Outcome variable | Measurement tool/Data collection method | Time-point (months) | ||
---|---|---|---|---|
0 | 12 | 24 | ||
Primary outcome | ||||
Difference in mean HRQoL (SF-36) Physical and Mental Health Summary scores at 12 and 24 month follow-up between the latent classes of depression and anxiety determined at baseline | Short Form 36 [47] | ✓ | ✓ | ✓ |
✓ | ✓ | ✓ | ||
Secondary outcomes | ||||
Medical history | ||||
Co-morbidities | Medical records | ✓ | ||
Medications | Self-report discharge scripts | ✓ | ✓ | ✓ |
Clinical indicators | ||||
Serum lipids; HbA1c; FBG; hs-CRP | Medical records | ✓ | ||
Blood pressure; pulse | Clinical assessment | ✓ | ✓ | ✓ |
Waist circumference | Clinical assessment | ✓ | ✓ | ✓ |
Body Mass Index | Clinical assessment | ✓ | ✓ | ✓ |
Diabetes | Self-report diagnosis; HbA1c | ✓ | ✓ | ✓ |
Heart Rate Variability | Clinical assessment | ✓ | ✓ | ✓ |
Depression/anxiety | ||||
Current depressive symptoms | ✓ | ✓ | ✓ | |
Current anxiety symptoms | STAI-S & STAI-T [43] | ✓ | ✓ | ✓ |
Phobic Anxiety | Crown Crisp Index[45] | ✓ | ✓ | ✓ |
Depression/anxiety history | CIDI- Auto 2.1 [50] | ✓ | ✓ | ✓ |
Behavioural measures | ||||
Worry | The Penn State Worry Short Form [48] | ✓ | ✓ | ✓ |
Sleep | Insomnia Severity Index [49] | ✓ | ✓ | ✓ |
Work related outcomes | Self-report | ✓ | ✓ | ✓ |
Economic measures | ||||
Preference-based measure of HRQoL (SF-6D) | Short Form 36 [47] | ✓ | ✓ | ✓ |
Health care utilisation | Self-report | ✓ | ✓ | ✓ |