A randomised, double-blind, three parallel-group, placebo controlled superiority trial assessing the effect of intravenous versus oral iron supplementation on physical performance, quality of life and cognitive function in iron deficient FRAIL elderly IndiviDuals with cardiovascular disease (FRAIL-ID trial)
This research, called the FRAIL-ID trial, is studying older people who have heart conditions, feel frail, and have low iron levels. The main goal is to compare two ways of giving iron: either through a drip into a vein or as a tablet taken by mouth. We want to find out which method is better at improving people's physical abilities, how they feel day-to-day (their quality of life), and their memory and thinking skills. The study compares real iron treatments with a dummy treatment (placebo) to see their true effects over a year.
At a glance
What is this study about?
You might be interested in a study called the FRAIL-ID trial. This study is looking into how different ways of giving iron treatment can help older people. Specifically, it's for those who have heart conditions, feel generally weak or frail, and have been found to have low iron levels. Having low iron can make you feel tired, weak, and can affect your overall well-being.
The main idea behind this research is to see if treating low iron can help improve important aspects of everyday life. The study wants to find out if taking iron, either as a pill or given directly into a vein, can make a difference to how physically strong you feel, how well you can do your daily activities, and even how clearly you can think. We also want to understand if one way of giving iron works better than another over a 12-month period.
This kind of study helps doctors understand the best ways to care for older people with these specific health challenges. By comparing different treatments, including a dummy treatment (placebo), researchers can gather important information to improve future care and help more people live healthier, more independent lives.
Key takeaways
- This study is for older people with heart conditions, frailty, and low iron.
- It compares two ways of giving iron (into a vein vs. by mouth) with dummy treatments.
- The goal is to see if iron treatment improves physical strength, quality of life, and thinking.
- Participation involves regular clinic visits and assessments over 12 months.
- You might receive active iron treatment or a dummy treatment.
Who may be eligible?
This study is looking for participants who are older adults because it focuses on conditions common in this age group. Specifically, they're looking for individuals who have a heart condition and also feel frail or weak, as well as having been diagnosed with iron deficiency.
There are no age limits set on how old or young you can be, as long as you are considered an adult. Both men and women are welcome to take part in this research.
To see if you are a good fit for this particular study, a doctor or nurse would need to check your medical history and current health to ensure it matches the study's specific requirements. They will confirm if you meet all the health criteria, such as having a heart condition and iron deficiency.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you an older adult?
- Do you have a pre-existing heart condition?
- Do you currently feel frail or generally weak?
- Have you been told by a doctor that you have low iron levels?
What does participation involve?
If you decide to take part in this study, you would be randomly assigned to receive one of four treatments: an iron treatment given into a vein, an iron tablet, a dummy treatment (placebo) given into a vein, or a dummy iron tablet. You wouldn't know which one you are getting, and neither would your doctors, until the study is over.
The treatment period will last for 12 months. During this time, you will have regular visits to the clinic so the research team can carry out assessments. These appointments will involve checking your physical performance, like your walking speed and balance, and asking you questions about your quality of life – how you feel day-to-day and your ability to do activities. They will also do tests to see how your memory and thinking skills are doing.
The study will also keep track of things like any falls you might have and whether you need to spend time in hospital. There will be assessments at the beginning of the study and then again at the 12-month mark to see if there have been any changes.
Potential risks and benefits
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Common questions
What does 'frail' mean in this study?
In this study, 'frail' refers to older people who may feel weak, tired, or have difficulty with everyday physical activities.
What is 'iron deficiency'?
Iron deficiency means your body doesn't have enough iron, which can lead to tiredness and weakness.
What's the difference between iron into a vein and an iron tablet?
One way is a liquid iron treatment given through a drip, and the other is a pill you swallow. The study compares them.
What is a 'placebo'?
A placebo is a 'dummy' treatment that looks just like the real treatment but contains no active medicine. It helps researchers know if the real medicine is truly working.
How long does the study last?
If you join this study, your treatment and follow-up would last for 12 months.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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