mRCT of SELF-BREATHE for Chronic Breathlessness
Research type
Research Study
Full title
A multicentre, randomised controlled trial comparing usual NHS care to a self-guided internet-based intervention (SELF-BREATHE) plus usual NHS care to reduce breathlessness in adults living with chronic breathlessness
IRAS ID
334979
Contact name
Charles Reilly
Contact email
Sponsor organisation
King’s College Hospital NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 0 months, 0 days
Research summary
Background
Some health conditions make breathing difficult and uncomfortable. When this happens every day, it is called chronic breathlessness. Over 3 million people living with heart and lung disease have chronic breathlessness in the UK. Breathlessness is very difficult for patients themselves and their families, resulting in disability and feelings of fear, distress, and isolation. Due a to lack of supportive breathlessness services many patients frequently attend hospital Accident and Emergency (A&E) departments seeking help.
Given the on-going challenges faced by the NHS such as long waiting times, staff shortages, increased demand for services because of the COVID-19 pandemic, there is an urgent need to develop new ways to support those living with chronic breathlessness. One potential solution is to offer support online as in the UK, 7 out of every 10 people with chronic breathlessness are internet users.
SELF-BREATHE was co-developed with patients and provides information and self-management tools such as breathing exercises online, that patients can do at home themselves. SELF-BREATHE is acceptable and valued by patients. But what is unknown is whether SELF-BREATHE improves patients’ breathlessness and their life? This is the question this research seeks to answer.
Study Aims
1. To test if using SELF-BREATHE for six-weeks improves patients’ breathlessness
2. To see if patients opt to continue to use SELF-BREATHE after six-weeks and what benefits this may have.
Methods
We will conduct a randomised controlled trial. For this, 246 people living with chronic breathlessness will be recruited. Each person will be randomly chosen by a computer to get their usual care or usual care plus access to SELF-BREATHE. All study participants will complete questionnaires at the start of the study, thereafter at 7 weeks and 12 weeks. The answers will be compared between the two groups to see of SELF-BREATHE is helpful.
REC name
London - Bromley Research Ethics Committee
REC reference
24/LO/0142
Date of REC Opinion
7 Mar 2024
REC opinion
Further Information Favourable Opinion