Study Information Sheet (Informed Consent Form)
Grey Matter Technologies
Polycythemia Vera (PV)
(Online Research Participants)
Study Title: Feasibility Study Using the Making Patients Heard™ App to Capture and Analyze Polycythemia Vera (PV) Patient Reports of Problems (PROP)
Sponsor: Grey Matter Technologies (GMT)
Thank you for expressing an interest in participating in this research study, sponsored by Grey Matter Technologies (GMT), in collaboration with the MPN Research Foundation (MPNRF), and funded by Protagonist Therapeutics.
You may print a copy of this form and think about or discuss with family or friends in making your decision to participate.
What is the purpose of this study?
The purpose of this research study is to collect and analyze self-reported health information from between 200 and 600 adult patient volunteers diagnosed with Polycythemia Vera (PV). This study involves new research approaches to learning what patients report.
A free downloadable app called Making Patients Heard is used to capture participant reports using their own smartphones or tablets. Participants, after downloading the app and enrolling into the study “Making Patients Heard PV,” You will be asked to reply to a series of questions, including open-ended questions that will be transcribed by voice (microphone voice-to-text transcription) or keyboard-entered text to capture what you experience in your own words. To investigate the PV-lived experience, the study will also collect a variety of information from study participants including health-related forms of information. The goal is to learn if this approach is practical and informative in understanding the problems that PV patients face.
This study is being done to help improve understanding of PV; for example, how the disease affects health, how patients feel about and experience their symptoms, and medications used to treat PV. For those participants who have undergone phlebotomy (excess blood removal by vein puncture) as a treatment for PV, we are also interested in how participants have experienced this procedure. At the end of the study, participants can share their experience and opinions in a satisfaction survey about using Making Patients Heard app.
Participation in the study is entirely voluntary. No medical treatments or medical advice will be provided as part of this study. After the group data are analyzed, participants may choose to receive by email an overall summary of the study findings.
What will you be asked to do in this study?
If you decide to take part in this study, you will be asked to complete the following tasks:
1. Download and install the “Making Patients Heard™” app using download instructions provided by GMT.
2. You will sign-up as a new user providing your same email id and creating your own login password.
3. You will receive an email with a unique verification code (from firstname.lastname@example.org) to complete your sign-up process. (NOTE: If this email does not arrive to your inbox, please check your spam folder.)
4. You will type in the unique verification code to get access to the app.
5. You will also receive a separate email containing your validation token (password) inviting you to join the study “Making Patients Heard PV.” The validation token is personalized to your email and should not be shared with others. If you do not receive the validation token within 24 hours, please email indicating that you did not receive your token.
6. Click on the study “Making Patients Heard PV,” and join the study by entering the validation token.
7. Thereafter, you will be asked to complete a series of questionnaires, preferably in one sitting in the privacy and comfort of home. These questionnaires will collect information about yourself, your medical history, PV medications, and other health- related information. It should take about 90 minutes to complete all this information.
To help protect privacy, information shared by research participants through the app will be collected, and de-identified by removing any personal health information (PHI) such as name, date of birth, email address, zip code. De-identification involves the following procedures:
The data are compiled by web services running on the secure Google Kubernetes Engine (GKE) clusters. All patient identifiable information are isolated to the Participant Datastore and stored on CloudSQL. The responses are then stored in Firestore and are de-identified. Only authorized GMT personnel have access to identifiable personal health information (PHI). Only the de-identified data will be made available to qualified researchers for analysis and for future research on PV and related disorders.
If you agree to participate in this research study, you have two ways to provide your information:
1. Enter information yourself, without any assistance.
2. Enter information with the help of an assistant who is someone that knows you well enough to help answer questions about you. This may be your spouse/significant other, child, friend or anyone else that you are comfortable with and give permission to help answer health questions about you.
In addition to the procedures described above, this study includes the option to receive messages about study updates and other PV-related studies that may be developed in the future. You may consider additional research participation, but you have no obligation to reply at all. You may report unwelcome or inappropriate emails to the sponsor Grey Matter Technologies (GMT) via the email PVStudy@greymattertech.org. If you have technical problems with the app or study content, you can also contact GMT by using the “Need Help? Contact Us” link under the “Reach Out” link on the Home Screen of the App.
Are there any risks to being in this study?
This study involves collecting and storing personal, identifiable information about you, so there is a potential for invasion of privacy or breach in confidentiality. To minimize these risks, we will not include any directly identifiable personal health information in data that are shared with researchers. Only transcribed text will be kept. No voice recordings will be captured or retained. Your information will be assigned a unique code number by GMT and stored in a secure manner. Information shared with researchers through the de-identified analytic dataset will only include the code number. No personal, identifiable information will be shared outside the GMT research study team. We recommend you use a secure wireless network (i.e., not free public Wi-Fi) while participating in this study.
Even with removal of identifying information, in some circumstances it may be possible in theory to re-identify individuals, given the type and amount of data provided. Therefore, we cannot fully guarantee that your identity will never become known.
Are there any benefits to being in this study?
The study may help you think more about how PV affects you and prioritize the problems you would like to see improved.
Will you be paid to participate in this study?
You will not be paid to participate in this study.
Are there any costs to being in this study?
There will be no cost to you for participating in this study, except for the time that you spend answering questions and providing data. There is no fee for downloading the GMT Making Patients Heard PV App from the Apple IOS or Google Android stores, corresponding to the format for your smartphone.
What happens to your data?
GMT, based in the United States of America (Longboat Key, FL) www.greymattertech.org, makes reasonable efforts to keep the information collected from you private, protected and secure. GMT may contract with other entities to help conduct the study, or store or prepare your data for use. In doing so, it will require such other entities to keep private, protect and secure your data. Before your health information is made available to other researchers, the data you provide will be de-identified, which means none of your personal identifiers will be included (for example, your name, date of birth, email address, zip code). Also, the de-identified data will combine your information with the information provided by other volunteers in the study before it is made available for research purposes to qualified researchers. Qualified researchers must agree to certain terms and conditions in order to receive and use the information for research purposes, such as not to attempt to identify individual research participants.
Some of the questions about you and your PV are required to proceed to the PV research questions. Thereafter, you may choose to not answer questions or withdraw from the study at any time by not sharing additional information. If you choose to withdraw from the study, GMT will keep the information we have already collected about you indefinitely. De-identified data that have already been entered prior to your withdrawal will not be removed. Your permission to use the de-identified health information provided to GMT will not expire.
What happens if you do not wish to participate in this study?
Your participation in this study is voluntary. You may decide not to participate, or you may leave the study at any time, for whatever reason. You may email to withdraw your participation in the study or you can simply opt to not share any additional information. Your decision will not result in any penalty.
Who do you contact if you have questions?
For more information or questions about this PV research study, please email PVStudy@greymattertech.org. In case you have any questions about the mobile app, please email email@example.com.
If you have any questions about your rights as a research subject, you may contact: WCG Institutional Review Board (IRB), an affiliate of Western IRB, at 800-232-9570.
After you have read this form and reviewed the website Terms and Conditions, you will be asked to sign your name, using your finger or a stylus on the consent screen within the app, to indicate you agree to participate in this study.
Signing the consent
By signing your name, you are confirming that you have reviewed and agree to this Information Sheet and the GMT website Terms and Conditions. This indicates your agreement to participate in the “Making Patients Heard App to Capture and Analyze PV PROP”. and allow use of your data by GMT, its contractors, and qualified researchers.