Long Life Study 2

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

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 older participants nationwide. The plan for LLS2 is to repeat the LLS protocol on all surviving members of the LLS cohort who consent to a second study visit. The expected number of LLS2 visits to be completed is approximately 4000. All of these women will be at least 72 years of age by 6/1/2022. The visit will involve a brief physical exam, including anthropometry, blood pressure and pulse, and an assessment of functional status. A fasting blood sample will also be taken

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.

All living Long Life Study (LLS) participants who are capable and willing to provide informed consent are eligible for the LLS2. A subset of 2000 participants identified from the LILAC study, who were not part of LLS, and capable and willing to provide informed consent are eligible for the LILAC-LLS.

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

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.

Women are free to take part in the Long Life Study 2 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.

After the Long Life Study 2 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 2 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.

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.

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.

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.

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.

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.

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.

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

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 1-844-726-8715, and leave a message requesting another copy of the consent form. In the message, please leave a current address and telephone number.

We appreciate your willingness to participate in this study. 10,000 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 10,000, we truly hope you will agree to take part. However, if you are not among the 10,000, we will not be able to include you in this particular study.

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.

Within 1-3 weeks of our 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 research assistant will call to confirm. The ExamOne research assistant will show her identification when she comes to the door. For more information about ExamOne, please see their website: http://www.ExamOne.com.

ExamOne will have both male and female examiners on staff. Additionally, the ExamOne research assistants are well-trained by both ExamOne and WHI, and are experienced in drawing blood and taking the study measurements. All ExamOne 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. ExamOne will keep your WHI ID number and contact information confidential.

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

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.

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

The ExamOne research assistants 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 research assistant or the process of scheduling your Long Life Study 2 appointment. We will do our best to address your concerns as quickly as possible.

At the end of your visit, the ExamOne 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.

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

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.

Yes. The research assistant will give you a card with your blood pressure, pulse, height, and weight recorded at the end of the visit. Within a few weeks of your appointment, we will mail you the results of your complete blood count. Please note that we will not offer any diagnosis or treatment, nor will we pay for any follow-up medical care your doctor may recommend.

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

You can reschedule/cancel your appointment at any time. You can call this phone number – [INSERT PHONE NUMBER] 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.

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.

Yes, the ExamOne phlebotomists will be required to be vaccinated. They will also be required to wear the required protective clothing – i.e., gloves, lab coats and/or long sleeves under scrubs, long pants, and closed-toe shoes, and a medical-grade, 3-ply face mask.

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