Title of Research Study: Juvenile Dermatomyositis Physical Activity and Fatigue Study (JDM PLAY Study)
Principal Investigator: Rodolfo Curiel, MD, FACP, FACR
Key Information:
You are being asked to take part in a research study looking at how juvenile dermatomyositis (JDM) may affect physical activity and fatigue in people with JDM. This page will give you key information to help you decide whether or not you want to participate in this study. More detailed information can be found on the next pages. Ask the research team questions during the consent process, and use the contact information on this form to ask questions later.
WHAT IS THE PURPOSE, PROCEDURES, AND DURATION OF THIS STUDY?
This study uses an online questionnaire to ask you questions about your child with JDM or about yourself if you are an adult with JDM. People who do not have JDM will also be asked to complete the questionnaire either for themselves if they are an adult or for one of their kids who does not have JDM. We will compare answers from people with JDM with answers from people who do not have JDM so we can see how the disease affects peoples’ lives. The questions ask about JDM tests and symptoms, fatigue levels, and physical activity. We hope to learn how JDM affects peoples’ ability to participate in daily activities. Your participation in this research will last about 30 minutes to complete, and may take up to an hour depending how fast you go.
WHAT ARE THE REASONS YOU MIGHT CHOOSE TO VOLUNTEER FOR THIS STUDY?
People choose to participate in this study to help us learn how we can better help people with JDM. For a complete description of benefits please refer to the Detailed Consent.
WHAT ARE THE REASONS YOU MIGHT NOT CHOOSE TO VOLUNTEER FOR THIS STUDY?
People may not want to participate in this study because it takes 30-60 minutes to complete. For a complete description of risks please refer to the Detailed Consent.
DO YOU HAVE TO TAKE PART IN THIS STUDY?
You do not have to take part in this research. It is your choice whether or not you want to take part. You can agree to take part and later change your mind. If you choose not to take part or choose to stop taking part at any time, there will be no penalty to you or loss of benefits to which you are otherwise entitled.
As a student/employee, if you decide not to take part in this study, your choice will have no effect on your academic status or class grade(s) or employment status.
WHAT IF YOU HAVE QUESTIONS OR CONCERNS?
The person in charge of this study is Rodolfo Curiel, MD, FACP, FACR. If you have questions, suggestions, or concerns regarding this study or you want to withdraw from the study his contact information is: 202-741-2488 or jdm@gwu.edu.
This research is being overseen by an Institutional Review Board (“IRB”). You may talk to them at 202-994-2715 or via email at ohrirb@gwu.edu if:
- You have questions, concerns, or complaints that are not being answered by the research team or if you wish to talk to someone independent of the research team.
- You have questions about your rights as a research subject.
Detailed Consent Form:
Why am I being invited to take part in a research study?
We invite you to take part in a research study because:
- You are able to read and understand English
- You have access to a computer, tablet, or smartphone and have access to the Internet or a cellular service provider that allows you to use an Internet browser
- You (and your children if applicable) live in the USA or Canada
- You are:
- a parent or guardian of a child with a diagnosis of juvenile dermatomyositis (JDM) and/or you have a child without JDM
OR
-
- an adult with a diagnosis of JDM
OR
-
- an adult healthy without JDM
- For: Parents/guardians of children with JDM AND parents/guardians of children without JDM:
- Children must be at least 5 years old in order for you to participate
- Children without JDM must not have any other autoimmune disease or disease that affects their muscles
- Children with JDM must also have been diagnosed with JDM while living in the USA or Canada
- For: Adults with JDM:
- You must be 18-30 years of age in order to participate
- In addition to currently living in the USA or Canada, you must also have been diagnosed with JDM while living in the USA or Canada
- For: Healthy adults without JDM:
- You must be 18-30 years of age in order to participate
- You must be free from all autoimmune diseases or any disease that affects your muscles
What should I know about a research study?
- Participation is voluntary; whether or not you take part is up to you.
- You can agree to take part and later change your mind.
- Your decision not to take part or to stop your participation will not be held against you.
- Your decision will not affect the medical care you receive from GW. If you decide not to take part, you can still receive medical care from GW.
- You may request a copy of this document to read or to discuss with your family members or doctor before deciding to take part in this research study.
Who can I talk to if I have questions?
If you have questions, concerns, or complaints, or think the research has hurt you, talk to the Principal Investigator at: 202-741-2488 or jdm@gwu.edu.
This research is being overseen by an Institutional Review Board (“IRB”). You may talk to them at 202-994-2715 or via email at ohrirb@gwu.edu if:
- You have questions, concerns, or complaints that are not being answered by the research team or if you wish to talk to someone independent of the research team.
- You have questions about your rights as a research subject.
Why is this research being done?
Our research team would like to better understand how JDM influences a person’s ability to participate in physical activities. We would also like to see if any differences exist between children and adults with JDM and those who do not have JDM.
How long will I be in the study?
