Epilepsy Clinical Trial
Official title:
CHILD-BRIGHT READYorNot[TM] Brain-Based Disabilities Trial
NCT number | NCT03852550 |
Other study ID # | 1666 |
Secondary ID | |
Status | Terminated |
Phase | N/A |
First received | |
Last updated | |
Start date | June 22, 2020 |
Est. completion date | May 22, 2023 |
Verified date | November 2023 |
Source | McMaster University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 52 |
Est. completion date | May 22, 2023 |
Est. primary completion date | May 22, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 15 Years to 17 Years |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
Canada | Alberta Health Services and The Governors of the University of Alberta | Edmonton | Alberta |
Canada | Izaak Walton Killam Health Centre (IWK) | Halifax | Nova Scotia |
Canada | McMaster Children's Hospital, Hamilton Health Sciences | Hamilton | Ontario |
Canada | Lawson Health Research Institute | London | Ontario |
Canada | Centre Hospitalier Universitaire Sainte-Justine | Montréal | Quebec |
Canada | Research Institute of the McGill University Health Centre | Montréal | Quebec |
Canada | Children's Hospital of Eastern Ontario Research Institute Inc. | Ottawa | Ontario |
Canada | Horizon Health Network | Saint John | New Brunswick |
Canada | Holland Bloorview Kids Rehabilitation Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
McMaster University | Canadian Institutes of Health Research (CIHR), Hamilton Health Sciences Corporation, Harvard Medical School (HMS and HSDM), McGill University Health Centre/Research Institute of the McGill University Health Centre, McMaster Children's Hospital Foundation, New Brunswick Health Research Foundation, Oregon Health and Science University, The Hospital for Sick Children, The Montreal Children's Hospital Foundation |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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. | 6-Month Visit | |
Primary | 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. | Baseline and 6-Month Visit | |
Secondary | 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'. | Baseline and 6-Month Visit | |
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. 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. | Screen prior to Baseline and 6-Month Visit | |
Secondary | 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. |
Baseline and 6-Month Visit | |
Secondary | 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. | Baseline and 6-Month Visit | |
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. 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. | Baseline and 6-Month Visit | |
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 have also included some questions to capture information about serious illnesses during the study including information about hospitalizations, ICU admissions, etc. | Baseline and 6-Month Visit | |
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. | 6-Month Visit |
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