SELF-BREATHE RCT for Chronic Breathlessness

A Self - Guided, Internet - Based Intervention for Patients With Chronic Breathlessness (SELF-BREATHE): Feasibility Randomised Controlled Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04574050

Enrollment

Registered

2020-10-05

Start date

2021-01-11

Completion date

2022-01-30

Last updated

2024-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Bronchiectasis Adult, Cancer, Chronic Heart Failure, COPD, Cystic Fibrosis, Dyspnea, Interstitial Lung Disease, Liver Failure, Post COVID-19, Renal Failure, Sickle Cell Disease

Brief summary

A feasibility RCT comprising two groups: 1. Intervention (SELF-BREATHE in addition to standard NHS care) 2. Control group (standard / currently available NHS care)

Interventions

OTHERSELF-BREATHE

A self -guided, internet -based intervention for patients with chronic breathlessness

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Masking description

Single blind

Intervention model description

A feasibility RCT comprising two groups: 1. Intervention (SELF-BREATHE in addition to standard NHS care) 2. Control group (standard / currently available NHS care)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Adults ≥ 18 years of age, with the ability to read and type in English * Access to a computer, or tablet or smart phone, with internet access and the ability to email * Chronic breathlessness (CB) defined as; breathlessness that persists (\>3months) despite optimal pharmacological treatment of the underlying disease including cancer, chronic obstructive pulmonary disease (COPD),asthma, interstitial lung disease (ILD), bronchiectasis, cystic fibrosis (CF) chronic heart failure (CHF), sickle cell disease, chronic renal/ liver failure or post COVID-19 * Chronic breathlessness at rest or on exertion; MRC dysponea score \>2 * Willing to engage with short-term self-guided internet-based breathlessness intervention (SELF-BREATHE) * Able to provide informed consent

Exclusion criteria

* Breathlessness of unknown cause * A primary diagnosis of chronic hyperventilation syndrome * Currently participating in a rehabilitation programme, e.g. pulmonary/cardiac rehabilitation

Design outcomes

Primary

Measure	Time frame	Description
Feasibility: the number of patients recruited into this study over a 12-month period	12 months	The number of patients recruited into this study over a 12-month period

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026