IF-AMD: Improving Function in Age-Related Macular Degeneration

• Sponsor: Thomas Jefferson University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00572039
• Collaborator: Dartmouth-Hitchcock Medical Center (Other), Johns Hopkins University (Other)
• Enrollment: 241
• Location: 1
• Arms: 2
• Duration (Months): 94
• Patients Per Site Per Month: 2.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Age-Related Macular Degeneration	Behavioral: PST; Behavioral: ST	Phase 3

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 241 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Improving Function in Age-Related Macular Degeneration
• Study Start Date: Aug 1, 2005
• Actual Primary Completion Date: Jun 1, 2013
• Actual Study Completion Date: Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PST Problem Solving Treatment (PST)	Behavioral: PST; PST will be delivered in subjects' homes over the course of 6 weeks.
Placebo Comparator: ST Supportive Therapy (ST)	Behavioral: ST; ST will be delivered in subjects' homes over the course of 6 weeks.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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 Outcome Measures

1. 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.

2. Vision-related Quality of Life [6 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

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

• Principal Investigator: Barry W Rovner, MD, Jefferson Medical College of Thomas Jefferson University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Thomas Jefferson University
• ClinicalTrials.gov Identifier: NCT00572039
• Other Study ID Numbers: 5U01EY015839; NEI grant
• First Posted: Dec 12, 2007
• Last Update Posted: Oct 15, 2015
• Last Verified: Sep 1, 2015

• Keywords provided by Thomas Jefferson University: Age-Related Macular Degeneration; AMD; Vision Function; Problem Solving Treatment; PST
• Additional relevant MeSH terms: Macular Degeneration

Study Results

Participant Flow

Arm/Group Title	Problem Solving Treatment	Supportive Therapy
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	121	120
COMPLETED	105	110
NOT COMPLETED	16	10

Baseline Characteristics

Arm/Group Title	Problem Solving Treatment	Supportive Therapy	Total
Arm/Group Description	Problem Solving Treatment (PST) PST: PST will be delivered in subjects' homes over the course of 6 weeks.	Supportive Therapy (ST) ST: ST will be delivered in subjects' homes over the course of 6 weeks.	Total of all reporting groups
Overall Participants	121	120	241
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	82.7 (6.6)	82.8 (7.3)	82.7 (6.9)
Sex: Female, Male (Count of Participants)
Female	82 67.8%	71 59.2%	153 63.5%
Male	39 32.2%	49 40.8%	88 36.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 0.8%	1 0.8%	2 0.8%
White	120 99.2%	119 99.2%	239 99.2%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	121 100%	120 100%	241 100%
Targeted vision function (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	2.71 (.52)	2.73 (.52)	2.72 (.52)
NEI VFQ-25 + supplement total score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	66.2 (14.3)	65.8 (14.2)	66.0 (14.2)
Patient Health Questionnaire-9 (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	1.39 (2.67)	1.17 (2.28)	1.28 (2.48)
Number of resources/rehabilitative devices used (number of resources/devices used) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [number of resources/devices used]	5.14 (3.34)	4.71 (3.02)	4.93 (3.18)

Outcome Measures

1. Primary Outcome

Title	Targeted Vision Function (TVF)
Description	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

Outcome Measure Data

Analysis Population Description

106 PST and 112 ST participants provided data at 3 months.

Arm/Group Title	Problem Solving Treatment	Supportive Therapy
Arm/Group Description	Problem Solving Treatment (PST) PST: PST will be delivered in subjects' homes over the course of 6 weeks.	Supportive Therapy (ST) ST: ST will be delivered in subjects' homes over the course of 6 weeks.
Measure Participants	106	112
Mean (Standard Error) [units on a scale]	2.18 (.88)	2.14 (.96)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Problem Solving Treatment, Supportive Therapy
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.47
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.079
	Confidence Interval	(2-Sided) 95%; -0.14 to 0.29
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Vision-related Quality of Life
Description	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

Outcome Measure Data

Analysis Population Description

106 PST and 112 ST participants provided data at 3 months.

Arm/Group Title	Problem Solving Treatment	Supportive Therapy
Arm/Group Description	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.	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.
Measure Participants	106	112
Mean (Standard Deviation) [units on a scale]	66.6 (14.9)	65.2 (16.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Problem Solving Treatment, Supportive Therapy
	Comments	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.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.7
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	0.40
	Confidence Interval	(2-Sided) 95%; -1.96 to 2.77
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Primary Outcome

Title	Targeted Vision Function
Description	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

Outcome Measure Data

Analysis Population Description

105 PST and 110 ST participants provided data at 6 months.

Arm/Group Title	Problem Solving Treatment	Supportive Therapy
Arm/Group Description	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.	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.
Measure Participants	105	110
Mean (Standard Deviation) [units on a scale]	2.18 (.95)	2.15 (.96)

4. Secondary Outcome

Title	Vision-related Quality of Life
Description	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

Outcome Measure Data

Analysis Population Description

105 PST and 110 ST participants provided data at 6 months.

Arm/Group Title	Problem Solving Treatment	Supportive Therapy
Arm/Group Description	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.	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.
Measure Participants	105	110
Mean (Standard Deviation) [units on a scale]	66.4 (16.7)	64.8 (17.4)

Adverse Events

Arm/Group Title	Problem Solving Treatment		Supportive Therapy
Arm/Group Description	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.		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.
All Cause Mortality
	Problem Solving Treatment		Supportive Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Problem Solving Treatment		Supportive Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	35/121 (28.9%)		29/120 (24.2%)
Cardiac disorders
Congestive Heart Failure	2/121 (1.7%)	2	3/120 (2.5%)	3
Death due to CHF	1/121 (0.8%)	1	1/120 (0.8%)	1
Cardiac event	4/121 (3.3%)	4	2/120 (1.7%)	2
Endocrine disorders
hypoglycemia	1/121 (0.8%)	1	0/120 (0%)	0
Gastrointestinal disorders
Severe reflux, Hiatal hernia, Bowel obstruction	3/121 (2.5%)	3	0/120 (0%)	0
General disorders
Death NOS	2/121 (1.7%)	2	1/120 (0.8%)	1
Metabolism and nutrition disorders
Dehydration/anemia	0/121 (0%)	0	3/120 (2.5%)	3
Musculoskeletal and connective tissue disorders
Fall	6/121 (5%)	6	8/120 (6.7%)	8
Amputation	1/121 (0.8%)	1	0/120 (0%)	0
Knee pain/back pain	1/121 (0.8%)	1	1/120 (0.8%)	1
Fracture	1/121 (0.8%)	1	0/120 (0%)	0
Myasthenia Gravis	1/121 (0.8%)	1	0/120 (0%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pagets diesease	0/121 (0%)	0	1/120 (0.8%)	1
Nervous system disorders
Syncope	1/121 (0.8%)	1	0/120 (0%)	0
Psychiatric disorders
Depression	5/121 (4.1%)	5	1/120 (0.8%)	1
Respiratory, thoracic and mediastinal disorders
Pneumonia	1/121 (0.8%)	1	5/120 (4.2%)	5
Pulmonary hypertension	1/121 (0.8%)	1	0/120 (0%)	0
Vascular disorders
Stroke	3/121 (2.5%)	3	2/120 (1.7%)	2
Varicosities	1/121 (0.8%)	1	0/120 (0%)	0
Subdural hematoma	0/121 (0%)	0	1/120 (0.8%)	1
Other (Not Including Serious) Adverse Events
	Problem Solving Treatment		Supportive Therapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/121 (0%)		0/120 (0%)

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.