READYorNot[TM] Brain-Based Disabilities Trial

CHILD-BRIGHT READYorNot[TM] Brain-Based Disabilities Trial

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.

Study Overview

• Status: Terminated
• Conditions: Epilepsy; Cerebral Palsy; Autism Spectrum Disorder; Spina Bifida; Fetal Alcohol Spectrum Disorders
• Intervention / Treatment: Other: e-health application

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2C8
      • Alberta Health Services and The Governors of the University of Alberta
  • New Brunswick
    • Saint John, New Brunswick, Canada, E3B 4R3
      • Horizon Health Network
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3K 6R8
      • Izaak Walton Killam Health Centre (IWK)
  • Ontario
    • Hamilton, Ontario, Canada, L8L 8E7
      • McMaster Children's Hospital, Hamilton Health Sciences
    • London, Ontario, Canada, N6C 2R5
      • Lawson Health Research Institute
    • Ottawa, Ontario, Canada, K1H 8L1
      • Children's Hospital of Eastern Ontario Research Institute Inc.
    • Toronto, Ontario, Canada, M4G 1R8
      • Holland Bloorview Kids Rehabilitation Hospital
  • Quebec
    • Montréal, Quebec, Canada, H4A 3J1
      • Research Institute of the McGill University Health Centre
    • Montréal, Quebec, Canada, H3T 1C5
      • Centre Hospitalier Universitaire Sainte-Justine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Usual Care + MyREADYTransition[TM] BBD App; 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).	Other: e-health application; In the first part of this study, an e-health application (MyREADY Transition[TM] BBD App) was developed, targeting the needs of youth with BBD during their transition and transfer from pediatric to adult health care. Program development centered on three core foci of health care transition planning: education, empowerment, and navigation. The intervention has an emphasis on the process of transition in which youth and young adults learn information and develop skills in order to eventually assume maximal responsibility for self-management of their conditions (e.g., learning how to speak directly with health providers) while also providing information to prepare youth for the event of the transfer from pediatric to adult health care.; Other Names: MyREADY Transition[TM] BBD App
No Intervention: Control Group: Usual Care; Participants in the no intervention Control group continue to get the same care they have been getting (their usual care). The researchers aim to supply the App to participants in both the intervention and control group for a limited time after participation in the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transition Readiness Assessment Questionnaire (TRAQ) Change	While 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 (16 items) and a Self-advocacy domain (13 items). Each item is scored 1-5, where 1 = "No, I do not know how" and 5 = "Yes, I always do this when I need to." It takes 5-10 minutes to complete.	Baseline and 6-Month Visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Canadian Occupational Performance Measure (COPM) Change	The 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 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 from 'not able to do it' to 'able to do it very well'. Participants are also asked to rate satisfaction with performance on a 10-point scale from 'not satisfied at all' to 'extremely satisfied'.	Baseline and 6-Month Visit
TRANSITION-Q Change	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. 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.	Screen prior to Baseline and 6-Month Visit
Pediatric Quality of Life Instrument (PedsQL[TM]) Change	The 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) will be 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.	Baseline and 6-Month Visit
Measure of Process of Care (MPOC) Change	The Measure of Processes of Care is a well-validated and reliable self-report measure of parents' perceptions of the extent to which the health services they and their child(ren) receive are family-centred. The original version of MPOC is a 56-item questionnaire; as of 1999 there is a shorter, 20-item version. MPOC has been used internationally in many evaluations of family-centred service.	Baseline and 6-Month Visit
Health Utilities Index® (Hui2/3) Proxy-Assessed Change	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. A multi-attribute utility function is used to assign weights to each level for each attribute. The weights for each attribute are combined statistically to derive a single utility using a scoring formula. The use of a preference-based measure such as the HUI will permit the calculation of quality-adjusted life years (QALYs) for a cost-utility analysis.	Baseline and 6-Month Visit
Resource Use Questionnaire (RUQ) Change	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 have also included some questions to capture information about serious illnesses during the study including information about hospitalizations, ICU admissions, etc.	Baseline and 6-Month Visit
System Usability Scale (SUS)	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.	6-Month Visit

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Utilization of Intervention (Usage, Adherence, and Fidelity)	Mixed methods will be used to assess MyREADY Transition[TM] BBD App usage, adherence and fidelity, and to identify the barriers and facilitators to using the e-health application for users. Quantitative data will be collected through participant self-report and by the app daily through study completion. For a subset of participants in the intervention group, qualitative data will be collected via interview. Utilization of Intervention reporting at 6-Month Visit.	6-Month Visit

Collaborators and Investigators

• Sponsor: McMaster University
• Collaborators: Harvard Medical School (HMS and HSDM); The Hospital for Sick Children; Canadian Institutes of Health Research (CIHR); Oregon Health and Science University; McGill University Health Centre/Research Institute of the McGill University Health Centre; Hamilton Health Sciences Corporation; New Brunswick Health Research Foundation; The Montreal Children's Hospital Foundation; McMaster Children's Hospital Foundation
• Investigators: Principal Investigator: Jan Willem Gorter, MD,PhD,FRCPC, McMaster University; Principal Investigator: Ariane Marelli, MD,MPH,FRCPC, McGill University; Principal Investigator: Adrienne Kovacs, PhD,CPsych, Oregon Health and Science University

Publications and helpful links

General Publications

• 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.

Helpful Links

• Study page on the CHILD-BRIGHT network website

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2020
• Primary Completion (Actual): May 22, 2023
• Study Completion (Actual): May 22, 2023

Study Registration Dates

• First Submitted: February 19, 2019
• First Submitted That Met QC Criteria: February 21, 2019
• First Posted (Actual): February 25, 2019

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 2, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: randomized controlled trial; Health Care Transition; Brain-Based Disabilities; CHILD-BRIGHT; e-health application
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Alcohol-Related Disorders; Substance-Related Disorders; Congenital Abnormalities; Brain Damage, Chronic; Fetal Diseases; Pregnancy Complications; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Nervous System Malformations; Neural Tube Defects; Alcohol-Induced Disorders; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Cerebral Palsy; Autism Spectrum Disorder; Spinal Dysraphism; Fetal Alcohol Spectrum Disorders
• Other Study ID Numbers: 1666

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No