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NCT04574050 Clinical Trial

SELF-BREATHE RCT for Chronic Breathlessness

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04574050
Other study ID # IRAS 285303
Secondary ID 20/LO/1108
Status Completed
Phase N/A
First received
Last updated
Start date January 11, 2021
Est. completion date January 30, 2022

Study information
Verified date March 2024
Source King's College Hospital NHS Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)

Recruitment information / eligibility
Status Completed
Enrollment 52
Est. completion date January 30, 2022
Est. primary completion date January 11, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• SELF-BREATHE
A self -guided, internet -based intervention for patients with chronic breathlessness

Locations
Country Name City State
United Kingdom King's College Hospital NHS Foundation TRUST London

Sponsors (2)
Lead Sponsor Collaborator
King's College Hospital NHS Trust King's College London

Country where clinical trial is conducted

United Kingdom, 

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