Age-Related Macular Degeneration
Conditions
Keywords
Age-Related Macular Degeneration, AMD, Vision Function, Problem Solving Treatment, PST
Brief summary
This randomized, controlled clinical trial will test the efficacy of Problem-Solving Treatment (PST) to improve vision function in older persons with age-related macular degeneration (AMD). AMD is a highly prevalent, disabling disease of aging that causes severe vision loss and functional decline. It is the leading cause of blindness in older persons in the United States and may affect more than 10 million people. Currently, there are no effective treatments to restore vision. Thus, improving Vision Function is a major goal of treatment. Vision function refers to vision-related abilities to perform daily living activities (e.g. reading recipes to prepare meals). Decrements in vision function will become a major public health problem as the population ages and the prevalence of AMD increases. PST is a brief, standardized, cognitive-behavioral treatment that teaches problem-solving skills. We believe PST will enable patients with AMD find practical solutions to vision-related problems and thereby improve vision function. We will recruit 240 AMD patients from the retina clinics of Wills Eye Institute, Philadelphia, PA, with bilateral AMD and visual acuity worse than 20/70 in the better eye. PST-trained therapists will deliver 6 1-hour, in-home sessions to the 120 subjects randomized to PST. The control treatment is Supportive Therapy (ST), a similarly structured, standardized psychological treatment that controls for the non-specific effects of treatment (n=120). ST contains no active elements beyond its non-specific components; in this way it is a placebo treatment. Independent raters, masked to treatment assignment, will assess Targeted Vision Function (primary outcome) and vision-related quality of life (secondary outcome) at 3 months to assess PST's efficacy, and at 6 months to evaluate its long-term effects. As the population ages, the disability of AMD will become more prevalent, costly, and burdensome to patients, families, and ophthalmologists. This makes devising and testing practical and affordable interventions to improve vision function a national priority.
Detailed description
The primary hypothesis will address treatment group differences in Targeted Vision Function at 3-months, and secondary hypotheses will the long-term effect (6-months) of Problem Solving Treatment (PST) on TVF and vision-related quality of life.
Interventions
Sponsors
Dartmouth College
Johns Hopkins University
Thomas Jefferson University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Being at least 65 years old * Having bilateral Age-Related Macular Degeneration (AMD) (atrophic or neovascular) * Having a best corrected visual acuity of 20/70 or worse * Moderate difficulty in at least one valued vision functional goal
Exclusion criteria
* Ophthalmologic Criteria. Patients who have uncontrolled glaucoma (continued visual field loss and increase in optic nerve cupping), diabetic retinopathy (due to macular edema), or cataracts for which surgery within 6 months is likely will not be eligible to participate. This information will be obtained from patients' ophthalmology charts and discussion with the patient's ophthalmologist. * Cognitive Impairment Criteria. Cognitive functioning will be evaluated by the Project Director during the telephone screen (see Chapter 9). Patients with cognitive impairment will not be eligible to participate. * Health Criteria. Patients with life-threatening illness (e.g., terminal cancer, need for oxygen) will not be eligible to participate. Information regarding heath status will be gleaned from patient's ophthalmology charts.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Targeted Vision Function (TVF) | 3-Months | We identified and quantified the TVF goals that subjects valued but found difficult to achieve. To derive the TVF measure, at baseline subjects completed the Activities Inventory, a structured vision function questionnaire that asks patients to rate the value and difficulty of 48 vision function goals (e.g., daily meal preparation) and the tasks (e.g., seeing stove settings) that are required to achieve them. If a goal is important (range of 0 \[not important\]to 4 \[very important\]), the subject rates its difficulty (on a scale of 0 \[not difficult\] to 4 \[impossible\]). The average TVF score is the sum of the difficulty ratings of the (up to) 4 self-selected goals divided by the number of goals (from 1 to 4). Higher average scores indicate greater disability. At each outcome assessment subjects again rated the difficulty of the same targeted goals and the average TVF score was calculated. |
