Population Survey Patient

Population Survey Patient

Discussion Group Member

Cohort Member

Population survey

Who is it aimed at?

It’s aimed at Quito and Esmeraldas residents who are voluntarily willing to take part in the survey, which seeks to learn about diabetes prevalence and risk factors of noncommunicable diseases. In total, 1,440 people will be chosen at random (720 Quito residents and 720 living in the province of Esmeraldas).

Firstly, you will answer a questionnaire in your own home; secondly, you will be asked to come to a prearranged place in your communities to have some laboratory tests done, which involve blood collection plus taking weight, height and abdominal girth measurements. It is very important for you to come to your appointment, which will be arranged on the day the questionnaire is done in your home.

All the data obtained from these tests are confidential and protected. Their use is exclusively for this investigation.

Quito

Esmeraldas

What are the two parts at this stage of the project?

QUESTIONNAIRE

MEASUREMENTS

Questionnaire

Members of the research team will come to your house and after explaining what the tests are like and their goals, you will be asked to voluntarily take part in the study and to sign the “informed consent” documents to participate. At the beginning, you will be asked for personal details including age, marital status, and level of education.

Then, there will be some questions regarding behaviour and practices such as tobacco or alcohol consumption, your diet, physical activity, working and leisure conditions, as these can influence your health situation.

Next, there will be some questions regarding your medical background, such as blood pressure, cholesterol or high triglycerides levels, cardiovascular disease, or diabetes.

Finally, you will be asked about the recommendations health care professionals may have given you in the past.

Laboratory tests and anthropometric measurements

After the research staff complete the questionnaire in your house, an appointment will be arranged for you to go to a place near your community to undergo the tests below.

When the tests are finished, you will be given a snack as blood tests must be done without having any breakfast.

1. BLOOD COLLECTION

Blood tests will provide the following results in the laboratory:

  • Fasting blood glucose level to assess the risk of developing diabetes.
  • Cholesterol and triglyceride levels to assess the risk of cardiovascular disease
  • Creatinine levels to assess renal function

Just 1 blood sample is needed to obtain these three results.

  • Oral glucose tolerance test, which is one of the methods used to detect diabetes. Two blood samples will be needed.
  • It consists of seeing how the body responds when glucose level in blood is increased after drinking a sweetened drink (75 gr of glucose). If 2 hours after having the drink, glucose levels are not back to normal, we can establish that it is difficult for the individual to store blood sugar in the tissues.
  • First, blood is drawn having had no food; then, you drink a sweetened drink and 2 hours later a blood sample is taken again.
  • And, what do the glucose levels in blood tell us in the second sample?

≤140 mg/dl No diabetes
140-199 mg/dl Risk of Diabetes
>200 mg/dl Diabetes

2. ANTHROPOMETRIC MEASUREMENTS (body measurements)

They help to establish the possible risk factors for developing diabetes. The following measurements will be taken:

  • Height
  • Weight
  • Abdominal girth
  • Blood pressure

More information about the steps to be taken during these tests

1
PARTICIPANT’S ARRIVAL

You must come to the test without having breakfast (you must have nothing to eat or drink, other than water, from 10:00 pm the day before). Our staff will check your identity and ask you some questions to include you in the waiting list.

2
FIRST BLOOD SAMPLE

Your identity will be checked again and you will be asked whether you are being treated with insulin or with oral medicines for diabetes; whether you are pregnant, suffer from haemophilia or have undergone chemotherapy treatment in the last 4 weeks. A glycaemia test in capillary blood will also be conducted to make sure the blood glucose levels are not too high.

In the event of answering yes to any of the questions above or if the capillary test results are abnormal, the glucose tolerance test will NOT be done; we will only draw blood once and take your corporal measurements.

In the event of going ahead with the test, blood will be drawn by means of a venipuncture.

3
HAVING A SUGARY DRINK

Before starting this section, you can ask the staff any doubts you may have regarding the test.

You will have to drink a sugary drink (75 gr glucose) in five minutes for the test to be valid. When you finish, the staff will make a note of the time to take the second blood sample.

The sugary drink may make some people thirsty. You can ask for a glass of water whenever you wish.

4
CORPORAL MEASUREMENTS

Next, while you are waiting for your second blood collection, you will be taken to a different room for privacy. The following measurements will be taken:

Height

You will be asked to remove your shoes and any ornaments or hairdos that could make the process difficult. The staff will tell how you should stand for taking your height measurement correctly.

