Reducing Chronic Breathlessness in Adults by Following a Self-guided, Internet Based Supportive Intervention (SELF-BREATHE)

Sponsor
King's College Hospital NHS Trust
Study ID
NCT06326957
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 110 Years
Healthy Volunteers
Not accepted

Interventions

  • SELF-BREATHE — OTHER
    SELF-BREATHE is on online supportive self - management intervention for individuals living with chronic breathlessness due to respiratory disease. SELF-BREATHE provides user with educational resources about breathlessness and self - management techniques such as breathing exercises, goal setting which aims to help with their breathlessness.

Study Details

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.

Key Dates

First listed
Mar 22, 2024
Start date
Jul 4, 2024
Status verified
Jun 2024
Primary completion
Feb 29, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
246 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SELF-BREATHE (Intervention)
    SELF-BREATHE + usual NHS care (Intervention)
  • No Intervention: Usual NHS care (Control)
    Participants randomised to the control group continue with usual NHS care, as was available to them prior to entry into the trial

Primary Outcome Measure

Numerical Rating Scale (NRS) Worst Breathlessness [ Time Frame: previous 24 hours ]

Central Contacts

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