Clinical trial NCT03852550: READYorNot[TM] Brain-Based Disabilities Trial
Official title: CHILD-BRIGHT READYorNot[TM] Brain-Based Disabilities Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Autism Spectrum Disorder
Cerebral Palsy
Epilepsy
Fetal Alcohol Spectrum Disorders
Spina Bifida
Keywords: Health Care Transition
Brain-Based Disabilities
CHILD-BRIGHT
e-health application
randomized controlled trial
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: The Montreal Children's Hospital Foundation
name: McMaster Children's Hospital Foundation
name: Hamilton Health Sciences Corporation
name: New Brunswick Health Research Foundation
name: The Hospital for Sick Children
name: Harvard Medical School (HMS and HSDM)
name: Oregon Health and Science University
First posted: 2019-02-25
Enrollment: 52
Sex: ALL
Minimum age (years): 15
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Embedded experimental model design, embedding a qualitative component within the randomized controlled trial (RCT). Randomization will be stratified by region with a 1:1 allocation ratio for patients: intervention group (receiving MyREADY Transition\[TM\] BBD App intervention) or control group (continuing with usual care). The unit of randomization is the patient, using variable block randomization with block sizes of 2, 4, 6 and 8.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to find out if there is a benefit to using the MyREADY Transition\[TM\] BBD App for brain-based disabilities, compared to not using it. To do this, some of the participants in this study will use the MyREADY Transition\[TM\] BBD App and others will not use the App. Everyone will continue to get the same care they have been getting (their usual care).

The study team wants to see how youth will use the MyREADY Transition\[TM\] BBD App as they are getting ready to leave the children's hospital or children's treatment centre. And, they want to see if it will help youth to be knowledgeable about their own health. The study team hopes to see youth taking steps to develop the skills so they become better managers of their health. For example, this would include knowing about their medication or knowing when to ask for help from parents/caregivers and health care providers.

Detailed description: Youth with brain-based disabilities (BBD) see a variety of pediatric doctors and health care providers during their childhood years. Pediatric doctors and care teams are trained to manage the health of children, including physical, behavioural, and mental health issues. Typically by their eighteenth birthday, youth in Canada will need to leave their pediatric doctors and health care providers and go to adult providers instead. Generally, there are more expectations for youth to take charge of their own care when they see an adult care provider. Yet, if youth are not ready for this responsibility, or it is not clear where youth should go for care as adults, their health can sometimes be affected (for example when appointments or medications are missed). We also know that this change can be especially difficult and stressful for youth with BBD and for their families.

In the first part of this project, researchers, healthcare professionals, technology designers, youth and families have worked together to co-create an e-health application called MyREADY Transition\[TM\] BBD App. In this next part of the project, pediatric health care providers will be asked to share it with their patients who are between 15 and 17 years of age, and who have one of the following conditions: autism spectrum disorder, cerebral palsy, epilepsy, spina bifida, or fetal alcohol spectrum disorder. The MyREADY Transition\[TM\] BBD App is designed to help youth with health care transition planning, in preparation for their transfer out of the child health system and into the adult health system. The study team wants to see how youth will use the MyREADY Transition\[TM\] BBD App as they are getting ready to go from pediatric to adult health care services. And, the study team wants to see if it will help them to be more prepared and knowledgeable to manage their own health. The study team hopes to see youth taking steps to be better managers of their health. For example, this would include knowing about their condition or knowing when to ask for help from parents/caregivers and health care providers. After the completion of the study, the researchers will explore the potential to make the App more widely available.

Eligibility criteria: Inclusion Criteria:

* Youth with chronological age between 15 and 17 years of age (i.e. before 18th birthday), in one of the four Canadian study regions (Alberta, Ontario, Quebec, Maritimes), followed in pediatric care and for whom a discharge from pediatric care is planned but not for at least 6 months.
* A diagnosis of one of the following neurological brain-based disabilities: autism spectrum disorder, cerebral palsy, epilepsy, spina bifida, or fetal alcohol spectrum disorder.
* Cognitive ability to provide informed consent and the ability to read and understand English or French.
* Access to internet and a smartphone, iPad/tablet or desktop computer.
* TRANSITION-Q score \>40 (as a screen to define a minimum threshold for transition readiness based on earlier work).

Exclusion Criteria:

* Youth is in "acute crisis" with unstable physical or mental health that would interfere with the ability to participate in the study.
* Sensory impairments, such as uncorrected vision or hearing loss, which interfere with use of the App intervention.
* Enrolled in a potentially confounding trial (e.g., a different transition intervention study).

Primary outcomes:
measure: Transition Readiness Assessment Questionnaire (TRAQ) Change
timeFrame: Baseline and 6-Month Visit
Secondary outcomes:
measure: Canadian Occupational Performance Measure (COPM) Change
timeFrame: Baseline and 6-Month Visit
measure: TRANSITION-Q Change
timeFrame: Baseline and 6-Month Visit
measure: Pediatric Quality of Life Instrument (PedsQL[TM]) Change
timeFrame: Baseline and 6-Month Visit
measure: Measure of Process of Care (MPOC) Change
timeFrame: Baseline and 6-Month Visit
measure: Health Utilities Index® (Hui2/3) Proxy-Assessed Change
timeFrame: Baseline and 6-Month Visit
measure: Resource Use Questionnaire (RUQ) Change
timeFrame: 6-Month Visit
measure: System Usability Scale (SUS)
timeFrame: 6-Month Visit
Other outcomes:
measure: Utilization of Intervention (Usage, Adherence, and Fidelity)
timeFrame: 6-Month Visit
Locations:
city: Edmonton
country: Canada
facility: Alberta Health Services and The Governors of the University of Alberta
state: Alberta
city: Saint John
country: Canada
facility: Horizon Health Network
state: New Brunswick
city: Halifax
country: Canada
facility: Izaak Walton Killam Health Centre (IWK)
state: Nova Scotia
city: Hamilton
country: Canada
facility: McMaster Children's Hospital, Hamilton Health Sciences
state: Ontario
city: London
country: Canada
facility: Lawson Health Research Institute
state: Ontario
city: Ottawa
country: Canada
facility: Children's Hospital of Eastern Ontario Research Institute Inc.
state: Ontario
city: Toronto
country: Canada
facility: Holland Bloorview Kids Rehabilitation Hospital
state: Ontario
city: Montréal
country: Canada
facility: Centre Hospitalier Universitaire Sainte-Justine
state: Quebec
city: Montréal
country: Canada
facility: Research Institute of the McGill University Health Centre
state: Quebec
Study officials:
affiliation: McMaster University
name: Jan Willem Gorter, MD,PhD,FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: McGill University
name: Ariane Marelli, MD,MPH,FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: Oregon Health and Science University
name: Adrienne Kovacs, PhD,CPsych
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gorter JW, Amaria K, Kovacs A, Rozenblum R, Thabane L, Galuppi B, Nguyen L, Strohm S, Mahlberg N, Via-Dufresne Ley A, Marelli A; CHILD-BRIGHT READYorNotTM Brain-Based Disabilities Trial Study Group; CHILD-BRIGHT READYorNot(TM) Brain-Based Disabilities Trial Study Group. 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. BMJ Open. 2021 Mar 26;11(3):e048756. doi: 10.1136/bmjopen-2021-048756.