Improving Function in Age-Related Macular Degeneration (IF-AMD)

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:
NCT00572039
First received: December 10, 2007
Last updated: September 14, 2015
Last verified: September 2015
  Purpose

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 Intervention Phase
Age-Related Macular Degeneration
Behavioral: PST
Behavioral: ST
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving Function in Age-Related Macular Degeneration

Resource links provided by NLM:


Further study details as provided by Thomas Jefferson University:

Primary Outcome Measures:
  • Targeted Vision Function (TVF) [ Time Frame: 3-Months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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:
  • Vision-related Quality of Life [ Time Frame: 3-Months ] [ Designated as safety issue: No ]
    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.

  • Vision-related Quality of Life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 241
Study Start Date: August 2005
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00572039

Locations
United States, Pennsylvania
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT00572039     History of Changes
Other Study ID Numbers: 5U01EY015839  NEI grant 
Study First Received: December 10, 2007
Results First Received: August 11, 2015
Last Updated: September 14, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Thomas Jefferson University:
Age-Related Macular Degeneration
AMD
Vision Function
Problem Solving Treatment
PST

Additional relevant MeSH terms:
Macular Degeneration
Eye Diseases
Retinal Degeneration
Retinal Diseases

ClinicalTrials.gov processed this record on April 27, 2016