Improving function in age-related macular degeneration: design and methods of a randomized clinical trial.
Age-Related Macular Degeneration (AMD) is the leading cause of severe vision loss in older adults and impairs the ability to read, drive, and live independently and increases the risk for depression, falls, and earlier mortality. Although new medical treatments have improved AMD's prognosis, vision-related disability remains a major public health problem. Improving Function in AMD (IF-AMD) is a two-group randomized, parallel design, controlled clinical trial that compares the efficacy of Problem-Solving Therapy (PST) with Supportive Therapy (ST) (an attention control treatment) to improve vision function in 240 patients with AMD. PST and ST therapists deliver 6 one-hour respective treatment sessions to subjects in their homes over 2 months. Outcomes are assessed masked to treatment assignment at 3 months (main trial endpoint) and 6 months (maintenance effects). The primary outcome is targeted vision function (TVF), which refers to specific vision-dependent functional goals that subjects highly value but find difficult to achieve. TVF is an innovative outcome measure in that it is targeted and tailored to individual subjects yet is measured in a standardized way. This paper describes the research methods, theoretical and clinical aspects of the study treatments, and the measures used to evaluate functional and psychiatric outcomes in this population.
Departments of Psychiatry and Neurology, Jefferson Medical College, Jefferson Hospital for Neuroscience, 900 Walnut Street, 4th Floor, Philadelphia, PA 19107, United States. barry.rovner@jefferson.edu
Barry W
BW
Rovner
Robin J
RJ
Casten
Mark T
MT
Hegel
Robert W
RW
Massof
Benjamin E
BE
Leiby
William S
WS
Tasman
D000203:Activities of Daily Living / Q000523:psychology; D000368:Aged; D005260:Female; D006801:Humans; D008268:Macular Degeneration / Q000523:psychology / Q000534:rehabilitation*; D008297:Male; D010349:Patient Compliance; D011340:Problem Solving; D011613:Psychotherapy; D011788:Quality of Life / Q000523:psychology; D016032:Randomized Controlled Trials as Topic / Q000379:methods*; D020377:Self Efficacy; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014787:Vision Tests; D014785:Vision, Ocular