READYorNot[TM] Brain-Based Disabilities Trial

NCT03852550 | Terminated Results

• 1 other identifier: 1666
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 9

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.

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

Outcome Measures

Primary Outcomes (1)

• Transition Readiness Assessment Questionnaire (TRAQ) Change

  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.

  Baseline and 6-Month Visit

Secondary Outcomes (7)

• Canadian Occupational Performance Measure (COPM) Change

  Baseline and 6-Month Visit

• TRANSITION-Q Change

  Baseline and 6-Month Visit

• Pediatric Quality of Life Instrument (PedsQL[TM]) Change

  Baseline and 6-Month Visit

• Measure of Process of Care (MPOC) Change

  Baseline and 6-Month Visit

• Health Utilities Index® (Hui2/3) Proxy-Assessed Change

  Baseline and 6-Month Visit

Other Outcomes (1)

• Utilization of Intervention (Usage, Adherence, and Fidelity)

  6-Month Visit

Study Arms (2)

Usual Care + MyREADYTransition[TM] BBD App

EXPERIMENTAL

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

Control Group: Usual Care

NO INTERVENTION

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.

Interventions

e-health application 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.

Also known as: MyREADY Transition[TM] BBD App

Usual Care + MyREADYTransition[TM] BBD App

Eligibility Criteria

• Age: 15 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• McMaster University: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• McGill University Health Centre/Research Institute of the McGill University Health Centre: collaborator
• The Montreal Children's Hospital Foundation: collaborator
• McMaster Children's Hospital Foundation: collaborator
• Hamilton Health Sciences Corporation: collaborator
• New Brunswick Health Research Foundation: collaborator
• The Hospital for Sick Children: collaborator
• Harvard Medical School (HMS and HSDM): collaborator
• Oregon Health and Science University: collaborator

Study Sites (9)

Alberta Health Services and The Governors of the University of Alberta

Edmonton, Alberta, T6G 2C8, Canada

Location

Horizon Health Network

Saint John, New Brunswick, E3B 4R3, Canada

Location

Izaak Walton Killam Health Centre (IWK)

Halifax, Nova Scotia, B3K 6R8, Canada

Location

McMaster Children's Hospital, Hamilton Health Sciences

Hamilton, Ontario, L8L 8E7, Canada

Location

Lawson Health Research Institute

London, Ontario, N6C 2R5, Canada

Location

Children's Hospital of Eastern Ontario Research Institute Inc.

Ottawa, Ontario, K1H 8L1, Canada

Location

Holland Bloorview Kids Rehabilitation Hospital

Toronto, Ontario, M4G 1R8, Canada

Location

Centre Hospitalier Universitaire Sainte-Justine

Montreal, Quebec, H3T 1C5, Canada

Location

Research Institute of the McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Location

Related Publications (2)

• 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.

  PMID: 33771833 BACKGROUND

• 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.

  PMID: 39352737 DERIVED

Related Links

• Study page on the CHILD-BRIGHT network website

MeSH Terms

Conditions

Autism Spectrum Disorder; Cerebral Palsy; Epilepsy; Fetal Alcohol Spectrum Disorders; Spinal Dysraphism

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Alcohol-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Neural Tube Defects; Nervous System Malformations; Congenital Abnormalities

Limitations and Caveats

The planned sample size was 264; 43 participants completed follow-up. With significant start-up delays and recruitment curtailed by the COVID-19 pandemic, the limited feasibility to recruit our sample ultimately led to the early stop of the trial. As approved by ethics, we dropped the health economic outcome analysis (Health card number linking, Health Utilities Index (HUI), Resource Use Questionnaire (RUQ)) and destroy stored health card number data.

Results Point of Contact

• Title: Research Coordinator
• Organization: McMaster University

galuppi@mcmaster.ca

9055259140

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 19, 2019
• First Posted: February 25, 2019
• Study Start: June 22, 2020
• Primary Completion: May 22, 2023
• Study Completion: May 22, 2023
• Last Updated: March 21, 2025
• Results First Posted: March 21, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (9)