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

Table 2 Phase II and III primary and secondary outcomes

PHASE II
Primary outcome	Timepoint	Detail
Feasibility and acceptability	6 months	Number of participants enrolled, randomised, and who complete the program. Completion is defined as attending 8 of 12 singing sessions or completing the week 12 assessment for control arm participants
PHASE III
Primary outcome	Timepoint	Detail
Quality of life	12 weeks	Between arm difference in SF-36
Secondary outcome	Timepoint	Detail
Anxiety and depression	12 weeks	Between arm difference in HADS
Breathlessness	12 weeks	Between arm difference in Dypnoea-12
Mastery of breathing	12 weeks	Between arm difference in mastery subdomain of CRQ-SAS
Exercise tolerance	12 weeks	Between arm difference in 6MWT
Loneliness	12 weeks	Between arm difference in UCLA-3
Healthcare utilisation	12 weeks	Between arm difference in self-reported healthcare utilisation
Carer quality of life (optional)	12 weeks	Between arm difference in carer SF-36
Patient and carer perceptions of group singing	Baseline, 4-weeks, 12-weeks	Semi-structured interview thematic analysis
Social dynamics and interactions	Throughout intervention	Ethnographic study of group classes

SF-36 36-Item Short Form Survey, HADS Hospital Anxiety and Depression Scale, CRQ-SAS Chronic Respiratory Disease Questionnaire—Self Administered Standardised, 6MWT 6-Minute Walk Test, UCLA-3 University of California Los Angeles Loneliness Scale version 3 Short Form

ISSN: 1465-993X