| Targeted Vision Function | 6 months | We identified and quantified the TVF goals that subjects valued but found difficult to achieve. To derive the TVF measure, at baseline subjects completed the Activities Inventory, a structured vision function questionnaire that asks patients to rate the value and difficulty of 48 vision function goals (e.g., daily meal preparation) and the tasks (e.g., seeing stove settings) that are required to achieve them. If a goal is important (range of 0 \[not important\]to 4 \[very important\]), the subject rates its difficulty (on a scale of 0 \[not difficult\] to 4 \[impossible\]). The average TVF score is the sum of the difficulty ratings of the (up to) 4 self-selected goals divided by the number of goals (from 1 to 4). Higher average scores indicate greater disability. At each outcome assessment subjects again rated the difficulty of the same targeted goals and the average TVF score was calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Vision-related Quality of Life | 3-Months | We administered the 25-item National Eye Institute Vision Function Questionaire plus Supplement (NEI-VFQ).19 This version of the NEI VFQ consists of 39 items that assess self-reported vision function and vision-related QoL. The latter yields a multidimensional index of vision-related health composed of social functioning (social interactions), mental health (worry, frustration), role difficulties (accomplishing less), and dependency (relying more on others) due to vision loss. Scores range from 0 to 100, with higher scores indicating better function. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Problem Solving Treatment Problem Solving Treatment (PST)
PST: PST will be delivered in subjects' homes over the course of 6 weeks. | 121 |
| Supportive Therapy Supportive Therapy (ST)
ST: ST will be delivered in subjects' homes over the course of 6 weeks. | 120 |
| Total | 241 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 2 | 3 |
| Overall Study | Ill | 5 | 1 |
| Overall Study | Withdrawal by Subject | 9 | 6 |
Baseline characteristics
| Characteristic | Total | Problem Solving Treatment | Supportive Therapy |
|---|---|---|---|
| Age, Continuous | 82.7 years STANDARD_DEVIATION 6.9 | 82.7 years STANDARD_DEVIATION 6.6 | 82.8 years STANDARD_DEVIATION 7.3 |
| NEI VFQ-25 + supplement total score | 66.0 units on a scale STANDARD_DEVIATION 14.2 | 66.2 units on a scale STANDARD_DEVIATION 14.3 | 65.8 units on a scale STANDARD_DEVIATION 14.2 |
| Number of resources/rehabilitative devices used | 4.93 number of resources/devices used STANDARD_DEVIATION 3.18 | 5.14 number of resources/devices used STANDARD_DEVIATION 3.34 | 4.71 number of resources/devices used STANDARD_DEVIATION 3.02 |
| Patient Health Questionnaire-9 | 1.28 units on a scale STANDARD_DEVIATION 2.48 | 1.39 units on a scale STANDARD_DEVIATION 2.67 | 1.17 units on a scale STANDARD_DEVIATION 2.28 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 239 Participants | 120 Participants | 119 Participants |
| Region of Enrollment United States | 241 participants | 121 participants | 120 participants |
| Sex: Female, Male Female | 153 Participants | 82 Participants | 71 Participants |
| Sex: Female, Male Male | 88 Participants | 39 Participants | 49 Participants |
| Targeted vision function | 2.72 units on a scale STANDARD_DEVIATION 0.52 | 2.71 units on a scale STANDARD_DEVIATION 0.52 | 2.73 units on a scale STANDARD_DEVIATION 0.52 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 121 | 0 / 120 |
| serious Total, serious adverse events | 35 / 121 | 29 / 120 |
Outcome results
Primary
Targeted Vision Function
We identified and quantified the TVF goals that subjects valued but found difficult to achieve. To derive the TVF measure, at baseline subjects completed the Activities Inventory, a structured vision function questionnaire that asks patients to rate the value and difficulty of 48 vision function goals (e.g., daily meal preparation) and the tasks (e.g., seeing stove settings) that are required to achieve them. If a goal is important (range of 0 \[not important\]to 4 \[very important\]), the subject rates its difficulty (on a scale of 0 \[not difficult\] to 4 \[impossible\]). The average TVF score is the sum of the difficulty ratings of the (up to) 4 self-selected goals divided by the number of goals (from 1 to 4). Higher average scores indicate greater disability. At each outcome assessment subjects again rated the difficulty of the same targeted goals and the average TVF score was calculated.
