SELF-BREATHE: a self-guided online program to reduce chronic breathlessness in adults

A Multicentre, Randomised Controlled Trial Comparing Usual NHS Care to a Self-guided Internet-based Intervention (SELF-BREATHE) Plus Usual NHS Care to Reduce Breathlessness in Adults Living With Chronic Breathlessness

This study will test whether SELF-BREATHE, a self-guided internet-based support program, can help adults with chronic breathlessness from lung or heart conditions breathe easier and feel less distressed.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 246 (estimated)
• Ages: 18 Years to 110 Years
• Sex: All
• Sponsor: King's College Hospital NHS Trust (Academic / other)
• Locations: 1 site (London)
• Trial ID: NCT06326957 on ClinicalTrials.gov

What this trial studies

SELF-BREATHE delivers a self-guided, internet-based supportive program aimed at adults living with chronic breathlessness from conditions such as COPD, interstitial lung disease, bronchiectasis, asthma, or lung cancer. Eligible participants are adults with breathlessness lasting more than three months, with an MRC dyspnea score of 2 or higher, and access to a computer, tablet, or smartphone. The intervention is provided online and outcomes will focus on breathlessness severity, distress, and related health service use. The trial is run from King's College Hospital NHS Foundation Trust in London and targets patients who can participate remotely via the internet.

Who should consider this trial

Good fit: Adults aged 18 or older with chronic breathlessness (>3 months) despite treatment, an MRC dyspnea score ≥2, ability to consent, and access to an internet-capable device are ideal candidates.

Not a fit: Patients with breathlessness of unknown cause, primary chronic hyperventilation syndrome, those currently enrolled in pulmonary or cardiac rehabilitation, or those without internet access are unlikely to benefit from this online program.

Why it matters

Potential benefit: If successful, SELF-BREATHE could offer widely accessible support that reduces breathlessness-related distress and may reduce emergency visits and disability.

How similar studies have performed: Face-to-face pulmonary rehabilitation and some digitally supported rehabilitation programs have improved breathlessness and quality of life, but fully self-guided internet-only interventions for chronic breathlessness remain less well tested.

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).

Where this trial is running

London

• King's College Hospital NHS Foundation Trust — London, United Kingdom (Recruiting)

Study contacts

• Principal investigator: Charles C Reilly, PhD,MSc,BSc — King's College Hospital NHS Foundation Trust, King's College London
• Study coordinator: Charles C Reilly, PhD,MSc,BSc

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