SELF-BREATHE RCT for Chronic Breathlessness

NCT04574050 | Completed DMC

• 2 other identifiers: IRAS 28530320/LO/1108
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

A feasibility RCT comprising two groups:

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

SELF-BREATHE

EXPERIMENTAL

Access to a self -guided, internet -based intervention for patients with chronic breathlessness known as SELF-BREATHE

Other: SELF-BREATHE

Control

NO INTERVENTION

standard / currently available NHS care

Interventions

SELF-BREATHE OTHER

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

SELF-BREATHE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• King's College Hospital NHS Trust: lead
• King's College London: collaborator

Study Sites (1)

King's College Hospital NHS Foundation TRUST

London, SE5 9RS, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms; Pulmonary Disease, Chronic Obstructive; Asthma; Lung Diseases, Interstitial; Cystic Fibrosis; Anemia, Sickle Cell; Renal Insufficiency; Liver Failure; Dyspnea

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Pancreatic Diseases; Digestive System Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Hepatic Insufficiency; Liver Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: September 28, 2020
• First Posted: October 5, 2020
• Study Start: January 11, 2021
• Primary Completion: January 11, 2022
• Study Completion: January 30, 2022
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)