READYorNot[TM] Brain-Based Disabilities Trial

Not Applicable

Terminated

Conditions: Epilepsy
Autism Spectrum Disorder
Cerebral Palsy
Spina Bifida
Fetal Alcohol Spectrum Disorders

Interventions: Other: e-health application

Registration Number: NCT03852550

Lead Sponsor: McMaster University

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 52

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).

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care + MyREADYTransition[TM] BBD App	e-health application	Participants in the experimental Intervention group continue to get the same care they have been getting (their usual care) and they receive the MyREADY Transition\[TM\] BBD App e-health application. There are 19 parts in the App with videos and games to help youth learn and practice ways to manage their health. There are approximately 5-7 hours of content in total. Participants will be asked to wait at least one day between the parts. There is a timer in the App to help to moderate pace and align with how young people learn and digest information. Participants can choose how much time they want to take to do the App. It is recommended that participants make their own routine for using it. The recommended shortest and longest intervention exposure times are: 1 part each day (this will take 19 days to do all of the App), 1 part each week (this will take 19 weeks to do all of the App).

Primary Outcome Measures

Name	Time	Method
Transition Readiness Assessment Questionnaire (TRAQ) Change	Baseline and 6-Month Visit	While Transition Readiness Assessment Questionnaire (TRAQ) measure refinement is ongoing, and other versions are now available, our sample size calculation is based on findings from an intervention trial where the 29-item version of the TRAQ was used. The 29-item version has a Self-management domain score (16 items) and a Self-advocacy domain score (13 items). Both the TRAQ Self-management and TRAQ Self-advocacy domain scores are reported. Scores range from 1 to 5. Higher scores mean better transition readiness.

Secondary Outcome Measures

Name	Time	Method
Canadian Occupational Performance Measure (COPM) Change	Baseline and 6-Month Visit	The Canadian Occupational Performance Measure (COPM) is an evidence-based, generic, and individualized outcome measure used to capture a client's self-perception of performance and satisfaction in everyday living over time, by identifying problems in performing activities of daily living. Participants are encouraged to think about things (goals) that they want to do, need to do or are expected to do but can't do, don't do or aren't satisfied with the way they do. Participants are asked to rate current performance using a 10-point scale ranging from 1'not able to do it' to 10 'able to do it very well'. Higher performance scores indicate better perceived performance of the goal. Participants are also asked to rate satisfaction with performance on a 10-point scale ranging from 1 'not satisfied at all' to 10 'extremely satisfied'. Higher satisfaction scores indicate better perceived satisfaction with their performance of the goal.
TRANSITION-Q Change	Baseline and 6-Month Visit	The TRANSITION-Q is a 14-item transition readiness/self-management ability scale. This short, clinically meaningful and psychometrically sound scale can be used in research and in pediatric and adolescent clinics to help evaluate readiness for transition to adult care. Item responses ("never" = 0, "sometimes" = 1, and "always" = 2) are summed to create a raw score, with a possible range from 0 to 28. Raw scores are transformed using a table provided by the developers and the transformed scores range from 0-100. A higher score indicates greater transition readiness; exhibiting more self-management skills with higher frequency.
Pediatric Quality of Life Instrument (PedsQL[TM]) Change	Baseline and 6-Month Visit	The Pediatric Quality of Life Instrument (PedsQL\[TM\]) takes a modular approach to measuring health-related quality of life (HRQOL) in healthy children and adolescents and those with acute and chronic health conditions. In this study the PedsQL\[TM\] Pediatric Quality of Life Instrument, Generic Core, Teen Report (13-18 years) was completed. The form is brief (23 items), practical (less than 4 minutes to complete), multidimensional (Physical, Emotional, Social, School Functioning), reliable (Child Self-Report; 0.90) and valid (Distinguishes between healthy children and children with acute and chronic health conditions; distinguishes disease severity within a chronic health condition), and responsive to clinical change over time. Overall Score reported in table, on a 0-100 scale, with higher scores indicating better Health-Related Quality of Life (HRQOL).
Measure of Process of Care (MPOC) Change	Baseline and 6-Month Visit	The Measure of Processes of Care (MPOC) is a well-validated and reliable self-report measure of parents' perceptions of the extent to which the health services they and their children receive are family-centred. The original version of MPOC is a 56-item questionnaire; as of 1999 there is a shorter, 20-item version called MPOC-20 which was used (and modified with permission) in this study. Five MPOC-20 scale scores are reported: Enabling and Partnership, Providing General Information, Providing Specific Information, Coordination and Comprehensive Care, Respectful and Supportive Care. A 7-point scale is used, ranging from 7 "to a very great extent", 6 = "to a great extent", 5 = "to a fairly great extent", 4 = "to a moderate extent", 3 = "to a small extent", 2 = "to a very small extent", and 1 = "not at all". A score of 0 indicates "not applicable". Higher MPOC-20 scale scores indicate better family-centred care.
Health Utilities Index® (Hui2/3) Proxy-Assessed Change	Baseline and 6-Month Visit	The HUI is a generic health status instrument developed in Canada for use with children and has been incorporated in numerous clinical studies as well as the Canadian Community Health Survey, allowing the generation of norms for most age groups. The HUI Mark II includes 7 attributes: Sensation, Mobility, Emotion, Cognition, Self-care, Pain and Fertility with each attribute divided into 3 to 5 levels. The HUI III includes 8 attributes: Vision, Hearing, Speech, Ambulation, Dexterity, Emotion, Cognition and Pain. Each attribute of the HUI III consists of 5 to 6 levels. We report the overall health rating at Baseline and 6-Month Visit measured on a scale from 1 (Poor) to 5 (Excellent)
Resource Use Questionnaire (RUQ) Change	6-Month Visit	The RUQ is typically an interviewer-administered questionnaire for parents of children aged 11 to 18 years. The original RUQ measures the family resource use of condition-related treatments, services and programs, as well as parent time losses and family out-of-pocket costs. It also documents condition-related government subsidies and funding that families receive. Resources measured include those delivered by a parent, by other providers (e.g. behavioural specialist) or a combination of both. In this project, we will use a modified subset of RUQ questions, self-completed by the parent/caregiver. We report information collected at the 6-Month Visit about the number of participants in each arm who reported any hospitalizations during the study.
System Usability Scale (SUS)	6-Month Visit	The SUS will be administered to youth in the Experimental Arm. The measure focus is on users' utilization of the application and its features, the perceived value and their experience and satisfaction with the intervention. The self-reported survey will provide additional information about the users' adherence, behavior, motivation and experience with the IT platform, as well as about the main reasons for using or not using it. Measures youth's subjective perceptions of the usability of the App, scored from 0 - 100 with a higher score indicating greater usability.

Trial Locations

Locations (9): Horizon Health Network
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Saint John, New Brunswick, Canada
McMaster Children's Hospital, Hamilton Health Sciences
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Hamilton, Ontario, Canada
Izaak Walton Killam Health Centre (IWK)
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Halifax, Nova Scotia, Canada
Alberta Health Services and The Governors of the University of Alberta
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Edmonton, Alberta, Canada
Lawson Health Research Institute
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London, Ontario, Canada
Holland Bloorview Kids Rehabilitation Hospital
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Toronto, Ontario, Canada
Centre Hospitalier Universitaire Sainte-Justine
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Montréal, Quebec, Canada
Children's Hospital of Eastern Ontario Research Institute Inc.
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Ottawa, Ontario, Canada
Research Institute of the McGill University Health Centre
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Montréal, Quebec, Canada