BACKGROUND: Any study with human subjects must have a robust consent process to ensure that participants understand the study and can decide whether they want to be involved. Investigators must determine whether a potential study participant is able to make an informed decision and what modifications or supports are needed to maximize participation in decision making. A variety of approaches have been used to modify consent forms and the consent process to increase the research participants' decisional capacity. This protocol describes a randomized controlled trial (RCT) of a digital health app to support decision making among individuals contemplating providing consent to participate in a clinical trial.
OBJECTIVE: The objective of this RCT will be to determine if the use of a tablet-based app facilitates greater participation in and satisfaction with the consent process compared with standard practice and identify which individual factors are associated with better response to the decision aid. We hypothesize that the tablet-based version of the consent process will promote more informed decision making, including decisions that are more consistent with individual preferences and values expressed during qualitative data collection.
METHODS: A two-arm RCT will be conducted in a sample of approximately 100 individuals with fragile X syndrome in their homes across the United States.
RESULTS: Data analysis will be completed by late 2018.
CONCLUSIONS: By developing and testing a novel consent decision aid, we will have a better understanding of whether and how technological support can optimize the fit between the decisional capacity and the decisional process.
TRIAL REGISTRATION: ClinicalTrials.gov NCT02465931; https://clinicaltrials.gov/ct2/show/NCT02465931 (Archived by WebCite at http://www.webcitation.org/72Q3xJQAw).
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/10360.