VITAL: Low Vision Depression Prevention Trial for Age Related Macular Degeneration

• Sponsor: Thomas Jefferson University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00769015
• Collaborator: Dartmouth-Hitchcock Medical Center (Other), Johns Hopkins University (Other)
• Enrollment: 188
• Location: 1
• Arms: 2
• Duration (Months): 60
• Patients Per Site Per Month: 3.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Age-related Macular Degeneration; Depression	Behavioral: BA-LVR; Behavioral: ST-LVR	Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 188 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Low Vision Depression Prevention Trial for Age Related Macular Degeneration
• Study Start Date: Jun 1, 2009
• Actual Primary Completion Date: Jan 1, 2014
• Actual Study Completion Date: Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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.	Behavioral: BA-LVR; Low vision clinic-based optometry plus 6 in-home occupational therapy visits
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.	Behavioral: ST-LVR; Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy

Outcome Measures

Primary Outcome Measures

1. Depression [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.

Secondary Outcome Measures

1. Vision Function: Distance Activities [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.

2. Quality of Life: Dependency [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.

3. Vision Function: Near Activities [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.

4. Quality of Life: Mental Health [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.

5. Quality of Life: Role Functioning [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.

6. Quality of Life: Social Function [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Thomas Jefferson University	Philadelphia	Pennsylvania	United States	19107

Sponsors and Collaborators

• Thomas Jefferson University
• Dartmouth-Hitchcock Medical Center
• Johns Hopkins University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Thomas Jefferson University
• ClinicalTrials.gov Identifier: NCT00769015
• Other Study ID Numbers: 1U01EY018819
• First Posted: Oct 8, 2008
• Last Update Posted: Nov 20, 2014
• Last Verified: Nov 1, 2014

• Keywords provided by Thomas Jefferson University: age-related macular degeneration; depression; vision loss
• Additional relevant MeSH terms: Vision, Low; Macular Degeneration; Depression; Depressive Disorder

Study Results

Participant Flow

Recruitment Details	Subjects were recruited from July 2009 through Feb 2013 from a large, private retina practice.

Arm/Group Title	BA-LVR	ST-LVR
Arm/Group Description	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	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
Period Title: Overall Study
STARTED	96	92
COMPLETED	87	76
NOT COMPLETED	9	16

Baseline Characteristics

Arm/Group Title	BA-LVR	ST-LVR	Total
Arm/Group Description	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	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 of all reporting groups
Overall Participants	96	92	188
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	85.2 (6.6)	82.7 (6.9)	84.0 (6.8)
Sex: Female, Male (Count of Participants)
Female	70 72.9%	62 67.4%	132 70.2%
Male	26 27.1%	30 32.6%	56 29.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 1%	0 0%	1 0.5%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 1%	2 2.2%	3 1.6%
White	94 97.9%	90 97.8%	184 97.9%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 1%	0 0%	1 0.5%
Not Hispanic or Latino	95 99%	92 100%	187 99.5%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Depression
Description	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.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BA-LVR	ST-LVR
Arm/Group Description	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	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
Measure Participants	87	76
Total Sample	11 11.5%	18 19.6%
Worse Vision Group (< 20/100)	5 5.2%	11 12%
Better Vision Group (20/70 to 20/100)	6 6.3%	7 7.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BA-LVR, ST-LVR
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.067
	Comments	Mantel-Haenszel chi-square test. The p-value refers to the overall test of between group differences in rates of depression.
	Method	Mantel Haenszel
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	.54
	Confidence Interval	(2-Sided) 95%; .27 to 1.06
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Vision Function: Distance Activities
Description	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.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BA-LVR	ST-LVR
Arm/Group Description	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	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
Measure Participants	87	76
Least Squares Mean (95% Confidence Interval) [units on a scale]	0.31	1.12

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BA-LVR, ST-LVR
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.75
	Comments
	Method	Linear Mixed effects model
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-.81
	Confidence Interval	(2-Sided) 95%; -5.92 to 4.30
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Quality of Life: Dependency
Description	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.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BA-LVR	ST-LVR
Arm/Group Description	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	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
Measure Participants	87	76
Least Squares Mean (95% Confidence Interval) [units on a scale]	2.07	5.54

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BA-LVR, ST-LVR
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.68
	Comments
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Change in least squares mean
	Estimated Value	3.47
	Confidence Interval	(2-Sided) 95%; -12.22 to 5.29
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Vision Function: Near Activities
Description	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.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BA-LVR	ST-LVR
Arm/Group Description	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	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
Measure Participants	87	76
Least Squares Mean (95% Confidence Interval) [units on a scale]	4.78	2.36

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BA-LVR, ST-LVR
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.34
	Comments
	Method	Least squares mean
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.42
	Confidence Interval	(2-Sided) 95%; -2.58 to 7.41
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Quality of Life: Mental Health
Description	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.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BA-LVR	ST-LVR
Arm/Group Description	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	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
Measure Participants	87	76
Least Squares Mean (95% Confidence Interval) [units on a scale]	2.23	4.25

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BA-LVR, ST-LVR
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.68
	Comments
	Method	Least squares mean
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-2.02
	Confidence Interval	(2-Sided) 95%; -9.80 to 5.76
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Quality of Life: Role Functioning
Description	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.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BA-LVR	ST-LVR
Arm/Group Description	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	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
Measure Participants	87	76
Least Squares Mean (95% Confidence Interval) [units on a scale]	2.33	.93

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BA-LVR, ST-LVR
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.68
	Comments
	Method	Least squares mean
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.39
	Confidence Interval	(2-Sided) 95%; -4.04 to 6.82
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	Quality of Life: Social Function
Description	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.
Time Frame	4 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	BA-LVR	ST-LVR
Arm/Group Description	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	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
Measure Participants	87	76
Least Squares Mean (95% Confidence Interval) [units on a scale]	-.38	-2.00

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	BA-LVR, ST-LVR
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.68
	Comments
	Method	Least squares mean
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.62
	Confidence Interval	(2-Sided) 95%; -5.94 to 9.17
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	12 months
Arm/Group Title	BA-LVR		ST-LVR
Arm/Group Description	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		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
All Cause Mortality
	BA-LVR		ST-LVR
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	BA-LVR		ST-LVR
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	30/96 (31.3%)		28/92 (30.4%)
Cardiac disorders
Cardiac	2/96 (2.1%)	2	3/92 (3.3%)	3
Gastrointestinal disorders
GI	2/96 (2.1%)	2	2/92 (2.2%)	2
General disorders
death NOS	5/96 (5.2%)	5	4/92 (4.3%)	4
Metabolism and nutrition disorders
dehydration	1/96 (1%)	1	0/92 (0%)	0
Musculoskeletal and connective tissue disorders
Break/fracture	8/96 (8.3%)	8	9/92 (9.8%)	9
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer	3/96 (3.1%)	3	2/92 (2.2%)	2
Renal and urinary disorders
UTI	0/96 (0%)	0	1/92 (1.1%)	1
Respiratory, thoracic and mediastinal disorders
Respiratory	1/96 (1%)	1	4/92 (4.3%)	4
Vascular disorders
Stroke/TIA	8/96 (8.3%)	8	3/92 (3.3%)	3
Other (Not Including Serious) Adverse Events
	BA-LVR		ST-LVR
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/96 (11.5%)		5/92 (5.4%)
General disorders
falls with no break/uti	11/96 (11.5%)	11	5/92 (5.4%)	5

Limitations/Caveats

[Not Specified]

More Information

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.