NCT04360642

Brief 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. The study will look at the impact of singing on breathing, wellbeing, frailty and engagement.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 10, 2017

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

January 25, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2019

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

April 24, 2020

Completed
Last Updated

April 29, 2020

Status Verified

April 1, 2020

Enrollment Period

1.9 years

First QC Date

January 25, 2019

Last Update Submit

April 27, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • Lung function

    Lung function will be assessed by Spirometry (FVC and FEV1)

    12 weeks

  • Lung function

    Lung function will be assessed by Medical Research Council (MRC) breathlessness scale (Scores 1-5, good to worse)

    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

    12 weeks

Secondary Outcomes (2)

  • Mental Wellbeing

    12 weeks

  • Frailty

    12 weeks

Study Arms (1)

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.

Other: singing

Interventions

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:

singing arm

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Torbay Hospital

Torquay, Devon, TQ2 7AA, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Singing

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhonationRespiratory Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Fiona Roberts

    Torbay and South Devon NHS Foundation Trust

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2019

First Posted

April 24, 2020

Study Start

May 10, 2017

Primary Completion

March 30, 2019

Study Completion

March 30, 2019

Last Updated

April 29, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations