The WHI Long Life Study 2 (LLS2)

Scientists and leaders at the National Institutes of Health (NIH) funded the WHI Long Life Study 2 to continue to learn about health and aging in women. Women who are eligible started receiving consent forms in the mail late 2022.

The WHI is working with a national healthcare examination company called ExamOne. If a woman consents to participate, a trained Examiner from ExamOne will schedule a convenient time for an appointment at the participant’s home, or other location if preferred. The Examiner will collect a fasting blood sample and some of the same measurements that were taken for the Long Life Study 1 in 2012 - 2013, for example, blood pressure, height, and weight.

The ExamOne Examiners are experienced in drawing blood and will be trained in taking the study measurements by both ExamOne and WHI staff. All ExamOne Examiners will wear appropriate Personal Protective Equipment (PPE) such as masks, and to perform a daily symptom screen. WHI participants will not be required to be vaccinated.

For more information about ExamOne, please visit their website at www.examone.com.

If you have questions about this study, please see our list of frequently asked questions or call us toll-free at 1-844-726-8715 and leave a message. Please leave your first and last name, and the best day and time for us to return your call. We will call you back with an answer as soon as possible.

Frequently Asked Questions

General Questions

What is the Long Life Study 2?

In 2012-2013, the Women's Health Initiative (WHI) Clinical Coordinating Center (CCC) implemented a home visit protocol, called the Long Life Study (LLS) to repeat selected elements of the original WHI physical exam and blood collection among ~8000 participants nationwide. The plan for Long Life Study 2 (LLS2) is to repeat the LLS study activities on all surviving members of the LLS who consent to a second study visit. The Long Life Study 2 will also include women from the sub-study Life and Longevity After Cancer (LILAC) and other participants from WHI who were not a part of LLS1. The expected number of LLS2 visits to be completed is approximately 6200. The visit will involve a brief physical exam, including physical measurements, blood pressure and pulse, and an assessment of functional status. A fasting blood draw will also be taken.

What data are collected in the Long Life Study 2?

During the Long Life Study 2 appointment, an Examiner with ExamOne 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. Some women may also have a vision screening.

What are the eligibility requirements?

All Long Life Study (LLS) participants who are capable and willing to provide informed consent are eligible for the LLS2, as well as an additional subset of women who were not part of LLS1 and currently enrolled in the WHI Extension Study including a subset of participants identified from the LILAC study.

How long is participation in the Long Life Study 2?

The Long Life Study 2 appointment will take about one hour. During and after the Long Life Study 2, women will still be enrolled in the WHI Study and will continue to complete their annual forms.

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

The Long Life Study 2 data collection will be conducted in the participant’s home, or in another location if the participant prefers. Long Life Study 2 participants do not need to travel to their original WHI clinic for visits.

Do women who are invited to join the Long Life Study 2 have to participate?

No. Women are free to take part in the Long Life Study 2 or not, or they can drop out after joining. Whatever a participant 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.

What will happen during the home visit?

The examiner will conduct the following activities to assess the participant's overall health and to test the physical strength of her arms and legs. All activities will be explained in detail before they are conducted, they will be demonstrated if applicable, and personal comfort and safety will always be taken into consideration before carrying out the activities. Participants may refuse all or some of the activities at any time.

• Blood pressure
• Pulse
• Fasting blood draw (you will be asked to fast for 12 hours if possible)
• Grip strength (we will use a hand-held device to measure the strength of your forearm muscles)
• Height, weight, waist measurement and visual assessment of spinal curvature
• Balance test (we will request you to maintain 4 different positions to assess your balance)
• Timed walk (we will lay down a temporary walking course in your home and request you to walk at your usual pace)
• Chair stand (using a chair available in your own home, we will assess the strength of your legs)
• A vision screening for some participants (using a smartphone held by an examiner)

What will be done with the Long Life Study 2 blood samples?

After the Long Life Study 2 blood is collected, we will send one tube to a hospital lab or research 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. Just like in the past, we will not give participants the results of any future research that uses their blood. However participants may be informed if some of their CBC results suggest that they may need to follow up for repeat testing with their primary care providers.

