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

NCT06326957 | Recruiting

• 3 other identifiers: 334979 V1 15/01/2024NIHR30290424/LO/0142
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.To see if patients opt to continue to use SELF-BREATHE after six-weeks and what benefits this may have for patients.

Conditions

Chronic Obstructive Pulmonary Disease; Bronchiectasis; Interstitial Lung Disease; Lung Cancer; Asthma; Dyspnea; Fibrotic Lung Disease; Chronic Lung Disease

Outcome Measures

Primary Outcomes (1)

• Numerical Rating Scale (NRS) Worst Breathlessness

  The primary outcome is patient rated intensity of worst breathlessness over the previous 24 hours, using a validated 11-point (0-10) numerical rating scale (NRS), where 0 = no breathlessness, and 10 = worst imaginable breathlessness (Patient self-reported out-come measure)

  previous 24 hours

Study Arms (2)

SELF-BREATHE (Intervention)

EXPERIMENTAL

SELF-BREATHE + usual NHS care (Intervention)

Other: SELF-BREATHE

Usual NHS care (Control)

NO INTERVENTION

Participants randomised to the control group continue with usual NHS care, as was available to them prior to entry into the trial

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.

SELF-BREATHE (Intervention)

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead

Study Sites (1)

King's College Hospital NHS Foundation Trust

London, MK40 4DG, United Kingdom

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Bronchiectasis; Lung Diseases, Interstitial; Lung Neoplasms; Asthma; Dyspnea

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Charles C Reilly, PhD,MSc,BSc

  King's College Hospital NHS Foundation Trust, King's College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charles C Reilly, PhD,MSc,BSc

CONTACT

00442032998062; charles.reilly@nhs.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: A statistician blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: March 22, 2024
• Study Start: July 4, 2024
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: June 13, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)