READYorNot[TM] Brain-Based Disabilities Trial

NCT ID: NCT03852550

Last Updated: 2025-03-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-22
• Study Completion Date: 2023-05-22

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.

Conditions

Autism Spectrum Disorder; Cerebral Palsy; Epilepsy; Fetal Alcohol Spectrum Disorders; Spina Bifida

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

e-health application

Intervention Type: OTHER

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

MyREADY Transition[TM] BBD App

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).

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role: collaborator

The Montreal Children's Hospital Foundation

UNKNOWN

Sponsor Role: collaborator

McMaster Children's Hospital Foundation

UNKNOWN

Sponsor Role: collaborator

Hamilton Health Sciences Corporation

OTHER

Sponsor Role: collaborator

New Brunswick Health Research Foundation

OTHER

Sponsor Role: collaborator

The Hospital for Sick Children

OTHER

Sponsor Role: collaborator

Harvard Medical School (HMS and HSDM)

OTHER

Sponsor Role: collaborator

Oregon Health and Science University

OTHER

Sponsor Role: collaborator

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jan Willem Gorter, MD,PhD,FRCPC

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Ariane Marelli, MD,MPH,FRCPC

Role: PRINCIPAL_INVESTIGATOR

McGill University

Adrienne Kovacs, PhD,CPsych

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

Alberta Health Services and The Governors of the University of Alberta

Edmonton, Alberta, Canada

Horizon Health Network

Saint John, New Brunswick, Canada

Izaak Walton Killam Health Centre (IWK)

Halifax, Nova Scotia, Canada

McMaster Children's Hospital, Hamilton Health Sciences

Hamilton, Ontario, Canada

Lawson Health Research Institute

London, Ontario, Canada

Children's Hospital of Eastern Ontario Research Institute Inc.

Ottawa, Ontario, Canada

Holland Bloorview Kids Rehabilitation Hospital

Toronto, Ontario, Canada

Centre Hospitalier Universitaire Sainte-Justine

Montreal, Quebec, Canada

Research Institute of the McGill University Health Centre

Montreal, Quebec, Canada

Countries

Canada

References

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.

Reference Type: BACKGROUND

PMID: 33771833 (View on PubMed)

Marelli A, Rozenblum R, Bolster-Foucault C, Via-Dufresne Ley A, Maynard N, Amaria K, Galuppi B, Strohm S, Nguyen L, Dawe-McCord C, Putterman C, Kovacs AH, Gorter JW. Development of MyREADY Transition BBD Mobile App, a Health Intervention Technology Platform, to Improve Care Transition for Youth With Brain-Based Disabilities: User-Centered Design Approach. JMIR Pediatr Parent. 2024 Oct 1;7:e51606. doi: 10.2196/51606.

Reference Type: DERIVED

PMID: 39352737 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://www.child-bright.ca/readyornot/

Study page on the CHILD-BRIGHT network website

Other Identifiers

1666

Identifier Type: -

Identifier Source: org_study_id