Remote data collection to objectively quantify the severity of Parkinson's disease.Click here to download the consent form.
Please click the "Yes" button to enroll in the study. If you choose not to participate, there will be no penalty to you. A blank copy of this consent form can be downloaded from this attachment for your review prior to providing consent. Please keep this copy for your records.
You may revoke your consent at any time.
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Dr. M. Ehsan Hoque
Assistant Professor, Department of Computer Science, University of Rochester, firstname.lastname@example.org
Ray Dorsey, MD, MBA
University of Rochester, Center for Health and Technology, Saunders Research Building, 2nd Floor, 585.276.6824
Mohammad Rafayet Ali
Ph.D. Student, Department of Computer Science, University of Rochester, email@example.com, 585.520.8113
We are inviting you to take part in this study because you have expressed interest in participating in research studies of Parkinson disease (PD). We are interested in enrolling both individuals with Parkinson disease and individuals not diagnosed with Parkinson disease. We would like to study whether the use of web-based technology can measure day-to-day fluctuations in symptoms of Parkinson disease, and distinguish these individuals from individuals who do not have Parkinson disease. This study is being conducted by Dr. Ehsan Hoque and Dr. Ray Dorsey of the University of Rochester's Department of Computer Science and Department of Neurology.
The clinical data on Parkinson disease are usually recorded during periodic assessment in the academic research center. These data are low-frequency and are not suitable for computer aided objective analysis. In this study, we want to explore the possibility of a web-based application which is able to capture audio and video data from the research subjects and objectively analyze those generating some feedback (or measure the severity of the disease). The application will give you the instructions to perform the tasks by showing them animation. This collected data and the automatic analysis may uncover key characteristics of the research subjects thus helping the specialist make better recommendations.
The specific objectives of the study are as follows:
Aim 1: To assess the feasibility of research subjects using the web application from their home.
Aim 2: Collect high-quality audio and video data from the research subjects’ movement tests.
Aim 3: To objectively measure and quantify five factors of Parkinson disease (voice, postural sway, dexterity, gait, and reaction time) using the application.
You are being asked to participate in a research study individuals with self-reported Parkinson disease and without Parkinson disease.
You must have a computer/laptop with a working webcam and Internet. Access to Internet connection throughout the duration of this study is necessary. Once you consent to join the study after completing an electronic consent form, you will receive the link to the web-application.
Using the web-application you will perform the five tasks once from MDS-UPDRS (Movement Disorder Society - Unified Parkinson’s Disease Rating Scale). You need to do the tasks once in one session. However, you can take a break between tasks without closing the application. These tasks are:
Each task should not take more than one minute. You will be able to close the web-application anytime you want. You will be able to redo a test. Also, the web application allows you to take rest in between the tasks if you want to. During the tests, the web-application will collect the audio and video data using the microphone of the computer and the webcam. After the completion of the tests, the web-application will upload the data to our secure web server. This web server is password protected and only the study personnel will have access to this data. After the recording, you will fill out an online survey. This survey will include questions regarding your experience with the web application, your feedback, and demographics information.
We aim to enroll approximately 2000 research subjects in this study, 1500 with self-reported PD and 500 with no PD.
The total time involved for the study visit is at most 10 minutes, including both the motor tasks and the online survey.
There is minimal risk to you from this research, as no human tissue will be collected, and no procedures or human testing (beyond surveys and standard clinical assessments) will occur. Participant risks from participation in this research study are considered minimal and include breach of confidentiality and privacy of information transmitted using technology.
However, protection against these risks is a priority. The research subjects with PD may feel stress. To minimize this the web application will allow you to stop the application anytime they want. There is risk involved with your privacy. All data will be securely transmitted from the web application and de-identified before data analysis. Data collected from surveys will be transmitted in encrypted form and stored in a secure database housed at the University of Rochester. All web-based assessments will be conducted using secure, HIPAA-compliant video-conferencing software to protect your confidentiality.
There are no direct benefits; however, the data collected may inform future research and increase understanding of Parkinson disease (PD).
There will be no cost to you to participate in this study. You can withdraw anytime. Withdrawal will have no effect on your current or future treatment or other benefits.
After completing the program (recording and survey) we will ask you whether you want to receive an Amazon gift card ($50) or not. If you want to have it then we will ask for your email address where we will send the gift card. We will not pay for the cost associated with the internet connection.
The University of Rochester makes every effort to keep the information collected from you. In order to do so, we will store the data in password protected lab machines. All the data will be de-identified by replacing the names with an ID number. The videos will be transferred from the web application to the server using a secure web transfer protocol. The server is password protected and only the research staff has access to it. We will not keep the videos which include your face or any object that can identify you. Your information will not be included in any Electronic Medical Report (EMR). Sometimes, however, researchers need to share information that may identify you with people that work for the University, regulators or the study sponsor. If this does happen we will take precautions to protect the information you have provided. Results of the research may be presented at meetings or in publications, but your name will not be used.
For more information concerning this research or if you feel that your participation has resulted in any research related injury, emotional or physical discomfort please contact: Mohammad Rafayet Ali (research coordinator) at 585-520-8113 (Email: firstname.lastname@example.org)
Please contact the University of Rochester Research Subjects Review Board at 265 Crittenden Blvd., CU 420628, Rochester, NY 14642, Telephone (585) 276-0005 or (877) 449-4441 for the following reasons:
Taking part in this study is voluntary. You are free not to take part or to withdraw at any time, for whatever reason. No matter what decision you make, there will be no penalty or loss of benefit to which you are entitled. In the event that you withdraw yourself from this study, the information you have already provided will be kept in a confidential manner.
I have read the contents of this consent form and have been encouraged to ask questions. I have received answers to my questions. I agree to participate in this study. By selecting "Yes" in both of the questions above, I acknowledge that I have provided my electronic consent to join this research study. I have had the opportunity to download a blank copy of this form (in PDF format) for my review prior to providing consent. This blank copy can be kept for my personal records.