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READYorNot[TM] Brain-Based Disabilities Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03852550
Recruitment Status : Not yet recruiting
First Posted : February 25, 2019
Last Update Posted : August 14, 2019
Sponsor:
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
Oregon Health and Science University
Information provided by (Responsible Party):
McMaster University

Brief Summary:

The purpose of this study is to find out if there is a benefit to using the MyREADY Transition 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 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 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.


Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Cerebral Palsy Epilepsy Fetal Alcohol Spectrum Disorders Spina Bifida Other: e-health application Not Applicable

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 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 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 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 264 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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 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)
Primary Purpose: Health Services Research
Official Title: CHILD-BRIGHT READYorNot[TM] Brain-Based Disabilities Trial
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Usual Care + MyREADYTransition 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 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. There is a timer in the App to make sure participants wait at least one day between the parts. 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).
Other: e-health application
In the first part of this study, an e-health application (MyREADY Transition 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.
Other Name: MyREADY Transition BBD App

No Intervention: 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.



Primary Outcome Measures :
  1. Transition Readiness Assessment Questionnaire (TRAQ) Change [ Time Frame: Baseline and 6-Month Visit ]
    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 :
  1. Canadian Occupational Performance Measure (COPM) Change [ Time Frame: Baseline and 6-Month Visit ]
    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'.

  2. TRANSITION-Q Change [ Time Frame: Screen prior to 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. 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.

  3. Pediatric Quality of Life Instrument (PedsQL[TM]) Change [ Time Frame: Baseline and 6-Month Visit ]

    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.


  4. Patient Activation Measure (PAM) Change [ Time Frame: Baseline and 6-Month Visit ]

    The Patient Activation Measure (PAM) (http://www.insigniahealth.com/products/pam-survey) is a valid, reliable, unidimensional, Guttman-like scale based on a developmental model of activation. Activation appears to involve four stages: (1) believing the patient role is important, (2) having the confidence and knowledge necessary to take action, (3) actually taking action to maintain and improve one's health, and (4) staying the course even under stress. The measure has good psychometric properties indicating that it can be used at the individual patient level to tailor intervention and assess changes.

    PAM originally included 22 questions, and through subsequent validation of the short-version now has 13 questions. The PAM assesses a patient's confidence in self-managing their condition


  5. Measure of Process of Care (MPOC) Change [ Time Frame: Baseline and 6-Month Visit ]
    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.

  6. Health Utilities Index® (Hui2/3) Proxy-Assessed Change [ Time Frame: 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. 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.

  7. Resource Use Questionnaire (RUQ) Change [ Time Frame: Baseline and 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 have also included some questions to capture information about serious illnesses during the study including information about hospitalizations, ICU admissions, etc.

  8. System Usability Scale (SUS) [ Time Frame: 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.


Other Outcome Measures:
  1. Utilization of Intervention (Usage, Adherence, and Fidelity) [ Time Frame: 6-Month Visit ]
    Mixed methods will be used to assess MyREADY Transition 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03852550


Contacts
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Contact: Jan Willem Gorter, MD,PhD,FRCPC 905-525-9140 ext 27855 gorter@mcmaster.ca
Contact: Research Coordinator 905-525-9140 ext 27852 galuppi@mcmaster.ca

Sponsors and Collaborators
McMaster University
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
Oregon Health and Science University
Investigators
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Principal Investigator: Jan Willem Gorter, MD,PhD,FRCPC McMaster University
Principal Investigator: Ariane Marelli, MD,MPH,FRCPC McGill University
Principal Investigator: Adrienne Kovacs, PhD,CPsych Oregon Health and Science University

Additional Information:
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Responsible Party: McMaster University
ClinicalTrials.gov Identifier: NCT03852550     History of Changes
Other Study ID Numbers: 1666
First Posted: February 25, 2019    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by McMaster University:
Health Care Transition
Brain-Based Disabilities
CHILD-BRIGHT
e-health application
randomized controlled trial
Additional relevant MeSH terms:
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Fetal Alcohol Spectrum Disorders
Child Development Disorders, Pervasive
Fetal Diseases
Alcohol-Induced Disorders
Alcohol-Related Disorders
Cerebral Palsy
Spinal Dysraphism
Disease
Autism Spectrum Disorder
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Brain Damage, Chronic
Neurodevelopmental Disorders
Mental Disorders
Neural Tube Defects
Nervous System Malformations
Congenital Abnormalities
Pregnancy Complications
Substance-Related Disorders
Chemically-Induced Disorders