We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

SELF-BREATHE RCT for Chronic Breathlessness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04574050
Recruitment Status : Recruiting
First Posted : October 5, 2020
Last Update Posted : September 9, 2021
Sponsor:
Collaborator:
King's College London
Information provided by (Responsible Party):
King's College Hospital NHS Trust

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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)

Condition or disease Intervention/treatment Phase
Cancer COPD Asthma Bronchiectasis Adult Interstitial Lung Disease Cystic Fibrosis Chronic Heart Failure Sickle Cell Disease Renal Failure Liver Failure Post COVID-19 Dyspnea Other: SELF-BREATHE Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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)
Masking: Single (Outcomes Assessor)
Masking Description: Single blind
Primary Purpose: Treatment
Official Title: A Self - Guided, Internet - Based Intervention for Patients With Chronic Breathlessness (SELF-BREATHE): Feasibility Randomised Controlled Trial
Actual Study Start Date : January 11, 2020
Estimated Primary Completion Date : April 4, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Feasibility: the number of patients recruited into this study over a 12-month period [ Time Frame: 12 months ]
    The number of patients recruited into this study over a 12-month period


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04574050


Locations
Layout table for location information
United Kingdom
King's College Hospital NHS Foundation TRUST Recruiting
London, United Kingdom, SE5 9RS
Contact: Charles Reilly, PhD    02032998062    charles.reilly@nhs.net   
Sponsors and Collaborators
King's College Hospital NHS Trust
King's College London
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: King's College Hospital NHS Trust
ClinicalTrials.gov Identifier: NCT04574050    
Other Study ID Numbers: IRAS 285303
20/LO/1108 ( Other Identifier: REC / HRA )
First Posted: October 5, 2020    Key Record Dates
Last Update Posted: September 9, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Cystic Fibrosis
Liver Failure
Lung Diseases
Dyspnea
Lung Diseases, Interstitial
Bronchiectasis
Anemia, Sickle Cell
Pancreatic Diseases
Digestive System Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
 Infant, Newborn, Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Respiration Disorders
Signs and Symptoms, Respiratory
Bronchial Diseases
Hepatic Insufficiency
Liver Diseases