The TOPSY pessary self-management intervention for pelvic organ prolapse: a study protocol for the process evaluation

Table 1 Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) figure for the study

	Enrolment	Allocation	Follow-ups		Close out	On completion of all recruitment at a centre
Timepoint	-t1	0	6 months	12 months	18 months	variable
Screening and eligibility	X
Informed consent		X
Interventions: Clinic-based care Self-management
ASSESSMENTS
Qualitative
Audio-recording of recruitment sessions	X
Interviews with randomised women (both groups)		X			X
Interviews with non-randomised women who use a pessary as treatment		X			X
Interviews with health professional recruiters and those who deliver the intervention						X
Open question with main trial questionnaires		X	X	X	X
Quantitative
General Self-Efficacy		X			X
Pessary Confidence Questionnaire		X	X	X	X
Quality of life		X	X	X	X
Pessary Use Questionnaire		X	X	X	X
Checklist completion about self-management teaching appointment		X
Recording sample of self-management teaching appointments		X
Checklist completion for 2-week follow-up phone call		X (2 weeks after teaching)
Recording sample of 2-week follow-up calls		X (2 weeks after teaching)

ISSN: 1745-6215