DVD Consent for Research in Older Schizophrenia Patients

University Of California, San Diego, La Jolla CA

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Abstract

DESCRIPTION: (provided by applicant) As the population of middle-aged and elderly persons with schizophrenia increases over the coming decades, more treatment research will be needed in this population. Because of factors such as age-related cognitive impairment, it is important to study methods for evaluating and enhancing consent procedures for treatment research in these patients. The proposed investigation will be a randomized, controlled comparison of an innovative procedure for providing informed consent - a Digital Video Disc DVD)-based, multimedia consent procedure with a routine consent procedure (supplemented with a short "control" DVD). The multimedia consent procedure is based on cognitive models of learning. Participants will be persons 40 years or older with schizophrenia (N=192) and normal comparison subjects (N=192). Each subject will be randomly assigned to receive informed consent for one of two studies, one entailing a relatively lower and lower complexity risk (cognitive training), or one involving substantially higher risk and greater complexity (a randomized, double-blind, placebo-controlled trial of a cognitive-enhancing drug with potential for serious adverse effects). The primary outcome measure will be the subjects' decisional capacity assessed with the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR), at baseline and again at a one-month follow-up. We will also evaluate subject and protocol characteristics associated with usefulness of DVD versus routine consent procedure. The DVD-based consent is not intended to supplant, but rather to supplement, the researcher-participant in-person interaction involved in consent process.