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NCT03852550

READYorNot[TM] Brain-Based Disabilities Trial

Terminated NA Results posted Last updated 21 March 2025
What this trial tests

NA trial testing e-health application in Autism Spectrum Disorder in 52 participants. Terminated before completion.

Timeline
22 June 2020
Primary endpoint
22 May 2023
22 May 2023

Quick facts

Lead sponsorMcMaster University
PhaseNA
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposehealth services research
Enrollment52
Start date22 June 2020
Primary completion22 May 2023
Estimated completion22 May 2023
Sites9 locations across Canada

Drugs / interventions tested

Conditions studied

Sponsor

McMaster University

Who can join

Adults 15 to 17, any sex, with Autism Spectrum Disorder or Cerebral Palsy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Transition Readiness Assessment Questionnaire (TRAQ) Change Primary · 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.

Self-management Baseline Visit
GroupValue95% CI
Usual Care + MyREADYTransition[TM] BBD App2.3± 0.6
Control Group: Usual Care2.2± 0.5
Self-management 6-Month Visit
GroupValue95% CI
Usual Care + MyREADYTransition[TM] BBD App2.5± 0.7
Control Group: Usual Care2.5± 0.9
Self-advocacy Baseline visit
GroupValue95% CI
Usual Care + MyREADYTransition[TM] BBD App3.4± 0.6
Control Group: Usual Care3.0± 0.5
Self-advocacy 6-Month Visit
GroupValue95% CI
Usual Care + MyREADYTransition[TM] BBD App3.6± 0.6
Control Group: Usual Care3.2± 0.8
Canadian Occupational Performance Measure (COPM) Change Secondary · 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 ver

Performance Baseline Visit
GroupValue95% CI
Usual Care + MyREADYTransition[TM] BBD App4.3± 1.8
Control Group: Usual Care5.3± 2.2
Performance 6-Month Visit
GroupValue95% CI
Usual Care + MyREADYTransition[TM] BBD App6.0± 1.6
Control Group: Usual Care6.7± 2.3
Satisfaction Baseline Visit
GroupValue95% CI
Usual Care + MyREADYTransition[TM] BBD App4.8± 2.1
Control Group: Usual Care5.2± 2.2
Satisfaction 6-Month Visit
GroupValue95% CI
Usual Care + MyREADYTransition[TM] BBD App6.3± 1.9
Control Group: Usual Care7.3± 2.3
TRANSITION-Q Change Secondary · 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-managem

Baseline Visit
GroupValue95% CI
Usual Care + MyREADYTransition[TM] BBD App57.0± 10.1
Control Group: Usual Care56.1± 10.4
6-Month Visit
GroupValue95% CI
Usual Care + MyREADYTransition[TM] BBD App59.4± 13.2
Control Group: Usual Care52.2± 19.6
Pediatric Quality of Life Instrument (PedsQL[TM]) Change Secondary · 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

Baseline Visit
GroupValue95% CI
Usual Care + MyREADYTransition[TM] BBD App64.5± 16.5
Control Group: Usual Care64.6± 20.8
6 Month Visit
GroupValue95% CI
Usual Care + MyREADYTransition[TM] BBD App63.2± 18.3
Control Group: Usual Care66.2± 18.1
Measure of Process of Care (MPOC) Change Secondary · 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

Enabling and Partnership Baseline Visit
GroupValue95% CI
Usual Care + MyREADYTransition[TM] BBD App4.6± 1.5
Control Group: Usual Care4.3± 1.6
Enabling and Partnership 6-Month Visit
GroupValue95% CI
Usual Care + MyREADYTransition[TM] BBD App4.5± 1.8
Control Group: Usual Care4.4± 1.7
Providing General information Baseline Visit
GroupValue95% CI
Usual Care + MyREADYTransition[TM] BBD App3.4± 1.6
Control Group: Usual Care3.6± 1.7
Providing General information 6 Month Visit
GroupValue95% CI
Usual Care + MyREADYTransition[TM] BBD App3.3± 1.7
Control Group: Usual Care3.6± 1.8
Providing Specific information Baseline Visit
GroupValue95% CI
Usual Care + MyREADYTransition[TM] BBD App4.2± 1.5
Control Group: Usual Care4.3± 1.4
Providing Specific information 6-Month Visit
GroupValue95% CI
Usual Care + MyREADYTransition[TM] BBD App4.2± 2.1
Control Group: Usual Care4.4± 1.6
Coordination and comprehensive care Baseline Visit
GroupValue95% CI
Usual Care + MyREADYTransition[TM] BBD App4.8± 1.5
Control Group: Usual Care4.7± 1.3
Coordination and comprehensive care 6-Month Visit
GroupValue95% CI
Usual Care + MyREADYTransition[TM] BBD App4.6± 2.0
Control Group: Usual Care4.7± 1.6
Health Utilities Index® (Hui2/3) Proxy-Assessed Change Secondary · 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 healt

Baseline Visit
GroupValue95% CI
Usual Care + MyREADYTransition[TM] BBD App3.9± 0.9
Control Group: Usual Care4.1± 1.0
6-Month Visit
GroupValue95% CI
Usual Care + MyREADYTransition[TM] BBD App4.0± 0.8
Control Group: Usual Care4.0± 0.7
Resource Use Questionnaire (RUQ) Change Secondary · 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/caregiv

GroupValue95% CI
Usual Care + MyREADYTransition[TM] BBD App2
Control Group: Usual Care3
System Usability Scale (SUS) Secondary · 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.

GroupValue95% CI
Usual Care + MyREADYTransition[TM] BBD App65.4± 26.8
Utilization of Intervention (Usage, Adherence, and Fidelity) Secondary · 6-Month Visit

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. Usage reported here as the average number of times intervention participants logged into the App.

GroupValue95% CI
Usual Care + MyREADYTransition[TM] BBD App11.2± 9.5

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. 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.
    Gorter JW, Amaria K, Kovacs A, Rozenblum R, et al · · 2021 · cited 13× · PMID 33771833 · DOI 10.1136/bmjopen-2021-048756
  2. 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.
    Marelli A, Rozenblum R, Bolster-Foucault C, Via-Dufresne Ley A, et al · · 2024 · PMID 39352737 · DOI 10.2196/51606

Verify or expand the search:

Other trials of e-health application

Trials testing the same drug.

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Other McMaster University trials

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03852550.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing