SINFONIA study protocol: a phase II/III randomised controlled trial examining benefits of guided online group singing in people with chronic obstructive pulmonary disease and interstitial lung disease and their carers.
Advanced lung disease
Breathlessness
Chronic obstructive pulmonary disease
Community
Interstitial lung disease
Intervention
Music therapy
Online
Singing
Journal
Respiratory research
ISSN: 1465-993X
Titre abrégé: Respir Res
Pays: England
ID NLM: 101090633
Informations de publication
Date de publication:
16 Aug 2022
16 Aug 2022
Historique:
received:
22
03
2022
accepted:
06
08
2022
entrez:
16
8
2022
pubmed:
17
8
2022
medline:
19
8
2022
Statut:
epublish
Résumé
Chronic obstructive pulmonary disease (COPD) and interstital lung disease (ILD) are incurable conditions characterised by airflow limitation, persisting respiratory symptoms, and progressive respiratory failure. People living with COPD or ILD often suffer from chronic and severe breathlessness, with limited treatment options and low engagement rates with current therapies. Group singing represents a potential community-based therapy to improve quality of life for patients with COPD or ILD and breathlessness. This protocol papers describes SINFONIA, a parallel, double-arm, randomised, blinded-analysis, mixed-methods phase II/III trial of guided, online group singing that will be conducted over 24 months. Adults with confirmed COPD or ILD, on stable treatment for at least four weeks at time of recruitment, with a modified Medical Research Council (mMRC) dyspnoea score of two or greater, who are capable and willing to give consent, and not currently participating in pulmonary rehabilitation will be eligible to participate. Carers may optionally enrol in the trial. Data will be collected on quality of life, anxiety and depression, breathlessness, mastery of breathing, exercise tolerance, loneliness, healthcare utilisation, and carer quality of life (optional). Participants will be randomised 1:1 to intervention or control arms with intervention arm attending one 90 min, guided, online, group singing session per week for 12 weeks and control arm continuing routine care. Phase II of the trial aims to determine the feasibility and acceptability of guided, online group singing and will collect preliminary data on effectiveness. Phase III aims to determine whether guided, online group singing has an effect on quality of life with the primary outcome being a between arm difference in quality of life (36-item Short Form Survey) measured at 12 weeks. SINFONIA is the first study is the first of its kind in Australia and to our knowledge, the first to deliver the singing intervention program entirely online. Determining the feasibility, acceptability, and effectiveness of guided, online group singing is an important step towards improving low-cost, low-risk, community-based therapeutic options for patients living with COPD or ILD and breathlessness. Phase II- ACTRN12621001274864 , registered 20th September 2021; Phase III- ACTRN12621001280897 , registered 22nd September 2021.
Sections du résumé
BACKGROUND
BACKGROUND
Chronic obstructive pulmonary disease (COPD) and interstital lung disease (ILD) are incurable conditions characterised by airflow limitation, persisting respiratory symptoms, and progressive respiratory failure. People living with COPD or ILD often suffer from chronic and severe breathlessness, with limited treatment options and low engagement rates with current therapies. Group singing represents a potential community-based therapy to improve quality of life for patients with COPD or ILD and breathlessness.
METHODS
METHODS
This protocol papers describes SINFONIA, a parallel, double-arm, randomised, blinded-analysis, mixed-methods phase II/III trial of guided, online group singing that will be conducted over 24 months. Adults with confirmed COPD or ILD, on stable treatment for at least four weeks at time of recruitment, with a modified Medical Research Council (mMRC) dyspnoea score of two or greater, who are capable and willing to give consent, and not currently participating in pulmonary rehabilitation will be eligible to participate. Carers may optionally enrol in the trial. Data will be collected on quality of life, anxiety and depression, breathlessness, mastery of breathing, exercise tolerance, loneliness, healthcare utilisation, and carer quality of life (optional). Participants will be randomised 1:1 to intervention or control arms with intervention arm attending one 90 min, guided, online, group singing session per week for 12 weeks and control arm continuing routine care. Phase II of the trial aims to determine the feasibility and acceptability of guided, online group singing and will collect preliminary data on effectiveness. Phase III aims to determine whether guided, online group singing has an effect on quality of life with the primary outcome being a between arm difference in quality of life (36-item Short Form Survey) measured at 12 weeks.
DISCUSSION
CONCLUSIONS
SINFONIA is the first study is the first of its kind in Australia and to our knowledge, the first to deliver the singing intervention program entirely online. Determining the feasibility, acceptability, and effectiveness of guided, online group singing is an important step towards improving low-cost, low-risk, community-based therapeutic options for patients living with COPD or ILD and breathlessness.
