RecruitingNAINTERVENTIONAL

Stepcare Extended Follow-up Substudy

The Stepcare substudy is investigating the long-term effects of different treatments given to people who have had a cardiac arrest outside of a hospital. It wants to understand if managing body temperature, blood pressure, and sedation differently helps survivors recover better, especially with their memory and thinking skills, up to a year after the event. The study also explores the challenges and impact on family members who care for these survivors. This will give doctors important information about the best ways to help people regain their health and how their families cope.

At a glance

Status

Recruiting

Phase

Sponsor

Region Skane

Enrolment target

600

Start

01 Aug 2023

Estimated completion

31 Jul 2027

Cardiac Arrest With Successful Resuscitation Hypoxia, Brain Cognitive Impairment Caregiver Burden

What is this study about?

When someone has a sudden cardiac arrest, where their heart stops beating, it's a very serious situation. Even if their heart is restarted, they can sometimes have problems with their brain, affecting their memory and how they think. This study, called the Stepcare Extended Follow-up Substudy, aims to find out the best ways to help people recover in the long run after a cardiac arrest.

Doctors are using different methods to help patients after their heart is restarted. These methods include carefully controlling body temperature, blood pressure, and how much sedation (medicine to make them calm or sleep) they receive. This study will follow patients for 6 months and 12 months to see how these different approaches affect their ability to think and remember, and how well they generally recover. The main goal is to see if any specific treatment approach helps protect the brain and leads to a better recovery.

Another important part of this study is understanding the impact on the people who care for these survivors, such as family members. Caring for someone who has had a serious illness can be challenging. The study wants to learn about the stresses and difficulties faced by caregivers to better support them in the future. By looking at both the patient's recovery and the caregiver's experience, researchers hope to get a full picture of life after a cardiac arrest.

Key takeaways

This study looks at long-term recovery after cardiac arrest.
It checks how different treatments affect memory and thinking skills.
The study also explores the challenges faced by family caregivers.
Participants are followed up at 6 and 12 months.
It aims to improve future care for cardiac arrest survivors and their families.

Who may be eligible?

This study is for adults who have already taken part in the main STEPCARE study. To be included in this specific follow-up part, you must have survived your cardiac arrest and agree to continue with the study.

The original STEPCARE study included people who had a cardiac arrest outside of a hospital, where their heart attack wasn't caused by an injury. They needed to have their heart restarted and be unconscious afterwards, requiring intensive care. They couldn't have had certain other conditions like being pregnant or bleeding in the brain.

For caregivers, you can take part if you live with the survivor or are in regular contact with them, at least once a week. Usually, it will be the person who is the main caregiver.

Quick self-check

Are you an adult (18 or older)?
Did you previously take part in the main STEPCARE study?
Did you survive your cardiac arrest?
Are you willing to give your agreement to continue in this follow-up study?

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

What does participation involve?

If you take part in this study, you will have follow-up assessments at 6 months and 12 months after your cardiac arrest. These assessments will look at your memory and thinking skills. If you are a caregiver taking part, you will be asked questions about your experience at 6 months.

Potential risks and benefits

The main benefit of taking part is that it helps doctors learn more about the best ways to care for people after a cardiac arrest, which could improve treatments for future patients. There are no direct medical risks as this study only involves answering questions and performing assessments, not new treatments. You are free to stop taking part in the study at any time, for any reason, without it affecting your usual care.

Locations (34)

Princess Alexandra Hospital
Brisbane, Australia· Recruiting
The Sutherland Hospital
Caringbah, Australia· Recruiting
The Prince Charles Hospital
Chermside, Australia· Recruiting
Nepean hospital
Kingswood, Australia· Recruiting
St George hospital
Kogarah, Australia· Recruiting
Liverpool hospital
Liverpool, Australia· Recruiting
Austin hospital
Melbourne, Australia· Recruiting
Royal North Shore Hospital
Sydney, Australia· Recruiting
Ziekenhuis Oost Limburg
Genk, Belgium· Recruiting
Ghent university hospital
Ghent, Belgium· Recruiting
Helsinki Helsingfors university central hospital
Helsinki, Finland· Recruiting
Jorvi hospital
Jorvi, Finland· Recruiting

+22 more sites — see the official record for the full list.

Common questions

What is a cardiac arrest?

A cardiac arrest happens when your heart suddenly stops pumping blood around your body. It's different from a heart attack, where blood flow to the heart is blocked.

What does 'out of hospital cardiac arrest' mean?

This means your heart stopped beating when you were not in a hospital, for example, at home or in a public place.

What is 'cognitive function'?

Cognitive function refers to your brain's abilities like memory, thinking clearly, solving problems, and paying attention.

What is 'caregiver burden'?

'Caregiver burden' describes the physical, emotional, or financial stress that can be experienced by someone caring for another person.

Will I get any new treatments in this study?

No, this study is about checking how people recover from treatments they've already received in the main STEPCARE study. No new treatments are given as part of this follow-up.

How to find out more

Gisela Lilja, PhD

gisela.lilja@med.lu.se +4646176393 Official trial record

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