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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. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE September 28, 2020
First Posted Date  ICMJE October 5, 2020
Last Update Posted Date March 19, 2024
Actual Study Start Date  ICMJE January 11, 2021
Actual Primary Completion Date January 11, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 1, 2020)		 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SELF-BREATHE RCT for Chronic Breathlessness
Official Title  ICMJE A Self - Guided, Internet - Based Intervention for Patients With Chronic Breathlessness (SELF-BREATHE): Feasibility Randomised Controlled Trial
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)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Cancer
  • COPD
  • Asthma
  • Bronchiectasis Adult
  • Interstitial Lung Disease
  • Cystic Fibrosis
  • Chronic Heart Failure
  • Sickle Cell Disease
  • Renal Failure
  • Liver Failure
  • Post COVID-19
  • Dyspnea
Intervention  ICMJE Other: SELF-BREATHE
A self -guided, internet -based intervention for patients with chronic breathlessness
Study Arms  ICMJE
  • Experimental: SELF-BREATHE
    Access to a self -guided, internet -based intervention for patients with chronic breathlessness known as SELF-BREATHE
    Intervention: Other: SELF-BREATHE
  • No Intervention: Control
    standard / currently available NHS care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 18, 2024)		 52
Original Estimated Enrollment  ICMJE
 (submitted: October 1, 2020)		 40
Actual Study Completion Date  ICMJE January 30, 2022
Actual Primary Completion Date January 11, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04574050
Other Study ID Numbers  ICMJE IRAS 285303
20/LO/1108 ( Other Identifier: REC / HRA )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party King's College Hospital NHS Trust
Original Responsible Party Same as current
Current Study Sponsor  ICMJE King's College Hospital NHS Trust
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE King's College London
Investigators  ICMJE Not Provided
PRS Account King's College Hospital NHS Trust
Verification Date March 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP