​Questions and Answers

Women’s Health Initiative LONG LIFE STUDY Questions (General):

How many people are in the WHI Extension Study?

Over 93,000 women, representing 87% of those who were eligible, have agreed to continue in the WHI Extension Study.

What is the Long Life Study and how does it relate to the WHI Extension Study?

The WHI Long Life Study is an addition to the WHI Extension Study. About 12,000 of the women who consented to the WHI Extension Study are eligible for the Long Life Study. The data and blood collected from women in the Long Life study will be used to conduct studies on healthy aging, as well as the causes of disease. The goal is to increase our understanding of health and disease, and on how women maintain independence in later life. The study has a special focus on physical activity and heart disease.

What data are collected in the Long Life Study?

During the Long Life Study appointment, a research assistant will collect several blood samples, measure blood pressure, pulse, height, weight, and grip strength, and observe a few physical activities, like walking across a room and standing up from a chair.

What are the eligibility requirements?

A Long Life Study participant must (1) be a current WHI Extension Study participant, (2) be at least 60 years old, and (3) not reside in a nursing care center. Only a sample of Extension Study participants are needed for the Long Life Study, so not all women who meet the eligibility requirements will be asked to join the Long Life Study.

How long is participation in the Long Life Study?

The Long Life Study appointment will take a little more than one hour. In addition, women will be invited to join an optional physical activity study. Women who consent to the physical activity part of the study will be asked to wear a physical activity monitor and keep a sleep log for 7 days, complete a Physical Activity Questionnaire, and record any falls they have on a calendar for a year. During and after the Long Life Study, women will still be enrolled in the WHI Extension Study and will continue to complete their annual forms.

What if a woman wants to take part in the Long Life Study, but prefers not to do the physical activity study (for example, wearing the monitor)?

Women may take part in the Long Life Study even if they decide not to join the physical activity part of the study. A woman should check "No" to the Physical Activity portion of the Participant’s Statement on the consent form if she does not want to join the physical activity study.

Does a woman have to go to a clinic to participate?

The Long Life Study data collection will be conducted in the participant’s home, or in another location if the participant prefers. Long Life Study participants do not need to travel to their original WHI clinic for visits.

Do women who are invited to join the Long Life Study have to participate?

Women are free to take part in the Long Life Study or not, or they can drop out after joining. Whatever a woman decides, her regular medical care will not change and she will still be part of the WHI Extension Study. Participants do not give up any personal legal rights when agreeing to take part in this study.

Why can’t women who live in a skilled nursing care facility take part?

We are not able to include residents of a skilled nursing care center. Women who expect to be living in a nursing center during the next three months should check the ‘Current Residence is a Nursing Center’ box on page 5 of the Long Life Study consent form, and return the signature page to us in the reply envelope.

What will be done with the Long Life Study blood samples?

After the Long Life Study blood is collected, we will send one tube to a hospital lab for a complete blood count (CBC). We will store the rest of the blood, and the blood’s genetic material (DNA and RNA), for future research testing. About 3 weeks after a woman’s Long Life Study appointment, we will send her the results of her CBC in a letter. Just like in the past, we will not give participants the results of any future research that uses their blood.

Who has access to the Long Life Study blood and information?

Data, blood, genetic material (that is, DNA or RNA), and genetic data may be shared with qualified and approved medical or research organizations, but only after approval by the National Heart Lung and Blood Institute (NHLBI) and after identifying information, such as name and birth date, has been removed.

What will be done with the information collected?

Just as in WHI, individual data will be combined with data from other participants to study the health of women.  As in WHI, study data may be shared with scientists in qualified and approved organizations – but only after identifying information (for example, name, address, birth date) has been removed. These organizations may be non-profit (for example, a university) or for-profit (for example, a drug company). Any sharing with other organizations requires the approval of NHLBI and an Institutional Review Board, whose job is to make sure the research study protects the rights and welfare of the study participants.

Is participant privacy protected?

Study records will be kept confidential to the extent permitted by law. There may be times when we are required by law to release study data. Also, some people or organizations may need to look at research records for quality assurance or data analysis. They include: Researchers involved with this study Institutional Review Boards (IRB), including the Fred Hutchinson Cancer Research Center IRB US National Institutes of Health and the Office of Human Research Protections These people and organizations are interested in study data, not personal information that can identify a participant (for example, birth date). We will do our best to keep participant personal information confidential, but we cannot guarantee it.

What are the risks involved in being part of the Long Life Study?

The blood draw may briefly hurt or cause a temporary lightheadedness or bruising; even with careful monitoring by the research assistant, a participant could fall during the balance and walking measurements; and, as with all research studies, there is a very minimal chance that personal/private information could be accidentally released.

What happens if a participant gets hurt in the Long Life Study?

If a Long Life Study participant falls or has a serious health problem during an appointment, the research assistant will call 911 and stay with the participant until help arrives. The cost for treatment of any study-related injuries will be billed to the participant or her medical or hospital insurance.

What are the benefits of being involved in the Long Life Study?

During the visit, each participant will receive a card with her blood pressure, pulse, height, and weight recorded, and a few of weeks after the appointment, she will receive the results of her Complete Blood Count (CBC) in the mail. Please note that we will not offer any diagnosis or treatment, nor will we pay for any follow-up medical care a doctor may recommend. Women who take part in the physical activity study will receive $10 as a small token of our appreciation when they return the physical activity monitor to us by mail.

Does it cost anything to participate?

Other than a participant’s time, there are no costs for taking part in the Long Life Study.

I lost the consent form you mailed to me. Can I get another one?

You can access another copy of the consent form by clicking on this link.  Just download, print, sign, and send the last page (the page with the signature) back to us. Be sure to neatly print your name. You can also call our toll free number at 1-800-550-0025, and leave a message requesting another copy of the consent form. In the message, please leave a current address and telephone number.

I did not receive a consent form in the mail, but I would like to participate. Can you send me a consent form?

We appreciate your willingness to participate in this study. 12,000 of the women who meet the eligibility requirements have been selected and will be sent an invitation to join and a consent form sometime between January and November 2012. If you are one of these 12,000, we truly hope you will agree to take part. However, if you are not among the 12,000, we will not be able to include you in this particular study.

Who is conducting the study visits?

The study visits are being conducted by EMSI (Examination Management Services, Inc.), a national health care examination company. The EMSI research assistants are well-trained by both EMSI and WHI, and are experienced in drawing blood and taking the Long Life Study measurements. All EMSI research assistants have passed background checks before they were hired, and in most cases, they are from the same communities where WHI participants live. EMSI will keep your WHI ID number and contact information confidential.Within a few weeks of our receipt of a woman’s signed consent form, EMSI staff will call to schedule the study appointment. The day before a Long Life Study appointment, the EMSI research assistant will call to confirm. The EMSI research assistant will show her identification when she comes to the door. For more information about EMSI, please see their website.

Can I request a female research assistant?

All of the EMSI research assistants working with the Long Life Study are female. Additionally, the EMSI research assistants are well-trained by both EMSI and WHI, and are experienced in drawing blood and taking the study measurements. All EMSI research assistants have passed background checks before they were hired, and in most cases, the research assistants are from the same communities where WHI participants live. EMSI will keep your WHI ID number and contact information confidential.
 

Women’s Health Initiative LONG LIFE STUDY Questions (For Participants):

I consented, but have decided that I would rather not participate. How can I withdraw my consent?

Please call us at 1-800-550-0025 and leave a message. We will get back to you within 48 hours. Thank you for your participation up to this point.

I have moved. How do I tell the Long Life Study about my new address or phone number?

Please call us at 1-800-550-0025 and leave a message with your updated contact information. If necessary, we will do our best to call you back within 48 hours.

How do I reschedule or cancel my Long Life Study an appointment?

Please call EMSI at 1-866-202-5310 at least 48 hours in advance of your appointment time.

I have a comment or complaint about my EMSI research assistant. Who should I call?

The EMSI research assistants are well-trained by both EMSI and WHI, and we hope that participation in the Long Life Study is a positive one. Please call us at 1-800-550-0025 if you have any feedback regarding your EMSI research assistant or the process of scheduling your Long Life Study appointment. We will do our best to address your concerns as quickly as possible.

Can I find out the results of the tests that were taken?

At the end of your visit, the EMSI research assistant should have given you a Results Card that includes information on your Blood Pressure and Pulse. Additionally, a few weeks after the examination, you will receive a thank you letter that includes the results from your Complete Blood Count, including platelet count, hematocrit values, hemoglobin values, and white blood cell count, with corresponding “normal” values for each. Other testing on your blood is considered for research purposes, and those results will not be provided to you.

What do the blood pressure numbers on the Long Life Study results card mean?

