search
Back to results

READYorNot[TM] Brain-Based Disabilities Trial

Primary Purpose

Autism Spectrum Disorder, Cerebral Palsy, Epilepsy

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
e-health application
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Autism Spectrum Disorder focused on measuring Health Care Transition, Brain-Based Disabilities, CHILD-BRIGHT, e-health application, randomized controlled trial

Eligibility Criteria

15 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Alberta Health Services and The Governors of the University of Alberta
  • Horizon Health Network
  • Izaak Walton Killam Health Centre (IWK)
  • McMaster Children's Hospital, Hamilton Health Sciences
  • Lawson Health Research Institute
  • Children's Hospital of Eastern Ontario Research Institute Inc.
  • Holland Bloorview Kids Rehabilitation Hospital
  • Centre Hospitalier Universitaire Sainte-Justine
  • Research Institute of the McGill University Health Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Usual Care + MyREADYTransition[TM] BBD App

Control Group: Usual Care

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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'.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
February 19, 2019
Last Updated
March 14, 2023
Sponsor
McMaster University
Collaborators
Canadian Institutes of Health Research (CIHR), McGill University Health Centre/Research Institute of the McGill University Health Centre, The Montreal Children's Hospital Foundation, McMaster Children's Hospital Foundation, Hamilton Health Sciences Corporation, New Brunswick Health Research Foundation, The Hospital for Sick Children, Harvard Medical School (HMS and HSDM), Oregon Health and Science University
search

1. Study Identification

Unique Protocol Identification Number
NCT03852550
Brief Title
READYorNot[TM] Brain-Based Disabilities Trial
Official Title
CHILD-BRIGHT READYorNot[TM] Brain-Based Disabilities Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 22, 2020 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
Collaborators
Canadian Institutes of Health Research (CIHR), McGill University Health Centre/Research Institute of the McGill University Health Centre, The Montreal Children's Hospital Foundation, McMaster Children's Hospital Foundation, Hamilton Health Sciences Corporation, New Brunswick Health Research Foundation, The Hospital for Sick Children, Harvard Medical School (HMS and HSDM), Oregon Health and Science University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care + MyREADYTransition[TM] BBD App
Arm Type
Experimental
Arm Description
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).
Arm Title
Control Group: Usual Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
e-health application
Other Intervention Name(s)
MyREADY Transition[TM] BBD App
Intervention Description
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.
Primary Outcome Measure Information:
Title
Transition Readiness Assessment Questionnaire (TRAQ) Change
Description
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.
Time Frame
Baseline and 6-Month Visit
Secondary Outcome Measure Information:
Title
Canadian Occupational Performance Measure (COPM) Change
Description
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'.
Time Frame
Baseline and 6-Month Visit
Title
TRANSITION-Q Change
Description
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.
Time Frame
Screen prior to Baseline and 6-Month Visit
Title
Pediatric Quality of Life Instrument (PedsQL[TM]) Change
Description
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.
Time Frame
Baseline and 6-Month Visit
Title
Measure of Process of Care (MPOC) Change
Description
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.
Time Frame
Baseline and 6-Month Visit
Title
Health Utilities Index® (Hui2/3) Proxy-Assessed Change
Description
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.
Time Frame
Baseline and 6-Month Visit
Title
Resource Use Questionnaire (RUQ) Change
Description
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.
Time Frame
Baseline and 6-Month Visit
Title
System Usability Scale (SUS)
Description
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.
Time Frame
6-Month Visit
Other Pre-specified Outcome Measures:
Title
Utilization of Intervention (Usage, Adherence, and Fidelity)
Description
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.
Time Frame
6-Month Visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Willem Gorter, MD,PhD,FRCPC
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ariane Marelli, MD,MPH,FRCPC
Organizational Affiliation
McGill University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Adrienne Kovacs, PhD,CPsych
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alberta Health Services and The Governors of the University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2C8
Country
Canada
Facility Name
Horizon Health Network
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E3B 4R3
Country
Canada
Facility Name
Izaak Walton Killam Health Centre (IWK)
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada
Facility Name
McMaster Children's Hospital, Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 8E7
Country
Canada
Facility Name
Lawson Health Research Institute
City
London
State/Province
Ontario
ZIP/Postal Code
N6C 2R5
Country
Canada
Facility Name
Children's Hospital of Eastern Ontario Research Institute Inc.
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L1
Country
Canada
Facility Name
Holland Bloorview Kids Rehabilitation Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4G 1R8
Country
Canada
Facility Name
Centre Hospitalier Universitaire Sainte-Justine
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
Facility Name
Research Institute of the McGill University Health Centre
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33771833
Citation
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.
Results Reference
derived
Links:
URL
http://www.child-bright.ca/readyornot/
Description
Study page on the CHILD-BRIGHT network website

Learn more about this trial

READYorNot[TM] Brain-Based Disabilities Trial

We'll reach out to this number within 24 hrs