The IMPaCT Cohort is led by the Biomedical Research Networking Center (CIBER) for Epidemiology and Public Health of the Carlos III Health Institute (ISCIII). The study is funded by public funds from the ISCIII and the European Union. It is the largest study conducted in Primary Health Care in Spain, involving the Health Services of all the Autonomous Communities and Cities (Ceuta and Melilla) of Spain, as well as the National Institute of Statistics.
A cohort is a group of individuals studied over time to better understand the magnitude of major health issues and identify their possible causes.
Specifically, the aim of the IMPaCT Cohort is to understand the social, environmental, and biological determinants of the most significant public health conditions and diseases in Spain. To achieve this, we are building a large cohort in Spain, with the participation of at least 200,000 individuals, including you. These individuals will be tracked regarding their health status for a period of 20 years.
Therefore, the IMPaCT Cohort will be a great public health research infrastructure, which will allow the scientific community to better understand how to prevent diseases, functional decline associated with age, injuries and disability.
The IMPaCT Cohort will reach out to randomly selected participants from Health Centers. Invitations are individual and do not extend to other members of your family or acquaintances. This random selection method helps ensure that the study more accurately represents the population residing in Spain.
Yes, you can choose to participate in a visit and then change your mind, although the data and results obtained up to that point will still be part of the study. Likewise, donating biological samples is entirely voluntary. If you change your decision, stored samples will be destroyed, though this won't impact the research conducted up to that point. Remember, your participation is entirely voluntary and you can discontinue it whenever you wish.
The study professionals will explain it to you in detail during the first visit to the Health Center.
By participating, you'll be contributing to advancing scientific knowledge and improving the health status of people like yourself. Specifically, you'll assist in the development of Precision Medicine; this approach aims to propose the treatment that best suits each patient's individual characteristics, potentially yielding greater health benefits. Your assistance will also contribute to advancing Precision Public Health, identifying health policies that bring the most benefits to specific population groups.
With your participation, Spain will be able to create a large cohort, reaching the same level as other benchmark countries such as the United Kingdom, Germany, France, or the United States.
If you are selected to participate, you will receive an official letter followed by a phone call to arrange an appointment at the Health Center closest to your home.
During the first visit, we'll explain the study, address your concerns, and ask for your consent to participate. Over several visits, scheduled according to your needs, some physical health tests will be conducted.
We'll ask you to fill out health questionnaires, either online or in person at the Health Center with the assistance of our technical staff.
The nursing staff at the Health Center will take blood samples, and we'll ask you to collect urine, stool, and nail samples at home. All of this will be repeated every 5 years.
Additionally, we'll request permission for the study staff to access your medical records and information available about you in the databases of the National Institute of Statistics.
The physical examination will include several tests:
We'll draw 8 tubes of blood, totaling approximately 50 ml.
The health exams and blood sample collection will be conducted every 5 years. Additionally, periodically, we'll send you brief questionnaires about new relevant health data, either online or, if you prefer, at our facilities.
The blood sample collection (venipuncture) might cause a burning sensation at the needle insertion site and a small bruise or slight infection, which typically disappears within a few days. Less commonly, it might lead to dizziness during the blood draw. The nursing staff will be attentive to these possible effects. Additionally, the IMPaCT team will address any discomfort or issues during the physical examination. Moreover, the study has liability insurance that covers any potential problems.
If you are pregnant, generally, we can perform all physical tests, except for some, such as cardiorespiratory capacity assessment.
Yes, you can be accompanied to the appointments if you wish.
Yes, you can voluntarily choose not to participate in the tests you don't want to undergo. However, whenever possible, we kindly request that you allow us to conduct all the examinations to contribute the greatest amount of data possible.
Yes, we'll provide you with a certificate of participation during each visit if you require one.
No, we won't ask you for any personal information over the phone. We'll only call to schedule an appointment at the Health Center.No tienes que pagar nada por participar en el estudio.
If you receive any fraudulent or suspicious calls requesting personal information or money on behalf of the IMPaCT Cohort, please contact us at your IMPaCT Center.
This test, called bioimpedance, involves measuring the resistance that body tissues offer to the passage of a very low-intensity electric current. With it, we can estimate the approximate proportion of fat and muscle in a person. The test is entirely safe for everyone.
We will measure hand grip strength using a dynamometer. You'll simply need to exert force by squeezing the instrument with your hand. We'll repeat this test three times to obtain a more accurate measurement.
We'll use an ultrasound machine to take specific measurements of the quadriceps muscle in the thigh, as well as the fat in the abdominal area.
We'll use two devices. One, to be worn on the wrist, is similar to a smartwatch or activity tracker. The other is a small device placed on the thigh. The IMPaCT staff will provide, set up, and position both devices. After 7 days, during your next visit to the Health Center, you'll return both devices to the staff.
