Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000584437
Ethics application status
Approved
Date submitted
1/05/2016
Date registered
5/05/2016
Date last updated
5/05/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of being part of a weekly singing group on health and wellbeing, for people with chronic lung disease who choose not to attend pulmonary rehabilitation programme.
Scientific title
A cohort study of the effects of a weekly singing group (SYLO) for patients with chronic lung disease who decline standard pulmonary rehabilitation
Secondary ID [1] 289115 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COPD 298587 0
Chronic lung disease with breathlessness 298588 0
Condition category
Condition code
Respiratory 298663 298663 0 0
Chronic obstructive pulmonary disease
Respiratory 298671 298671 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Parallel cohort observational study. SYLO is available to all breathless patients .
We are not assigning singing group participation, but prospectively observing those that choose to do it instead of pulmonary rehabilitation
Participation in a weekly singing group (Sing Your Lungs Out)
1 hour, once a week, with register of attendance. Participants will be monitored for one year after joining the singing group.
Intervention code [1] 294621 0
Not applicable
Comparator / control treatment
Comparator is the people accepting contemporaneous standard pulmonary rehabilitation : 6 to 8 week outpatient programme of individualised exercise and education. 1.5 hours twice a week. With record of attendance.
Control group
Active

Outcomes
Primary outcome [1] 298157 0
Composite of anxiety and depression assessed by total HADS score
Timepoint [1] 298157 0
At enrollment, and at 4 months and at one year post first SYLO enrollment.
At enrollment and at end of Pulmonary rehabilitation for the ' control/ comparator' group
Secondary outcome [1] 323317 0
Six minute walk test ( meters) to assess physical exercise tolerance
Timepoint [1] 323317 0
At enrollment, and at 4 months and at one year post first SYLO session

Eligibility
Key inclusion criteria
People living with COPD or chronic lung disease with breathlessness, referred to standard pulmonary rehabilitation programme, who decline or attend less than 3 sessions who choose to participate in the Sing Your Lungs Out weekly singing sessions.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any conditions that might interfere with the patient's ability to participate in rehabilitation process such as disabling arthritis and unstable angina, or they have active and transmissible respiratory infection eg TB

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
The sample size for this study is limited by the number of patients who decline or attend less than three sessions of PR, and in turn who are likely to then enrol in the SYLO group. In the 2014/5 audit of PR at CCDHB, 323 patients were referred to the pulmonary rehabilitation programme at Wellington, Kenepuru and Kapiti hospitals. Sixty-seven patients (20%) declined, and forty-four (25%) attended less than 4 sessions. We estimate it is likely that about 30 patients will agree to attend the SYLO intervention. The comparator group of patients attending S-PR is anticipated to be between 250 and 300 patients. The primary outcome variable for this study will be HADS score for which the minimally clinical important difference (MCID) is 1.5 points and standard deviation in our feasibility study was 2.3 points. (35)

The nominated sample size of 30 in SYLO and 250 in S-PR has over 90% power to detect the MCID for the HADS.

Simple data descriptions and plots will be used to characterise the participants. We will compare continuous outcome variables using t tests, sensitivity analyses by ANCOVA, and count variables using Poisson regression.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/05/2016
Actual
Date of last participant enrolment
Anticipated
11/11/2016
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
280
Accrual to date
Final
Recruitment outside Australia
Country [1] 7845 0
New Zealand
State/province [1] 7845 0
Porirua

Funding & Sponsors
Funding source category [1] 293488 0
Self funded/Unfunded
Name [1] 293488 0
Amanda McNaughton
Country [1] 293488 0
New Zealand
Primary sponsor type
Individual
Name
Dr Amanda McNaughton
Address
Medical Research Institute of New Zealand
Wellington Hospital
Riddiford Street
Wellington 6021 NZ
Country
New Zealand
Secondary sponsor category [1] 292312 0
None
Name [1] 292312 0
None
Address [1] 292312 0
None
Country [1] 292312 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294932 0
Wellington Hospital Clinical Trials Governance Group
Ethics committee address [1] 294932 0
Ethics committee country [1] 294932 0
New Zealand
Date submitted for ethics approval [1] 294932 0
13/04/2015
Approval date [1] 294932 0
20/04/2016
Ethics approval number [1] 294932 0
Not applicable

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

Contacts
Principal investigator
Name 65534 0
Dr Amanda McNaughton
Address 65534 0
Medical Research Institute of New Zealand
Wellington Hospital
Riddiford Street
Wellington 6021 NZ
Country 65534 0
New Zealand
Phone 65534 0
+64 27 8386925
Fax 65534 0
Email 65534 0
[email protected]
Contact person for public queries
Name 65535 0
Priti Kansara
Address 65535 0
Respiratory Scientist
Department of Respiratory Medicine
Hutt Hospital
High Street
Lower Hutt 5010
NewZealand
Country 65535 0
New Zealand
Phone 65535 0
+64, 4 5666999
Fax 65535 0
Email 65535 0
[email protected]
Contact person for scientific queries
Name 65536 0
Amanda McNaughton
Address 65536 0
Medical Research Institute of New Zealand
Wellington Hospital
Riddiford Street
Wellington 6021 NZ
Country 65536 0
New Zealand
Phone 65536 0
+64,27 8386925
Fax 65536 0
Email 65536 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
No additional documents have been identified.