@article {Gortere048756, author = {Jan Willem Gorter and Khush Amaria and Adrienne Kovacs and Ronen Rozenblum and Lehana Thabane and Barbara Galuppi and Linda Nguyen and Sonya Strohm and Nadilein Mahlberg and Alicia Via-Dufresne Ley and Ariane Marelli}, editor = {, and , and Thomson, Donna and Stoddard, Roger and Mosel, JoAnne and Putterman, Connie and Pozniak, Kinga and Tasker, Nathan and Hanes, Julia and Chambers, Kyle and Havens, Jessica and Dawe-McCord, Claire and Arafeh, Dana and Alazem, Hana and Andersen, John and Azar, Rima and Boyd, Kerry and Cassidy, Caitlin and Churchill, Jamie and Curran, CJ and Doucet, Shelley and Fournier, Anne and Gander, Sarah and Mackie, Andrew and McCormick, Anna and Mesterman, Ronit and Oskoui, Maryam and Rennick, Janet and Sheriko, Jordan and Speechley, Kathy and Wynne, Kelly and Zwaigenbaum, Lonnie and Breault, Fabiola and Elshamy, Yomna and Gutierrez, Rocio and Hasan, Hashaam and Hicks, Rhiannon and P{\'e}pin, Andr{\'e} and Sorzano, Rochelle and Zaidi, Sarah and Ungar, Wendy J and Zwicker, Jennifer and Moretti, Myla E}, title = {CHILD-BRIGHT READYorNot Brain-Based Disabilities Trial: protocol of a randomised controlled trial (RCT) investigating the effectiveness of a patient-facing e-health intervention designed to enhance healthcare transition readiness in youth}, volume = {11}, number = {3}, elocation-id = {e048756}, year = {2021}, doi = {10.1136/bmjopen-2021-048756}, publisher = {British Medical Journal Publishing Group}, abstract = {Introduction Youth with brain-based disabilities (BBDs), as well as their parents/caregivers, often feel ill-prepared for the transfer from paediatric to adult healthcare services. To address this pressing issue, we developed the MyREADY TransitionTM BBD App, a patient-facing e-health intervention. The primary aim of this randomised controlled trial (RCT) was to determine whether the App will result in greater transition readiness compared with usual care for youth with BBD. Secondary aims included exploring the contextual experiences of youth using the App, as well as the interactive processes of youth, their parents/caregivers and healthcare providers around use of the intervention.Methods and analysis We aimed to randomise 264 youth with BBD between 15 and 17 years of age, to receive existing services/usual care (control group) or to receive usual care along with the App (intervention group). Our recruitment strategy includes remote and virtual options in response to the current requirements for physical distancing due to the COVID-19 pandemic. We will use an embedded experimental model design which involves embedding a qualitative study within a RCT. The Transition Readiness Assessment Questionnaire will be administered as the primary outcome measure. Analysis of covariance will be used to compare change in the two groups on the primary outcome measure; analysis will be intention-to-treat. Interviews will be conducted with subsets of youth in the intervention group, as well as parents/caregivers and healthcare providers.Ethics and dissemination The study has been approved by the research ethics board of each participating site in four different regions in Canada. We will leverage our patient and family partnerships to find novel dissemination strategies. Study findings will be shared with the academic and stakeholder community, including dissemination of teaching and training tools through patient associations, and patient and family advocacy groups.Trial registration number NCT03852550.}, issn = {2044-6055}, URL = {https://bmjopen.bmj.com/content/11/3/e048756}, eprint = {https://bmjopen.bmj.com/content/11/3/e048756.full.pdf}, journal = {BMJ Open} }