Autism Spectrum Disorder, Cerebral Palsy, Epilepsy, Fetal Alcohol Spectrum Disorders, Spina Bifida
Conditions
Keywords
Health Care Transition, Brain-Based Disabilities, CHILD-BRIGHT, e-health application, randomized controlled trial
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.
Interventions
OTHERe-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.
Sponsors
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
McMaster University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
15 Years to 17 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Transition Readiness Assessment Questionnaire (TRAQ) Change | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Canadian Occupational Performance Measure (COPM) Change | 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 very well'. Higher performance scores indicate better perceived performance of the goal. Participants are also asked to rate satisfaction with performance on a 10-point scale ranging from 1 'not satisfied at all' to 10 'extremely satisfied'. Higher satisfaction scores indicate better perceived satisfaction with their performance of the goal. |
| TRANSITION-Q Change | 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-management skills with higher frequency. |
| Pediatric Quality of Life Instrument (PedsQL[TM]) Change | 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 chronic health conditions; distinguishes disease severity within a chronic health condition), and responsive to clinical change over time. Overall Score reported in table, on a 0-100 scale, with higher scores indicating better Health-Related Quality of Life (HRQOL). |
| Health Utilities Index® (Hui2/3) Proxy-Assessed Change | 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 health rating at Baseline and 6-Month Visit measured on a scale from 1 (Poor) to 5 (Excellent) |
| Resource Use Questionnaire (RUQ) Change | 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/caregiver. We report information collected at the 6-Month Visit about the number of participants in each arm who reported any hospitalizations during the study. |
| System Usability Scale (SUS) | 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. |
| Measure of Process of Care (MPOC) Change | 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 scale is used, ranging from 7 to a very great extent, 6 = to a great extent, 5 = to a fairly great extent, 4 = to a moderate extent, 3 = to a small extent, 2 = to a very small extent, and 1 = not at all. A score of 0 indicates not applicable. Higher MPOC-20 scale scores indicate better family-centred care. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Utilization of Intervention (Usage, Adherence, and Fidelity) | 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. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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). | 24 |
| 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. | 28 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 3 |
| Overall Study | Only parent outcomes completed | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Usual Care + MyREADYTransition[TM] BBD App | Control Group: Usual Care | Total |
|---|---|---|---|
| Age, Continuous | 16.0 years STANDARD_DEVIATION 0.6 | 16.0 years STANDARD_DEVIATION 0.8 | 16.0 years STANDARD_DEVIATION 0.7 |
| Race/Ethnicity, Customized Ancestry East and South Asian | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Ancestry European | 23 Participants | 19 Participants | 42 Participants |
| Race/Ethnicity, Customized Ancestry Latin Central and South American | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Ancestry North American Aboriginal | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Ancestry Other | 0 Participants | 3 Participants | 3 Participants |
| Region of Enrollment Canada Alberta | 5 Participants | 5 Participants | 10 Participants |
| Region of Enrollment Canada Maritimes | 3 Participants | 4 Participants | 7 Participants |
| Region of Enrollment Canada Ontario | 14 Participants | 15 Participants | 29 Participants |
| Region of Enrollment Canada Quebec | 2 Participants | 4 Participants | 6 Participants |
| Sex/Gender, Customized Boy/Young man | 9 Participants | 12 Participants | 21 Participants |
| Sex/Gender, Customized Girl/Young woman | 13 Participants | 14 Participants | 27 Participants |
| Sex/Gender, Customized Other | 2 Participants | 2 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 24 |
| other Total, other adverse events | 0 / 19 | 0 / 24 |
| serious Total, serious adverse events | 0 / 19 | 0 / 24 |
Outcome results
Primary
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.
