The thyroid gland is located in the neck and controls how quickly the body uses energy and produces proteins; it also controls how sensitive the body is to various hormones.
What is subclinical hypothyroidism?
What is the TRUST-project?
Why have I been invited to take part?
Do I have to take part?
What will happen to me if I take part?
If you decide that you are interested in taking part in screening, you will be asked to sign a consent form. Then you would be invited to a screening visit at the Glasgow Clinical Research Facility, Western Infirmary at a time that suits you or at the Cork (Cork: please fill in). However, you may prefer to be assessed at home and this can be arranged with the study nurse. The screening visit would take place up to up to six weeks before the study starts and will last up to 30 minutes. The purpose of screening is to decide if you are eligible to take part in the TRUST study. To decide this, you would be asked some medical questions and a blood test would be taken. We would also collect some information from your medical record (paper-based and computerised, held by your GP or hospital; examples include information about your diagnoses, lab results, medical procedures, and medications). This is because we need to know if you have any problems with your health.
If the results from the screening tests and medical record examination are satisfactory you would be invited to take part in the TRUST study. The blood results from this visit will be available within 1 week. If these confirm that you are suitable to take part in the study you will be sent further details by post including a written invitation to take part in the treatment phase of the study. You will be informed in writing if you are not suitable for entry into the treatment phase of the study, with the reasons explained. If we find a medical condition of which you are unaware (e.g. high blood pressure), we will inform you, and write to your GP.
If you are suitable to take part in the full study, and decide to take part, the drug that will be tested is Levothyroxine, given as a capsule and taken by mouth. The purpose of the TRUST study is to determine whether there are benefits and drawbacks of giving Levothyroxine to older people with subclinical hypothyroidism.
We will follow up the long-term health outcomes of all people who are screened for entry into the TRUST trial, whether or not they enter the treatment phase of the study. We plan to do this by looking at routinely recorded health information held by the NHS and records maintained by the General Register Office in Scotland/ Fill in Cork. Your paper and computerised health records will be used by the University of Glasgow to follow up your future long-term health status. This will include paper and computerised records held by the NHS and electronic records maintained by the General Register Office at the Scottish Government.
If you are suitable to enter the full study, and decide to take part, the drug that will be tested is levo-thyroxine, given as a capsule orally (by mouth). We are testing whether it gives benefits to older people with a mildly underactive thyroid.
Will my expenses be paid?
Will my taking part in this study be kept confidential?
All information which is collected about you will be kept strictly confidential. We will keep your personal details on a secure computer at Glasgow University and the Clinical Research Facility. This is required to allow us to communicate with you (e.g. by post or telephone), and for us to link to the routine health information that is held by the Scottish Government.
However your name and contact details will not be disclosed to any other people, other than to your GP or hospital doctor who is providing care to you. Your GP and any hospital doctors who are caring for you will be notified of your screening for participation in the trial. Agreement from you that your GP can be informed is a condition of entering the study.
Any information which leaves your GP surgery or hospital will have your contact details, including name and address, removed so that you cannot be recognised from it. Your anonymised details and results will be shared with our collaborating investigators in the Netherlands, Ireland, Switzerland and the USA.