The "S" on the Results Card stands for Systolic Blood Pressure, and the "D" stands for Diastolic Blood Pressure. You should contact a doctor right away if:
  • The "S" value is 180 or above, OR
  • The "D" value is 110 or above, OR
  • The pulse value is less than 40 or more than 110

I have a bruise on my arm where the blood was taken. What do I do?

The bruise is simply a little blood pooling under the skin, which happens sometimes after blood is taken from a vein. Generally, there is no reason for alarm, but keep an eye on it. Putting ice on it should help. If you have any specific questions or complaints about your blood draw, please call us at 1-800-550-0025 and leave a message. We’ll return your call as quickly as possible.

Questions?

For questions about any part of the WHI Long Life Study or a woman’s rights as a study participant, please feel free to call the WHI toll-free message number, 1-800-550-0025. We will do our best to respond within 48 hours.
 

PHYSICAL ACTIVITY part of the WHI Long Life Study (For Participants)

Physical Activity Monitor & Sleep Log

Why are there two belts in my Physical Activity Packet?

Two belts are included in the Physical Activity Packet in order to accommodate the different body types of our numerous participants. Please do not throw the extra belt away, but rather, include both belts, the physical activity monitor, and your completed Physical Activity Questionnaire in the padded return envelope after wearing the monitor for 7 days.

How long should I wear the belt and activity monitor?

Please keep the sleep log and wear the belt and physical activity monitor for 7 complete days. Counting of the 7 days starts the day after your appointment, when the examiner fits the belt to you. After 7 days, please put your completed sleep log, the Physical Activity Questionnaire, the unused belt strap, and the belt strap containing the physical activity monitor into the padded return envelope and put it in the mail. The postage has already been paid for!

How do I know if the physical activity monitor is working?

Your monitor was tested prior to your appointment, so it should be working. You do not need to worry about turning the monitor on or off. The activity monitor is on when it is given to you and cannot be turned off until it is returned to us.

What does the physical activity monitor measure?

The monitor measures your movements during the day. We can use this data to get a measure of how active you are during the day.

Can you tell if I am not wearing the physical activity monitor?

We can’t tell for sure if you are wearing the monitor. However, the physical activity monitor is continuously recording data and storing it in the device itself. Once you send it back to WHI in the padded return envelope, we will download the stored data and may be able to tell when you had the monitor on or off during the 7 days of wear.

Do I wear the physical activity belt when I’m sleeping?

Try to keep the belt on at all times during the 7 days, except for when you are showering or bathing. If it bothers you to wear the belt at night, you can take it off while you sleep and then put it on again first thing in the morning.

Do I wear the physical activity monitor when I’m swimming or bathing?

Please do not wear the physical activity monitor when swimming or bathing. It is water resistant, but excessive water exposure will damage the device.

I can’t remember when I started wearing the physical activity monitor. What do I do?

You can look on your calendar or your sleep log to see what date your Long Life Study appointment was, then count seven days following the visit. If you do not have a calendar or a sleep log that you can check, please call our toll free number (1-800-550-0025) and leave a message. We will get back to you as soon as possible and let you know when you should send it back to us.

How do I complete the Sleep Log?

Please fill in each column on the sleep log. We are interested in when you went to sleep and when you got out of bed on each of the 7 days that you wear the physical activity monitor. After 7 days, please put your completed sleep log in the padded return envelope with the physical activity monitor, belt straps, and the Physical Activity Questionnaire, and put it in the mail. The postage has already been paid for!

What if the monitor or belt irritates my skin?

This should not happen, but if it does, please try wearing a piece of clothing under the belt. It is important that the device rests snugly against the body, whether it is in direct contact or not with your skin. In order for the data to be useful, it should not be loose and bouncing around.

What if I need to go through a metal detector (like in airport security lines)?

If you need to go through a metal detector, like the kind that is in an airport security line, you may need to take the monitor off. It is okay to let it go through the scanner with, for example, your purse and other belongings, as directed by the security agent. Be sure to put the monitor back on after you have gone through the detector.

I think I damaged my physical activity monitor. Should I still send it back?

YES! Even if you think it may be damaged, please continue wearing the monitor for the remainder of the 7 days and then send it back to us in the padded return envelope with the Physical Activity Questionnaire and the other belt strap. We need to account for all devices that we send out, and we may be able to repair devices that are not working. We understand that accidents happen; however, please do your best to protect the device from getting knocked around, dropped, or wet.

