Supporting informed clinical trial decisions: Results from a randomized controlled trial evaluating a digital decision support tool for those with intellectual disability.

ABSTRACT: BACKGROUND:Informed consent requires that individuals understand the nature of the study, risks and benefits of participation. Individuals with intellectual disabilities (ID) have cognitive and adaptive impairments that may affect their ability to provide informed consent. New treatments and clinical trials for fragile X syndrome, the most commonly known inherited cause of ID, necessitate the development of methods to improve the informed consent process. The goal of this study was to compare the efficacy of a digital decision support tool with that of standard practice for informed consent and to examine whether the tool can improve decisional capacity for higher functioning individuals. METHODS:Participants (N = 89; mean age = 21.2 years) were allocated to the experimental group (consent

SUBMITTER: McCormack LA 

PROVIDER: S-EPMC6808417 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature