvankar, Assistant Professor, Lawson Health Research Institute: Low-vision; health related quality of life; visual aids; randomized controlled trial
• Additional relevant MeSH terms: Blindness; Vision, Low

Study Results

No Results Posted as of Aug 24, 2017