I can’t find my physical activity monitor. Can you send me another one?

We are sorry, but we cannot send another activity monitor if you have misplaced the one you were given at you appointment. Please make every effort to find the lost monitor and mail it back using the padded envelope provided. If you cannot find your monitor, please call our toll free number (1-800-550-0025) and leave a message.

I can’t find the return envelope for my physical activity monitor. Can you send me another one?

Yes. Please call our toll free number (1-800-550-0025) and leave a message. We will get back to you as soon as possible to confirm your mailing address.

I don’t want WHI to send me $10 for mailing back my activity monitor. How can I opt out (or donate my $10 to research)?

Given the large number of participants in our study, it is difficult for us to accommodate this type of personal request. We hope you will accept the $10 as a small token of our appreciation. If you prefer, you are welcome to donate the $10 to a charity of your choice.
 

Falls Calendar

How do I complete the Falls Calendar?

Please make a mark on the calendar each day, indicating whether or not you had a fall. At the end of each month, simply tear off the calendar page for the completed month and mail it to us in the provided envelope. W

What type of falls should I report on my Falls Calendar?

Please report a fall by marking "yes", I fell on the calendar day the fall happened. A fall does not have to result in injury for you to report it. For the purposes of this study, we would like you to report a fall if you: Fell all the way to the floor or the ground, or Fell and hit an object like a chair or stair

Should I report injuries on the Falls Calendar?

For this study, we are interested in knowing about any falls that you have over a 1 year period, whether they result in injury or not. If you report a fall, a study interviewer will call you to ask about how the fall occurred and if you were injured. It is not necessary to report injuries on your Fall Calendar.

What happens if I record a fall on the Falls Calendar?

If you indicate "Yes", I fell on one of the Calendar forms, we will follow up with you. We will call you to ask you a few more questions about the nature of the fall and any resulting injuries you may have had. The phone conversation will take approximately 15 minutes, and we will make every effort to call at a time that is convenient for you.

I lost my Falls Calendar (or the return envelopes for Falls Calendar pages). Can you send me another?

Yes. Please call our toll free number (1-800-550-0025) and leave a message. We will get back to you as soon as possible to confirm your mailing address.

I found an old completed Calendar page that I forgot to send in. Should I still send it in?

Yes. Please send us any completed calendar pages in the pre-paid postage envelopes provided in the back pocket of the Calendar. If you need to, you may put more than one completed Calendar page in a postage paid reply envelope.

I don’t want to continue with the physical activity part of the study. How do I cancel?

We will certainly honor your request to discontinue participation in the Physical Activity Study. Thank you very much for your time and your contribution to the Long Life Study. Please call our toll free number (1-800-550-0025) and leave a message, stating whether or not you would like to be called back for a confirmation. If you decide later that you would like to take part in the Physical Activity Study, you may always call us again on that same toll free message line. Participating or not participating in the Physical Activity Study or the Long Life Study has no impact on your participation in the WHI Extension Study.
 

Physical Activity Questionnaire

I’m confused on how to answer one of the questions on the Physical Activity Questionnaire. Who can I call for help?

Please call our toll free number (1-800-550-0025) and leave a message. We will do our best to get back to you within 48 hours to answer any question you may have.

I lost my Physical Activity Questionnaire. Can you send me another?

Yes. Please call our toll free number (1-800-550-0025) and leave a message. We will get back to you as soon as possible to confirm your mailing address.

I already sent back my physical activity monitor, but didn’t include the Physical Activity Questionnaire in the packet. Can you send me another return envelope?

Yes. Please call our toll free number (1-800-550-0025) and leave a message. We will get back to you as soon as possible to confirm your mailing address.
 

WHI Food Intake Study (WHI-FI)

FOOD FREQUENCY QUESTIONNAIRE

I’m confused on how to answer one of the questions on the Food Frequency Questionnaire. Who can I call for help?

Please call our toll free number (1-800-550-0025) and leave a message. We will do our best to get back to you within 48 hours to answer any question you may have.

I lost my Food Frequency Questionnaire and/or return envelope. Can you send me another?

Yes. Please call our toll free number (1-800-550-0025) and leave a message. We will get back to you as soon as possible to confirm your mailing address.

I have another question that isn’t listed here.

If you have any questions about any part of the WHI Long Life Study or your rights as a study participant, please feel free to call the WHI toll-free message number, 1-800-550-0025. We will do our best to return your message within 48 hours.