1. 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
- Author
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Sarah Gander, Sarah Zaidi, Andrew Mackie, Roger Stoddard, Myla E Moretti, Lonnie Zwaigenbaum, Wendy J Ungar, Khush Amaria, Adrienne Kovacs, Ronen Rozenblum, Barbara Galuppi, Linda Nguyen, Sonya Strohm, Nadilein Mahlberg, Alicia Via-Dufresne Ley, Ariane Marelli, Donna Thomson, JoAnne Mosel, Connie Putterman, Kinga Pozniak, Nathan Tasker, Julia Hanes, Kyle Chambers, Jessica Havens, Claire Dawe-McCord, Dana Arafeh, Hana Alazem, John Andersen, Kerry Boyd, Caitlin Cassidy, Jamie Churchill, CJ Curran, Anne Fournier, Anna McCormick, Ronit Mesterman, Maryam Oskoui, Janet Rennick, Jordan Sheriko, Kathy Speechley, Kelly Wynne, Fabiola Breault, Yomna Elshamy, Rocio Gutierrez, Hashaam Hasan, Rhiannon Hicks, André Pépin, Rochelle Sorzano, and Jennifer Zwicker
- Subjects
Adult ,Telemedicine ,Canada ,Transition to Adult Care ,Adolescent ,Health intervention ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Nursing ,Randomized controlled trial ,law ,030225 pediatrics ,Intervention (counseling) ,Intellectual Disability ,Health care ,Medicine ,Humans ,030212 general & internal medicine ,Randomized Controlled Trials as Topic ,Research ethics ,clinical trials ,business.industry ,rehabilitation medicine ,Paediatrics ,General Medicine ,Mobile Applications ,3. Good health ,Clinical trial ,developmental neurology & neurodisability ,business ,Delivery of Health Care ,Qualitative research - Abstract
IntroductionYouth 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 analysisWe 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 disseminationThe 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 numberNCT03852550.
- Published
- 2021