Purpose of the Study and Reason for Your Involvement:
If you are providing consent for someone else (e.g., your child, a next-of-kin, or someone for whom you are the legal guardian or are designated as a surrogate decision maker on a medical power of attorney), please note that in the sections that follow the word “you” refers to the person for whom you are providing consent.
The purpose of this pilot study is to record daily human activities, and to develop predictive models of physical activity. We hope this study will enable researchers to test and validate new technologies that may subsequently be used to study and inform researchers and potentially caregivers regarding Alzheimer's Disease and other forms of dementia.
To achieve this overall goal, we will collect the following:
- Wearable device data by recording daily human activities (sleep, heartrate, oxygen levels and steps walked). Fitbit is the wearable fitness device we are currently using for this study, and henceforth it will be called “the device” or “activity tracker.” This will also involve downloading the Fitbit app to your smart cell phone.
a. Research personnel will provide the device to you.
b. Data from the device will be downloaded to UTSA research files and kept secure.
c. You will need to notify the research team via phone or email if the activity tracker malfunctions or is lost. Another wearable device will be provided if you are consistently compliant with wearing the activity tracker (>75% of time since the device was activated).
- Stem cell, proteomic, and DNA data from blood samples. DNA testing will be used to determine if you carry known genes that increase the risk of developing Alzheimer’s Disease.
a. You will have your biospecimens collected at your clinic. The biospecimens will then be sent to UTSA and collaborating facilities for processing, storage, and research.
b. When a commercial DNA testing company is used for DNA testing (i.e. 23andMe), you will be given access to the data/app as provided by the company.
- Recorded PET/fMRI, PSG, and OCT retinal image data from a subset of the study volunteers.
a. This data will be transferred from health science centers or collaborating hospitals and clinics over secure internet. All scans will be for research purposes only.
b. PET scans will be used to measure blood flow, oxygen use, and will be conducted as an outpatient procedure.
c. fMRI imaging will be used to measure brain activity (note, this does not use radiation). This will be used to detect changes in blood oxygenation.
d. PSG will be used to monitor EEG, EMG, EOG, EKG, and respiratory effort and flow during sleep.
e. OCT imaging will be used to look at the health of your optic nerve.
- Survey data using basic health and social questionnaires.
- Medical records from collaborating clinicians.
a. Clinicians will use their own discretion in deciding which medical records are relevant to the study (i.e., cognitive test results, apnea/hypopnea index, etc).
b. As data is collected and analyzed by the research team, specific medical records may be requested by the research staff from the clinician.
- Cognitive tests.
You may be placed into one of three groups to explore the connections between behavior patterns and the cellular and molecular changes in the body.
- One group will be asked to complete cognitive training via the Tali Health app for 30 minutes per day over a 6 week period.
- One group will be asked to get 10,000 steps per day, 5 days a week for 6 weeks.
- One group will be asked to use artificial UV light exposure for 30 minutes per day over a 6 week period.
Blood draws will be collected pre- and post- intervention, from which proteomic data and neural network characterizations will be collected. Each group of 60 subjects will be unique to that cohort (no overlap between intervention subjects). 20 subjects of each cohort will be healthy controls, 20 subjects will have a 1st/2nd degree family member with Alzheimer’s Disease or a sleep disorder, and 20 subjects will have a diagnosis of AD.
This study will enable researchers to test and validate new technologies that we hope will subsequently be applied to study and inform treatment of Alzheimer's Disease and other forms of dementia.
Participation in the Study:
- Whether or not you take part is up to you.
- Participation is totally voluntary.
- You can agree to take part in the study and later change your mind.
- Your decision not to participate will not be held against you.
- You may ask all the questions you want about the study before you decide.
- Subjects who have diminished capacity and a medical power of attorney in place may participate in the study with the consent of their agent. That agent would sign the consents and contact the Principal Investigator if they wish the subject to discontinue the participation in the study.
If you have questions, concerns, complaints, or think the research has harmed you, you may talk to the research team at Phone: (210) 458-7092 / Email: email@example.com
This research is being overseen by an Institutional Review Board (“IRB”). You may also talk to them at (210) 458-6473 or IRB@utsa.edu if you have questions regarding your rights as a research participant or other questions, concerns, or complaints.
This study requires that you be an adult volunteering yourself or an adult with medical power-of-attorney volunteering on behalf of your charge, and you (or your charge) have the capacity to: a) give consent to participate in this study and b) wear a Fitbit tracker continuously for at least 6 months, or a child (age< 18 years) with parent or guardian’s permission. For those volunteering for the bioassays, this also requires you are willing to provide blood samples and permission to access your retinal scan, MRI and polysomnography data (where relevant).
In order to participate in this study, you must wear the offered fitness device every day and night, including while asleep, and allow your de-identified activity data to be part of the study. You must commit to at least 6 months of activity tracking
It is possible that this study will identify information about you that was previously unknown, such as disease status or risk. If you provide us with your primary care physician’s name and phone number, we will provide them with a report on our findings and any subsequent imaging, test results, etc. We can not provide this to you directly.
Risks and Discomforts:
The risks and discomfort associated with participation in this study are no greater than those ordinarily encountered in daily life.
RISK: Bruising, soreness at blood draw site | LIKELIHOOD of occurrence (probability): Common | SERIOUSNESS (Magnitude): Not serious – same risk as normal doctor appointment blood draw | DURATION: Brief
RISK: fMRI – feeling claustrophobic | LIKELIHOOD of occurrence (probability): Infrequent | SERIOUSNESS (Magnitude): Not serious – subject may withdraw | DURATION: Brief
RISK: PET scan – exposure to radiation | LIKELIHOOD of occurrence (probability): Likely | SERIOUSNESS (Magnitude): Not serious- radiation levels will be within normal standard-of-care levels | DURATION: Brief
RISK: PSG – allergic reaction of adhesives | LIKELIHOOD of occurrence (probability): Infrequent | SERIOUSNESS (Magnitude): Not serious – alternatives can be used | DURATION: Brief
RISK: FitBit tracking – exposure to EM radiation/heavy metals | LIKELIHOOD of occurrence (probability): Infrequent | SERIOUSNESS (Magnitude): Not serious- subject may withdraw | DURATION: Brief
Participant Privacy and Research Record Confidentiality:
By participating in the study, you understand and agree that The University of Texas at San Antonio (UTSA) may be required to disclose your consent form, data and other personally identifiable information as required by law, regulation, subpoena or court order. Your activity data will also be collected by FitBit. Otherwise, your confidentiality will be maintained in the following manner:
Your data and consent form will be kept separate. Your consent form will be stored in a locked location on UTSA property and will not be disclosed to third parties. By participating, you understand and agree that the data and information gathered during this study may be used and published and/or disclosed by UTSA to others outside UTSA. However, your name, address, contact information and other direct personal identifiers will not be disclosed by UTSA in any such publication or dissemination of the research data and/or results.
The researchers will take the following steps to protect your identity during this study:
- You will be assigned a number and all identifying information in the database will be stripped out.
- Any original recordings or data files will be stored in a secured location accessible only to authorized researchers.
Your research records will not be released without your consent unless required by law or a court order. Your records may be viewed by the Institutional Review Board, but the confidentiality of your records will be protected to the extent permitted by law. The data resulting from your participation may be used in publications and/or presentations, but your identity will not be disclosed.
Your signature documents your permission for the named participant to take part in this research.
My signature below documents that the information in the consent document and any other written information was accurately explained to, and apparently understood by, the participant, and that consent was freely given by the participant.