Trial Outcomes & Findings for READYorNot[TM] Brain-Based Disabilities Trial (NCT NCT03852550)
NCT ID: NCT03852550
Last Updated: 2025-03-21
Results Overview
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.
TERMINATED
NA
52 participants
Baseline and 6-Month Visit
2025-03-21
Participant Flow
Participant milestones
| Measure |
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).
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
28
|
|
Overall Study
COMPLETED
|
19
|
24
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
| Measure |
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).
|
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.
|
|---|---|---|
|
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
race/ethnicity missing for 2 participants in control group
Baseline characteristics by cohort
| Measure |
Usual Care + MyREADYTransition[TM] BBD App
n=24 Participants
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).
|
Control Group: Usual Care
n=28 Participants
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.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
16.0 years
STANDARD_DEVIATION 0.6 • n=24 Participants
|
16.0 years
STANDARD_DEVIATION 0.8 • n=28 Participants
|
16.0 years
STANDARD_DEVIATION 0.7 • n=52 Participants
|
|
Sex/Gender, Customized
Girl/Young woman
|
13 Participants
n=24 Participants
|
14 Participants
n=28 Participants
|
27 Participants
n=52 Participants
|
|
Sex/Gender, Customized
Boy/Young man
|
9 Participants
n=24 Participants
|
12 Participants
n=28 Participants
|
21 Participants
n=52 Participants
|
|
Sex/Gender, Customized
Other
|
2 Participants
n=24 Participants
|
2 Participants
n=28 Participants
|
4 Participants
n=52 Participants
|
|
Race/Ethnicity, Customized
Ancestry · European
|
23 Participants
n=24 Participants • race/ethnicity missing for 2 participants in control group
|
19 Participants
n=26 Participants • race/ethnicity missing for 2 participants in control group
|
42 Participants
n=50 Participants • race/ethnicity missing for 2 participants in control group
|
|
Race/Ethnicity, Customized
Ancestry · East and South Asian
|
0 Participants
n=24 Participants • race/ethnicity missing for 2 participants in control group
|
2 Participants
n=26 Participants • race/ethnicity missing for 2 participants in control group
|
2 Participants
n=50 Participants • race/ethnicity missing for 2 participants in control group
|
|
Race/Ethnicity, Customized
Ancestry · North American Aboriginal
|
0 Participants
n=24 Participants • race/ethnicity missing for 2 participants in control group
|
2 Participants
n=26 Participants • race/ethnicity missing for 2 participants in control group
|
2 Participants
n=50 Participants • race/ethnicity missing for 2 participants in control group
|
|
Race/Ethnicity, Customized
Ancestry · Latin Central and South American
|
1 Participants
n=24 Participants • race/ethnicity missing for 2 participants in control group
|
0 Participants
n=26 Participants • race/ethnicity missing for 2 participants in control group
|
1 Participants
n=50 Participants • race/ethnicity missing for 2 participants in control group
|
|
Race/Ethnicity, Customized
Ancestry · Other
|
0 Participants
n=24 Participants • race/ethnicity missing for 2 participants in control group
|
3 Participants
n=26 Participants • race/ethnicity missing for 2 participants in control group
|
3 Participants
n=50 Participants • race/ethnicity missing for 2 participants in control group
|
|
Region of Enrollment
Canada · Alberta
|
5 Participants
n=24 Participants
|
5 Participants
n=28 Participants
|
10 Participants
n=52 Participants
|
|
Region of Enrollment
Canada · Ontario
|
14 Participants
n=24 Participants
|
15 Participants
n=28 Participants
|
29 Participants
n=52 Participants
|
|
Region of Enrollment
Canada · Quebec
|
2 Participants
n=24 Participants
|
4 Participants
n=28 Participants
|
6 Participants
n=52 Participants
|
|
Region of Enrollment
Canada · Maritimes
|
3 Participants
n=24 Participants
|
4 Participants
n=28 Participants
|
7 Participants
n=52 Participants
|
PRIMARY outcome
Timeframe: Baseline and 6-Month VisitWhile 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.