The ankle-brachial index test indicates the risk of peripheral arterial disease. This disease results from the narrowing of arteries, causing reduced blood flow in the arms and legs.
The test involves measuring and comparing the blood pressure in the ankle and arm. It's a quick, non-invasive test that takes a few minutes.
MAPA stands for Ambulatory Blood Pressure Monitoring. This portable device records a person's blood pressure measurements over 24 hours. The device will be programmed by our technical staff to take measurements every 20 minutes during the day and every 30 minutes at night.
The cardiorespiratory capacity test will use a modified stationary bike to measure resistance to pedaling. Depending on your health status, you'll perform a specific test type. Simultaneously, we'll monitor your heart rate and conduct an electrocardiogram.
An electrocardiogram (ECG) is a painless test that records the heart's electrical activity using electrodes attached to the chest and limbs. An abnormal ECG could indicate heart damage or disease.
For echocardiographic measurements, we'll use an ultrasound machine to capture various images of your heart from different angles. This painless test provides comprehensive data on heart structure and function, serving as vital predictors for cardiovascular disease risk.
The Short Physical Performance Battery (SPPB) is used for individuals over 65 years old to assess lower extremity function. It involves brief tests measuring balance, gait speed (over 4 meters), and the ability to rise from a chair 5 times. If there are difficulties performing any test, it will be stopped.
The hearing test aims to evaluate your hearing capacity and auditory threshold. We'll use the AudCal application and headphones, and you'll simply indicate when you hear sounds of various frequencies.
This test is intended to have a general idea of the situation of your oral health. To do this, we will determine the number and condition of the teeth present (natural or fixed false teeth), removable prostheses, as well as symptoms and signs of temporomandibular joint disorders.
To analyze the risk of type 2 diabetes, we use the Finnish Diabetes Risk Score (FINDRISC) questionnaire, one of the most effective tools for diabetes prevention. It consists of 8 simple questions to detect the risk of type 2 diabetes or identify people with undiagnosed diabetes.
These are a series of brief tests used to determine cognitive status. We'll use tests with pictures (Phototest), symbols (Symbol and Digit Test), and words (Mini-Cog).
We will ask you to provide your social security number and other details from your health card. Therefore, please bring it with you.
During the first visit, we'll ask for various contact numbers (mobile, home, work), and the number of a family member or acquaintance for future contact if necessary.
On the day of the MAPA configuration visit, please wear clothing with loose sleeves or short sleeves to allow for the placement of the bracelet on the forearm. However, we will notify you in advance.
We also recommend that you wear easily removable clothing and footwear as we'll need you to take these off for some tests. Comfortable clothing and shoes are advisable as one of the tests is similar to a stationary bicycle.
We'll be taking blood samples for various analyses. The IMPaCT staff will inform you of the day this will happen so you can come to the Health Center on an empty stomach.
The collection and processing of personal data required for this study will comply with Regulation (EU) 2016/679 General Data Protection Regulation, the Organic Law 3/2018 on personal data protection and digital rights guarantee, and Law 14/2007, of July 3, on biomedical research. The responsible entity for processing your data is CIBER, where you can exercise your rights of access, rectification, deletion, limitation, opposition to processing, and data portability. This information will be used with your consent and/or for public interest in the field of public health or compliance with legal obligations.
The results of physical tests and biological samples will be treated confidentially.
A code will be assigned to them, known only to the researcher, the personnel involved in the Cohort, and the biobank.
Please note that tests are conducted exclusively for research purposes, and the detailed analysis of many (like electrocardiograms or cardiac and muscular ultrasounds) may take time.
Under no circumstances will the answers to the questionnaires be published associated with your name. Scientific studies may use data collected from questionnaires, ensuring participant confidentiality.
You'll have access to the reported results of some tests through the application.
Systems containing personal data will be physically located in CIBER's infrastructure (Instituto de Salud Carlos III) or other CIBER-owned cloud locations, always within the European Union. Therefore, the data will never leave the umbrella of protection in the European Union.
Access to personal data is generally pseudonymized, except for those responsible for patient follow-up and contact tasks, like IMPaCT technical staff. Researchers do not access participants' identifiable data.
No, the project has multiple compliance guarantees and has been approved by the Ethics Committee of the Instituto de Salud Carlos III and the respective Ethics Committees of the Autonomous Communities and Cities. The IMPaCT project has implemented security measures, complying with privacy principles from the design phase.
Yes, you can revoke the consent given. Note that this revocation won't affect the data processing carried out until the revocation date.
You have rights such as access, rectification, deletion, restriction of processing, opposition, and data portability.
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