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Trial Title:
Reducing Chronic Breathlessness in Adults by Following a Self-guided, Internet Based Supportive Intervention (SELF-BREATHE)
NCT ID:
NCT06326957
Condition:
Chronic Obstructive Pulmonary Disease
Bronchiectasis
Interstitial Lung Disease
Lung Cancer
Asthma
Dyspnea
Fibrotic Lung Disease
Chronic Lung Disease
Conditions: Official terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Dyspnea
Lung Diseases, Interstitial
Bronchiectasis
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Investigator)
Masking description:
A statistician blind
Intervention:
Intervention type:
Other
Intervention name:
SELF-BREATHE
Description:
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.
Arm group label:
SELF-BREATHE (Intervention)
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 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.
Criteria for eligibility:
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).
Gender:
All
Minimum age:
18 Years
Maximum age:
110 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
King's College Hospital NHS Foundation Trust
Address:
City:
London
Zip:
MK40 4DG
Country:
United Kingdom
Contact:
Last name:
Charles C Reilly
Phone:
00442032998062
Email:
charles.reilly@nhs.net
Start date:
May 2024
Completion date:
July 2028
Lead sponsor:
Agency:
King's College Hospital NHS Trust
Agency class:
Other
Source:
King's College Hospital NHS Trust
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06326957