We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00769015
Recruitment Status : Completed
First Posted : October 8, 2008
Results First Posted : November 20, 2014
Last Update Posted : November 20, 2014
Sponsor:
Collaborators:
Dartmouth-Hitchcock Medical Center
Johns Hopkins University
Information provided by (Responsible Party):
Thomas Jefferson University

Tracking Information
First Submitted Date  ICMJE October 7, 2008
First Posted Date  ICMJE October 8, 2008
Results First Submitted Date  ICMJE October 9, 2014
Results First Posted Date  ICMJE November 20, 2014
Last Update Posted Date November 20, 2014
Study Start Date  ICMJE June 2009
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 13, 2014)
Depression [ Time Frame: 4 months ]
The primary outcome was a DSM-IV diagnosis of major or minor depression based on the Patient Health Questionnaire-9 (PHQ-9).13 The PHQ-9 includes the 9 criteria that define DSM-IV diagnoses of depression and is valid in low-vision patients. A scoring algorithm determines whether the profile of symptoms meets categorical diagnoses of depression. The model is adjusted for treatment group, vision stratum (20/70 to 20/100 vs. < 20/100), baseline better eye scotoma size, baseline depression scores [Patient Health Questionnaire (PHQ-9)], Medical Outcome Study score (MOS-6), which is a global index of self-rated physical and mental health, and baseline neuroticism scores.
Original Primary Outcome Measures  ICMJE
 (submitted: October 7, 2008)
Depression [ Time Frame: 4 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 13, 2014)
  • Vision Function: Distance Activities [ Time Frame: 4 months ]
    Distance vision function was assessed using the near activities subscale of the National Eye Institute Vision Function Questionaire-25 (NEI-VFQ). This subscale measures self-reported difficulty in completing activities that require distance function. The subscale is scored from 0 to 100 with higher scores indicating better function. Changes in least squares mean (95% CI) from month 0 to month 4 are reported.
  • Quality of Life: Dependency [ Time Frame: 4 months ]
    Self-reported depencency was assessed using the Dependency subscale from the National Eye Institute Vision Function Questionaire-25 (NEI-VFQ). Scores range from 0 to 100, with higher scores indicating less dependency. Changes in least square means from baseline to 4 months are presented.
  • Vision Function: Near Activities [ Time Frame: 4 months ]
    Near vision function was assessed using the near activities subscale of the National Eye Institute Vision Function Questionaire-25 (NEI-VFQ). This subscale measures self-reported difficulty in completing activities that require near function. The subscale is scored from 0 to 100 with higher scores indicating better function. Changes in least squares mean (95% CI) from month 0 to month 4 are reported.
  • Quality of Life: Mental Health [ Time Frame: 4 months ]
    Self-reported menthal health was assessed using the Mental Health subscale from the National Eye Institute Vision Function Questionaire-25 (NEI-VFQ). Scores range from 0 to 100, with higher scores indicating better mental health. Changes in least square means from baseline to 4 months are presented.
  • Quality of Life: Role Functioning [ Time Frame: 4 months ]
    Self-reported role functioning was assessed using the Role Difficulties subscale from the National Eye Institute Vision Function Questionaire-25 (NEI-VFQ). Scores range from 0 to 100, with higher scores indicating fewer role difficulties . Changes in least square means from baseline to 4 months are presented.
  • Quality of Life: Social Function [ Time Frame: 4 months ]
    Self-reported social function was assessed using the Social Functioning subscale from the National Eye Institute Vision Function Questionaire-25 (NEI-VFQ). Scores range from 0 to 100, with higher scores indicating better social function. Changes in least square means from baseline to 4 months are presented.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2008)
  • Vision Function [ Time Frame: 4 months ]
  • Quality of Life [ Time Frame: 4 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Low Vision Depression Prevention Trial for Age Related Macular Degeneration
Official Title  ICMJE Low Vision Depression Prevention Trial for Age Related Macular Degeneration
Brief 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.
Detailed Description

Age-related macular degeneration (AMD) is the leading cause of blindness in older persons in the U.S. and affects more than 10 million people. One third of patients with AMD become clinically depressed when they lose the ability to pursue valued activities. Because their depression is disabling and unlikely to be treated, preventing depression in AMD is a public health imperative as the population ages.

We will recruit 200 subjects who have bilateral AMD and subthreshold depressive symptoms. Their bilateral vision loss and subthreshold depressive symptoms increase their risk to develop more severe depressive disorders and functional decline. We will randomize eligible subjects to collaborative Low Vision Rehabilitation (LVR) (optometrist and home-based OT) or enhanced LVR (optometrist and home-based Supportive Therapy). In this study, usual care LVR is enhanced with Supportive Therapy (ST), which is a standardized placebo psychological treatment that controls for attention.

Many older persons with AMD understandably become depressed when their vision loss prevents them from pursuing valued goals. This necessitates a disease management strategy that combines treatment for vision loss and depression. Because depression in AMD is rarely treated, preventing depression is more sensible than waiting to treat it after diagnosis or failing to treat it at all. As the population ages and more people are affected with AMD, finding ways to prevent depression and improve daily functioning has great public health importance. For these reasons, the VITAL Trial has high clinical significance to patients with AMD, and wider public health significance as our society confronts the challenge of caring for the growing population of older adults with chronic disabilities.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Age-related Macular Degeneration
  • Depression
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Behavioral: BA-LVR
  • Placebo Comparator: 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.
    Intervention: Behavioral: ST-LVR
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 13, 2014)
188
Original Estimated Enrollment  ICMJE
 (submitted: October 7, 2008)
200
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age at least 65 years old
  • Bilateral AMD
  • Subthreshold depressive symptoms
  • At least 1 vision goal that is important yet difficult to carry out

Exclusion Criteria:

  • Uncontrolled glaucoma, diabetic retinopathy, corneal dystrophy, or cataracts for which surgery within 6 months is likely will be exclusionary conditions
  • Current diagnosis of depression
  • Cognitive impairment
  • Life-threatening illness or any other health conditions that interferes with study activities.
  • Patients who have received low vision rehabilitation or home-based OT in the preceding 12 months will be excluded.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00769015
Other Study ID Numbers  ICMJE 1U01EY018819( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Thomas Jefferson University
Original Responsible Party Barry W. Rovner, MD, Thomas Jefferson University
Current Study Sponsor  ICMJE Thomas Jefferson University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Dartmouth-Hitchcock Medical Center
  • Johns Hopkins University
Investigators  ICMJE Not Provided
PRS Account Thomas Jefferson University
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP