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

History of Changes

Tracking Information
First Received Date ^ICMJE	October 7, 2008
Last Updated Date	November 13, 2014
Start Date ^ICMJE	June 2009
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 ] [ Designated as safety issue: No ] 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 ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT00769015 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: November 13, 2014)	Vision Function: Distance Activities [ Time Frame: 4 months ] [ Designated as safety issue: No ] 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 ] [ Designated as safety issue: No ] 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 ] [ Designated as safety issue: No ] 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 ] [ Designated as safety issue: No ] 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 ] [ Designated as safety issue: No ] 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 ] [ Designated as safety issue: No ] 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 ] [ Designated as safety issue: No ] Quality of Life [ Time Frame: 4 months ] [ Designated as safety issue: No ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	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	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (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 Arm (s)	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.
* 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
Enrollment ^ICMJE	188
Completion Date	June 2014
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.
Gender	Both
Ages	65 Years and older (Adult, Senior)
Accepts Healthy Volunteers	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
Has Data Monitoring Committee	Yes
Plan to Share Data	Not Provided
IPD Description	Not Provided
Responsible Party	Thomas Jefferson University
Study Sponsor ^ICMJE	Thomas Jefferson University
Collaborators ^ICMJE	Dartmouth-Hitchcock Medical Center Johns Hopkins University
Investigators ^ICMJE	Not Provided
Information Provided By	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

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