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Low Vision Depression Prevention Trial for Age Related Macular Degeneration (VITAL)

This study has been completed.
Sponsor:
Collaborators:
Dartmouth-Hitchcock Medical Center
Johns Hopkins University
Information provided by (Responsible Party):
Thomas Jefferson University
ClinicalTrials.gov Identifier:
NCT00769015
First received: October 7, 2008
Last updated: November 13, 2014
Last verified: November 2014
Results First Received: October 9, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Age-related Macular Degeneration
Depression
Interventions: Behavioral: BA-LVR
Behavioral: ST-LVR

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited from July 2009 through Feb 2013 from a large, private retina practice.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
BA-LVR

In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.

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

ST-LVR

Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.

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


Participant Flow:   Overall Study
    BA-LVR   ST-LVR
STARTED   96   92 
COMPLETED   87   76 
NOT COMPLETED   9   16 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
BA-LVR

In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.

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

ST-LVR

Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.

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

Total Total of all reporting groups

Baseline Measures
   BA-LVR   ST-LVR   Total 
Overall Participants Analyzed 
[Units: Participants]
 96   92   188 
Age 
[Units: Years]
Mean (Standard Deviation)
 85.2  (6.6)   82.7  (6.9)   84.0  (6.8) 
Gender 
[Units: Participants]
     
Female   70   62   132 
Male   26   30   56 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   1   0   1 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   1   2   3 
White   94   90   184 
More than one race   0   0   0 
Unknown or Not Reported   0   0   0 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   1   0   1 
Not Hispanic or Latino   95   92   187 
Unknown or Not Reported   0   0   0 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Depression   [ Time Frame: 4 months ]

2.  Secondary:   Vision Function: Distance Activities   [ Time Frame: 4 months ]

3.  Secondary:   Quality of Life: Dependency   [ Time Frame: 4 months ]

4.  Secondary:   Vision Function: Near Activities   [ Time Frame: 4 months ]

5.  Secondary:   Quality of Life: Mental Health   [ Time Frame: 4 months ]

6.  Secondary:   Quality of Life: Role Functioning   [ Time Frame: 4 months ]

7.  Secondary:   Quality of Life: Social Function   [ Time Frame: 4 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Robin Casten
Organization: Thomas Jefferson University
phone: 215-503-1250
e-mail: Robin.Casten@jefferson.edu


Publications of Results:

Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00769015     History of Changes
Other Study ID Numbers: 1U01EY018819 ( US NIH Grant/Contract Award Number )
Study First Received: October 7, 2008
Results First Received: October 9, 2014
Last Updated: November 13, 2014
Health Authority: United States: Federal Government