Please note: If you would like more detailed information about anything on this page and/or on the study, please speak with your neurologist or email Dr. Aldridge (email can be found HERE).
As a reminder to participants who are enrolled, this information (and more) may also be found in the Informed Consent form you signed and were given a copy of before starting any procedures for the study. Please refer back to it if you have any questions, or contact someone from the research team (contact information can be found at the top of the Informed Consent form) if you have questions that the Informed Consent form does not answer.
Terms of Service or: How long will I be in this study?
If you agree to participate in this study, your involvement will last:
- Until death (or until drop-out), with follow-up intervals.
- These follow-up intervals will take place at >6 months apart, with a target of yearly.
- Depending on your situation, intervals can take place less frequently or just once.
Depending on the part of the study you consent to (detailed below), you will visit the hospital:
- Up to two times, yearly.
- Depending on your situation, you may only have to visit the hospital once, yearly.
- The visit, for eligible participants, will last from 1-4 hours (dependent on the section of the study you consent to).
What will happen during this study?
If you agree to participate in the study, you will sign a consent before any study procedures are done. There is one required section, along with a few other separate, optional sections of this study that you may be eligible for.
Optional sections are limited by equipment availability and what you have available at home (e.g., internet access).
The sections are:
Clinical Review (required): Clinical chart will be reviewed.
Questionnaires and Cognitive/Mood Tests (optional): 1) Do a timing game up to 10 times a day for 1 month. 2) Answer three short scales asking about mood and sleep. 3) Fill out a folder of standardized questionnaires that assess cognition, sleep, mood, and general impression.
Home-based Actigraphy/Biosensors and Cognitive/Mood Tests (optional): 1) Initial visit: cognitive assessments, actigraphy explanation and calibration. 4 hours 2) Home monitoring: Wear an actigraph for 1 month. 3) Final visit: cognitive assessments. 3 hours
Number of study visits and how long study visits will be: The total number of scheduled in-person visits for the Cognitive/Mood Tasks, and Questionnaires is 1; for the Actigraph portion, it’s up to 2. These visits will last approximately 1-4 hours.
Main risks of taking part in this research study: Loss of privacy is possible with all procedures.
As mentioned above, it is a requirement of your participation in this study that you give us permission to use your protected health information (PHI). However, we will not be adding any data/information we collect from the actigraph(s), cognitive timing game, or questionnaires (if you consent to any of those portions) to your medical record. All information will be stored in a separate database and de-identified, explained below.
As part of your participation in this study, we will incorporate information from your electronic medical record (as stated in the section above) to begin forming a pilot, hypothesis-generating database, that only authorized members of the research team will have access to. Additionally, as stated above, this information will be de-identified to protect your confidential information. The electronic medical record can be accessed until dropout (i.e., you may get into contact with us at any point in time and ask that we stop collecting data and delete the codes linking your PHI to this database).
What about my confidentiality?
We will keep your participation in this research study confidential to the extent permitted by law. However, it is possible that other people such as those indicated below may become aware of your participation in this study and may inspect and copy records pertaining to this research. Some of these records could contain information that personally identifies you.
- Federal government regulatory agencies
- Auditing departments of the University of Iowa
- The University of Iowa Institutional Review Board (a committee that reviews and approves research studies)
To help protect your confidentiality, records of participation in this research will be maintained in a locked cabinet, in a locked office, at University of Iowa. The electronic data will be kept on a secure, University of Iowa server, which is password protected. Your name (or any other identifiers) will not be attached to the information gathered from the timing task, research data, or actigraphy. All of these can only be accessed by authorized personnel on the research team. As mentioned, the participants’ names will be separated from their data. A coding scheme will be employed to identify the data by subject number only, with a minimum 5-digit code (e.g., 42935). For the timing game, subjects will be given an unrelated word and number combination to make entering their ID easy (e.g., Green32). Results of the research may be used for publication in professional journals, and presentations at professional meetings. In this case, we will describe the study results in a summarized manner so that you cannot be directly identified.
The University of Iowa Hospitals and Clinics generally requires that we document your participation in research occurring in a University of Iowa Health Care facility. This documentation will be in either your medical record or a database maintained on behalf of the institution reflecting that you are participating in this study. The information included will provide contact information for the research team, as well as information about the risks associated with this study.
We will keep the Informed Consent Document for our research files; it will not be placed in your medical record chart.
Will my health information be used during this study?
Yes. We will review your chart, and that information will be stored with the other data we’re collecting for the database. This information will also be de-identified, as with all other data. It will be assigned the same subject ID number that you will be given for the other sections of the study you have consented to. No other personal identifiers will be left on these data.
The Federal Health Insurance Portability and Accountability Act (HIPAA) requires the University of Iowa Hospitals and Clinics (UIHC) Neurology Clinic to obtain your permission for the research team to access or create “protected health information” about you for purposes of this research study. Protected health information is information that personally identifies you and relates to your past, present, or future physical or mental health condition or care. We will access or create health information about you, as described in this document, for purposes of this research study. Once the Neurology Clinic has disclosed your protected health information to us, it may no longer be protected by the Federal HIPAA privacy regulations, but we will continue to protect your confidentiality as described under “Confidentiality.”
We may share your de-identified health information related to this study with other parties including federal government regulatory agencies, the University of Iowa Institutional Review Boards and support staff, the SMASH dementia research team, federal funding agency, and colleagues at the University of Iowa involved in this study.
You cannot participate in this study unless you permit us to use your protected health information. If you choose not to allow us to use your protected health information, your decision will not affect your right to medical care that is not research-related. Your signature on the Informed Consent document authorizes the Neurology Clinic to give us permission to use or create health information about you.
Although you may not be allowed to see study information until after this study is over, you may be given access to your health care records by contacting your health care provider. Your permission for us to access or create protected health information about you for purposes of this study has no expiration date. You may withdraw your permission for us to use your health information for this research study by sending a written notice to Dr. Georgina Aldridge, at the following address: 200 Hawkins Drive, Dept. of Neurology, Iowa City IA 52246. However, we may still use your health information that was collected before withdrawing your permission. Also, if we have sent your health information to a third party, such as the study sponsor, or we have removed your identifying information, it may not be possible to prevent its future use.
Once again, if you are not a participant and would like to be and/or have additional questions before deciding, please speak to your neurologist or contact Dr. Aldridge. If you are a participant, the most up-to-date information will be found in your copy of the Informed Consent document you were given. If you have any additional questions that the document does not answer, feel free to contact one of the members on the research team (contact information is at the top of the consent form).