Time frame: Baseline and 6-Month Visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care + MyREADYTransition[TM] BBD App | Transition Readiness Assessment Questionnaire (TRAQ) Change | Self-management Baseline Visit | 2.3 score on a scale | Standard Deviation 0.6 |
| Usual Care + MyREADYTransition[TM] BBD App | Transition Readiness Assessment Questionnaire (TRAQ) Change | Self-management 6-Month Visit | 2.5 score on a scale | Standard Deviation 0.7 |
| Usual Care + MyREADYTransition[TM] BBD App | Transition Readiness Assessment Questionnaire (TRAQ) Change | Self-advocacy Baseline visit | 3.4 score on a scale | Standard Deviation 0.6 |
| Usual Care + MyREADYTransition[TM] BBD App | Transition Readiness Assessment Questionnaire (TRAQ) Change | Self-advocacy 6-Month Visit | 3.6 score on a scale | Standard Deviation 0.6 |
| Control Group: Usual Care | Transition Readiness Assessment Questionnaire (TRAQ) Change | Self-advocacy 6-Month Visit | 3.2 score on a scale | Standard Deviation 0.8 |
| Control Group: Usual Care | Transition Readiness Assessment Questionnaire (TRAQ) Change | Self-management Baseline Visit | 2.2 score on a scale | Standard Deviation 0.5 |
| Control Group: Usual Care | Transition Readiness Assessment Questionnaire (TRAQ) Change | Self-advocacy Baseline visit | 3.0 score on a scale | Standard Deviation 0.5 |
| Control Group: Usual Care | Transition Readiness Assessment Questionnaire (TRAQ) Change | Self-management 6-Month Visit | 2.5 score on a scale | Standard Deviation 0.9 |
Secondary
Canadian Occupational Performance Measure (COPM) Change
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 very well'. Higher performance scores indicate better perceived performance of the goal. Participants are also asked to rate satisfaction with performance on a 10-point scale ranging from 1 'not satisfied at all' to 10 'extremely satisfied'. Higher satisfaction scores indicate better perceived satisfaction with their performance of the goal.
Time frame: Baseline and 6-Month Visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care + MyREADYTransition[TM] BBD App | Canadian Occupational Performance Measure (COPM) Change | Performance Baseline Visit | 4.3 score on a scale | Standard Deviation 1.8 |
| Usual Care + MyREADYTransition[TM] BBD App | Canadian Occupational Performance Measure (COPM) Change | Satisfaction Baseline Visit | 4.8 score on a scale | Standard Deviation 2.1 |
| Usual Care + MyREADYTransition[TM] BBD App | Canadian Occupational Performance Measure (COPM) Change | Satisfaction 6-Month Visit | 6.3 score on a scale | Standard Deviation 1.9 |
| Usual Care + MyREADYTransition[TM] BBD App | Canadian Occupational Performance Measure (COPM) Change | Performance 6-Month Visit | 6.0 score on a scale | Standard Deviation 1.6 |
| Control Group: Usual Care | Canadian Occupational Performance Measure (COPM) Change | Satisfaction 6-Month Visit | 7.3 score on a scale | Standard Deviation 2.3 |
| Control Group: Usual Care | Canadian Occupational Performance Measure (COPM) Change | Satisfaction Baseline Visit | 5.2 score on a scale | Standard Deviation 2.2 |
| Control Group: Usual Care | Canadian Occupational Performance Measure (COPM) Change | Performance 6-Month Visit | 6.7 score on a scale | Standard Deviation 2.3 |
| Control Group: Usual Care | Canadian Occupational Performance Measure (COPM) Change | Performance Baseline Visit | 5.3 score on a scale | Standard Deviation 2.2 |
Secondary
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. We report the overall health rating at Baseline and 6-Month Visit measured on a scale from 1 (Poor) to 5 (Excellent)
Time frame: Baseline and 6-Month Visit
Population: 1. overall health rating missing at both Baseline and 6-Month Visit in Control Group: Usual Care Arm.~2. overall health ratings missing at 6-Month visit in Usual Care + MyREADYTransition\[TM\] BBD App Arm.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care + MyREADYTransition[TM] BBD App | Health Utilities Index® (Hui2/3) Proxy-Assessed Change | Baseline Visit | 3.9 units on a scale | Standard Deviation 0.9 |
| Usual Care + MyREADYTransition[TM] BBD App | Health Utilities Index® (Hui2/3) Proxy-Assessed Change | 6-Month Visit | 4.0 units on a scale | Standard Deviation 0.8 |
| Control Group: Usual Care | Health Utilities Index® (Hui2/3) Proxy-Assessed Change | Baseline Visit | 4.1 units on a scale | Standard Deviation 1 |
| Control Group: Usual Care | Health Utilities Index® (Hui2/3) Proxy-Assessed Change | 6-Month Visit | 4.0 units on a scale | Standard Deviation 0.7 |
Secondary
Measure of Process of Care (MPOC) Change
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 scale is used, ranging from 7 to a very great extent, 6 = to a great extent, 5 = to a fairly great extent, 4 = to a moderate extent, 3 = to a small extent, 2 = to a very small extent, and 1 = not at all. A score of 0 indicates not applicable. Higher MPOC-20 scale scores indicate better family-centred care.
Time frame: Baseline and 6-Month Visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care + MyREADYTransition[TM] BBD App | Measure of Process of Care (MPOC) Change | Providing Specific information 6-Month Visit | 4.2 score on a scale | Standard Deviation 2.1 |
| Usual Care + MyREADYTransition[TM] BBD App | Measure of Process of Care (MPOC) Change | Respectful and supportive care 6-Month Visit | 4.8 score on a scale | Standard Deviation 1.6 |
| Usual Care + MyREADYTransition[TM] BBD App | Measure of Process of Care (MPOC) Change | Providing Specific information Baseline Visit | 4.2 score on a scale | Standard Deviation 1.5 |
| Usual Care + MyREADYTransition[TM] BBD App | Measure of Process of Care (MPOC) Change | Enabling and Partnership Baseline Visit | 4.6 score on a scale | Standard Deviation 1.5 |
| Usual Care + MyREADYTransition[TM] BBD App | Measure of Process of Care (MPOC) Change | Coordination and comprehensive care Baseline Visit | 4.8 score on a scale | Standard Deviation 1.5 |
| Usual Care + MyREADYTransition[TM] BBD App | Measure of Process of Care (MPOC) Change | Providing General information Baseline Visit | 3.4 score on a scale | Standard Deviation 1.6 |
| Usual Care + MyREADYTransition[TM] BBD App | Measure of Process of Care (MPOC) Change | Providing General information 6 Month Visit | 3.3 score on a scale | Standard Deviation 1.7 |
| Usual Care + MyREADYTransition[TM] BBD App | Measure of Process of Care (MPOC) Change | Coordination and comprehensive care 6-Month Visit | 4.6 score on a scale | Standard Deviation 2 |
| Usual Care + MyREADYTransition[TM] BBD App | Measure of Process of Care (MPOC) Change | Respectful and supportive care Baseline Visit | 5.1 score on a scale | Standard Deviation 1.1 |
| Usual Care + MyREADYTransition[TM] BBD App | Measure of Process of Care (MPOC) Change | Enabling and Partnership 6-Month Visit | 4.5 score on a scale | Standard Deviation 1.8 |
| Control Group: Usual Care | Measure of Process of Care (MPOC) Change | Respectful and supportive care Baseline Visit | 5.1 score on a scale | Standard Deviation 1.1 |
| Control Group: Usual Care | Measure of Process of Care (MPOC) Change | Enabling and Partnership 6-Month Visit | 4.4 score on a scale | Standard Deviation 1.7 |
| Control Group: Usual Care | Measure of Process of Care (MPOC) Change | Providing Specific information Baseline Visit | 4.3 score on a scale | Standard Deviation 1.4 |
| Control Group: Usual Care | Measure of Process of Care (MPOC) Change | Providing Specific information 6-Month Visit | 4.4 score on a scale | Standard Deviation 1.6 |
| Control Group: Usual Care | Measure of Process of Care (MPOC) Change | Coordination and comprehensive care Baseline Visit | 4.7 score on a scale | Standard Deviation 1.3 |
| Control Group: Usual Care | Measure of Process of Care (MPOC) Change | Coordination and comprehensive care 6-Month Visit | 4.7 score on a scale | Standard Deviation 1.6 |
| Control Group: Usual Care | Measure of Process of Care (MPOC) Change | Respectful and supportive care 6-Month Visit | 4.9 score on a scale | Standard Deviation 1.5 |
| Control Group: Usual Care | Measure of Process of Care (MPOC) Change | Enabling and Partnership Baseline Visit | 4.3 score on a scale | Standard Deviation 1.6 |
| Control Group: Usual Care | Measure of Process of Care (MPOC) Change | Providing General information Baseline Visit | 3.6 score on a scale | Standard Deviation 1.7 |
