DESCRIPTION:  You are invited to complete a screening questionnaire to identify if you qualify to participate in a research study of a mobile technology system to manage high blood pressure (hypertension) at home, using a home blood pressure cuff and mobile phone application. If you qualify and are selected to participate, you will be provided with an FDA-approved home blood pressure cuff; you will be asked to download a mobile smartphone application and will be asked to start measuring your blood pressure regularly. If you choose to enroll in this study, you may undergo a testing period of approximately 6 weeks using the mobile technology system. After the testing period, you may be assigned to either the mobile technology group or the usual care group. If you’re assigned to the mobile technology group, you will be assigned a Stanford doctor to oversee your hypertensive care during your study period. Stanford doctors will use the Stanford MyHealth tracking system to track your home blood pressure readings and treat your blood pressure using a computer dashboard. If you’re assigned to the usual care group, your doctor may receive blood pressure data manually and manage your blood pressure as per usual, but will not treat your blood pressure using a computer dashboard. As part of this study, you will be asked to come to attend a virtual study visit approximately once every 3 months for blood pressure checks, and will be asked to check your blood pressure regularly at home (the exact frequency will be recommended by your doctor). You will receive a baseline survey at the start of the research study and a follow up survey after at least 12 weeks of participation in the research study. 

TIME INVOLVEMENT:  Your participation will take approximately 6 months.

RISKS AND BENEFITS:  The risks associated with this study, in both the mobile technology or usual care group, are that although you will use an FDA-approved and validated home blood pressure monitor, there is a risk that the home blood pressure readings may not be accurate. This can lead to treatment changes that may lower your blood pressure either too much or not enough, and may have adverse effects. If you are in the mobile technology group, the doctors will use a computer dashboard and the Stanford MyHealth Tracking system to track your home blood pressures and prescribe new medications, and if these systems break down, they will not be able to see your blood pressures correctly or make treatment changes remotely, at which point you will need to continue care without using the mobile technology system. Treatment changes that are made remotely based on incorrect or incomplete data in your Stanford medical record (including your medical history, laboratory values, and blood pressure data) could lead to too much or not enough blood pressure lowering or adverse effects.

The benefits which may reasonably be expected to result from this study are obtaining regular blood pressure management without requiring as many physical visits to a clinic, which could minimize life disruptions and costs associated with clinic visits for blood pressure measurement, and may allow more regular home blood pressure readings for your doctors to review and treat in a more timely manner. We cannot and do not guarantee or promise that you will receive any benefits from this study.  Your decision whether or not to participate in this study will not affect your ability to receive usual care at Stanford or with your doctor.

PAYMENTS:  You will receive no reimbursement as payment for your participation. 

Who is sponsoring this trial? 

This trial is sponsored through a grant awarded to Dr. Paul Wang by the American Heart Association. 

Disclosure: The technology being evaluated in this research study is going to be used by HrtEx Inc, founded by Dr. Paul Wang and Dr. Vivek Bhalla. HrtEx Inc. was created to support the development of this this technology.

PARTICIPANT’S RIGHTS:  If you have read this form and have decided to participate in this project, please understand your participation is voluntary and you have the right to withdraw your consent or discontinue participation at any time without penalty or loss of benefits to which you are otherwise entitled.  The alternative is not to participate.  You have the right to refuse to answer particular questions.  The results of this research study may be presented at scientific or professional meetings or published in scientific journals.  Your individual privacy will be maintained in all published and written data resulting from the study. 

Identifiers might be removed from identifiable private information and, after such removal, the information could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from you.

As a study participant, you have the following rights.  These rights include but are not limited to the participant’s right to: 

1. Be informed of the nature and purpose of the experiment; 
2. Be given an explanation of the procedures to be followed in the medical experiment, and any drug or device to be utilized; 
3. Be given a description of any attendant discomforts and risks reasonably to be expected;
4. Be given an explanation of any benefits to the participant reasonably to be expected, if applicable; 
5. Be given a disclosure of any appropriate alternatives, drugs or devices that might be advantageous to the participant, their relative risks and benefits;
6. Be informed of the avenues of medical treatment, if any available to the participant after the experiment if complications should arise; 
7. Be given an opportunity to ask questions concerning the experiment or the procedures involved; 
8. Be instructed that consent to participate in the medical experiment may be withdrawn at any time and the participant may discontinue participation without prejudice; 
9. Be given a copy of the signed and dated consent form; and
10. Be given the opportunity to decide to consent or not to consent to a medical experiment without the intervention of any element of force, fraud, deceit, duress, coercion or undue influence on the participant’s decision.

Authorization To Use Your Health Information For Research Purposes 

Because information about you and your health is personal and private, it generally cannot be used in this research study without your authorization.  If you agree to this form, it will provide that authorization.  The form is intended to inform you about how your health information will be used or disclosed in the study.  Your information will only be used in accordance with this authorization form and the informed consent form and as required or allowed by law.  Please read it carefully before agreeing to it.  

What is the purpose of this research study and how will my health information be utilized in the study?

The purpose of the research study is to evaluate the feasibility of a mobile technology to manage blood pressure (hypertension) at home rather than requiring patients to come into a doctor’s office every time for blood pressure measurement. This involves using a home blood pressure cuff with direct transmission of readings to your doctor. Your health information will be used in the context of your doctor changing your blood pressure medications based on your home blood pressure readings and this information will be tracked, including data such as age, blood pressure levels, comorbidities, and medications. The results of this study may be published or provided to the study sponsor with only deidentified, aggregate health information relating to blood pressure management and health, without any identifying, individual patient health information.

Do I have to agree to this authorization form?

You do not have to agree to this authorization form.  But if you do not, you will not be able to participate in this research study including receiving any research-related technologies.  Agreeing to the form is not a condition for receiving any medical care outside the study.

If I agree, can I revoke it or withdraw from the research later?

If you decide to participate, you are free to withdraw your authorization regarding the use and disclosure of your health information (and to discontinue any other participation in the study) at any time.  After any revocation, your health information will no longer be used or disclosed in the study, except to the extent that the law allows us to continue using your information (e.g., necessary to maintain integrity of research).  If you wish to revoke your authorization for the research use or disclosure of your health information in this study, you must write to: Dr. Paul Wang, 300 Pasteur Drive, Room A260, MC 5233, Stanford, CA 94305, Phone: (650) 723-9363.

What Personal Information Will Be Obtained, Used or Disclosed?

Your health information related to this study, may be used or disclosed in connection with this research study, including, but not limited to information pertaining to blood pressure management. This includes blood pressure readings, blood pressure medications and other information that your doctor will use to make blood pressure management decisions, which include kidney function lab tests, electrolyte lab tests, race/ethnicity, age, weight, and pregnancy information, responses to surveys.

Who May Use or Disclose the Information?

The following parties are authorized to use and/or disclose your health information in connection with this research study:

• The Protocol Director (Dr. Paul Wang)
• The Stanford University Administrative Panel on Human Subjects in Medical Research and any other unit of Stanford University as necessary
• Research Staff

Who May Receive or Use the Information?

The parties listed in the preceding paragraph may disclose your health information to the following persons and organizations for their use in connection with this research study: 

• The Office for Human Research Protections in the U.S. Department of Health and Human Services
• The American Heart Association
• The Food and Drug Administration

The study team will purchase materials from Omron HealthCare, Inc, for this study.

Your information may be re-disclosed by the recipients described above, if they are not required by law to protect the privacy of the information.

When will my authorization expire?

Your authorization for the use and/or disclosure of your health information will end on December 31, 2050 or when the research project ends, whichever is earlier. 

CONTACT INFORMATION: 

Questions:  If you have any questions, concerns or complaints about this research, its procedures, risks and benefits, contact the Protocol Director, Dr. Paul Wang at (650) 723-9363. 

You should also contact them at any time if you feel you have been hurt by being a part of this study.

Independent Contact:  If you are not satisfied with how this study is being conducted, or if you have any concerns, complaints, or general questions about the research or your rights as a participant, please contact the Stanford Institutional Review Board (IRB) to speak to someone independent of the research team at 650-723-5244 or toll free at 1-866-680-2906.  You can also write to the Stanford IRB, Stanford University, 1705 El Camino Real, Palo Alto, CA 94306.

Please print a copy of this page for your records.