Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NEI grant |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Dartmouth College | OTHER |
| Johns Hopkins University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PST | Experimental | Problem Solving Treatment (PST) |
|
| ST | Placebo Comparator | Supportive Therapy (ST) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PST | Behavioral | PST will be delivered in subjects' homes over the course of 6 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3-Months |
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Barry W Rovner, MD | Jefferson Medical College of Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21746979 | Derived | Rovner BW, Casten RJ, Massof RW, Leiby BE, Tasman WS; Wills Eye AMD Study. Psychological and cognitive determinants of vision function in age-related macular degeneration. Arch Ophthalmol. 2011 Jul;129(7):885-90. doi: 10.1001/archophthalmol.2011.146. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Problem Solving Treatment | Problem-solving therapy teaches problem solving skills in a structured way to enable a patient to systematically identify his or her problems, generate alternative solutions for each problem, select the best solution, develop and conduct a plan, and evaluate whether the problem is solved. |
| FG001 | Supportive Therapy | Supportive therapy is a structured, standardized, psychological treatment that controls for nonspecific treatment effects. Supportive therapy resembles PST in all ways but for PST's problem-solving skills training. Both interventions are based on written treatment manuals and similar in dose and intensity of attention (number and duration of sessions). Supportive therapy is nondirective and supportive, facilitates personal expression, and conveys empathy, respect, and optimism (i.e., a general sense that things can get better). The ST therapist informs subjects that ST's purpose is to explore the impact of vision loss on their lives. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Problem Solving Treatment | Problem Solving Treatment (PST) PST: PST will be delivered in subjects' homes over the course of 6 weeks. |
| BG001 | Supportive Therapy | Supportive Therapy (ST) ST: ST will be delivered in subjects' homes over the course of 6 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 106 PST and 112 ST participants provided data at 3 months. | Posted | Mean | Standard Error | units on a scale | 3-Months |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Problem Solving Treatment | Problem-solving therapy teaches problem solving skills in a structured way to enable a patient to systematically identify his or her problems, generate alternative solutions for each problem, select the best solution, develop and conduct a plan, and evaluate whether the problem is solved. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Depression | Psychiatric disorders | Systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Barry W. Rovner, MD | Thomas Jefferson University | 2155031254 | Barry.Rovner@jefferson.edu |
Not provided
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ST |
| Behavioral |
ST will be delivered in subjects' homes over the course of 6 weeks. |
|
| 3-Months |
| 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. | 6 months |
| Ill |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Targeted vision function | 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 goal and the tasks that are required to achieve them. If a goal is important, the subject rates its "difficulty". 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. | Mean | Standard Deviation | units on a scale |
|
| NEI VFQ-25 + supplement total score | 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. | Mean | Standard Deviation | units on a scale |
|
| Patient Health Questionnaire-9 | To assess depression, we used the 9-item Patient Health Questionnaire, which yields a continuous measure of depression severity. Scores range from 0 to 27, with higher scores indicating worse depression. | Mean | Standard Deviation | units on a scale |
|
| Number of resources/rehabilitative devices used | Mean | Standard Deviation | number of resources/devices used |
|
| OG000 |
| Problem Solving Treatment |
Problem Solving Treatment (PST) PST: PST will be delivered in subjects' homes over the course of 6 weeks. |
| OG001 | Supportive Therapy | Supportive Therapy (ST) ST: ST will be delivered in subjects' homes over the course of 6 weeks. |
|
|
|
| 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. | 106 PST and 112 ST participants provided data at 3 months. | Posted | Mean | Standard Deviation | units on a scale | 3-Months |
|
|
|
|
| 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. | 105 PST and 110 ST participants provided data at 6 months. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
| 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. | 105 PST and 110 ST participants provided data at 6 months. | Posted | Mean | Standard Deviation | units on a scale | 6 months |
|
|
|
| 35 |
| 121 |
| 0 |
| 121 |
| EG001 | Supportive Therapy | Supportive therapy is a structured, standardized, psychological treatment that controls for nonspecific treatment effects. Supportive therapy resembles PST in all ways but for PST's problem-solving skills training. Both interventions are based on written treatment manuals and similar in dose and intensity of attention (number and duration of sessions). Supportive therapy is nondirective and supportive, facilitates personal expression, and conveys empathy, respect, and optimism (i.e., a general sense that things can get better). The ST therapist informs subjects that ST's purpose is to explore the impact of vision loss on their lives. | 29 | 120 | 0 | 120 |
| Fall | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Amputation | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Congestive Heart Failure | Cardiac disorders | Systematic Assessment |
|
| Death due to CHF | Cardiac disorders | Systematic Assessment |
|
| Cardiac event | Cardiac disorders | Systematic Assessment |
|
| Stroke | Vascular disorders | Systematic Assessment |
|
| Dehydration/anemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Knee pain/back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| hypoglycemia | Endocrine disorders | Systematic Assessment |
|
| Varicosities | Vascular disorders | Systematic Assessment |
|
| Death NOS | General disorders | Systematic Assessment |
|
| Pagets diesease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
|
| Subdural hematoma | Vascular disorders | Systematic Assessment |
|
| Fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Severe reflux, Hiatal hernia, Bowel obstruction | Gastrointestinal disorders | Systematic Assessment |
|
| Syncope | Nervous system disorders | Systematic Assessment |
|
| Myasthenia Gravis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
Not provided
Not provided