TY - JOUR
T1 - CHILD-BRIGHT READYorNot Brain-Based Disabilities Trial
T2 - 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
AU - Gorter, Jan Willem
AU - Amaria, Khush
AU - Kovacs, Adrienne
AU - Rozenblum, Ronen
AU - Thabane, Lehana
AU - Galuppi, Barbara
AU - Nguyen, Linda
AU - Strohm, Sonya
AU - Mahlberg, Nadilein
AU - Via-Dufresne Ley, Alicia
AU - Marelli, Ariane
N1 - Funding Information:
Funding We gratefully acknowledge funding from the Child Health Initiatives Limiting Disability–Brain Research Improving Growth and Health Trajectories network, funded under the Canadian Institutes of Health Research (CIHR-SCA-145104) Strategy for Patient-Oriented Research initiative, and with funding partner support from Montreal Children’s Hospital Foundation, Faculty of Health Sciences of McMaster University, New Brunswick Health Research Foundation, McMaster Children’s Hospital Foundation and Hamilton Health Sciences.
Funding Information:
Competing interests JWG and AJM received research grants from the Canadian Institutes of Health Research Strategy for Patient-Oriented Research. JWG holds the Scotiabank Chair in Child Health Research. AK and RR were paid in part for their work as consultants. BG, LN, SS, NM and AV-D-L were paid for their work as project staff members. LT was paid in part for his work as statistical consultant.
Publisher Copyright:
© Author(s) 2021.
PY - 2021/3/26
Y1 - 2021/3/26
N2 - 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 Transition TM 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.
AB - 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 Transition TM 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.
KW - clinical trials
KW - developmental neurology & neurodisability
KW - rehabilitation medicine
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U2 - 10.1136/bmjopen-2021-048756
DO - 10.1136/bmjopen-2021-048756
M3 - Article
C2 - 33771833
AN - SCOPUS:85103442864
SN - 2044-6055
VL - 11
JO - BMJ Open
JF - BMJ Open
IS - 3
M1 - e048756
ER -