RESEARCH CONSENT SUMMARY

‍You are being asked for your consent to take part in a research study. This document provides a concise summary of this research. It describes the key information that we believe most people need to decide whether to take part in this research. Later sections of this document will provide all relevant details.

What should I know about this research?

• Someone will explain this research to you.
• Taking part in this research is voluntary. Whether you take part is up to you.
• If you don’t take part, it won’t be held against you.
• You can take part now and later drop out, and it won’t be held against you
• If you don’t understand, ask questions.
• Ask all the questions you want before you decide.

Why is this research being done?

The purpose of this research is to assess pregnant women’s interest in, and use of, remote blood pressure monitoring tools. We will learn how often women use blood pressure monitors that electronically send their measurements to Maven, and how often those measurements are higher or lower than expected. This research will also help us understand whether or not providing blood pressure monitors to Maven members leads to greater use of Maven’s digital pregnancy health program. 

How long will I be in this research?

We expect that your taking part in this research will last until six weeks after you give birth to your baby.

What happens to me if I agree to take part in this research?

If you decide to take part in this research study, Maven will send you a blood pressure monitor and written instructions for measuring your blood pressure at home. The monitor is “connected”, which means that when you use it, your measurements will automatically be sent to Maven. You do not need WiFi or Bluetooth to use the monitor. 
‍
Each time you use your monitor to measure your blood pressure, you will receive a follow-up text message from Maven. The text message will include instructions about what to do next, depending on your measurement: sometimes, you will simply be asked to continue monitoring your blood pressure as normal; in other cases, you will be asked to take a second measurement, or to contact your doctor, or visit the nearest emergency room. A Maven Care Advocate may also call you or send a follow-up message. If your measurements are often high, or if your health changes during the study, a Maven doctor may reach out to you with updated instructions for monitoring your blood pressure. 
‍
At the end of the study, you will receive a text message and email letting you know that the study has ended. Your measurements will no longer be sent to Maven, but you may keep the blood pressure monitor.

Could being in this research hurt me?

The most important risks or discomforts that you may expect from taking part in this research include: 1) loss of confidentiality; and 2) stress, worry, or anxiety about your health or your baby’s health. To avoid loss of confidentiality, your name and other information that could be used to identify you will be stored in an electronically-secure database and separated from your study data before the data is analyzed. Health-related stress, worry, or anxiety are often temporary and will likely go away when blood pressure monitoring has stopped. If you develop these feelings, your Care Advocate can help you schedule an appointment with a Maven doctor or a Maven mental health provider. Maven providers will help you understand your blood pressure measurements, what they say about you and your baby’s health, and how to manage difficult feelings that arise. 

Will being in this research benefit me?

We cannot promise any benefits to you or others from your taking part in this research. This research is not designed to prevent the development of health conditions like high blood pressure.

What other choices do I have besides taking part in this research?

If you do not take part in this research, you can opt to receive the “connected” monitor. If you opt not to receive the monitor, you will still be able to use Maven’s pregnancy program resources.

You are being invited to take part in a research study. A person who takes part in a research study is called a research subject, or research participant. 

What should I know about this research?

• Someone will explain this research to you.
• This form sums up that explanation.
• Taking part in this research is voluntary. Whether you take part is up to you.
• You can choose not to take part. There will be no penalty or loss of benefits to which you are otherwise entitled.
• You can agree to take part and later change your mind. There will be no penalty or loss of benefits to which you are otherwise entitled.
• If you don’t understand, ask questions.
• Ask all the questions you want before you decide.

Why is this research being done?

The purpose of this research is to assess pregnant women’s interest in, and use of, remote blood pressure monitoring tools. We will learn how often women use blood pressure monitors that electronically send their measurements to Maven, and how often those measurements are higher or lower than expected. This research will also help us understand whether or not providing blood pressure monitors to Maven members leads to greater use of Maven’s digital pregnancy health program. 

About 300 participants will take part in this research.

How long will I be in this research?

We expect that your taking part in this research will last until six weeks after you give birth to your baby.  

What happens to me if I agree to take part in this research?

If you decide to take part in this research study, Maven will send you a blood pressure monitor and written instructions for measuring your blood pressure at home. The monitor is “connected”, which means that when you use it, your measurements will automatically be sent to Maven. You do not need WiFi or Bluetooth to use the monitor. 

Each time you use your monitor to measure your blood pressure, you will receive a follow-up text message with instructions from Maven. The text message will include instructions about what to do next, depending on your measurement: sometimes, you will simply be asked to continue monitoring your blood pressure as normal; in other cases, you will be asked to take a second measurement, or to contact your doctor, or visit the nearest emergency room. A Maven Care Advocate may also call you or send a follow-up message. If your measurements are often high, or if your health changes during the study, a Maven doctor may reach out to you with updated instructions for monitoring your blood pressure. 

At the end of the study, you will receive a text message and email letting you know that the study has ended. Your measurements will no longer be sent to Maven, but you may keep the blood pressure monitor.

