SELF-BREATHE RCT for Chronic Breathlessness

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

A feasibility RCT comprising two groups:

1. Intervention (SELF-BREATHE in addition to standard NHS care)
2. Control group (standard / currently available NHS care)

Study Overview

• Status: Completed
• Conditions: Liver Failure; Cancer; Asthma; Renal Failure; Cystic Fibrosis; Chronic Heart Failure; Sickle Cell Disease; Interstitial Lung Disease; COPD; Dyspnea; Post COVID-19; Bronchiectasis Adult
• Intervention / Treatment: Other: SELF-BREATHE

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE5 9RS
    • King's College Hospital NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SELF-BREATHE; Access to a self -guided, internet -based intervention for patients with chronic breathlessness known as SELF-BREATHE	Other: SELF-BREATHE; A self -guided, internet -based intervention for patients with chronic breathlessness
No Intervention: Control; standard / currently available NHS care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: King's College Hospital NHS Trust
• Collaborators: King's College London

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2021
• Primary Completion (Actual): January 11, 2022
• Study Completion (Actual): January 30, 2022

Study Registration Dates

• First Submitted: September 28, 2020
• First Submitted That Met QC Criteria: October 1, 2020
• First Posted (Actual): October 5, 2020

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Hepatic Insufficiency; Respiratory Tract Diseases; Respiration Disorders; Hematologic Diseases; Infant, Newborn, Diseases; Liver Diseases; Bronchial Diseases; Genetic Diseases, Inborn; Anemia; Signs and Symptoms, Respiratory; Pancreatic Diseases; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Liver Failure; Bronchiectasis; Lung Diseases; Cystic Fibrosis; Anemia, Sickle Cell; Lung Diseases, Interstitial; Dyspnea
• Other Study ID Numbers: IRAS 285303; 20/LO/1108 (Other Identifier: REC / HRA)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No