Table 1.
Endpoint | Measuring instrument | Sources | Baseline | Year 1 | Year 2 | Year 3 |
---|---|---|---|---|---|---|
Cardiovascular events |
eCRF completed with the CCR |
General practitioners |
✓ |
✓ |
✓ |
✓ |
Mortality and cause of death |
Death certificate Family reported |
General practitioners, National Death Index Interview by psychologist |
✓ |
✓ |
✓ |
✓ |
Major depressive disorder |
MINI |
Interview by psychologist |
|
✓ |
✓ |
✓ |
Generalized anxiety disorder |
MINI |
Interview by psychologist |
|
✓ |
✓ |
✓ |
Sociodemographic variables |
Self-report questionnaire |
Interview by psychologist |
✓ |
|
|
|
Personal health habits |
Self-report |
Interview by psychologist |
✓ |
✓ |
✓ |
✓ |
Anthropometric variables |
eCRF completed with the CCR |
General practitioners |
✓ |
✓ |
✓ |
✓ |
Comorbidity and complications |
eCRF completed with the CCR |
General practitioners |
✓ |
✓ |
✓ |
✓ |
Laboratory results |
eCRF completed with the CCR |
General practitioners |
✓ |
✓ |
✓ |
✓ |
Treatment |
eCRF completed with the CCR |
General practitioners |
✓ |
✓ |
✓ |
✓ |
Sleep quantity |
Self-report |
Interview by psychologist |
✓ |
✓ |
✓ |
✓ |
Sleep quality |
AIS |
Interview by psychologist |
✓ |
✓ |
✓ |
✓ |
Personal and family history of psychiatric disorder |
Self-report |
Interview by psychologist |
✓ |
|
|
|
|
CCR |
General practitioners |
||||
Social support |
First item of RSE |
Interview by psychologist |
|
✓ |
✓ |
✓ |
HRQoL | SF-12 | Interview by psychologist | ✓ | ✓ | ✓ |
eCRF: electronic case report forms; CCR: computerized clinical records; MINI: Mini-International Neuropsychiatric Interview; AIS: Athens Insomnia Scale ; SF-12: Short-Form Health Survey.