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

Sponsor: King's College Hospital NHS Trust

NCT ID: NCT06326957

View on ClinicalTrials.gov ↗

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.

Chronic Obstructive Pulmonary DiseaseBronchiectasisInterstitial Lung DiseaseLung CancerAsthmaDyspneaFibrotic Lung DiseaseChronic Lung Disease

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What we know so far

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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

PR

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
Inclusion Criteria: * Adults ≥ 18 years of age * Chronic Breathlessness at rest and / or exertion * Chronic Breathlessness (CB) defined as breathlessness that persists (\>3months) despite pharmacological treatment of the underlying disease including, but not limited to; cancer, chronic obstructive pulmonary disease (COPD), interstitial lung disease (ILD), bronchiectasis, chronic fibrotic lung disease following SARS-CoV2 infection * Medical Research Council (MRC) dyspnea score ≥ 2 (MRC 2= short of breath when hurrying on the level or walking up a slight hill * Availability to a computer, tablet, or smart phone with internet access * Able to provide informed consent. Exclusion Criteria: * Breathlessness of unknown cause * Primary diagnosis of chronic hyperventilation syndrome * Currently participating in a rehabilitation programme e.g.,pulmonary/cardiac rehabilitation (patients that have completed PR \>4-weeks will be eligible).

Where Is This Study? (1 UK site)

King's College Hospital NHS Foundation Trust

London MK40 4DG, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Charles C Reilly, PhD,MSc,BSc

Sponsor contact

CONTACT

00442032998062 charles.reilly@nhs.net
Data sourced from ClinicalTrials.gov · Last verified: 2024-06