Objective | Outcome | |
---|---|---|
1 | To examine participant recruitment and identify barriers to recruitment | • The proportion of eligible individuals agreeing to participate • Reasons for declining to participate |
2 | To examine the suitability of two candidate primary outcomes for a full-scale trial | The extent and pattern of missing data, presence of floor/ceiling effects, and variability in responses in: a) number of true positive and false positive screens identified by usual care and digital screening between baseline and 8 weeks postpartum b) MINI at 6 months postpartum |
3 | To examine the suitability of other proposed clinical measures and health economic measures | The extent and pattern of missing data, presence of floor/ceiling effects, and variability in responses in: • PHQ-9 (baseline and after positive screen) • GAD-7 (baseline and after positive screen) • MINI (8 weeks) • Postpartum Bonding Questionnaire (8 weeks, 6 months) • Healthcare Resource Use Questionnaire (baseline, 8 weeks, 6 months) • EQ-5D-5L (baseline, 8 weeks, 6 months) |
4 | To examine the acceptability and usability of the digital screening system and participants’ experiences of using it | Qualitative (interview) and quantitative (MARS) data from participants in the app use group regarding app acceptability, usability, and experiences of using the digital screening system |
5 | To examine the safety of the digital monitoring system and study procedures | The number of adverse events (AEs) and serious adverse events (SAEs) and whether they are judged to be related to the app or other study procedures |