NCT03046485

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2010

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 8, 2017

Completed
Last Updated

February 8, 2017

Status Verified

February 1, 2017

Enrollment Period

9.6 years

First QC Date

October 29, 2010

Last Update Submit

February 6, 2017

Conditions

Keywords

AMDvision lossself-management strategieslow-vision rehabilitationIVI

Outcome Measures

Primary Outcomes (1)

  • Impact of Vision Impairment Questionnaire (IVI)

    1 year

Study Arms (2)

Self management program

EXPERIMENTAL

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'

Wait list control

NO INTERVENTION

Wait list control

Interventions

group met for 6 weeks, 2 hours per week, to discuss strategies for living with low vision

Self management program

Eligibility Criteria

Age55 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • vestibular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vision Rehabilitation Center

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Macular DegenerationVision Disorders

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mary Lou Jackson, MD

    MEEI Vision REhabilitation Center Dir.

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal Investigator

Study Record Dates

First Submitted

October 29, 2010

First Posted

February 8, 2017

Study Start

May 1, 2007

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

February 8, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations