Use of Self-management Group to Improve Quality of Life in Patients With Low Vision

A Randomized Controlled Trial to Assess if Attending an Interactive, Self-management Group, 'Living With Vision Loss', in Addition to Having Vision Rehabilitation in Our Clinic, Improves Patients' Quality of Life

120 Patients with visual acuity <6/12 will be randomized to receive either usual care or participate in a 6-week, 2 hour 'Living with Vision Loss' program led by trained leaders. We hypothesize that a structured self-management low-vision rehabilitation program provides a greater improvement in participation in daily activities, and improves quality of life in vision-impaired people compared to the provision of the usual low vision rehabilitation services. We also plan to document barriers that prevent patients with low vision (visual acuity <6/12) from participating in self-management course.

Study Overview

• Status: Withdrawn
• Conditions: Age Related Macular Degeneration
• Intervention / Treatment: Behavioral: Self management program 'Living with Vision Loss'

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Vision Rehabilitation Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clients who have attended the MEEI Vision Rehabilitation for the first time within 12 months
• Visual acuity of <6/12 in the better eye with habitual correction
• Age 55+ years
• Living independently (not in a nursing home)
• English speaking
• No cognitive impairment
• Adequate hearing to respond to normal conversation

Exclusion Criteria:

• vestibular disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Self management program; Self management program 'Living with Vision Loss' 6 week course that met for 2 hours each week led by a trained leader.	Behavioral: Self management program 'Living with Vision Loss'; group met for 6 weeks, 2 hours per week, to discuss strategies for living with low vision
No Intervention: Wait list control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Impact of Vision Impairment Questionnaire (IVI)	1 year

Collaborators and Investigators

• Sponsor: Massachusetts Eye and Ear Infirmary
• Investigators: Principal Investigator: Mary Lou Jackson, MD, MEEI Vision REhabilitation Center Dir.

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: October 29, 2010
• First Submitted That Met QC Criteria: February 6, 2017
• First Posted (Estimate): February 8, 2017

Study Record Updates

• Last Update Posted (Estimate): February 8, 2017
• Last Update Submitted That Met QC Criteria: February 6, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: AMD; vision loss; IVI; self-management strategies; low-vision rehabilitation
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration
• Other Study ID Numbers: 07-02-013 (Other Identifier: Massachusetts Eye and Ear Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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