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SELF-BREATHE RCT for Chronic Breathlessness

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ClinicalTrials.gov Identifier: NCT04574050
Recruitment Status : Not yet recruiting
First Posted : October 5, 2020
Last Update Posted : October 5, 2020
Sponsor:
Collaborator:
King's College London
Information provided by (Responsible Party):
King's College Hospital NHS Trust

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

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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
Estimated Study Start Date : December 3, 2020
Estimated Primary Completion Date : April 4, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


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



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



Information from the National Library of Medicine

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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
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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: October 5, 2020
Last Verified: September 2020
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
Bronchiectasis
Lung Diseases, Interstitial
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