At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- SELF-BREATHE (other)
- How long the study runs
- Study runs about 48 months (dates as stated)
- About the drug or intervention
- SELF-BREATHE — other: SELF-BREATHE is on online supportive self - management intervention for individuals living with chronic breathlessness due to respiratory disease.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years to 110 Years
- Who
- All
- Number of participants
- 246
- Started
- 2024-07-04
- Last checked
- 2024-06
Plain English Summary
What is this study?
- • Testing a new treatment for chronic obstructive pulmonary disease
- • NA - 246 participants
- • Background: Some health conditions make breathing difficult and uncomfortable
Who can take part?
- • Ages 18 Years to 110 Years
- • Diagnosed with chronic obstructive pulmonary disease
Where?
- • London - King's College Hospital NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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 National Health Service (NHS) in the United Kingdom, 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 it is estimated that in the UK, 7 out of every 10 people with chronic breathlessness are internet users. With the help of patients and NIHR funding the research team lead by Dr Charles Reilly, developed an online breathlessness supportive website called SELF-BREATHE. SELF-BREATHE provides information and self-management tools such as breathing exercises, that patients can do at home themselves. SELF-BREATHE has been tested as part of its development. 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. Aims 1. To test if using SELF-BREATHE for six-weeks improves patients' breathlessness, their quality of life and whether SELF-BREATHE should be offered within the NHS 2. To see if patients opt to continue to use SELF-BREATHE after six-weeks and what benefits this may have for patients. Methods The research team are undertaking a randomised controlled trial. For this, 246 people living with chronic breathlessness will be recruited in to this study. Each person will be randomly chosen by a computer to continue with their usual care or their usual care plus access to SELF-BREATHE. All study participants will complete questionnaires at the start of the study, thereafter at seven and twelve weeks after randomisation. These questionnaires will ask patients about 1) their breathlessness and its effect on their life and 2) planned and unplanned hospital visits. At the end of the study, we will compare answers to these questionnaires between the two groups at seven and 12 weeks. This will tell if SELF-BREATHE improved patients' breathlessness and reduced their need for unplanned hospital visits e.g., A\&E attendances due to breathlessness.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 110 Years
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Adults ≥ 18 years of age
- ✓Chronic Breathlessness at rest and / or exertion
- ✓Medical Research Council (MRC) dyspnea score ≥ 2 (MRC 2= short of breath when hurrying on the level or walking up a...
- ✓Availability to a computer, tablet, or smart phone with internet access
- ✓Able to provide agreement to take part.
Who cannot take part
- ✗Breathlessness of unknown cause
- ✗Primary diagnosis of chronic hyperventilation syndrome
- ✗Currently participating in a rehabilitation programme e.g.,lung/heart rehabilitation (patients that have...
See the full criteria
Where Is This Study? (1 UK site)
King's College Hospital NHS Foundation Trust
London MK40 4DG, United Kingdom
How to Get in Touch
Charles C Reilly, PhD,MSc,BSc
Sponsor contactCONTACT
