- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04830033
ENO Breathe vs Usual Care in COVID-19 Recovery (SHIELD ENO)
A Randomised Controlled Trial of the English National Opera Breathe Programme Compared With Usual Care in People Recovering From COVID-19
Study Overview
Detailed Description
BACKGROUND:
ENO Breathe is a breathing and wellbeing programme developed specifically for people recovering from COVID-19, who are still suffering from breathlessness and associated anxiety. Delivered by ENO in collaboration with Imperial College Healthcare teams entirely online, the programme focuses on breathing re-training through singing. Initial evaluation of the project suggested health improvements related to participation, however, a properly conducted efficacy study is needed.
DESIGN: An assessor blind, parallel group, randomised controlled trial, to assess the effects of ENO Breathe compared to usual care on health status. The study will also evaluate the impact on respiratory symptoms, anxiety, depression, and breathlessness perception to investigate the mechanisms involved.
RESEARCH QUESION AND OUTCOME MEASURES:
The primary outcome will be change in health status, assessed using the RAND-36 tool (RAND SF-36), comparing ENO Breathe and Usual Care arms.
Additional endpoints will be: the COPD assessment test score (CAT), 0-100 Visual Analogue Scales (VAS) for breathlessness (at rest, walking around the house, climbing stairs, and running), Dyspnoea-12, anxiety (GAD-7), and depression (PHQ-9).
Assessments: The outcomes outlined above will be recorded at baseline prior to randomisation, and then repeated after 6 weeks.
POPULATION: Adult patients recovering from COVID-19 will be recruited from specialist COVID-19 clinics, where participants will have been fully assessed and investigated by referring healthcare professionals. Participants in the active arm will attend once weekly ENO online workshop sessions for 6 weeks, and have access to bespoke online digital resources, designed to support participants between sessions. The comparison arm will receive usual care. Randomization will be 1:1.
SAMPLE SIZE Sample size: Based on pilot data in people with COPD, where the standard deviation (SD) for change in SF-36 was 15 points, to identify a clinically relevant 10 point difference in SF-36 responses at a 0.05 level of significance with a 90% power would require 48 patients in each treatment arm. Allowing for 20% dropout, we will therefore recruit 120 patients.
Primary analysis will be on an intention to treat basis. Change in parameters will be assessed comparing ENO Breathe and Usual Care, using Generalised Linear Models to estimate treatment effects. In order to better understand changes in the RAND-36 "anchor measure", the investigator will relate this to changes in measures of anxiety, depression, breathlessness, and other respiratory symptoms.
An additional responder analysis will compare the proportion in each treatment arm achieving a clinically important (10%) improvement in RAND-36 scores.
Update 21 JUNE 2021
To calculate the sample size, pilot data from a singing-based intervention in COPD, (considered the most relevant data available at study inception) was used, as outlined above, where the researchers aimed to recruit 120 patients. Data subsequently became available from ENO Breathe participants that rook part in the program prior to the research study, in which the SD was 8 for change in SF-36 scores. We have also decided using an MCID of 5 for the SF-36 is more appropriate, as this is not specific to a particular medical condition. As such, a total sample of 108 participants is required, using 1 to 1 study arm allocation. Allowing for 30% dropout, which is more appropriate, 158 participants will be recruited. Additionally, as a higher than expected number of participants were considered, study withdrawals due to be unable to attend the session times they were allocated, or despite meeting inclusion criteria, 1-to-1 meeting with the session leaders highlighted issues related excessive fatigue precipitated by exertion, so were not deemed appropriate at that point in time. As such, the researchers will also conduct a modified intention to treat analysis including all participants who were randomised and were deemed appropriate to participate following their 1-to-1. This consideration had not been included in the original exclusion criteria, due to limited awareness of its relevance at that time. These changes have been made, and here documented, before any baseline data has been sent to the analysis team, and before any follow up data has been collected.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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London, United Kingdom, SW3 6NP
- National Heart and Lung Institute, Imperial College London
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: ENO Breathe group
Participation in the online ENO Breathe programme for 6 weeks.
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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.
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No Intervention: Usual Care Group
Participants continue with usual care.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in RAND-36 (RAND SF-36)
Time Frame: At baseline, then repeated after 6 weeks.
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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.
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At baseline, then repeated after 6 weeks.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in COPD assessment test (CAT)
Time Frame: At baseline, then repeated after 6 weeks.
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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).
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At baseline, then repeated after 6 weeks.
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Changes in Generalised Anxiety Disorder Assessment (GAD-7)
Time Frame: At baseline, then repeated after 6 weeks.
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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.
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At baseline, then repeated after 6 weeks.
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Changes in Patient Health Questionnaire 9 (PHQ-9)
Time Frame: At baseline, then repeated after 6 weeks.
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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.
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At baseline, then repeated after 6 weeks.
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Changes in Dyspnoea-12 questionnaire
Time Frame: At baseline, then repeated after 6 weeks.
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Assessment of dyspnoea.
Includes 12 descriptors scored from 0 to 3, giving a total score of 36.
Lower scores indicate less severe dyspnoea.
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At baseline, then repeated after 6 weeks.
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Changes in Visual Analogue Scale ratings of breathlessness
Time Frame: At baseline, then repeated after 6 weeks.
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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).
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At baseline, then repeated after 6 weeks.
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Changes in SF-6D (Short-Form Six-Dimension) scores
Time Frame: At baseline, then repeated after 6 weeks.
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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.
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At baseline, then repeated after 6 weeks.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Nicholas S Hopkinson, Imperial College London
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SHIELD COVID - ENO sub-study 2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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