Stanford Wockets Activity Project (SWAP)

STANFORD UNIVERSITY - Research Consent Form
Protocol Director:  William L. Haskell, PhD
Protocol Title: Enabling Population-Scale Physical Activity measurement on Common Mobile Phones
IRB Approval Date:  January 25, 2011

IRB Expiration Date:  October 25, 2011

 

Enabling Population–Scale Physical Activity Measurement Using Common Mobile Phones

Are you participating in any other research studies? ____ Yes ____No

INTRODUCTION TO RESEARCH STUDIES

A research study is designed to answer specific questions, sometimes about a drug’s or device’s safety and effectiveness. Being in a research study is different from being a patient.  When you are a patient, you and your doctor have a great deal of freedom in making decisions about your health care.  When you are a research participant, the Protocol Director and the research staff will follow the rules of the research study (protocol) as closely as possible, without compromising your health.

PURPOSE OF RESEARCH

You are invited to participate in a research study to evaluate the usefulness of a research data collection system designed to measure the type, intensity, and amount of physical or sedentary activity a person performs throughout the day and then to estimate the amount of energy expended during these activities. The system includes two small wireless motion sensors worn on the body that send information to a mobile phone.  We hope to learn if participants can effectively use this system daily over a period of up to 8 months. Data collected during this study will be used to further develop a motion sensor-mobile phone system for use in large-scale research studies designed to better determine the causes of major chronic diseases. Additionally, participants will be asked to wear a physiologic monitor during waking hours for one week. This monitor is a cloth strap that goes around your chest and measure heart rate, breathing rate, body temperature and movement. You can participate in  the mobile phone part of the study and NOT wear this monitor. You will NOT be requested to change your physical activity as a participant in this study.

You were selected as a possible participant in this study because you currently are at least 18 years of age, live in the San Francisco Bay Region, have a contract with T-Mobile for your mobile phone service, are reasonably satisfied with the T-Mobile service and have no plans to switch to a different provider, and have expressed an interest in volunteering for this study.

Your participation in this study is entirely voluntary.
Your decision whether or not to participate will not prejudice you or your medical care.  If you decide to participate, you are free to withdraw your consent, and to discontinue participation at any time without prejudice to you or effect on your medical care.  If you decide to terminate your participation in this study, you should notify the Project Director William L. Haskell, PhD at 650-725-5012 (whaskell@stanford.edu).

You have the right to refuse to answer particular questions. This research study is looking for 50 men and women who routinely use a mobile phone. The study staff at Stanford University will recruit up to 50 subjects for this study. All recruitment will occur in the United States.

DURATION OF STUDY INVOLVEMENT
  • This research study is expected to take approximately 10 months to complete with each subject participating for up to 8 months. Each of the 50 subjects will complete a screening questionnaire via the Internet or over the telephone (10 minutes), attend a project orientation session (90 minutes), and attend a phone activation session (30 minutes) at the beginning of the study.
  • During the study you will be expected to take no more than about 5 minutes each day to take off one set of sensors, place them in a charger, put on two sensors that have been charged the previous day and check your mobile phone to see that the sensors are operating properly. At night (or other convenient time) you will charge your mobile phone so that it is fully charged in the morning.
  • Periodically during the study you will be asked to answer questions about your phone use, specific physical or sedentary activities, and the context in which you performed the physical or sedentary activities. These will be short sets of questions that will be sent to your phone by the research team. These will require no more than 30-60 seconds to answer. These will average no more than 5-10 times per week over the 8 months of the study.
  • For one week out of the 8 months of the study, you may be asked to wear an additional physiological monitor during waking hours. This is an optional addition to the mobile phone study, and your decision to use the additional monitor does not affect your participation in the rest of the study.
  • At the end of your participation in the study you will be requested to attend a study debriefing session with study staff. (60 minutes).
PROCEDURES
If you choose to participate, the Project Director and his research staff at an orientation meeting will: 
  • Describe requirements for your participation in the study, show you the equipment that will be used during the study (sensor devices, mobile phone, chargers) and answer any questions you have. The staff will explain the process by which you will be provided a project mobile phone, how information on your current phone can be transferred to the new phone, the T-Mobile service requirements (talk/voice, data/web, text) needed for participation and how that will be arranged and how payments will be made to you (approximately 30 minutes). See the brief description of the Physical Activity Monitoring System in the next section of this document.
  • Then you will be asked to review and sign an informed consent (this document).
  • You will be asked to complete a brief personal history questionnaire including questions about your mobile phone use (approximately 10 minutes).
  • The study staff will then measure your body height and weight (approximately 3 minutes).
  • After further discussion about the study and answering of questions, if you are still interested and considered eligible for study participation, the study staff will show you how to use the project mobile phone (HTC Touch Diamond 2), the study sensors and their corresponding chargers. The operation of the sensors and mobile phones will be reviewed and questions answered. Also, you will be shown a project web site where you can go to have questions answered (approximately 30 minutes).
  • The staff will also ask if you are interested in wearing a heart-rate type monitor for a week during your participation period. At this point, you can see the device and determine if you are interested in this addition. If you agree, the staff will make arrangements to meet you at a later time to give you the device and describe how to wear and charge it.
  • You will give the project staff your current mobile phone number and they will arrange with T-Mobile to have unlimited text messaging and web access (data) added to your existing T-Mobile contract. No changes will be made in your talk (voice) plan.
  • You will return for an in-person session 2-3 days later and be shown how to move the SIM card from your current mobile phone to the new project phone. The project staff will assist you in this process and go over the key features of the phone and sensors and answer any questions. They will also assist you to transfer your phone numbers to the new phone (approximately 30 minutes).
  • Arrangements for the project to pay for the phone services added to your T-Mobile contract will be discussed and a specific payment plan confirmed (See “Financial Considerations” on page 11).
  • During the next 8 months, you will be expected each day to wear one motion sensor device on an ankle and one on a wrist and carry your mobile phone within a close distance from you throughout the day, including during sleep. Each morning, you will take off the two sensors you have been wearing and place them in a charger, put on the two new sensors that have been charged, and check the phone to see they are operating properly. Changing sensors takes about 3 minutes. Before going to bed each night you will place your mobile phone in a charger located in the room where you sleep. You will be asked to wear the motion sensors overnight, because we are studying sleep behavior as well as physical activity. You would be asked to remove the sensors whenever you might remove a watch that is not waterproof, such as when bathing or swimming and put them back on when you are done.
  • Each night, the phone will send data collected from your motion sensors that day to a secure research server using the phone’s web connection. Only the research team will be able to access the data on the secure server, and your identity will not be stored with these data. The data to be transferred will include data from the motion sensors, location of the phone at times throughout the day using the GPS unit in the phone and information about how much you used your phone that day, including the number and length of phone calls, the number of text messages, and the amount of time you spent using other applications on the phone, such as the Internet browser. These data will be used to help monitor the sensor system’s battery life and understand how much battery power is needed to run similar projects. No information about the people you communicate with or what you are doing when you use applications, such as phone numbers, text message content, or websites visited, will be obtained from the phone by the research team.
  • Daily during the first 4 weeks the phone will prompt you via a subtle beep or vibration and present several brief questions to help the research team gather information from you about the operation of the phone and sensors, about specific bouts of activity you have engaged in that day or the previous day, and any special problems you have encountered using the sensors or phone (30-90 seconds to respond over your phone). If it is not convenient for you to answer the questions when they appear, you can answer them later in the day.
  • During the next month these questions will be asked just once each day and during next two months (3 & 4) just 2 times per week. During months 5-6 you will be asked questions once every week and during months 7-8 questions will be asked just once each month.
  • Throughout the study, the phone will occasionally beep or vibrate to help you remember to wear the sensors if the phone does not detect them, as well as to thank you with short notes or games when you have worn the sensors properly or answered surveys. You will also occasionally be presented with information about your behavior as measured by the sensors.
  • If you have opted to wear the additional physiological sensor, you will wear a strap around your chest during waking hours for one week. When you charge your phone, you will also remove the strap, and charge the “puck” or electronic piece of the devices in your charger. At the end of the week, you will return the device and the charger to the study staff.
  • At the end of the study you will be requested to attend a 60-minute in-person debriefing session with a study staff member during which we will ask you questions about your experiences using the motion sensor – mobile phone system.

 

PHYSICAL ACTIVITY MONITORING SYSTEM - DESCRIPTION

The physical activity monitoring system consists of two specially designed wireless motion sensors/transmitters and a mobile phone. A wireless sensor/transmitter unit contains a triaxial accelerometer, small memory chip, a Bluetooth radio and a small rechargeable battery. The unit is encased in a light plastic that makes it flexible (so it can bend around the wrist or ankle) and is water resistant. It is 2.2 inches x 2.0 inches x 0.2 inches in size and weighs 0.38 oz.  Each unit fits in a custom cloth/Velcro band with one worn on the dominant wrist and the other on the dominant ankle. The accelerometer in each unit detects any movement of the wrist or ankle, stores these data briefly on the memory chip and then this information is sent to the mobile phone by the Bluetooth radio.  The mobile phone, an HTC Touch Diamond 2 “smartphone” model, is able to receive these signals, store them in memory, and perform limited processing.  Using the data connection on the phone, small amounts of the motion sensor data can be sent automatically via wireless to a project secure server for monitoring and problem detection by project staff.  Using software installed on the phone, activity detection algorithms can be run and recent activity feedback can be sent to you.

The optional additional physiological sensor, the Zephyr Bioharness, is similar to a personal heart rate monitor, but records heart rate, breathing rate, skin temperature, posture and body motion. The device consists of a strap 3 inches wide worn next to the skin around the chest that has various sensors built into it Also a small plastic box snaps on to it which contains a rechargeable battery and a memory card to store the data. This electronic component is charged in a cradle-style charger each night. When the unit is returned to the project staff they download all the data collected during the week on the memory card to a computer.

 

PARTICIPANT RESPONSIBILITIES 

As a participant, your responsibilities include:

  • Follow the instructions of the Project Director and project staff.Keep your study appointments. 
  • If it is necessary to miss an appointment, please contact the Project Coordinator to reschedule as soon as you know you will miss the appointment.
  • While we don’t expect any medical side effects to results from participation in this project, please tell the Project Director or Project Coordinator about any side effects, injuries, doctor visits, or hospitalizations that in any way might be related to your participation in this study.
  • Complete the study questionnaires as instructed, including the short prompts that will be sent to you over the phone by study staff during the course of the study.
  • Ask questions as you think of them.
  • Stop using your current phone and start using the phone provided to you for use during this project. If you have a personal and work phone, you should switch your personal phone to the study phone.
  • Carry the phone on or near your body as much as possible throughout the study, and leave it by your bedside charging at night.
  • Take personal responsibility for the mobile phone, sensors and chargers provided to you by the project.
  • As long as you are actively participating in the project (wearing sensors, carrying phone and collecting data at least 25 days each month) you will continue to have the phone.
  • Take personal responsibility that your T-Mobile phone bill is paid on time each month and that your service contract stays active for the period that you are a participant in this study.
  • Tell the Project Director or Project Coordinator if you change your mind about participating in the study.

While participating in this research study, you should not take part in any other research project without approval from the Protocol Directors of each study. 

 

WITHDRAWAL FROM STUDY

If you first agree to participate and then you change your mind, you are free to withdraw your consent and discontinue your participation at any time.  Your decision will not affect your ability to receive medical care and you will not lose any benefits to which you would otherwise be entitled.

To withdraw from this study please contact the Protocol Director or any member of the study staff by phone or in-person. If you withdraw from the study, all of your personal identification information will be destroyed.

If you withdraw from the study you will return the project mobile phone provided to you as a study participant. Any T-Mobile phone services being paid by the project will be terminated. It will be your responsibility to maintain your T-Mobile contract or terminate it at your discretion, including the unlimited text messaging and data component of the plan added when you joined the study. The data and unlimited SMS messaging can be canceled at any time without impacting your contract, and the study staff will assist you with doing this upon your request.   

If you decide to withdraw from this research, please tell the Project Director.  There are no anticipated consequences to withdrawal from this research study.

The Project Director may also withdraw you from the study without your consent for one or more of the following reasons:

  • Failure to follow the instructions of the Project Director and project staff.
  • Abuse of the mobile phone service agreement.
  • Not using the project phone as your primary phone or disabling the project software on the phone.
  • The Project Director decides that continuing your participation could be harmful to you.
  • You need treatment not allowed in the project.
  • The study is cancelled.
  • Other administrative reasons.
  • Unanticipated circumstances.
POSSIBLE RISKS,DISCOMFORTS, AND INCONVENIENCES

There are risks, discomforts, and inconveniences associated with any research study.  These deserve careful thought.  You should talk with the Protocol Director if you have any questions.

  • Inconveniences associated with participation include the time spent traveling to Stanford University and the time spent each day to exchange and charge the motion sensors and respond to brief prompts on your phone during your participation in the research. You are free to ignore prompts that occur at times when you cannot respond to them, and you will have the ability to mute the phone or use the vibrate mode. You should ignore all prompts that occur when driving.
  • At first you may feel minor irritation from wearing the sensor bands until you get used to having them on. The bands may cause minor dryness or itchiness of the skin. In instances where the bands are bothering you, you can wear the sensors at different locations temporarily or remove the sensors. If you do not have a problem wearing a leather or cloth watchband, the sensor bands are unlikely to cause any irritation.
  • At times other people may notice the sensors and ask you questions about them. This might make you feel self-conscious. You are free to discuss the purpose of the study. You will also be able to wear the bands in several different locations under your clothing at times when you do not want others to notice them.
  • The study software may cause the battery on your phone to drain before the end of your day if you spend an unusually long time talking or using applications on the phone. You will be required to charge the phone nightly to keep the phone operating properly the next day.
  • The motion sensors (Wockets) are experimental devices and consequently not fully tested to commercial product regulatory proved standards. Consequently, although great care was taken in the design of the devices, there is some inherent risk both with the design and manufacturing that you assume when a Wocket is in close proximity to your body.
  • The sensors transmit radio waves in the 2.4GHz frequency using the Bluetooth protocol. The Wockets send out a maximum strength signal of 6.8 milliwatts.  In comparison, mobile phone radios usually send their radio signals at over 2000 milliwatts, which is 290 times more powerful and considered safe. The U.S. FDA website states, “If there is a risk from being exposed to radiofrequency energy (RF) from cell phones--and at this point we do not know that there is--it is probably very small.” In addition, the Wocket sensor Bluetooth radios are only on for less than 15 seconds per minute.  The radiation exposure caused by Bluetooth devices is below the international recommended levels. The information currently available does not suggest that this radiation represents a threat to health.
  • Any electronic device is subject to failure. The Wockets sensors are no different, despite being built to the highest engineering standards. Risks from electronics include electrical shock or burns from overheated components. There is also a risk of exposure to minute amounts of chemicals used in the manufacturing process of the electronics.Wockets transmit in the 2.4GHz frequency range. Wireless telephones, baby monitors, Wi-Fi, and other electronic devices also use this range. There is a small risk that the Wockets may cause radio interference with the operation of other electronic devices. In this case you can turn the Wockets off or increase the distance between the equipment and the Wocket.
  • Radio Frequency (RF) energy from the mobile phone. In the US for a phone to pass FCC certification it must meet a “specific absorption rate” (SAR) standard which is ≤1.6 watts per kilogram. SAR is a way of measuring the quantity of radio frequency (RF) energy absorbed by the body from the phone. The mobile phone being used for this project, HTC Touch Diamond 2, is rated at 0.85 SAR which is at the low end of exposure for mobile phone available in the US.
  • Study staff will attempt to transfer your phone numbers from your current phone to the study phone. However, for some models of phones, automatic transfer may not be possible, in which case you may have to enter some or all of the phone numbers into the new phone.
  • Participation in this protocol may involve risks which are currently unforeseeable.
POTENTIAL BENEFITS 

The only benefit you may receive from this study is to find out more about your own physical activity and inactivity level (including sleep) and how you might make changes to improve your health.

WE CANNOT AND DO NOT GUARANTEE OR PROMISE THAT YOU WILL RECEIVE ANY BENEFITS FROM THIS STUDY.

ALTERNATIVES

Since no medical treatments are provided during this study there are no alternative therapies. The only alternative is not to participate.

PARTICIPANT’S RIGHTS

You should not feel obligated to agree to participate.  Your questions should be answered clearly and to your satisfaction.

If you decide not to participate, tell the Protocol Director. You will be told of any important new information that is learned during the course of this research study, which might affect your condition or your willingness to continue participation in this study.

CONFIDENTIALITY
  • Your identity will be kept as confidential as possible as required by law.  Except as required by law, you will not be identified by name, social security number, address, telephone number, or any other direct personal identifier.  Your research records may be disclosed outside of Stanford, but in this case, you will be identified only by a unique code number.  Information about the code will be kept in a secure location and access limited to research study personnel. The results of this research study may be presented at scientific or medical meetings or published in scientific journals.  However, your identity will not be disclosed. Patient information may be provided to Federal and other regulatory agencies as required.  The Food and Drug Administration (FDA), for example, may inspect research records and learn your identity if this study falls within its jurisdiction.

 

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 written authorization.  If you sign 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 signing it. 

What is the purpose of this research study and how will my health information be utilized in the study?
The major goal of this project is to see how well we can collect information on the type and intensity of physical activity and inactivity performed throughout the day for up to 8 months in men and women using two wireless motion sensors (accelerometers) and a mobile phone that uses customized software. Data collected during this study will be used to further develop the activity detection system for use in large-scale, gene-environment interaction studies designed to better determine the causes of major chronic diseases. The purpose of this study is to evaluate the use of small motion sensors worn on the body. These data may be used in a scientific presentation or publication of the study results but your identity will not be revealed.

Do I have to sign this authorization form?
You do not have to sign this authorization form.  But if you do not, you will not be able to participate in this research study. Signing the form is not a condition for receiving any medical care outside the study.

If I sign, 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 contact William L. Haskell, PhD; 650-725-5012 or whaskell@stanford.edu.

What Personal Information Will Be 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 your measured body height, weight, gender, age and ethnicity/race. We also will have measurements of physical activity and inactivity you have performed throughout the day. 

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 (William L. Haskell, PhD)
  • 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
  • National Institutes of Health – National Heart Blood and Lung Institute
  • Stephen Intille, PhD, Massachusetts Institute of Technology and members of his research team who need to monitor the data for accuracy and completeness – Research collaborators on this project.

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 expire on December 31, 2015.

 

________________________________                    ______________
Signature of Participant                                                 Date

 

FINANCIAL CONSIDERATIONS

Payment: For participating in the research covered by this consent you will be paid $75 per month: $40.95 to cover the costs of unlimited data and text services from T-Mobile, including 17% to cover federal tax for these services. You will be paid an additional $34.05 to compensate you for your time and effort each month wearing the sensors and answering the questions on the phone. Payments will be made to you by check from the Massachusetts Institute of Technology between the 10th and 20th of each month that you are enrolled in the study. Payments may only be made to U.S. citizens, legal resident aliens, and those who have a work eligible visa. Upon successful completion of the study, ownership of the project mobile phone used during the study will be transferred to you.

Costs: There is no cost to you for participating in this study.

Sponsor: The National Institutes of Health are providing financial support for this study and it is being conducted in collaboration with the Massachusetts Institute of Technology.

COMPENSATION for Research-Related Injury

All forms of medical diagnosis and treatment – whether routine or experimental – involve some risk of injury.  In spite of all precautions, you might develop medical complications from participating in this study.  If such complications arise, the Protocol Director and the research study staff will assist you in obtaining appropriate medical treatment.  In the event that you have an injury or illness that is directly caused by your participation in this study, reimbursement for all related costs of care first will be sought from your insurer, managed care plan, or other benefits program.  You will be responsible for any associated co-payments or deductibles as required by your insurance.

If costs of care related to such an injury are not covered by your insurer, managed care plan or other benefits program, you may be responsible for these costs.  If you are unable to pay for such costs, the Protocol Director will assist you in applying for supplemental benefits and explain how to apply for patient financial assistance from the hospital.

Additionally, Stanford is not responsible for research and medical care by other institutions or personnel participating in this study.  You do not waive any liability rights for personal injury by signing this form.

CONTACT INFORMATION

Questions, Concerns, or Complaints:  If you have any questions, concerns or complaints about this research study, its procedures, risks and benefits, or alternative courses of treatment, you should ask the Protocol Director William L. Haskell, PhD at 650-725-5012 or whaskell@stanford.edu You should also contact him 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, Stanford, CA 94305-5401.

Appointment Contact: If you need to change your appointment, please contact Denise Shine at 650-725-8538.

EXPERIMENTAL SUBJECT’S BILL OF RIGHTS

As a research participant you have the following rights.  These rights include but are not limited to the participant's right to:

  • be informed of the nature and purpose of the experiment;
  • be given an explanation of the procedures to be followed in the medical experiment, and any drug or device to be utilized;
  • be given a description of any attendant discomforts and risks reasonably to be expected;
  • be given an explanation of any benefits to the subject reasonably to be expected, if applicable;
  • be given a disclosure of any appropriate alternatives, drugs or devices that might be advantageous to the subject, their relative risks and benefits;
  • be informed of the avenues of medical treatment, if any available to the subject after the experiment if complications should arise;
  • be given an opportunity to ask questions concerning the experiment or the procedures involved;
  • be instructed that consent to participate in the medical experiment may be withdrawn at any time and the subject may discontinue participation without prejudice;
  • be given a copy of the signed and dated consent form; and
  • 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 subject's decision.

May we contact you about future studies that may be of interest to you?

                                           ____ Yes                   ____ No  

 

YOUR SIGNATURE INDICATES THAT YOU HAVE READ AND UNDERSTAND THE ABOVE INFORMATION, THAT YOU HAVE DISCUSSED THIS STUDY WITH THE PERSON OBTAINING CONSENT, THAT YOU HAVE DECIDED TO PARTICIPATE BASED ON THE INFORMATION PROVIDED, AND THAT A COPY OF THIS FORM HAS BEEN GIVEN TO YOU.

 

_____________________________________                ________________

Signature of Adult Participant                                             Date

 

Person Obtaining Consent

I attest that the requirements for informed consent for the medical research project described in this form have been satisfied – that the subject has been provided with the Experimental Subject’s Bill of Rights, if appropriate, that I have discussed the research project with the subject and explained to him or her in non-technical terms all of the information contained in this informed consent form, including any risks and adverse reactions that may reasonably be expected to occur.  I further certify that I encouraged the subject to ask questions and that all questions asked were answered.

____________________________________                  ___________________

Signature of Person Obtaining Consent                               Date

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