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

• 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: Thomas Jefferson University
• Collaborators: Dartmouth-Hitchcock Medical Center; Johns Hopkins University
• Information provided by (Responsible Party): Thomas Jefferson University

Tracking Information

• First Submitted Date: October 7, 2008
• First Posted Date: October 8, 2008
• Results First Submitted Date: October 9, 2014
• Results First Posted Date: November 20, 2014
• Last Update Posted Date: November 20, 2014
• Study Start Date: June 2009
• Actual Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: October 7, 2008): Depression [ Time Frame: 4 months ]

Current Secondary Outcome Measures (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 (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: Low Vision Depression Prevention Trial for Age Related Macular Degeneration
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Prevention

Condition

• Age-related Macular Degeneration
• Depression

Intervention

• 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

• 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 *

• Rovner BW, Casten RJ, Hegel MT, Massof RW, Leiby BE, Ho AC, Tasman WS. Low vision depression prevention trial in age-related macular degeneration: a randomized clinical trial. Ophthalmology. 2014 Nov;121(11):2204-11. doi: 10.1016/j.ophtha.2014.05.002. Epub 2014 Jul 9.
• Deemer AD, Massof RW, Rovner BW, Casten RJ, Piersol CV. Functional Outcomes of the Low Vision Depression Prevention Trial in Age-Related Macular Degeneration. Invest Ophthalmol Vis Sci. 2017 Mar 1;58(3):1514-1520. doi: 10.1167/iovs.16-20001.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 13, 2014): 188
• Original Estimated Enrollment (submitted: October 7, 2008): 200
• Actual Study Completion Date: June 2014
• Actual Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 65 Years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00769015
• Other Study ID Numbers: 1U01EY018819( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Thomas Jefferson University
• Original Responsible Party: Barry W. Rovner, MD, Thomas Jefferson University
• Current Study Sponsor: Thomas Jefferson University
• Original Study Sponsor: Same as current

Collaborators

• Dartmouth-Hitchcock Medical Center
• Johns Hopkins University

• Investigators: Not Provided
• PRS Account: Thomas Jefferson University
• Verification Date: November 2014