- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04360642
Singing for Wellness: Is Singing a Useful Way of Supporting People in South Devon to Self-manage Aspects of Their COPD
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
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Devon
-
Torquay, Devon, United Kingdom, TQ2 7AA
- Torbay Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: singing arm
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. |
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lung function
Time Frame: 12 weeks
|
Lung function will be assessed by Spirometry (FVC and FEV1)
|
12 weeks
|
Lung function
Time Frame: 12 weeks
|
Lung function will be assessed by Medical Research Council (MRC) breathlessness scale (Scores 1-5, good to worse)
|
12 weeks
|
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
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mental Wellbeing
Time Frame: 12 weeks
|
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)
|
12 weeks
|
Frailty
Time Frame: 12 weeks
|
Rockwood Frailty Scale to categories a patient into one of nine general frailty classifications.
|
12 weeks
|
Collaborators and Investigators
Investigators
- Study Director: Fiona Roberts, Torbay and South Devon NHS Foundation Trust
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
Other Study ID Numbers
- 209103
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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