Who has access to the Long Life Study 2 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 aging 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:

1. Researchers involved with this study
2. Institutional Review Boards (IRB), including the Fred Hutchinson Cancer Center IRB
3. 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 2?

The blood draw may briefly hurt or cause a temporary lightheadedness or bruising; even with careful monitoring by the Examiner, 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 2?

If a Long Life Study 2 participant falls or has a serious health problem during an appointment, the Examiner 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 2?

We cannot and do not guarantee or promise that you will receive any direct benefit from this study. We hope the information will help us learn about the health of older women.

Does it cost anything to participate?

Other than a participant’s time, there are no costs for taking part in the Long Life Study 2.

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

Please call the WHI toll-free message line number at 1-844-726-8715 and leave a message requesting another copy of the consent form. In the message, please leave your first and last name, 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. Women who meet the eligibility requirements have been selected and will be sent an invitation to join and a consent form from August 2022 through 2023. If you are one of these women, we truly hope you will agree to take part. However, if you are not among the selected participants 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 ExamOne, a national health care examination company.

The ExamOne Examiners are well-trained by both ExamOne and WHI, and are experienced in drawing blood and taking the Long Life Study 2 measurements. All ExamOne Examiners have passed background checks before they were hired, and in most cases, they are from the same communities where WHI participants live. ExamOne will keep your WHI ID number and contact information confidential.

After receipt of a woman’s signed consent form, ExamOne staff will call to schedule the study appointment. The day before a Long Life Study 2 appointment, the ExamOne Examiner will call to confirm. For more information about ExamOne, please see their website: http://www.ExamOne.com.

Are all Examiners female?

ExamOne will have both male and female Examiners on staff.

Participant Questions

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

Please call us at 1-844-726-8715 and leave a message. We will get back to you within 48 business hours. Thank you for your participation up to this point.

I have moved. How do I tell the Long Life Study 2 about my new address or phone number?

Please call us at 1-844-726-8715 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 2 appointment?

Please call us at 1-844-726-8715 at least 48 hours in advance of your appointment time.

I have a comment or complaint about my ExamOne Examiner. Who should I call?

The ExamOne Examiners are well-trained by both ExamOne and WHI, and we hope that participation in the Long Life Study 2 is a positive one. Please call us at 1-844-726-8715 if you have any feedback regarding your ExamOne Examiner or the process of scheduling your Long Life Study 2 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 ExamOne Examiner should have given you an End of Visit Results Card that includes information on your Blood Pressure and Pulse, and vision screening (if done). Testing on your blood is considered for research purposes, and those results will not be provided to you. However participants may be informed if some of their CBC results suggest that they may need to follow up for repeat testing with their primary care providers.

What do the blood pressure numbers on the Long Life Study 2 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.

How long will I have to fast?

For the fasting blood draw, WHI participants will be asked to fast 12 hours prior to the home visit.

What if I have to take my medications with food?

If possible, please wait to take medications until after the blood draw. If not possible, the examiner will record the last time you had food.

Am I allowed to drink coffee before my blood draw?

While fasting, you may drink water. Please do not drink liquids such as black coffee or tea.

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 1-844-726-8715 and leave a message. We’ll return your call as quickly as possible.

How much will the visit cost?

Other than your time, there are no costs to you for taking part in the Long Life Study 2.

What if I become sick and do not want anyone to come to my house?

You can reschedule/cancel your appointment at any time. You can call this phone number 1-844-726-8715. As a reminder, ExamOne does not allow its Examiners to enter the home or otherwise interact with an individual suspected of or confirmed to have COVID-19.

What if I no longer want to participate and don’t want anyone coming to my house?

You can drop out of the study at anytime for any reason. If you do decide to drop out of the Long Life 2 study, you will continue to be enrolled in the WHI Extension Study.

Will I be required to be vaccinated?

No, though we would ask that you wear a mask during the home visit.

Other Questions?

For questions about any part of the WHI Long Life Study 2 please call the WHI toll free message line, 1-844-726-8715. We will do our best to respond within 48 business hours.

For questions about your rights as a study participant, you may call the Fred Hutch Institutional Review Office at 206-667-5900.

For questions about the vision assessment call University of North Carolina at 919-391-5614