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NCT00769015 · ClinicalTrials.gov registry record · Phase 3
Low Vision Depression Prevention Trial for Age Related Macular Degeneration
A Phase 3 study, sponsored by Thomas Jefferson University.
- Completed
- Registry status
- Phase 3
- Development phase
- 188
- Enrollment target
NCT00769015 is a Phase 3 study that has completed, run by Thomas Jefferson University. The registered enrollment target is 188 participants.
The verdict
NCT00769015, a Phase 3 study, has completed, sponsored by Thomas Jefferson University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 188 participants
- Enrollment target
Study 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.
Interventions
- BEHAVIORAL BA-LVR
- BEHAVIORAL ST-LVR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 188 participants |
| Start Date | 2009-06 |
| Est. Completion | 2014-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00769015
The ClinicalTrials.gov registry entry for NCT00769015 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 188 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Thomas Jefferson University, which has 292 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which BA-LVR is the first listed.
NCT00769015 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00769015 about?
NCT00769015 is a clinical study titled "Low Vision Depression Prevention Trial for Age Related Macular Degeneration". 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 occupationa...
What is the current status of trial NCT00769015?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 188 participants. The study started on 2009-06. Estimated completion is 2014-06.
What interventions are being tested in trial NCT00769015?
The interventions under investigation include: BA-LVR (BEHAVIORAL), ST-LVR (BEHAVIORAL).
Who is sponsoring clinical trial NCT00769015?
This trial is sponsored by Thomas Jefferson University, which has 292 total clinical trials registered on ClinicalTrials.gov.
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