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ENO Breathe vs Usual Care in COVID-19 Recovery (SHIELD ENO)

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: NCT04830033
Recruitment Status : Completed
First Posted : April 2, 2021
Last Update Posted : December 3, 2021
Sponsor:
Collaborator:
Imperial College Healthcare NHS Trust
Information provided by (Responsible Party):
Imperial College London

Brief Summary:
A randomised clinical trial to assess the impact of an online singing, breathing and wellbeing programme (ENO Breathe) developed specifically for people recovering from COVID-19.

Condition or disease Intervention/treatment Phase
COVID-19 Recovery Other: ENO Breathe group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 153 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Masking of participants not possible due to the nature of the intervention.
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial of the English National Opera Breathe Programme Compared With Usual Care in People Recovering From COVID-19
Actual Study Start Date : April 28, 2021
Actual Primary Completion Date : September 23, 2021
Actual Study Completion Date : September 23, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ENO Breathe group
Participation in the online ENO Breathe programme for 6 weeks.
Other: ENO Breathe group
Six weekly group online workshop sessions, led by an ENO vocal specialist. Workshops will encourage participants to take part in exercises and activities especially designed to support breathing control, providing tools for self-management of breath and anxiety. They will also have access to bespoke online digital resources, designed to support participants between sessions. These will include exercises, song sheets and audio and video materials, especially recorded by the ENO for participants on the programme.

No Intervention: Usual Care Group
Participants continue with usual care.



Primary Outcome Measures :
  1. Change from baseline in RAND-36 (RAND SF-36) [ Time Frame: At baseline, then repeated after 6 weeks. ]
    A well-established, supervised, self-completion health status questionnaire. This consists of eight sections for which a score of 0 to 100 is created, with 0 being maximum disability and 100 equivalent to no disability.


Secondary Outcome Measures :
  1. Changes in COPD assessment test (CAT) [ Time Frame: At baseline, then repeated after 6 weeks. ]
    A respiratory disease health status measure that has been validated in people recovering from COVID-19. This includes 8 items, scored 0-5 with a possible score from 0 (best) to 40 (worst).

  2. Changes in Generalised Anxiety Disorder Assessment (GAD-7) [ Time Frame: At baseline, then repeated after 6 weeks. ]
    Self-administered questionnaire to assess for symptoms, and severity, of anxiety. Includes seven questions scored from 0 to 3, giving a total score out of 21. Lower scores indicate less symptoms of anxiety.

  3. Changes in Patient Health Questionnaire 9 (PHQ-9) [ Time Frame: At baseline, then repeated after 6 weeks. ]
    Self-administered questionnaire to assess for symptoms, and severity, of depression. Includes nine questions scored from 0 to 3, giving a total score out of 27. Lower scores indicate less symptoms of depression.

  4. Changes in Dyspnoea-12 questionnaire [ Time Frame: At baseline, then repeated after 6 weeks. ]
    Assessment of dyspnoea. Includes 12 descriptors scored from 0 to 3, giving a total score of 36. Lower scores indicate less severe dyspnoea.

  5. Changes in Visual Analogue Scale ratings of breathlessness [ Time Frame: At baseline, then repeated after 6 weeks. ]
    Four Visual Analogue Scales, scored from 0 to 100, for participants to rate their breathlessness while i) at rest, ii) walking around the house, iii) climbing stairs, iv) running. Higher scores indicate more severe dyspnoea (breathlessness).

  6. Changes in SF-6D (Short-Form Six-Dimension) scores [ Time Frame: At baseline, then repeated after 6 weeks. ]
    The SF-6D uses data from the RAND SF-36 to generate a continuous index for health that can be used to create a quality-of-life score for cost utility analysis.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults recovering from COVID-19 with ongoing breathlessness and/or anxiety.
  • Referred from a specialist COVID-19 clinics aligned with the project, after appropriate clinical evaluation and investigation
  • Internet access with appropriate device (e.g. computer or tablet)

Exclusion Criteria:

- Unable to participate due to comorbidity (e.g. life limiting illness, cognitive impairment)


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): NCT04830033


Locations
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United Kingdom
National Heart and Lung Institute, Imperial College London
London, United Kingdom, SW3 6NP
Sponsors and Collaborators
Imperial College London
Imperial College Healthcare NHS Trust
Investigators
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Principal Investigator: Nicholas S Hopkinson Imperial College London
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT04830033    
Other Study ID Numbers: SHIELD COVID - ENO sub-study 2
First Posted: April 2, 2021    Key Record Dates
Last Update Posted: December 3, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared on reasonable request.
Supporting Materials: Study Protocol
Time Frame: The data will be available from the date of publication of the main study, and will remain available for at least 2 years.
Access Criteria: Data will be shared on reasonable request.

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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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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases