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

Sponsor
Massachusetts Eye and Ear Infirmary (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03046485
Collaborator
(none)
0
Enrollment
1
Location
2
Arms
115.1
Duration (Months)
0
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Self management program 'Living with Vision Loss'
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
May 1, 2007
Actual Primary Completion Date :
Dec 1, 2016
Actual Study Completion Date :
Dec 1, 2016

Arms and Interventions

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

Wait list control

Outcome Measures

Primary Outcome Measures

  1. Impact of Vision Impairment Questionnaire (IVI) [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
55 Years to 95 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Vision Rehabilitation Center Boston Massachusetts United States 02114

Sponsors and Collaborators

  • Massachusetts Eye and Ear Infirmary

Investigators

  • Principal Investigator: Mary Lou Jackson, MD, MEEI Vision REhabilitation Center Dir.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mary Lou Jackson, principal Investigator, Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier:
NCT03046485
Other Study ID Numbers:
  • 07-02-013
  • 07-02-013
First Posted:
Feb 8, 2017
Last Update Posted:
Feb 8, 2017
Last Verified:
Feb 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 Mary Lou Jackson, principal Investigator, Massachusetts Eye and Ear Infirmary
AMD
vision loss
self-management strategies
low-vision rehabilitation
IVI
Additional relevant MeSH terms:
Macular Degeneration

Study Results

No Results Posted as of Feb 8, 2017