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SELF-BREATHE RCT for Chronic Breathlessness


2021-01-11


2022-01-11


2022-01-30


52

Study Overview

SELF-BREATHE RCT for Chronic Breathlessness

A feasibility RCT comprising two groups: 1. Intervention (SELF-BREATHE in addition to standard NHS care) 2. Control group (standard / currently available NHS care)

N/A

  • 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
  • IRAS 285303
  • 20/LO/1108 (OTHER Identifier) (OTHER: REC / HRA)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2020-09-28  

N/A  

2024-03-18  

2020-10-01  

N/A  

2024-03-19  

2020-10-05  

N/A  

2024-03  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment


Allocation:
Randomized


Interventional Model:
Parallel


Masking:
Single


Arms and Interventions

Participant Group/ArmIntervention/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 MeasuresMeasure DescriptionTime Frame
Feasibility: the number of patients recruited into this study over a 12-month periodThe number of patients recruited into this study over a 12-month period12 months
Secondary Outcome MeasuresMeasure DescriptionTime Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

  • King's College London

  • : ,

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available