Table 1 Procedures and outcome measures (SPIRIT table)
Baseline | During intervention | Follow-up (4–6 months) | |
|---|---|---|---|
Procedure/outcome measure | |||
Eligibility screening | ♦ | ||
Informed consent | ♦ | ||
Randomisation/allocation | ♦ | ||
Set-up and installation of study app (in intervention groups) | ♦ | ||
Demographic/clinical characteristics | |||
Age (years) | ♦ | ||
Sex (male/female) | ♦ | ||
Body mass index (kg/m2) | ♦ | ||
Lifestyle (smoking, alcohol use) | ♦ | ||
RF and ACPA status (positive/negative) | ♦ | ||
Erosive changes on latest radiograph (yes/no) | ♦ | ||
Disease duration (months/years) | ♦ | ||
Current and prior DMARD therapy and glucocorticoid/analgesic intake | ♦ | ♦ | |
Comorbidities and extra-articular manifestations | ♦ | ||
Outcome measures as part of routine care | |||
Patient global assessment of disease activity (VAS) | ♦ | ♦ | |
Physician global assessment of disease activity (VAS) | ♦ | ♦ | |
Tender joint count and swollen joint count (0–28) | ♦ | ♦ | |
C-reactive protein (mg/L) | ♦ | ♦ | |
Erythrocyte sedimentation rate (mm/h) | ♦ | ♦ | |
Nocturnal pain (yes/no) | ♦ | ♦ | |
Morning stiffness (yes/no) | ♦ | ♦ | |
HAQ-DI (0–3) | ♦ | ♦ | |
Study-specific outcome measures | |||
RAID (0–10) | ♦ | ♦ | |
- Intervention group A: weekly | ♦ | ||
- Intervention group B: monthly | ♦ | ||
ASES (11–110) | ♦ | ♦ | |
PCS (0–52) | ♦ | ♦ | |
IPAQ-S (METs per week) | ♦ | ♦ | |
PSQI (0–21) | ♦ | ♦ | |
In-app logged usage dataa | ♦ | ||
Educational level (primary/secondary/Bachelor’s/Master’s/doctoral) | ♦ | ||
Prior experience with mHealth (yes/no) | ♦ | ||
Preference to continue using app after study (yes/no) | ♦ | ||
Satisfaction with intervention (VAS) | ♦ | ||