Combined impact of cardiovascular polypill treatment and a specific nurse education program on adherence to therapy in patients with ACS: a randomized study
This study is for people who have recently had a heart event, like a heart attack. It's looking into how well people take their prescribed medicines, which is often called 'adherence'. The study wants to see if using a special combined medicine, called a 'polypill', along with extra support from nurses, helps people stick to their treatment plan better. The main goal is to check how consistently patients take their medicines for a year after leaving hospital. Researchers will use different ways to measure this, such as asking questions, checking pharmacy records, and seeing if people attend their follow-up appointments. This is a Phase IV study, meaning the treatments are already approved for use, and researchers are studying how they work in real-world settings.
At a glance
What is this study about?
This research study is about helping people who have recently experienced a serious heart problem, like a heart attack, to manage their health moving forward. After such an event, it's really important to take several different medicines regularly to prevent future problems. However, remembering to take many pills can be tricky. This study aims to find out if combining several essential heart medicines into one pill (often called a 'polypill') makes it easier for people to stick to their treatment.
Alongside the 'polypill', the study is also testing if a special support programme run by nurses can help patients understand their medicines better and take them more consistently. The main thing researchers want to find out is how well people are taking their medicines one year after their hospital stay. They will check this in several ways, including talking to patients, looking at pharmacy records, and seeing if they attend follow-up appointments.
This kind of study, called a Phase IV trial, looks at treatments that are already approved and available. It helps doctors and nurses understand how best to use these treatments in everyday patient care and to improve long-term health outcomes for people with heart conditions.
Key takeaways
- A study for people who have recently had a heart attack.
- Investigating if a combined 'polypill' and nurse support help people take their heart medicines regularly.
- Aims to improve long-term heart health.
- Study will check medicine taking over one year.
- Already approved treatments are being studied in a real-world setting.
Who may be eligible?
To be part of this study, you need to be at least 18 years old. Both men and women can take part. The most important thing is that you've recently had a serious heart problem, like a heart attack, and your doctor thinks this study might be right for you.
Your medical team will check other details from your health history to make sure the study treatment is suitable and safe for you. They will explain everything clearly before you decide to join.
- Are you 18 years old or older?
- Have you recently had a serious heart problem, like a heart attack?
- Are you willing to take prescribed medicines as part of a study?
- Can you attend follow-up appointments for about a year?
- Are you happy for your treatment to be decided by chance (randomly allocated)?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you join this study, it would involve you taking your prescribed heart medicines regularly, which might include a special combined pill (polypill). You would also receive support from a nurse education program.
The main part of your participation is being checked for how well you're taking your medicines one year after you left the hospital. This check will happen at a special centre and will involve a few different things: answering questionnaires about your medicine habits, making sure you attend your follow-up appointments, and allowing the study team to look at your pharmacy records to see when you picked up your medicines. A team of nurses, who won't know which specific treatment group you're in, will carry out these checks to keep things fair. The total duration of active follow-up for the main assessment will be approximately one year.
Potential risks and benefits
Locations (1)
- —Spain
Common questions
What is a 'polypill'?
A polypill is a single tablet that combines several different medicines, often used to make it easier for people to take multiple prescriptions at once.
What does 'adherence' mean in this study?
Adherence means how well and consistently a person takes their medicines as prescribed by their doctor.
Will I know if I'm getting the polypill or other medicines?
Because this is a 'randomised' study, you might be put into a group that gets the polypill or a group that gets standard care. Sometimes, you might not know which group you're in until the study ends, to make the results fairer. Your doctors will explain this to you.
How long will this study last for me?
The main part of the study where your medicine taking is assessed will be for one year after you left the hospital for your heart problem.
Will I have extra appointments?
You will need to attend follow-up visits, which are part of how the study team checks your medicine adherence and overall health.
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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