Outcome measures
| Measure |
Usual Care + MyREADYTransition[TM] BBD App
n=19 Participants
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).
|
Control Group: Usual Care
n=24 Participants
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.
|
|---|---|---|
|
Transition Readiness Assessment Questionnaire (TRAQ) Change
Self-management Baseline Visit
|
2.3 score on a scale
Standard Deviation 0.6
|
2.2 score on a scale
Standard Deviation 0.5
|
|
Transition Readiness Assessment Questionnaire (TRAQ) Change
Self-management 6-Month Visit
|
2.5 score on a scale
Standard Deviation 0.7
|
2.5 score on a scale
Standard Deviation 0.9
|
|
Transition Readiness Assessment Questionnaire (TRAQ) Change
Self-advocacy Baseline visit
|
3.4 score on a scale
Standard Deviation 0.6
|
3.0 score on a scale
Standard Deviation 0.5
|
|
Transition Readiness Assessment Questionnaire (TRAQ) Change
Self-advocacy 6-Month Visit
|
3.6 score on a scale
Standard Deviation 0.6
|
3.2 score on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Baseline and 6-Month VisitThe 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.
Outcome measures
| Measure |
Usual Care + MyREADYTransition[TM] BBD App
n=19 Participants
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).
|
Control Group: Usual Care
n=24 Participants
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.
|
|---|---|---|
|
Canadian Occupational Performance Measure (COPM) Change
Performance Baseline Visit
|
4.3 score on a scale
Standard Deviation 1.8
|
5.3 score on a scale
Standard Deviation 2.2
|
|
Canadian Occupational Performance Measure (COPM) Change
Satisfaction Baseline Visit
|
4.8 score on a scale
Standard Deviation 2.1
|
5.2 score on a scale
Standard Deviation 2.2
|
|
Canadian Occupational Performance Measure (COPM) Change
Performance 6-Month Visit
|
6.0 score on a scale
Standard Deviation 1.6
|
6.7 score on a scale
Standard Deviation 2.3
|
|
Canadian Occupational Performance Measure (COPM) Change
Satisfaction 6-Month Visit
|
6.3 score on a scale
Standard Deviation 1.9
|
7.3 score on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: Baseline and 6-Month VisitThe 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.
Outcome measures
| Measure |
Usual Care + MyREADYTransition[TM] BBD App
n=19 Participants
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).
|
Control Group: Usual Care
n=24 Participants
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.
|
|---|---|---|
|
TRANSITION-Q Change
Baseline Visit
|
57.0 score on a scale
Standard Deviation 10.1
|
56.1 score on a scale
Standard Deviation 10.4
|
|
TRANSITION-Q Change
6-Month Visit
|
59.4 score on a scale
Standard Deviation 13.2
|
52.2 score on a scale
Standard Deviation 19.6
|
SECONDARY outcome
Timeframe: Baseline and 6-Month VisitThe 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).
Outcome measures
| Measure |
Usual Care + MyREADYTransition[TM] BBD App
n=19 Participants
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).
|
Control Group: Usual Care
n=24 Participants
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.
|
|---|---|---|
|
Pediatric Quality of Life Instrument (PedsQL[TM]) Change
Baseline Visit
|
64.5 score on a scale
Standard Deviation 16.5
|
64.6 score on a scale
Standard Deviation 20.8
|
|
Pediatric Quality of Life Instrument (PedsQL[TM]) Change
6 Month Visit
|
63.2 score on a scale
Standard Deviation 18.3
|
66.2 score on a scale
Standard Deviation 18.1
|
SECONDARY outcome
Timeframe: Baseline and 6-Month VisitThe 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.
