Help shape the future understanding of heart conditions - from home

An at-home, observational study using wearable sensors and secure digital tools to learn how everyday heart health changes over time. No drugs or medical procedures.

To better understand the natural course of common heart conditions using real-life data.

Prolaio is the study sponsor. An Institutional Review Board (IRB) reviews and oversees the research (IRB # shown in the consent).

It’s up to you. The study will run for up to 5 years, but you decide how long you stay in – whether a few months or a few years. Every bit of participation helps, and you’re free to take a break from participating anytime.

No, there is no cost to participate. If a device is provided, it’s shipped at no cost to you. A pre-paid return label is sent to you to return devices if you withdraw from the study.

No, you will not be paid for participation.

Participation does not change your current care. For insurance questions specific to your situation, please consult your plan. Your insurance plan will not be contacted based on your participation in OCORO Heart Study.

You’ll answer an eligibility check online. If you are eligible, you’ll see an electronic informed consent form (e-consent) explaining details and have an opportunity to ask questions before you decide.

Currently we’re only enrolling adults (18+) living in the U.S. This may change in the future.

No. The form just lets us contact you with information and next steps. You choose whether to proceed.

Once you receive your study kit, you use the devices to:

• Wear an ECG patch for 7 days every 90 days
• Wear a wrist-based health monitor continuously as much as possible
• Use a blood pressure cuff and weight scale about once per week
• Answer health questionnaires on a study-provided phone
• With your consent, we will work with you to connect your electronic medical records to the OCORO heart study research to help achieve its goal of understanding patterns across heart conditions.

You will not need to take any new medications, engage in new medical procedures, attend new required clinic visits, or make any changes to your current care due to the study.

Most tasks are brief. In short, this remote study does not require much time out of your regular daily life to participate. On most weeks, all study tasks take only a few minutes to complete.

Every month, you get a summary of data collected from you from your study-provided devices (e.g., heart rate, respiratory rate, weight, blood pressure, activity, and sleep.)

Yes— sharing with your doctor and any members of your care team is up to you. The monthly summary is provided for informational and for research purposes only. It is a summary of data collected from you during the study. It is not a diagnosis or medical advice. This report is not a guide for treatment nor is it a replacement for your doctor’s advice, although you are free to share the summary with your own doctor if you wish.

Commercially available devices (e.g., ECG patches, cardiobracelets, BP cuffs) will be provided to you.

Participants will be provided the locked mobile device needed to relay collected data but will need to have either reliable cellular signal or internet connection. We’ll confirm specifics during eligibility determination.

Data points, like heart rate, activity, sleep, and survey answers. With your consent, we will work with you to connect your electronic medical records to the OCORO heart study research to help achieve its goal of understanding patterns across heart conditions.

We use secure systems, end-to-end encryption, and access controls to protect your information. Your data is kept confidential as much as possible. Your information may be shared with authorized parties as described in the informed consent form signed for the study. Your personal health information will be processed in accordance with HIPAA, where applicable, and may be reviewed by the IRB. Any information that you provide through or that is collected on our website will be handled according to our Privacy Policy.

Please see our Privacy Policy for more details.

No, we do not sell your personal information.

If you proceed, you’ll see an optional consent that lets us use your medical information to tailor future messages. You can decline and still join the study, and you can revoke later anytime.

Yes, you can unsubscribe from emails/texts and revoke the HIPAA Authorization at any time.

No. The study team will not monitor your health, in real time or retroactively. All information collected from you is used only for research and is not monitored for emergencies or to guide your care. Always follow your device instructions and your healthcare provider’s advice. If you are in an emergency, you should call your doctor or call 911.

Yes., you can withdraw at any time without penalty and without affecting your care. Contact the study team so they can help you withdraw safely.

You are able to withdraw or take a break at any time. If you choose to withdraw, no further data collection will occur and any data already collected up to that point will remain part of the database for research purposes.

For study concerns, email heartstudy@prolaio.com or call 855-869-9054.

For concerns about your rights, contact the IRB listed in your consent.

In the event of emergency, please contact 911 and/or your medical provider.

Currently the study is only available in English but we hope to add additional languages in the future. If you need help now, contact support.

Email us at support@prolaio.com, and we will help update your account and coordinate shipping as needed.