Abstract
BackgroundChallenges in the clinical and research consent process indicate the need to develop tailored, supportive interventions for all individuals, especially those with limited decisional capacity. We developed a tool to enhance shared decision making and the decisional capacity for individuals with fragile X syndrome engaged in the informed consent process for a clinical trial.ObjectiveWe describe the design and development process of a tablet-based decision support tool.MethodsOur development process for the decision support tool employed a user-centered, feature-driven design approach. We began with an environmental scan to catalog relevant mobile apps, and we conducted interviews with people with a diagnosis of fragile X syndrome and clinicians at fragile X syndrome clinics. To develop content for the decision support tool, we extracted key concepts and elements from a real clinical trial consent form and rewrote it using plain-language principles.ResultsWe used iterative testing to continuously evaluate and revise the decision support tool content. The tool was finalized in 2016 and contained a series of vignettes, quiz questions, and a sorting activity. A randomized controlled trial was then conducted to compare the efficacy of the decision support tool with a standard verbal presentation of material that mimicked typical informed consent practice.ConclusionsThe informed consent process is primed to leverage digital health resources that promote increased understanding and engagement of research participants in the consent and research process. The process and experiences we describe may provide a model for other digital health design and development initiatives seeking to create more interactive and accessible decision support resources.Trial RegistrationClinicalTrials.gov NCT02465931; https://www.clinicaltrials.gov/ct2/show/NCT02465931 (Archived by WebCite at http://www.webcitation.org/6zx2KY9YW)
Highlights
Mobile Application AutisMate AutismXpress First Visual Schedule Grid Player Look2Learn - Alternative Communication (AAC) Pocket Cancer Care Guide Proloquo
This app allows users to take their own videos, pictures, and voice recordings to share with others on the Autism spectrum
This app uses colorful, animated icons which can be used by those with Autism to help express their emotions. This app is used for people who require a structured environment and assists with activity transitions by providing a visual schedule
Summary
This app allows users to take their own videos, pictures, and voice recordings to share with others on the Autism spectrum This app uses colorful, animated icons which can be used by those with Autism to help express their emotions. This app is used for people who require a structured environment and assists with activity transitions by providing a visual schedule. The app comes with pre-loaded vocal outputs that users can pair with photographs This app was designed for cancer patients or caregivers of cancer patients to compile questions for their physician. The app provides behavioral options for children to choose from
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