Time frame: 6 months
Population: 105 PST and 110 ST participants provided data at 6 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Problem Solving Treatment | Targeted Vision Function | 2.18 units on a scale | Standard Deviation 0.95 |
| Supportive Therapy | Targeted Vision Function | 2.15 units on a scale | Standard Deviation 0.96 |
Primary
Targeted Vision Function (TVF)
We identified and quantified the TVF goals that subjects valued but found difficult to achieve. To derive the TVF measure, at baseline subjects completed the Activities Inventory, a structured vision function questionnaire that asks patients to rate the value and difficulty of 48 vision function goals (e.g., daily meal preparation) and the tasks (e.g., seeing stove settings) that are required to achieve them. If a goal is important (range of 0 \[not important\]to 4 \[very important\]), the subject rates its difficulty (on a scale of 0 \[not difficult\] to 4 \[impossible\]). The average TVF score is the sum of the difficulty ratings of the (up to) 4 self-selected goals divided by the number of goals (from 1 to 4). Higher average scores indicate greater disability. At each outcome assessment subjects again rated the difficulty of the same targeted goals and the average TVF score was calculated.
Time frame: 3-Months
Population: 106 PST and 112 ST participants provided data at 3 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Problem Solving Treatment | Targeted Vision Function (TVF) | 2.18 units on a scale | Standard Error 0.88 |
| Supportive Therapy | Targeted Vision Function (TVF) | 2.14 units on a scale | Standard Error 0.96 |
Comparison: To test the efficacy of PST to improve TVF functional reserve measures at 3 months, we used an analysis of covariance in which group differences (PST vs ST) in 3-month average TVF scores were examined, adjusting for baseline TVF score and the vision severity stratification variable. To approximate an interval scale and compensate for ceiling and floor effects, we linearized TVF scores using a logit transform. 106 PST and 112 ST participants provided data at 3 months.p-value: 0.4795% CI: [-0.14, 0.29]ANCOVA
Secondary
Vision-related Quality of Life
We administered the 25-item National Eye Institute Vision Function Questionaire plus Supplement (NEI-VFQ).19 This version of the NEI VFQ consists of 39 items that assess self-reported vision function and vision-related QoL. The latter yields a multidimensional index of vision-related health composed of social functioning (social interactions), mental health (worry, frustration), role difficulties (accomplishing less), and dependency (relying more on others) due to vision loss. Scores range from 0 to 100, with higher scores indicating better function.
Time frame: 3-Months
Population: 106 PST and 112 ST participants provided data at 3 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Problem Solving Treatment | Vision-related Quality of Life | 66.6 units on a scale | Standard Deviation 14.9 |
| Supportive Therapy | Vision-related Quality of Life | 65.2 units on a scale | Standard Deviation 16.2 |
Comparison: To test the efficacy of PST to improve NE-VFQ scores at 3 months, we used an analysis of covariance in which group differences (PST vs ST) in 3-month average NEI-VFQ scores were examined, adjusting for baseline score and the vision severity stratification variable.p-value: 0.795% CI: [-1.96, 2.77]ANCOVA
Secondary
Vision-related Quality of Life
We administered the 25-item National Eye Institute Vision Function Questionaire plus Supplement (NEI-VFQ).19 This version of the NEI VFQ consists of 39 items that assess self-reported vision function and vision-related QoL. The latter yields a multidimensional index of vision-related health composed of social functioning (social interactions), mental health (worry, frustration), role difficulties (accomplishing less), and dependency (relying more on others) due to vision loss. Scores range from 0 to 100, with higher scores indicating better function.
Time frame: 6 months
Population: 105 PST and 110 ST participants provided data at 6 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Problem Solving Treatment | Vision-related Quality of Life | 66.4 units on a scale | Standard Deviation 16.7 |
| Supportive Therapy | Vision-related Quality of Life | 64.8 units on a scale | Standard Deviation 17.4 |