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Clinical Trials/ISRCTN80330546
ISRCTN80330546
Completed
未知

Breathlessness RElief AT HomE (BREATHE): a feasibility cluster randomised controlled trial (cRCT) to test if a definitive cRCT is possible to evaluate the effectiveness and cost-effectiveness of a paramedic-administered breathlessness crisis intervention for people with acute-on-chronic breathlessness compared with usual care

niversity of Hull0 sites42 target enrollmentNovember 11, 2019

Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
niversity of Hull
Enrollment
42
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33816602/ (added 14/04/2021) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36415651/ (added 24/11/2022)

Registry
who.int
Start Date
November 11, 2019
End Date
July 31, 2021
Last Updated
3 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversity of Hull

Eligibility Criteria

Inclusion Criteria

  • Paramedic\-participants:
  • 1\. From a participating ambulance stations
  • 2\. Able to provide informed consent
  • 3\. Willing to undergo training and to deliver intervention if so randomised
  • 4\. Willing to undergo training to participate in study measures and processes
  • Patient\-participants:
  • 1\. In their normal home environment experiencing a breathlessness crisis and receiving a 999 ambulance response from participating paramedics
  • 2\. Who do not require immediate life\-saving intervention/transfer to ED in the opinion of the attending paramedic
  • 3\. Call\-out due to breathlessness
  • 4\. Who experience chronic breathlessness (defined as short of breath most days in the last 3 months or longer)

Exclusion Criteria

  • Paramedic\-participants:
  • 1\. Failure of inclusion criteria
  • Patient\-participants:
  • 1\. Patients requiring urgent disease\-directed intervention and transfer to the ED for acute pathology in the opinion of the attending paramedic
  • 2\. Patient does not have capacity to provide retrospective consent
  • 3\. Patient is currently enrolled on the trial or has previously participated

Outcomes

Primary Outcomes

Not specified

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