Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000736549
Ethics application status
Approved
Date submitted
5/07/2015
Date registered
16/07/2015
Date last updated
4/05/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Sing Your Lungs Out: Effect of community singing group on lung function, anxiety and depression, and health care use in patients with COPD who have completed pulmonary rehabilitation programme.
Scientific title
Sing Your Lungs Out: Effect of participation in weekly community singing group for 1 year, on lung function, anxiety and depression and health care use in patients with COPD who have completed pulmonary rehabilitation: a quantitative and qualitative study.
Secondary ID [1] 286999 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COPD 295463 0
Breathlessness 295464 0
Condition category
Condition code
Respiratory 295718 295718 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Weekly attendance at one hour community singing group for one year, (with register of attendance) having completed pulmonary rehabilitation.
Intervention code [1] 292206 0
Rehabilitation
Intervention code [2] 292306 0
Lifestyle
Comparator / control treatment
We will compare number of acute exacerbations of COPD requiring hospital, GP or emergency attendance for each patient in the 12 months prior to joining the singing group,, with their health care use over the year of the SYLO study. Otherwise no controls.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 295421 0
Lung function: Spirometry, Lung volumes and 6 minute walk test.
CCQ: Clinical COPD Questionnaire ( with permission)
Timepoint [1] 295421 0
Baseline recordings 1 week prior to singing group attendance, then at 4 months and 1 year following commencement of intervention.
Primary outcome [2] 295422 0
Anxiety and depression: HADs: Hospital Anxiety and Depression Score
Timepoint [2] 295422 0
Baseline recordings 1 week prior to singing group attendance, then at 4 months and 1 year following commencement of intervention.
Secondary outcome [1] 315562 0
Acute exacerbation of COPD requiring Hospital, GP or emergency department attendance : from electronic GP and hospital records.
Timepoint [1] 315562 0
Baseline recordings 1 week prior to singing group attendance, then at 4 months and 1 year following commencement of intervention.
Secondary outcome [2] 323392 0
Qualitative description of individual interviews and focus group meeting with people participating in the singing group regarding their experience.
Timepoint [2] 323392 0
Six to nine months after starting with the singing group.

Eligibility
Key inclusion criteria
Have chronic lung disease and breathlessness.
Have completed a CCDHB pulmonary rehabilitation programme and are attending a weekly maintenance exercise class
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current enrolment in another clinical COPD trial.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients with COPD who have completed CCDHB pulmonary rehabilitation were invited to join a weekly community singing group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
This is a feasibility study to look at recruitment and estimate SD in a real population.
1. Basic descriptive statistics of this cohort sample of COPD Pulmonary rehabilitation patients.
2. Longitudinal data analysis of each individual looking at significant change in Lung function, HADscore and health care utilisation compared with baseline3. For patient interviews and focus group discussion:
Qualitative content analysis of transcribed interviews using QDA miner.
Analysis will be iterative allowing emerging themes to be explored in later interviews.
Themes will be coded and categorised for analysis..

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
20/10/2014
Actual
20/10/2014
Date of last participant enrolment
Anticipated
19/10/2015
Actual
12/05/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
23
Recruitment outside Australia
Country [1] 7005 0
New Zealand
State/province [1] 7005 0
Wellington

Funding & Sponsors
Funding source category [1] 291552 0
Self funded/Unfunded
Name [1] 291552 0
Country [1] 291552 0
Primary sponsor type
Individual
Name
Dr Amanda McNaughton
Address
Department of Respiratory Medicine
Wellington Hospital
Capital and Coast District Health Board
Wellington 6021
New Zealand
Country
New Zealand
Secondary sponsor category [1] 290229 0
None
Name [1] 290229 0
Address [1] 290229 0
Country [1] 290229 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293094 0
Capital and Coast District Health Board
Ethics committee address [1] 293094 0
Ethics committee country [1] 293094 0
New Zealand
Date submitted for ethics approval [1] 293094 0
23/09/2014
Approval date [1] 293094 0
23/09/2014
Ethics approval number [1] 293094 0
Low risk interventional study. Does not meet criteria for formal review by HDEC

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58450 0
Dr Amanda McNaughton
Address 58450 0
Department of Respiratory Medicine
Wellington Hospital
Riddiford Street
Wellington 6021
Country 58450 0
New Zealand
Phone 58450 0
+64278386925
Fax 58450 0
Email 58450 0
[email protected]
Contact person for public queries
Name 58451 0
Gayle Williams
Address 58451 0
Pulmonary Rehabilitation Nurse
Wellington Hospital
Riddiford Street
Wellington 6021
Country 58451 0
New Zealand
Phone 58451 0
+64272263260
Fax 58451 0
Email 58451 0
[email protected]
Contact person for scientific queries
Name 58452 0
Amanda McNaughton
Address 58452 0
Department of Respiratory Medicine
Wellington Hospital
Riddiford Street
Wellington 6021
Country 58452 0
New Zealand
Phone 58452 0
+64278386925
Fax 58452 0
Email 58452 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseSing Your Lungs Out: A qualitative study of a community singing group for people with chronic obstructive pulmonary disease (COPD).2016https://dx.doi.org/10.1136/bmjopen-2016-012521
EmbaseSing Your Lungs Out - A community singing group for chronic obstructive pulmonary disease: A 1-year pilot study.2017https://dx.doi.org/10.1136/bmjopen-2016-014151
N.B. These documents automatically identified may not have been verified by the study sponsor.