TRIAL REGISTRATION
BACKGROUND
Phase II- ACTRN12621001274864 , registered 20th September 2021; Phase III- ACTRN12621001280897 , registered 22nd September 2021.
Identifiants
pubmed: 35974347
doi: 10.1186/s12931-022-02133-3
pii: 10.1186/s12931-022-02133-3
pmc: PMC9380685
doi:
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
208Informations de copyright
© 2022. The Author(s).
Références
Chest. 2003 Oct;124(4):1421-9
pubmed: 14555575
BMJ Open Respir Res. 2020 Nov;7(1):
pubmed: 33239406
J Pain Symptom Manage. 2009 Jul;38(1):115-23
pubmed: 19232893
Ann Am Thorac Soc. 2017 Sep;14(9):1419-1427
pubmed: 28719225
Eur Respir J Suppl. 2001 Sep;32:2s-16s
pubmed: 11816822
BMC Psychol. 2018 Aug 17;6(1):41
pubmed: 30119704
Curr Opin Support Palliat Care. 2010 Jun;4(2):69-75
pubmed: 20375900
Med J Aust. 2013 Feb 18;198(3):144-8
pubmed: 23418694
Perspect Public Health. 2018 Jul;138(4):215-222
pubmed: 29757080
Chest. 2005 Dec;128(6):3810-6
pubmed: 16354849
Qual Life Res. 2019 Mar;28(3):725-735
pubmed: 30612266
Cochrane Database Syst Rev. 2017 Dec 19;12:CD012296
pubmed: 29253921
Res Aging. 2004;26(6):655-672
pubmed: 18504506
Int J Chron Obstruct Pulmon Dis. 2020 Nov 16;15:2941-2952
pubmed: 33235443
NPJ Prim Care Respir Med. 2016 Dec 1;26:16080
pubmed: 27906158
Intern Med J. 2018 Apr;48(4):483-484
pubmed: 29623984
Spine (Phila Pa 1976). 2000 Dec 15;25(24):3130-9
pubmed: 11124729
Thorax. 2002 Nov;57(11):939-44
pubmed: 12403875
Int J Chron Obstruct Pulmon Dis. 2009;4:1-8
pubmed: 19436683
Aust Health Rev. 2020 Sep;44(5):778-781
pubmed: 32943138
Ann Am Thorac Soc. 2019 Jan;16(1):99-106
pubmed: 30417670
J Educ Eval Health Prof. 2011;8:4
pubmed: 21637319
Int J Lang Commun Disord. 2020 May;55(3):303-319
pubmed: 32096327
Acta Psychiatr Scand. 1983 Jun;67(6):361-70
pubmed: 6880820
Lancet Respir Med. 2022 Apr 27;:
pubmed: 35489367
J Palliat Med. 2009 Jan;12(1):29-36
pubmed: 19284260
BMJ Open. 2016 Sep 20;6(9):e012521
pubmed: 27650768
BMJ Open. 2017 Jan 24;7(1):e014151
pubmed: 28119393
Eur Respir Rev. 2014 Sep;23(133):345-9
pubmed: 25176970
N Engl J Med. 2004 Mar 4;350(10):1005-12
pubmed: 14999112
Physiother Can. 2010 Fall;62(4):368-73
pubmed: 21886377
Rev Port Pneumol. 2014 Jul-Aug;20(4):225-8
pubmed: 24793633
Br Med J (Clin Res Ed). 1982 May 29;284(6329):1607-8
pubmed: 6805625
JAMA. 2001 Apr 18;285(15):2006-7
pubmed: 11308440
BMJ. 2013 Jan 08;346:e7586
pubmed: 23303884
Thorax. 2010 Jan;65(1):21-6
pubmed: 19996336
Am J Respir Crit Care Med. 1999 Jan;159(1):321-40
pubmed: 9872857
Thorax. 1987 Oct;42(10):773-8
pubmed: 3321537
BMC Pulm Med. 2010 Aug 03;10:41
pubmed: 20682030
Ann Intern Med. 2013 Feb 5;158(3):200-7
pubmed: 23295957
BMC Pulm Med. 2012 Nov 13;12:69
pubmed: 23145504
Qual Health Res. 2016 Nov;26(13):1753-1760
pubmed: 26613970
Thorax. 2020 Jul;75(7):597-599
pubmed: 32317268
Chest. 2016 Oct;150(4):837-859
pubmed: 27497743