Reducing chronic breathlessness in adults by following a self-guided, internet-based supportive intervention

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

Registry ID
ISRCTN13121835
Source registry
ISRCTN
Status
Recruiting
Study type
INTERVENTIONAL
Sponsor
King's College Hospital NHS Foundation Trust
Enrollment
246
Start date
2024-07-05
Completion date
2028-07-31
Last update
2026-08-17

Conditions

Summary

Adults living with chronic breathlessness due to malignant and non-malignant diseases

Detailed description

Intervention arm: SELF-BREATHE SELF-BREATHE is a complex, theoretically informed intervention developed with patients following the IDEAS and MRC frameworks. Participants allocated to the intervention group (SELF-BREATHE) will continue to receive their usual NHS care and they will also be given a username and password, which provides unlimited access to SELF-BREATHE. SELF-BREATHE has seven core components, delivered via multi-model media i.e., animations, written text, audio files, pictures, and instructional videos. 1. Patient education about chronic breathlessness and self-management. 2. Self-monitoring of breathlessness; breathlessness severity, distress due to breathlessness, and the impact of breathlessness on life, with real-time algorithm-based automated feedback. 3. Breathing exercises and techniques to improve breathlessness self-management e.g., breathing control exercises, pursed-lipped breathing, and body positions to relieve breathlessness. 4. Breathlessness self-management planning: patients can formulate a personalised breathlessness crisis plan, which will include the breathlessness management techniques used at points of breathlessness crisis e.g., breathing control. 5. Improving physical activity: advice on how to increase daily activity levels, self-directed and self-monitored home exercise programme of bed, chair and standing-based exercises. 6. Personalised Goal Setting: self-guided support for patients to set personalised goals and track achievement and success. 7. Ask the expert: inbuilt messaging service where patients can ask a question or get advice about any specific aspect of SELF-BREATHE (minimal response time of 48 hours).

Interventions

Inclusion criteria

1. Adults ≥ 18 years of age 2. Chronic Breathlessness at rest and/or exertion 3. Chronic Breathlessness (CB) defined as breathlessness that persists (> 3 months) 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 4. Medical Research Council (MRC) dyspnea score ≥ 2 (MRC 2= short of breath when hurrying on the level or walking up a slight hill 5. Access to a computer, tablet, or smartphone with internet access 6. Able to provide informed consent

Exclusion criteria

1. Breathlessness of unknown cause 2. Primary diagnosis of chronic hyperventilation syndrome 3. Currently participating in a rehabilitation programme e.g., pulmonary/cardiac rehabilitation (patients that have completed PR > 4 weeks will be eligible).

Locations

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