Welcome to the IdentifyHer Study. To move forward in this study you are required to watch the ICF (Informed Consent form) video and read through the ICF attached before attending your first screening visit. If you have any questions in regards to this ICF that is not answered in the FAQ section below or you would like further explanation, please come with your questions ready to your assigned appointment or email the clinic staff at clinic@kgkscience.com.
The following steps are required to proceed:
In this video, the purpose of this study, the study design, risks and benefits and what is expected from the participant and if you decide to participate. After listening to this recording, please read the informed consent and assent forms as well as the Frequently Asked Questions.
IdentifyHer introduction Video
2. ICF & Assent Consent Forms
Please take your time to read through the ICF form, your next step is to sign it virtually before you continue with this virtual trial.
3. Frequently Asked Questions
Welcome! We understand you might have questions about our research study. This study, sponsored by IdentifyHer Limited, aims to learn more about how a wearable device can accurately track common symptoms women experience during perimenopause.
Here’s what you need to know about participating:
What is the Purpose of this Clinical Trial?
Perimenopause is a natural transition that can bring a variety of symptoms, including hot flushes, night sweats, anxiety, and disrupted sleep—often years before menopause officially begins. These experiences can differ widely from person to person and are often difficult to track accurately using just memory or written diaries.
This study explores whether a non-invasive wearable device can help monitor these symptoms more reliably by measuring changes in your body in real time. Participants will also use a mobile app to log how they’re feeling, so researchers can compare personal reports with data from the device. This is an observational study, meaning no treatments or diagnoses will be given. The goal is simply to learn how well this kind of technology works across different individuals and everyday settings.
How long with the study last?
If you’re eligible to join the study, your participation will last about 14 days in total.
Will there be any in-person visits?
No! This study is completely virtual. Everything—from the screening and consent form to the daily check-ins and communication with the study team—will be done online through secure platforms. You can take part in the study from the comfort of your own home.
Who can participate in this study?
To be eligible to participate, you must:
Be a female between 35 and 55 years of age, inclusive.
Currently noticing self-reported perimenopausal symptoms, such as hot flushes or night sweats.
Agree to maintain your current lifestyle (including diet, exercise, medications, and sleep) throughout the 14-day study.
Be generally healthy, with no unstable medical conditions.
Be able to provide voluntary consent to participate.
Must not have an allergy or sensitivity to adhesives
No current skin conditions or sensitive area under breasts
Must not have a pacemaker
Additionally, if you are of childbearing potential, you must:
- Not be pregnant or planning to become pregnant.
- Agree to use a medically approved method of birth control for the duration of the study
What will I need to do if I join this study?
If you’re eligible and decide to take part, here’s what to expect over about 14 days:
- Consent & Screening: You’ll review and sign an online consent form, then complete a health and lifestyle form.
- Baseline Virtual Visit (Day 0): You’ll meet with the study team online to go over your health, receive instructions on using the wearable device and mobile app, and fill out some questionnaires. The device will be shipped to you before this visit.
- Wear the Device (Days 0–14): You’ll wear a non-invasive sensor continuously for 14 days, starting on Day 0 and removing it after your final virtual visit.
- Daily diary (Days 0–14): Each day, you’ll use the app on your Apple (iOS) or Android phone to log symptoms (like hot flushes, night sweats, or anxiety), your sleep quality, any changes in health, exercise, and diet.
- Questionnaires: You’ll complete short surveys in the app at the beginning (Day 0) , focusing on your anxiety, sleep, and menopause symptoms.
- Mid-Study Check-In (Around Day 7): A quick phone or online check-in to check if there are any changes to your health or to your medications/supplements/other therapies.
- Final Virtual Visit (Day 14): You’ll meet online with the study team to wrap up, and get instructions for returning the device using a prepaid shipping label.
You are also expected to report any significant changes in medication or health status in the study in the app. Please ensure the device is returned in good working condition. A prepaid shipping label will be provided to make the return process quick and convenient.
