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Low Vision Depression Prevention Trial for Age Related Macular Degeneration

NCT00769015 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2014-11-20

Study results available
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Summary

This randomized, controlled clinical trial, the Low Vision Depression Prevention TriAL (VITAL), will test the efficacy of collaborative low vision rehabilitation (LVR) to prevent depressive disorders in Age-Related Macular Degeneration (AMD). In this innovative intervention, a low vision occupational therapist collaborates with a low vision optometrist to develop and implement a care plan based on a subject's vision status, rehabilitation potential, and personal rehabilitation goals. An independent rater masked to treatment assignment will assess depressive disorders meeting DSM-IV criteria (primary outcome) and targeted vision function and vision-related quality of life (secondary outcomes) at baseline and then at 4 months to evaluate short-term effects (main trial end point) and at 12 months to evaluate long-term effects.

Conditions

Interventions

BEHAVIORAL

BA-LVR

Low vision clinic-based optometry plus 6 in-home occupational therapy visits

BEHAVIORAL

ST-LVR

Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy

Sponsors & Collaborators

  • Dartmouth-Hitchcock Medical Center

    collaborator OTHER

  • Johns Hopkins University

    collaborator OTHER

  • Thomas Jefferson University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2014-01-31
Completion
2014-06-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00769015 on ClinicalTrials.gov