What are my responsibilities if I take part in this research?

If you take part in this research, you will be responsible for: 

• Following the instructions you receive from Maven. These instructions include measuring your blood pressure with the device provided, and potentially, re-taking your blood pressure or other follow-up actions. If your blood pressure is very high, you should follow Maven’s instructions to seek immediate medical attention from your doctor or at the nearest emergency room.
• Responding to messages from Maven Care Advocates or providers that relate to the study. These messages may ask you if you were able to find care, or if you have any questions about your health or pregnancy.
• Telling your Maven Care Advocate or provider about any changes to your health or your baby’s health during the course of the study, such as the diagnosis of a new health condition, any hospitalizations, or that you started or stopped taking a certain medication. You also are encouraged to report new or increased stress, worry, or anxiety, so that we can connect you to a Maven provider for more information and help managing those feelings.

Could being in this research hurt me?

Possible risks and discomforts include:

• Stress, worry, or anxiety about your health or your baby’s health. For some women, focusing on health issues like blood pressure can lead to stress, worry, or anxiety about their health or their baby’s health. Health-related stress, worry, or anxiety are often temporary and will likely go away when blood pressure monitoring has stopped. Women with a history of health-related anxiety or worry may be more likely to have these feelings.  If you develop these feelings, your Care Advocate can help you schedule an appointment with a Maven doctor or a Maven mental health provider. Maven providers will help you understand your blood pressure measurements, what they say about you and your baby’s health, and how to manage difficult feelings that arise. If these feelings are still present at the end of the study period, your Care Advocate will help you find additional mental health support outside of Maven.
• Loss of confidentiality. To avoid loss of confidentiality, your name and other information that could be used to identify you will be stored in an electronically-secure database and separated from your study data before the data is analyzed.

Will it cost me money to take part in this research?

No, it will not cost you money to take part in this research.

Will being in this research benefit me?

We cannot promise any benefits to you or others from your taking part in this research. This research is not designed to prevent the development of health conditions like high blood pressure. However, possible benefits to you include: 1) finding out more information about your health; 2) potentially noticing a change in your health earlier than if you had not participated in the study; and 3) receiving a blood pressure monitor and extra contact with Maven Care Advocates, which may make your healthcare experience more enjoyable.

What other choices do I have besides taking part in this research?

Participation in this study is voluntary. If you do not take part in this research, you can opt to receive the “connected” monitor, and you will still receive instructional text messages and other contacts from Maven about your blood pressure; however, your data will not be included in this research. If you opt not to receive the monitor, you will still be able to use Maven’s pregnancy program resources. You will still have access to messaging and virtual appointments with Maven providers and Care Advocates.

What happens to the information collected for this research?

Your private information and your medical record will be shared with individuals and organizations that conduct or watch over this research, including:

• The research sponsor
• People who work with the research sponsor
• WCG IRB, the Institutional Review Board (IRB) that reviewed this research

If you wish, with your permission, we may be able to share certain information with your in-person prenatal care provider or other staff responsible for your health care.

We may publish the results of this research. However, we will keep your name and other identifying information confidential.

We protect your information from disclosure to others to the extent required by law. We cannot promise complete secrecy.

Who can answer my questions about this research?

If you have questions, concerns, or complaints, or think this research has hurt you or made you sick, talk to the research team at the phone number listed above on the first page.This research is being overseen by WCG IRB. An IRB is a group of people who perform independent review of research studies. You may talk to them at 855-818-2289 or researchquestions@wcgirb.com if:

• You have questions, concerns, or complaints that are not being answered by the research team.
• You are not getting answers from the research team.
• You cannot reach the research team.
• You want to talk to someone else about the research.
• You have questions about your rights as a research participant.

If you wish, with your permission, we may be able to share certain information with your in-person prenatal care provider or other staff responsible for your health care.

We may publish the results of this research. However, we will keep your name and other identifying information confidential.

We protect your information from disclosure to others to the extent required by law. We cannot promise complete secrecy.

What if I am injured because of taking part in this research?

We do not anticipate that participation in this research will lead to an injury. If you have questions about your rights as a research participant or wish to report a research-related injury, please contact: Dr. Neel Shah, 732-778-3227.

Can I be removed from this research without my approval?

The person in charge of this research can remove you from this research without your approval. Possible reasons for removal include:

• It is in your best interest
• The research is canceled by the sponsor

We will tell you about any new information that may affect your health, welfare, or choice to stay in this research.

What happens if I agree to be in this research, but I change my mind later?

If you decide to leave this research, contact your Care Advocate. Your Care Advocate will tell the research team about your decision so that the investigator can make note of your decision and ensure that your data is not used in future reports.

You may stop participating at any time, and you will not lose access to Maven’s educational resources, virtual provider network, or your Care Advocate. You can continue using your blood pressure monitor, and you will still receive instructional text messages and other contacts from Maven about your blood pressure. The care you receive from Maven will not be affected in any other way.

Will I be paid for taking part in this research?

You will not be paid for taking part in this research.