COPDNCT04360642
Singing for Wellness: Is Singing a Useful Way of Supporting People in South Devon to Self-manage Aspects of Their COPD
A study testing singing in people with COPD, run by Torbay and South Devon NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The aim of this study is to explore whether singing is a useful way of supporting people in South Devon to self manage aspects of their COPD and associated social isolation. It will also investigate whether a model of bespoke respiratory community choirs provides a useful service for our local community. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- COPD
- What is being tested?
- singing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 May 2017to 30 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with COPD
- Evidence of airflow obstruction as measured by spirometry
- Being independently mobile and able to get to location
- Being able to give permission to participate
- Over 18 years old
- Awaiting pulmonary rehabilitation or have completed pulmonary rehabilitation
Who cannot join
- Lacking capacity to give permission to participate e.g. severe dementia
- Other health issues which preclude participation e.g. psychosis, unstable physical health
- Under 18 years of age
- Not diagnosed with COPD
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Singing for Wellness: Is Singing a Useful Way of Supporting People in South Devon to Self-manage Aspects of Their COPD: Does a Bespoke Respiratory Choir Provide a Non-medical Intervention for Those With COPD in Our Local Community
The aim of this study is to explore whether singing is a useful way of supporting people in South Devon to self manage aspects of their COPD and associated social isolation. It will also investigate whether a model of bespoke respiratory community choirs provides a useful service for our local community. The study will look at the impact of singing on breathing, wellbeing, frailty and engagement.
- Conditions
- COPD
- Being tested
- singing
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
singingOther
Singing for Wellness will use an uncontrolled observational study design. Two mixed-cohort, 12-week community choirs will be delivered by experienced vocal practitioners in South Devon localities:
| Study group | Role | What they receive |
|---|---|---|
| singing arm | Other | Singing for Wellness will use an uncontrolled observational study design. Two mixed-cohort, 12-week community choirs will be delivered by experienced vocal practitioners in South Devon localities: Newton Abbott and Torquay.
Lung function, frailty and health-related quality of life will be assessed by Spirometry, CRQ (chronic respiratory questionnaire), MRC breathlessness scale, Rockwood frailty and Warwick-Edinburgh Mental Well-being Scale (WEMWBS). Participants will be assessed at baseline and then again at completion of the 12-week course.
Written feedback from participants to capture qualitative experience using narrative and Patient Reported Outcome Measures (PROMs). The attrition and attendance rate will also be recorded for later review. Receives: Other: singing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung function
Lung function will be assessed by Spirometry (FVC and FEV1)
Measured: 12 weeks
Lung function
Lung function will be assessed by Medical Research Council (MRC) breathlessness scale (Scores 1-5, good to worse)
Measured: 12 weeks
Lung function
Lung function will be assessed by Chronic Respiratory Questionnaire (CRQ), Likert scale 1-7, higher scores indicate better health related quality of life
Measured: 12 weeks
Secondary outcomes (2)
Mental Wellbeing
Warwick-Edinburgh Mental Wellbeing Scale which assesses the mental wellbeing (positive mental health) of a person.(scores 1-5 experiences from none of the time to all of the time)
Measured: 12 weeks
Frailty
Rockwood Frailty Scale to categories a patient into one of nine general frailty classifications.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2020
- Study start10 May 2017
- Primary completion30 Mar 2019
- Study completion30 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Singing for Wellness will use an uncontrolled observational study design. Two mixed-cohort, 12-week community choirs will be delivered by experienced vocal practitioners in South Devon localities: Newton Abbott and Torquay.
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Torbay and South Devon NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fiona Roberts, Study director, Torbay and South Devon NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04360642
- Sponsor's protocol ID
- 209103
- Status last verified
- Apr 2020
- First submitted
- 25 Jan 2019
- Last updated
- 29 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Singing for Wellness: Is Singing a Useful Way of Supporting People in South Devon to Self-manage Aspects of Their COPD: Does a Bespoke Respiratory Choir Provide a Non-medical Intervention for Those With COPD in Our Local Community
- ClinicalTrials.gov ID
- NCT04360642
- Acronym / sponsor ID
- 209103
- Conditions
- COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Torbay and South Devon NHS Foundation TrustUniversity, hospital or other
- Study start
- 10 May 2017 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 30 Mar 2019 (actual)
- First posted
- 24 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to explore whether singing is a useful way of supporting people in South Devon to self manage aspects of their COPD and associated social isolation. It will also investigate whether a model of bespoke respiratory community choirs provides a useful service for our local community. The study will look at the impact of singing on breathing, wellbeing, frailty and engagement.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Singing for Wellness will use an uncontrolled observational study design. Two mixed-cohort, 12-week community choirs will be delivered by experienced vocal practitioners in South Devon localities: Newton Abbott and Torquay.
| Arm | Type | Receives |
|---|---|---|
| singing arm | Other | Other: singingSinging for Wellness will use an uncontrolled observational study design. Two mixed-cohort, 12-week community choirs will be delivered by experienced vocal practitioners in South Devon localities: Newton Abbott and Torquay. Lung function, frailty and health-related quality of life will be assessed by Spirometry, CRQ (chronic respiratory questionnaire), MRC breathlessness scale, Rockwood frailty and Warwick-Edinburgh Mental Well-being Scale (WEMWBS). Participants will be assessed at baseline and then again at completion of the 12-week course. Written feedback from participants to capture qualitative experience using narrative and Patient Reported Outcome Measures (PROMs). The attrition and attendance rate will also be recorded for later review. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed with COPD
Key exclusion criteria (4 listed)
- Lacking capacity to give permission to participate e.g. severe dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| singingSinging for Wellness will use an uncontrolled observational study design. Two mixed-cohort, 12-week community choirs will be delivered by experienced vocal practitioners in South Devon localities: | Other | singing arm |
Primary outcome
Lung function
Time frame: 12 weeks
Lung function will be assessed by Spirometry (FVC and FEV1)
Lung function
Time frame: 12 weeks
Lung function will be assessed by Medical Research Council (MRC) breathlessness scale (Scores 1-5, good to worse)
Lung function
Time frame: 12 weeks
Lung function will be assessed by Chronic Respiratory Questionnaire (CRQ), Likert scale 1-7, higher scores indicate better health related quality of life
2 secondary outcomes
Mental Wellbeing
Time frame: 12 weeks
Frailty
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fiona Roberts study director
Torbay and South Devon NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing singing in people with COPD, run by Torbay and South Devon NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung function (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2020.