Outcome measures
| Measure |
Usual Care + MyREADYTransition[TM] BBD App
n=19 Participants
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).
|
Control Group: Usual Care
n=24 Participants
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.
|
|---|---|---|
|
Measure of Process of Care (MPOC) Change
Providing Specific information 6-Month Visit
|
4.2 score on a scale
Standard Deviation 2.1
|
4.4 score on a scale
Standard Deviation 1.6
|
|
Measure of Process of Care (MPOC) Change
Coordination and comprehensive care Baseline Visit
|
4.8 score on a scale
Standard Deviation 1.5
|
4.7 score on a scale
Standard Deviation 1.3
|
|
Measure of Process of Care (MPOC) Change
Enabling and Partnership Baseline Visit
|
4.6 score on a scale
Standard Deviation 1.5
|
4.3 score on a scale
Standard Deviation 1.6
|
|
Measure of Process of Care (MPOC) Change
Enabling and Partnership 6-Month Visit
|
4.5 score on a scale
Standard Deviation 1.8
|
4.4 score on a scale
Standard Deviation 1.7
|
|
Measure of Process of Care (MPOC) Change
Providing General information Baseline Visit
|
3.4 score on a scale
Standard Deviation 1.6
|
3.6 score on a scale
Standard Deviation 1.7
|
|
Measure of Process of Care (MPOC) Change
Providing General information 6 Month Visit
|
3.3 score on a scale
Standard Deviation 1.7
|
3.6 score on a scale
Standard Deviation 1.8
|
|
Measure of Process of Care (MPOC) Change
Providing Specific information Baseline Visit
|
4.2 score on a scale
Standard Deviation 1.5
|
4.3 score on a scale
Standard Deviation 1.4
|
|
Measure of Process of Care (MPOC) Change
Coordination and comprehensive care 6-Month Visit
|
4.6 score on a scale
Standard Deviation 2.0
|
4.7 score on a scale
Standard Deviation 1.6
|
|
Measure of Process of Care (MPOC) Change
Respectful and supportive care Baseline Visit
|
5.1 score on a scale
Standard Deviation 1.1
|
5.1 score on a scale
Standard Deviation 1.1
|
|
Measure of Process of Care (MPOC) Change
Respectful and supportive care 6-Month Visit
|
4.8 score on a scale
Standard Deviation 1.6
|
4.9 score on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Baseline and 6-Month VisitPopulation: 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.
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)
Outcome measures
| Measure |
Usual Care + MyREADYTransition[TM] BBD App
n=19 Participants
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).
|
Control Group: Usual Care
n=24 Participants
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.
|
|---|---|---|
|
Health Utilities Index® (Hui2/3) Proxy-Assessed Change
Baseline Visit
|
3.9 units on a scale
Standard Deviation 0.9
|
4.1 units on a scale
Standard Deviation 1.0
|
|
Health Utilities Index® (Hui2/3) Proxy-Assessed Change
6-Month Visit
|
4.0 units on a scale
Standard Deviation 0.8
|
4.0 units on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: 6-Month VisitThe 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.
Outcome measures
| Measure |
Usual Care + MyREADYTransition[TM] BBD App
n=19 Participants
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).
|
Control Group: Usual Care
n=24 Participants
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.
|
|---|---|---|
|
Resource Use Questionnaire (RUQ) Change
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 6-Month VisitThe 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.
Outcome measures
| Measure |
Usual Care + MyREADYTransition[TM] BBD App
n=18 Participants
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).
|
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.
|
|---|---|---|
|
System Usability Scale (SUS)
|
65.4 score on a scale
Standard Deviation 26.8
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6-Month VisitPopulation: Average number of times intervention group participants logged into the App intervention. Indicates App intervention access or engagement. Higher scores indicate better engagement.
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.
Outcome measures
| Measure |
Usual Care + MyREADYTransition[TM] BBD App
n=24 Participants
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).
|
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.
|
|---|---|---|
|
Utilization of Intervention (Usage, Adherence, and Fidelity)
|
11.2 times
Standard Deviation 9.5
|
—
|
Adverse Events
Usual Care + MyREADYTransition[TM] BBD App
Control Group: Usual Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place