RecruitingOBSERVATIONAL

Lifestyle Behaviours of Women Newly Diagnosed With Heart Failure

This study focuses on women who have recently been told they have heart failure. Heart failure means your heart has trouble pumping blood effectively, which can cause tiredness, breathlessness, and swollen ankles. While men and women share similar symptoms, there are differences in how the condition affects them. Researchers want to understand the lifestyle habits of these women, including how active they are, how much they sit, and how well they sleep. The study also aims to find out what makes it easier or harder for them to maintain these lifestyle choices. This research is important because women have often been left out of heart failure studies, meaning much of our current understanding and treatment advice is based on men.

At a glance

Status

Recruiting

Sponsor

Newcastle University

Enrolment target

Start

05 May 2022

Estimated completion

30 Jun 2026

Heart Failure

What is this study about?

Heart failure means your heart isn't pumping blood as well as it should. This can make you feel tired, breathless, and sometimes cause your ankles to swell. It can also affect other parts of your body and make it harder to do everyday things. While both men and women can get heart failure, there are some differences in how it affects each sex, and unfortunately, women haven't always been included enough in research. This means that a lot of the medical advice and treatments we have are based more on studies of men.

This study wants to change that by focusing specifically on women who have just found out they have heart failure. The researchers are interested in understanding their daily lives: how active they are, how much time they spend sitting, and how well they're sleeping. They also want to talk to these women to learn about the things that help them stay active and healthy, as well as any difficulties they face.

The main goal is to get a clearer picture of women's experiences with heart failure right from the start. By gathering this information, the researchers hope to improve our understanding of heart failure in women, which could lead to better support and more tailored advice for them in the future. This is a step towards making sure heart failure care is equally good for everyone.

Key takeaways

This study focuses on women recently diagnosed with heart failure.
It aims to understand daily activities, sleep, and overall well-being.
Participation involves wearing a small activity tracker.
An optional interview allows you to share your experiences.
The research helps improve heart failure care for women.
Your medical care will not be affected by your participation.

Who may be eligible?

To join this study, you need to be an adult woman who has recently been told by your doctor you have heart failure at the RVI Heart Failure Diagnostic Clinic. You should be able to walk and manage your daily activities on your own.

Your doctor will need to say that your heart failure symptoms fit into a certain category (NYHA Class II-IV). You also need to be happy to wear a device that tracks your activity and possibly talk about your experiences in an interview (though the interview is optional – you can still join the study even if you don't want to be interviewed). You must be able to read, write, and speak English without needing an interpreter, and be able to give your clear agreement to take part.

You won't be able to join if you're a man, or if you've already been diagnosed with heart failure before this new diagnosis. Also, if your symptoms are very severe, or you have other serious health problems like cancer, severe breathing difficulties, or significant mental health issues, you wouldn't be suitable. If you have a severe physical disability that stops you from looking after yourself, or if your medication has recently changed and you're not medically stable, you also can't take part. Lastly, if you're unable to understand and agree to participate, you won't be included.

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 adult woman with a new heart failure diagnosis from the RVI Heart Failure Clinic?
Can you walk and manage your daily activities independently?
Are you able to read, write, and speak English?
Are you willing to wear an activity tracking device?
Are you not currently experiencing very severe symptoms requiring urgent hospital care?
Do you have no other major serious illnesses (like severe cancer or lung disease)?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be asked to wear a small device called an Actigraph GT3X+BT. This device is worn on your body and helps to track your physical activity levels throughout the day. It will collect information about how much you move, how much you sit, and potentially your sleep patterns. There will also be an option to participate in an interview where you can talk about your experiences and what helps or hinders your daily activities and healthy lifestyle choices. This interview is completely optional, and your decision won't affect your ability to participate in the rest of the study. The study aims to understand what your lifestyle is like shortly after being diagnosed with heart failure. The total duration of your involvement will be explained to you in detail by the study team, but it will focus on this early period after diagnosis.

Potential risks and benefits

Taking part in this study could help us learn more about heart failure in women, which might lead to better care for others in the future. For you personally, wearing the activity monitor is generally very safe and shouldn't cause any harm. The interviews are a chance for you to share your story, which some people find helpful. However, there's always a chance that talking about your health might be tiring or bring up difficult feelings, though the researchers will be understanding and supportive. You are completely free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Newcastle upon Tyne Hospitals NHS Foundation Trust
Verified postcode
Newcastle upon Tyne, United Kingdom· Recruiting

Common questions

What is heart failure?

Heart failure means your heart isn't pumping blood as effectively as it should. It can lead to feeling tired, breathless, and having swollen ankles.

Why is this study only for women?

Women have often been left out of heart failure research, so this study aims to specifically understand their experiences and daily activities to improve their care.

What does wearing the Actigraph involve?

It's a small device, like a fitness tracker, that you wear to record your movements, activity levels, and potentially sleep patterns.

Do I have to do an interview?

No, the interview is optional. You can still participate in the study even if you choose not to be interviewed.

Will taking part affect my medical care?

No, your decision to join or not join, or to leave the study at any point, will not affect the medical care you receive.

How to find out more

Sarah Charman, PhD

sarah.charman@newcastle.ac.uk 01912086935 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.