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

Primary Purpose

Age Related Macular Degeneration

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Self management program 'Living with Vision Loss'
Sponsored by
Massachusetts Eye and Ear Infirmary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age Related Macular Degeneration focused on measuring AMD, vision loss, self-management strategies, low-vision rehabilitation, IVI

Eligibility Criteria

55 Years - 95 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Vision Rehabilitation Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Self management program

Wait list control

Arm Description

Self management program 'Living with Vision Loss' 6 week course that met for 2 hours each week led by a trained leader.

Wait list control

Outcomes

Primary Outcome Measures

Impact of Vision Impairment Questionnaire (IVI)

Secondary Outcome Measures

Full Information

First Posted
October 29, 2010
Last Updated
February 6, 2017
Sponsor
Massachusetts Eye and Ear Infirmary
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1. Study Identification

Unique Protocol Identification Number
NCT03046485
Brief Title
Use of Self-management Group to Improve Quality of Life in Patients With Low Vision
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Investigator left institution
Study Start Date
May 2007 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts Eye and Ear Infirmary

4. Oversight

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

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age Related Macular Degeneration
Keywords
AMD, vision loss, self-management strategies, low-vision rehabilitation, IVI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Self management program
Arm Type
Experimental
Arm Description
Self management program 'Living with Vision Loss' 6 week course that met for 2 hours each week led by a trained leader.
Arm Title
Wait list control
Arm Type
No Intervention
Arm Description
Wait list control
Intervention Type
Behavioral
Intervention Name(s)
Self management program 'Living with Vision Loss'
Intervention Description
group met for 6 weeks, 2 hours per week, to discuss strategies for living with low vision
Primary Outcome Measure Information:
Title
Impact of Vision Impairment Questionnaire (IVI)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Lou Jackson, MD
Organizational Affiliation
MEEI Vision REhabilitation Center Dir.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vision Rehabilitation Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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