Weight

You will be asked to remove your shoes and any heavy clothes (coats or jackets, for example) which may distort the measurement. You will be asked to stand in the middle of a scales in an upright position and relaxed shoulders.

Abdominal girth

A tape measure will be placed around your waist while you keep a relaxed abdomen to measure your abdominal girth.

Blood pressure

You will be asked to sit on a chair with your back upright and without crossing your legs. A strap will be placed around your arm, not too tightly, to measure your blood pressure.

You will be asked whether you have taken any medicine for high pressure in the past two weeks.

Before the measurements you must sit calmly for 5 minutes, have an empty bladder and not have done intense physical exercise.

During the test you must breathe normally and not speak.

2-3 measurements will be taken within a 1-2 minute interval in order to obtain the most reliable result possible.

5
SECOND BLOOD SAMPLE

Your identity may be checked again. Then, a new blood sample will be taken

6
BREAKFAST

After the second blood sample is taken, you will get a free healthy breakfast

Is there any benefits attached to my participation?

There is a wide range of benefits for participating in this phase of the project, both for you and for your community.

  • You will receive the results of the tests done (glucose tolerance, creatinine, cholesterol, or blood pressure). If any of the results are not normal, and you wish, a member of our team will contact you to facilitate access to your usual health care professional to give you a diagnosis and treatment if necessary.
  • You will receive information on how to reduce the individual risk of contracting noncommunicable diseases by measures aimed at improving your diet and increasing your physical activity.
  • Also, you will be collaborating with a project to try to help healthcare services improve the care given to people with diabetes in your community and carry out activities that prevent developing the disease.

Are there any risks involved in my participation?

Although very infrequent, the possible negative effects of these tests are the following:

  • From the sugary drink: nausea, vomiting, abdominal distension (swollen belly), headache, hypoglycaemia.
  • From drawing blood: bleeding, dizziness, fainting, bruise, or very infrequently, an infection in the puncture area.

What information has to be taken into account beforehand?

Why do I have to sign the informed consent?

Before taking part in the research you must have read and signed the informed consents so that you know the procedure to be carried out as well as the goals and potential risks/discomfort and benefits.

Why can I NOT eat or drink anything from 10:00 pm the previous day?

You must NOT eat or drink anything (except water) because it could interfere in the test results which then would not be regarded as valid. Before having the test done you will be asked about it and if you have had anything to eat, the test will be put off.

What clothes should I wear on the test day?

You are recommended to wear a loose shirt or T-shirt so that measurements can be taken without you having to remove your clothes.

What and why are Informed Consents important?

It’s important that you read and understand the informed consent about your participation in the research.

This way you will learn about the research goals and the reasons why you are requested to take these tests, their procedure, duration and their possible risks/discomfort and benefits. You will also learn about your rights (to voluntary participation and withdrawing from the study) and about the confidentiality conditions and the management of the data obtained.

What are we going to do with the information gathered in the survey?

The data of the study will be processed in Spain anonymously. They will be globally analysed with the aim of estimating the prevalence of diabetes, prediabetes, and risk factors of noncommunicable diseases. The research team is committed to establishing optimum mechanisms to guarantee the safety of your information.

Will I have access to my test results?

If you wish, as a participant in the study, you will receive the results of your biological and physical measurements as well as the existence of diabetes in the event of it being detected. The results will be delivered within 10 days.

What happens if my test results are abnormal?

People whose results are outside the normal range will be contacted by telephone. An appointment will be arranged for a health care professional to go to your home and give you advice.

What measures are going to be taken to keep confidentiality?

Your name or identity card will not be used at any moment to identify you. Instead, we will use a QR code (similar to a bar code) to connect all your details.

Only the research team will have access to your data. If you wish you can ask to have access to or erase this information.

No information about you will be collected, filed, processed, or divulged without your permission.

What happens if I change my mind and do not wish to take part after being accepted?

Participation is voluntary. Therefore, you can decide to leave the study at any time with no consequences at all. The health care provided or that will be provided to you or, if applicable, a family member, will not be affected at all either. The data obtained will be erased and cannot be used for any aim.

Also, your withdrawal will not entail a right to compensation for any of the parties.

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