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Frequently Asked Questions

Answers to the questions we hear most often, from first-timers and longtime participants alike.

Eligibility & Getting Started

Who can join?

This study is open to many in the heart disease community. If you’re an adult (18+) in the U.S. with a diagnosed heart condition, you may be eligible, even if you don’t see your condition on this list. We are currently welcoming people with:

Cardiomyopathies: Hypertrophic Cardiomyopathy (HCM), Dilated Cardiomyopathy (DCM), restrictive CM, arrhythmogenic CM
Heart valve dysfunction including stenosis, insufficiency or regurgitation: Aortic, Pulmonary, Tricuspid, Mitral
Arrhythmias: Atrial Fibrillation (AFib/AF), Long QT syndrome (LQTS), Brugada syndrome, catecholaminergic polymorphic ventricular tachycardia (CPVT), Wolff-Parkinson-White syndrome (WPW), atrioventricular nodal reentry tachycardia (AVNRT), ventricular tachycardia (VT)
Heart Failure (HF)
Hypertension (HTN — high blood pressure)
And other diagnosed heart conditions

How do I know if I may qualify?

To find out if you may qualify, 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.

Do I need to live in the U.S.?

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

About the OCORO Heart Study

What is this study?

This study is 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.

Why is this being done?

This is being done to better understand the natural course of common heart conditions using real-life data collected in everyday settings, not just in a clinic.

Who is running the study?

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

How long does the study last?

How long the study lasts is 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 anytime.

Costs, Payment & Insurance

Does it cost anything to join?

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 if you withdraw from the study.

Is there payment for taking part?

No, there is no payment for taking part — you will not be paid for participation.

Will this affect my insurance or benefits?

No, this will not affect your insurance or benefits. Participation does not change your current care, and your insurance plan will not be contacted based on your participation in the OCORO Heart Study.

What Participation Is Like

What will I do if I join?

If you join, once you receive your study kit, you’ll:

Wear an ECG patch for 7 days every 90 days
Wear a wrist-based health monitor as much as possible
Use a blood pressure cuff and weight scale about once per week
Answer health questionnaires on your study-provided phone

How much time will this take?

Most tasks are brief. On most weeks, all study tasks take only a few minutes to complete. This is a remote study, no required clinic visits.

What won’t I need to do?

You won’t need to take new medications, undergo medical procedures, attend required clinic visits, or make any changes to your current care.

Your Monthly Participant Summary Report

What is the monthly participant summary report?

The monthly participant summary report is sent to you every month and covers data collected from your study devices, heart rate, respiratory rate, weight, blood pressure, activity, and sleep. It’s for informational and research purposes, not medical advice.

Privacy & Your Data

How is my information protected?

Your information is protected with secure systems, end-to-end encryption, and access controls. Your data is handled in accordance with HIPAA, where applicable, and our Privacy Policy.

Will you sell my personal information?

No, we do not sell your personal information.

Can I unsubscribe or revoke permissions later?

Yes, you can unsubscribe from emails or texts and revoke the HIPAA Authorization at any time. Text STOP to unsubscribe from text messages. Standard message and data rates may apply. Your data is handled in accordance with HIPAA, where applicable, our Privacy Policy, and Terms of Service.

Leaving the Study

Can I stop participating later?

Yes, you can withdraw at any time without affecting your care. Contact the study team at support@prolaio.com so they can help you withdraw safely.

What happens to my data if I withdraw?

If you withdraw, no further data collection will occur. Data already collected up to that point will remain part of the database for research purposes, as described in your consent.

What if I move?

If you move, email us at support@prolaio.com, and we’ll help update your account and coordinate shipping as needed.

Study Design & Oversight

What type of study is OCORO?

The OCORO Heart Study is an at-home, observational study. This study does not require taking additional drugs or undergoing investigational procedures. Data is collected continuously through devices and administered ePROs.

Who is the IRB?

The IRB is the independent board that oversees the study. The IRB number and contact details are available in the participant informed consent document upon request.

What endpoints are being collected?

The endpoints being collected include continuous ECG, PPG, accelerometry, sleep patterns, weight, and blood pressure. Structured PRO surveys are administered via the study phone on a weekly and quarterly basis.

Patient Reports & Data Sharing

What is in the monthly participant summary report?

The monthly participant summary report is a lay-language summary of continuously collected metrics. It is provided for informational purposes only and is not a diagnostic tool. Participants may share this report with their clinicians voluntarily.

Can I access my patient’s study data directly?

No, you cannot access your patient’s study data directly. Study data is not shared with the treating clinician by the study sponsor, but a participant may choose to share their monthly participant summary report with you. For data access requests related to your own research, contact heartstudy@prolaio.com.

Is the monthly participant summary report considered a medical record?

No. The monthly participant summary report is a research summary, not a medical record. It should not be used to guide clinical decisions or as a substitute for standard diagnostic evaluation.

Safety & Monitoring

Does the study team monitor participants in real time?

No. The study team does not monitor participant health in real time or retroactively for clinical purposes. Participants are instructed to follow their treating physician’s guidance and contact emergency services in the event of an emergency.

What happens if a participant reports a safety concern?

If a participant reports a safety concern, they are directed to contact their treating physician or 911 for medical emergencies. The study team does not provide clinical advice. Adverse events are collected and reported per study protocol.

Step-by-step guidance