Active not recruitingNAINTERVENTIONAL

OPTIMISation of Cardio-renal-metabolic-pulmonary Disease Guideline Adherence in High Risk Community Dwelling Individuals

This study, called OPTIMISE, is looking to see if offering extra appointments with a heart specialist to people living in the community can improve their health. Many people have conditions like high blood pressure, high cholesterol, diabetes, or kidney problems, which increase their risk of heart disease. The NHS has guidelines for treating these conditions, but sometimes people might not be getting the full benefit of these. This study wants to find out if having a specialist review your treatment more closely helps to get these risk factors better managed. Half the participants will get these specialist check-ups, and the other half will have their usual GP appointments. We'll then compare the two groups to see if the specialist care leads to better health outcomes.

At a glance

Status

Active not recruiting

Phase

Sponsor

University of Leeds

Enrolment target

138

Start

07 May 2025

Estimated completion

01 Apr 2045

Cardiovascular Diseases Renal Disease Metabolic Disease Pulmonary Disease

What is this study about?

Heart and blood vessel diseases are a big health concern in the UK, causing a significant number of deaths. The good news is that by finding and treating risk factors early, like high blood pressure, high cholesterol, diabetes, and kidney disease, we can often prevent more serious problems. The NHS has clear guidelines, set by an organisation called NICE, on how best to tackle these issues. These guidelines recommend specific tests and treatments to keep people healthy.

While we know that getting these risk factors under control is important, we don't yet know the best way to help people achieve this in their day-to-day lives. This study aims to find out if having extra appointments with heart specialists, beyond your usual GP visits, can lead to better treatment and improved health. These specialists would help make sure your care is fully in line with the latest NHS guidelines.

Specifically, the OPTIMISE study will compare two groups of people. One group will have these extra appointments with a cardiology professional at their local GP practice. This specialist will review their treatment for conditions that affect the heart, kidneys, metabolism (like diabetes), and lungs. The other group will continue with their standard care, meaning their usual appointments with their GP. By comparing these two groups, we hope to learn if this specialist support makes a real difference in controlling risk factors and improving overall health.

Key takeaways

It aims to improve care for common conditions like high blood pressure and diabetes.
It compares specialist check-ups with standard GP care.
It is for people already in the FIND-AF study with higher risk scores.
Participation involves either specialist reviews or standard care and some questionnaires.
The study lasts about 6 months.
You can leave the study at any time without affecting your normal care.

Who may be eligible?

To be able to join this study, you first need to be taking part in another study called FIND-AF. This means that researchers have already identified you as someone who might be at a higher risk of certain heart-related conditions based on the FIND-AF scores.

You also need to be able to understand what being in the study involves and be able to give your clear agreement in writing. It's important that you can also follow the study's instructions and attend any required appointments or tests.

If you're unable to give your consent or can't commit to the study's requirements, then unfortunately, you won't be able to take part. The study is open to both men and women, aged 18 years and older, with no upper age limit.

Quick self-check

Are you currently taking part in the FIND-AF study?
Has the FIND-AF study identified you as having a higher health risk?
Can you give your written permission to join the study?
Are you able to attend appointments and follow study instructions?
Are you 18 years old or older?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in the OPTIMISE study, you'll be randomly put into one of two groups. Neither you nor the study team can choose which group you're in – it's like flipping a coin.

One group will have extra appointments with a heart specialist at your GP practice. This professional will review your current treatments and might suggest changes to make sure they match the latest NHS guidelines. You'll then have a follow-up appointment about 3 months later to check how things are going and make any further adjustments. The other group will continue to receive their usual care from their GP, as they would normally.

Before the study begins, and again after 6 months, everyone in both groups will fill out a short questionnaire about their quality of life. At the 6-month mark, we'll also look at your health records to see if there have been any changes to your medications and how this has affected things like your blood pressure, cholesterol, blood sugar levels, and weight. The total duration of your active involvement in the study will be around 6 months.

Potential risks and benefits

By taking part, you might benefit from your health conditions being more closely monitored and your treatments potentially being optimised according to the latest guidelines, which could lead to better control of your risk factors. There are no significant new risks from participating, as any recommended changes to your treatment would be based on established NHS guidelines and discussed with you as part of your usual care. You have the right to withdraw from the study at any time without giving a reason, and this will not affect your ongoing medical care.

Locations (1)

University of Leeds
Leeds, United Kingdom

Common questions

What is the main goal of this study?

To see if extra visits with a heart specialist help people manage conditions like high blood pressure and diabetes better, compared to standard GP care.

Who is running this study?

This study is being run by researchers looking into how healthcare can be improved for conditions affecting the heart, kidneys, metabolism, and lungs.

Will I get new medicines if I join?

You might. A specialist might suggest changes to your current medicines or new ones to ensure your treatment follows NHS guidelines, but this will be discussed with you.

How long will I be in the study?

Your active involvement in the study will last about 6 months.

What happens if I decide to leave the study early?

You can leave the study at any time, for any reason, and it will not affect the medical care you receive.