We expect that our questionnaire will take less than an hour. If you fill out more than one questionnaire (both for a child with JDM and for a child without JDM) you can expect to spend an additional 30-60 minutes for each additional questionnaire you fill out.
How many people will take part in this research study?
We expect about 1000 people will take part in the entire study.
What happens if I agree to be in this research?
If you agree to participate in this research study by reading this page and clicking that you understand this document and wish to participate in this study at the bottom of the screen, you will be sent to a page with instructions for filling out the questionnaire and a link to the questionnaire. If you or your child has JDM, the questionnaire will ask you questions about your or your child’s JDM (diagnosis information, medical tests, your/your child’s level of function before JDM diagnosis, at diagnosis, when the JDM was most severe, and at present time), followed by questions about fatigue and physical activity. People taking this questionnaire for themselves or their children who do not have JDM will be asked some general health questions followed by questions about fatigue and physical activity. The questionnaire takes less than an hour to complete, and can be done in more than one sitting. Once you have filled out the questionnaire, your participation in the study will be complete.
We ask you to provide your email address so we can send you a reminder to finish the questionnaire if needed. Once you start, you will have 1 week (7 days) to complete the questionnaire. A reminder may be sent if you have not completed the questionnaire. Once the 1-week period is over, the questionnaire will be locked. Once the questionnaire is locked, no further changes can be made to the questionnaire. Researchers may still analyze any partially-completed questionnaires.
If you are filling out the questionnaire for more than one child, we may use your email address to link your children for comparisons if they are related to each other. The questionnaire asks for your city, state, and zip code in order to help the researchers better understand how geographical and or seasonal factors might influence activity participation. This information may also be used by researchers to help match siblings with each other for research comparisons. Your email address will be deleted when the study is completed.
What are my responsibilities if I take part in this research?
If you take part in this study we ask that you complete the entire questionnaire to the best of your ability, as accurately as possible.
What other choices do I have besides taking part in the research?
You may decide to NOT participate in this study or to stop filling out the questionnaire at any time.
What happens if I agree to be in research, but later change my mind?
You may refuse to participate or you may discontinue your participation at any time without penalty or loss of benefits to which you would otherwise be entitled. If you have completed the questionnaire but later change your mind and don’t want your data included in the study, the researchers will not be able to identify information you provide on the questionnaire to be able to remove your data, and therefore will not be able to remove your data.
If you are a student or employee at The George Washington University (GWU), The George Washington University Hospital (GWUH), or the Medical Faculty Associates (MFA), your academic standing/employment status will not be affected in any way should you choose not to take part in this study or to withdraw from participation.
Your decision to participate or not participate will not affect the medical care you receive from medical professionals associated with GWUH or MFA. If you decide not to take part, you can still receive medical care from affiliates of GW.
Is there any way being in this study could be bad for me?
The risks and discomforts associated with participation in this study are not greater than those ordinarily encountered in daily life or in participating in examinations or tests that ask questions about your life.
This questionnaire invites self-assessment or a thoughtful evaluation of your experience with JDM either for yourself or through your children. This may result in some psychological distress as you think about possible declines in physical function or disease severity.
All data will be stored on a secure database. As with any computer-based questionnaire, despite our best efforts to keep your information safe through the best computer security measures available, there will always be a possibility that a data breach may occur as new criminal technologies become available.
Will being in this study help me in any way?
It is not expected that you will receive any benefits from participating in this research. The purpose of this study is to better understand relationships between changes in disease severity, activity participation, and fatigue. Knowledge obtained from this study will be used to help us understand JDM better, including better understanding the role of exercise and fatigue in the disease, and to guide future treatments for JDM.
What happens to my information collected for the research?
Only members of our research team will have access to the information we obtain from this study. However, given evolving vulnerabilities in all technology, we cannot promise complete secrecy from unlawful acts. Additionally, members of the Institutional Review Board (professionals responsible for ethical conduct of research) and other representatives of this organization may inspect and copy your information for safety or compliance purposes.
Your email address will only be used to remind you to complete the questionnaire and to possibly link siblings for comparison. It will be removed from your data once the study is completed. Researchers will only ask for parts of your address (for example, city, state, zip code) necessary in order to understand how your general geographic location may affect your physical activity patterns and to match people with JDM to their siblings who do not have JDM. This information will not be used to contact you and will not be shared with other entities.
De-identified results (meaning that the data or information you provide will not have any information that could link your identity to the data) will be kept indefinitely and will be used for future research.
Are there any costs for participating in this research?
No costs are associated with participation in this study.
Will I be paid for my participation in this research?
No payments are associated with participation in this study.
Electronic Signature
By clicking “agree” below you indicate that you have carefully and completely read the above information and agree to participate in this study as it has been explained above. You understand that you may ask questions about any aspect of this research during the course of the study and in the future. By clicking “I AGREE” below you agree to take part in this research. Clicking “I DO NOT AGREE” indicates that your do not wish to participate in this study.
I AGREE and Want to Participate I DO NOT AGREE and Do Not Want to Participate in This Study