Actively Recruiting

Phase Not Applicable
Age: 18Years - 110Years
All Genders
ID06326957

A Randomized Trial Comparing Usual NHS Care to SELF-BREATHE Plus Usual Care for Adults with Chronic Breathlessness

Led by King's College Hospital NHS Trust · Updated on 2025-06-13

246

Participants Needed

1

Research Sites

21 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the impact of an online supportive self-management intervention called SELF-BREATHE for adults living with chronic breathlessness due to various lung and heart conditions. Chronic breathlessness affects over 3 million people in the UK, causing significant distress and disability. This trial aims to determine whether using SELF-BREATHE improves breathlessness and quality of life, while also assessing its potential for NHS adoption. In this randomized controlled trial, 246 adults with chronic breathlessness will be assigned to receive either usual NHS care or usual care plus access to SELF-BREATHE. SELF-BREATHE is an internet-based program offering educational resources and self-management tools such as breathing exercises and goal setting. Participants will use the intervention for six weeks while continuing their normal care. Participants will complete questionnaires at the start, and at seven and twelve weeks after randomization, assessing their breathlessness, its impact on life, and hospital visits related to breathlessness. The main outcome measured is the worst breathlessness over the previous 24 hours using a numerical rating scale. The study will compare results between the groups to see if SELF-BREATHE reduces breathlessness and hospital visits, with a total involvement period of about 12 weeks.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 110Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults 18 years of age or older
  • Chronic breathlessness at rest and/or exertion lasting more than 3 months despite treatment
  • Breathlessness due to known conditions such as cancer, COPD, interstitial lung disease, bronchiectasis, fibrotic lung disease
  • Medical Research Council (MRC) dyspnea score of 2 or higher
  • Access to a computer, tablet, or smartphone with internet
  • Able to provide informed consent
Not Eligible

You will not qualify if you...

  • Breathlessness of unknown cause
  • Primary diagnosis of chronic hyperventilation syndrome
  • Currently participating in a rehabilitation program such as pulmonary or cardiac rehabilitation (completed programs over 4 weeks ago allowed)

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person or remote)

Treatment

Duration - Duration of the trial period as specified by the protocol

Participants in the intervention group follow the SELF-BREATHE online supportive self-management program alongside usual NHS care. Participants in the control group continue with usual NHS care.

As this is an online self-guided intervention, visit frequency varies and includes remote assessments

Trial Site Locations

Total: 1 location

1

King's College Hospital NHS Foundation Trust

London, United Kingdom, MK40 4DG

Actively Recruiting

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Research Team

C

Charles C Reilly, PhD,MSc,BSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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