| Control Group: Usual Care | Measure of Process of Care (MPOC) Change | Providing General information 6 Month Visit | 3.6 score on a scale | Standard Deviation 1.8 |
Secondary
Pediatric Quality of Life Instrument (PedsQL[TM]) Change
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 chronic health conditions; distinguishes disease severity within a chronic health condition), and responsive to clinical change over time. Overall Score reported in table, on a 0-100 scale, with higher scores indicating better Health-Related Quality of Life (HRQOL).
Time frame: Baseline and 6-Month Visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care + MyREADYTransition[TM] BBD App | Pediatric Quality of Life Instrument (PedsQL[TM]) Change | Baseline Visit | 64.5 score on a scale | Standard Deviation 16.5 |
| Usual Care + MyREADYTransition[TM] BBD App | Pediatric Quality of Life Instrument (PedsQL[TM]) Change | 6 Month Visit | 63.2 score on a scale | Standard Deviation 18.3 |
| Control Group: Usual Care | Pediatric Quality of Life Instrument (PedsQL[TM]) Change | Baseline Visit | 64.6 score on a scale | Standard Deviation 20.8 |
| Control Group: Usual Care | Pediatric Quality of Life Instrument (PedsQL[TM]) Change | 6 Month Visit | 66.2 score on a scale | Standard Deviation 18.1 |
Secondary
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 report information collected at the 6-Month Visit about the number of participants in each arm who reported any hospitalizations during the study.
Time frame: 6-Month Visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care + MyREADYTransition[TM] BBD App | Resource Use Questionnaire (RUQ) Change | 2 Participants |
| Control Group: Usual Care | Resource Use Questionnaire (RUQ) Change | 3 Participants |
Secondary
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. Measures youth's subjective perceptions of the usability of the App, scored from 0 - 100 with a higher score indicating greater usability.
Time frame: 6-Month Visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care + MyREADYTransition[TM] BBD App | System Usability Scale (SUS) | 65.4 score on a scale | Standard Deviation 26.8 |
Secondary
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 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-management skills with higher frequency.
Time frame: Baseline and 6-Month Visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Usual Care + MyREADYTransition[TM] BBD App | TRANSITION-Q Change | 6-Month Visit | 59.4 score on a scale | Standard Deviation 13.2 |
| Usual Care + MyREADYTransition[TM] BBD App | TRANSITION-Q Change | Baseline Visit | 57.0 score on a scale | Standard Deviation 10.1 |
| Control Group: Usual Care | TRANSITION-Q Change | Baseline Visit | 56.1 score on a scale | Standard Deviation 10.4 |
| Control Group: Usual Care | TRANSITION-Q Change | 6-Month Visit | 52.2 score on a scale | Standard Deviation 19.6 |
Other Pre-specified
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. Usage reported here as the average number of times intervention participants logged into the App.
Time frame: 6-Month Visit
Population: Average number of times intervention group participants logged into the App intervention. Indicates App intervention access or engagement. Higher scores indicate better engagement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care + MyREADYTransition[TM] BBD App | Utilization of Intervention (Usage, Adherence, and Fidelity) | 11.2 times | Standard Deviation 9.5 |