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

Primary Purpose

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

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Low-vision rehabilitation program
No Intervention
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Low Vision, One Eye, Unspecified Eye focused on measuring Low-vision, health related quality of life, visual aids, randomized controlled trial

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Joseph's Hospital, Ivey Eye Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Low-vision rehabilitation program

No Intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Health related Quality of Life (HRQoL)
HRQoL is measured using time trade-off (TTO) method

Secondary Outcome Measures

Change in Depression Score
Depression measured using the Patient Health Questionnaire (PHQ-9)
Change in Anxiety Score
Anxiety measured using the Generalized Anxiety Disorder (GAD-7)
Change in Low vision Score
Low visual function measured using the Veterans Affairs Low Vision Visual Functioning Questionnaire (VA LV VFQ-48)

Full Information

First Posted
May 23, 2017
Last Updated
August 22, 2017
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03166072
Brief Title
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

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2018 (Anticipated)
Primary Completion Date
July 1, 2019 (Anticipated)
Study Completion Date
December 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low-vision rehabilitation program
Arm Type
Active Comparator
Arm Description
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.
Arm Title
No Intervention
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Low-vision rehabilitation program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
No Intervention
Intervention Description
Participants will continue to receive treatment as usual
Primary Outcome Measure Information:
Title
Change in Health related Quality of Life (HRQoL)
Description
HRQoL is measured using time trade-off (TTO) method
Time Frame
Change from baseline up to 24 weeks
Secondary Outcome Measure Information:
Title
Change in Depression Score
Description
Depression measured using the Patient Health Questionnaire (PHQ-9)
Time Frame
Change from baseline up to 24 weeks
Title
Change in Anxiety Score
Description
Anxiety measured using the Generalized Anxiety Disorder (GAD-7)
Time Frame
Change from baseline up to 24 weeks
Title
Change in Low vision Score
Description
Low visual function measured using the Veterans Affairs Low Vision Visual Functioning Questionnaire (VA LV VFQ-48)
Time Frame
Change from baseline up to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Monali Malvankar, PhD
Phone
5196858500
Ext
61288
Email
monali.malvankar@sjhc.london.on.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monali Malvankar
Organizational Affiliation
Western University, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Hospital, Ivey Eye Institute
City
London
State/Province
Ontario
ZIP/Postal Code
N6G0H8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD will not be available to other researchers since the current research team has the necessary expertise to conduct data analysis.

Learn more about this trial

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

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