- Background
Individuals with a mild traumatic brain injury (mTBI)/concussion often experience symptoms
that are life-altering and
can affect a person’s quality of life. This research study will help develop a new mobile application
(app) called,
"MyBrainPacer™" tailored for individuals with a mTBI/concussion. This app is an updated
version of a time management
tool developed by an occupational therapist at Parkwood Institute, which was originally implemented
using pen and paper.
This time management tool aims to help individuals cope with their persistent symptoms associated with a
mTBI/concussion, which can improve self-management skills. Self-management refers to a person’s ability
to manage the
symptoms, treatment, physical and lifestyle changes inherent in living with a chronic condition.
- Invitation to Participate
You are invited to participate in a research study that will help develop
MyBrainPacer™. Through this
research trial we will be able to better understand the natural progression of symptoms following a
mTBI/concussion
as well as the relationship between activities and symptom intensity. We will also be able to further
test and
validate the app to ensure it is relevant to individuals with a mTBI/concussion.
- Purpose of the Letter
The purpose of this letter is to provide you with information required to make an informed
decision regarding participation in this research study. This letter will explain the objective of the
study and procedures to be followed as a participant. Please take your time reading this letter
carefully and ensure you fully understand it before agreeing to participate.
- Purpose of this Study
The purpose of this study is to 1) examine the usability and user satisfaction of
MyBrainPacer™, and 2) develop software analytics in order to determine patterns of recovery to
personalize the app.
- Inclusion Criteria
All participants must 1) Have experienced a mTBI/concussion; 2) Disclose the mechanism of
injury and whether you have been diagnosed with a concussion (and by who) 3) Be 18 years or older; 4)
Have access to a smartphone or tablet; and 5) Be able to read, write, and understand English.
- Exclusion Criteria
A participant will not be eligible to participate if he/she 1) Has not experienced a
mTBI/concussion; 2) Is not willing to disclose information about the injury or concussion diagnosis; 3)
Is less than 18 years old; 4) Does not have access to a smartphone or tablet; 5) Cannot read, write, or
understand English.
- Study Procedures
If you agree to participate and meet the inclusion criteria listed above, you are invited
to download and use the app. You are responsible for inputting: your email, gender, birthday, country
you currently live in, how and when you sustained your brain injury, what part of your head was injured,
whether you were diagnosed with a concussion (and the diagnosing clinician’s position, e.g. family
doctor, nurse, etc.), the symptoms you experienced when first injured, and your current symptoms. You
will then have access to the app to track and monitor your daily tasks and symptoms at any time, for as
long as you’d like to use the app. While using the app, you will be prompted to fill out short
assessments, including the Rivermead Post-Concussion Questionnaire once a month (to monitor your
symptoms), a community participation questionnaire once every 6 months (to see how you are performing
everyday activities), and an overall symptom question once a week (where you can rate how you are
feeling in general from a lot better to a lot worse). These will be completed directly within the app.
The answers from your questionnaires will be used to assess the usability and satisfaction with the app.
Your answers will also be used to customize the app for future users, including understanding activity
and symptom patterns.
- Possible Risks and Harms
Excessive screen time may increase your symptoms. In order to reduce this risk, consider
limiting your time spent on screens. Additionally, this app is not a substitute for seeking a medical
professional, and it not responsible for symptom aggravation. There is a potential to encounter
technical difficulties when using the app. In such case, technical support will be provided to ensure a
working system is available.
- Possible Benefits
This app may help you to better manage your daily activities and symptoms following a
mTBI/concussion. Furthermore, the feedback obtained from this study will help to create a more
customized version of the mobile application, which can benefit others with a mTBI/concussion.
- Voluntary Participation
Participation in this study is voluntary. You may refuse to participate or withdraw from
the study at any time by emailing us at mybrainpacer@sjhc.london.on.ca with no effect on your
future care or support. If you do not wish to answer any questions at any point in time while using the
app (when registering or any time after), you should stop using the app. One month of inactivity will
result in your withdrawal from the study. If you withdraw from the study, you will not be able to use
the app anymore. You do not waive any legal rights by signing this consent form.
- Confidentiality
All data collected will remain confidential and accessible only to the investigators of
this study. To maintain confidentiality, the system will automatically assign to you a numeric
participant ID upon registration of the app. This ensures all the data you enter into the app is
de-identified, and no one, not even the investigators will know what data is yours. Your personal
identity will never be revealed in any reports regarding this study. Electronic data will be encrypted
in the application, as well by a secure server at Lawson Health Research Institute, which will host all
data. If the results are published, your name will not be used. If you choose to withdraw from this
study, you can also choose to have your data removed and destroyed from our database. Otherwise, data
will be stored for 15 years and then destroyed as per Lawson Policy. While we will do our best to
protect your information, there is no guarantee that we will be able to do so. Representatives of The
University of Western Ontario Health Sciences Research Ethics Board may contact you or require access to
your study-related records to monitor the conduct of the research. Additionally, representatives of
Lawson Quality Assurance (QA) Education Program may look at study data for Quality Assurance purposes.
- Conflict of Interest
There is a possibility this app might involve some form of commercialization, although the
nature of this conflict of interest will not be clear until several iterations of usability and
validation testing are completed. Once these are completed, we will have a greater understanding if all
or some of the organization bodies involved in supporting our research and development (St. Joseph's
Foundation, St. Joseph's Health Care London, Parkwood Institute, Parkwood Institute Research and Lawson
Health Research Institute) will gain monetary benefit from commercialization of the app.
- Contacts for Further Information
If you require any further information regarding this research project or your
participation in the study, please contact mybrainpacer@sjhc.london.on.ca, or Lawson Health Research Institute.
If you have any questions about your rights as a research participant or the conduct of this study, you
may contact the Director of The Office of Human Research Ethics (519) 661-3036, email: ethics@uwo.ca. Additionally, you may also contact: St. Joseph's Health
Care London Patient Relations Consultant at 519-646-6100 ext. 64727
- Publication
Upon completion of the study, the results will be shared to inform future development of
self-management apps for individuals with a mTBI/concussion. Your name will not be used if the study
findings are shared in academic conferences or published as a written report in a scholarly,
peer-reviewed journal.
- Consent
By clicking "I accept" on the disclosure when installing the app, you are confirming that
you understand and accept the study procedures and your rights as a participant. By downloading and
registering the app, you are providing consent for your de-identified data to be used for research
purposes.