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SELF-BREATHE RCT for Chronic Breathlessness

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ClinicalTrials.gov Identifier: NCT04574050
Recruitment Status : Completed
First Posted : October 5, 2020
Last Update Posted : March 19, 2024
Sponsor:
Collaborator:
King's College London
Information provided by (Responsible Party):
King's College Hospital NHS Trust

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 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, 2021
Actual Primary Completion Date : January 11, 2022
Actual Study Completion Date : January 30, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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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
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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
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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
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United Kingdom
King's College Hospital NHS Foundation TRUST
London, United Kingdom, SE5 9RS
Sponsors and Collaborators
King's College Hospital NHS Trust
King's College London
More Information
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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: March 19, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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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