What is the wearable device?
It’s a small, non-invasive sensor that you wear on your body to help track common perimenopausal symptoms—like hot flushes, night sweats, anxiety, and sleep changes. While it’s designed to collect useful data, it’s not meant to diagnose or treat any medical conditions.
How will I use it?
You will receive a Product Manual and get clear instructions from the study staff during your first virtual visit. Once you receive the device, you’ll wear it continuously for 14 days, starting on Day 0. You’ll remove it the day after your final check-in (Day 14). Please treat it with care so it doesn’t get damaged while you go about your day.
What is the mobile app for?
The mobile app helps you share how you’re feeling throughout the study. You’ll use it to:
- Record your daily symptoms, sleep quality, and other details
- Complete a few short questionnaires on Day 0 and Day 14
You’ll get simple instructions during your first virtual visit, and you’ll need an Apple (iOS) or Android smartphone with internet access to use the app.
Will I be compensated for participating in this study?
Yes! You’ll receive up to $200 for your time if you complete the study and return the device in good working condition.
The money will be loaded onto a ClinCard, a prepaid Mastercard you can use for purchases or ATM withdrawals (ATM fees may apply). Some processes time maybe needed before funds are available on your card
For a full break down of the payment, please refer to the “Compensation for Participant” section of your ICF.
How will my personal information be protected?
Your privacy is our top priority. We take several steps to ensure your personal information and data are protected:
- Confidentiality: All your research data is kept secure in password-protected, electronic files. Only authorized study staff will have access to this data, and your name will not appear on most files (except for necessary administrative forms).
- Storage: Your data may be stored on secure servers in Canada or the United States.
- Anonymity in Results: When the study results are published, your identity will not be revealed.
- Access: Only authorized people, such as the study team, the sponsor (IdentifyHer Limited), auditors, and regulatory authorities like Health Canada, can access your study data.
- Retention: Your study records will be kept for at least 15 years as required by Canadian regulations.
- Limitations: While we take every step to protect your privacy, we cannot guarantee absolute confidentiality.
Additionally, by participating, you’ll use a mobile app and wearable device to collect data. For more details on how your data is handled, you can refer to the Terms of Use, End User License Agreement, or Privacy Policy related to these technologies, and you can always request a copy from the study team.
Can I withdraw from the study at any time?
Yes, your participation is completely voluntary. You can choose to withdraw from the study at any time, for any reason, without any penalty or loss of benefits that you are entitled to. If you decide to withdraw, simply notify the study team via email. If you withdraw, you’ll be asked to return the study device.
The study doctor or sponsor may also stop your participation if it’s not in your best interest, if you don’t follow study procedures, or if there are significant safety concerns.
- Anonymity in Results: When the study results are published, your identity will not be revealed.
- Access: Only authorized people, such as the study team, the sponsor (IdentifyHer Limited), auditors, and regulatory authorities like Health Canada, can access your study data.
- Retention: Your study records will be kept for at least 15 years as required by Canadian regulations.
- Limitations: While we take every step to protect your privacy, we cannot guarantee absolute confidentiality.
Additionally, by participating, you’ll use a mobile app and wearable device to collect data. For more details on how your data is handled, you can refer to the Terms of Use, End User License Agreement, or Privacy Policy related to these technologies, and you can always request a copy from the study team.
Who can I contact for more Information?
If you have any medical concerns, experience a research-related injury, or have any questions about the study, please contact the study team:
- Email: clinic@kgkscience.com
- Phone: 519-438-9374
If you have any questions about your rights as a research participant or have concerns, you can contact the Univo IRB (the independent ethics committee that reviewed this study)
- Call toll free: 919-910-7743
- Email: info@univo-group.com
Please reference the following number when contacting the Study Subject Adviser: IdentifyHer Limited / 24IDCFI01
Thank you for your interest in our study! If anything is unclear or you need more information, don’t hesitate to reach out.
For More information on this Study Please contact the clinic Staff at:
clinic@kgkscience.com
