Table 1 Scheduled assessments during study
Schedule | Baseline | Safety monitoring visita | 4-monthly telephone follow-up | 1-year outcomes assessment (in clinic) | 2-year outcomes assessment (in clinic) |
|---|---|---|---|---|---|
Eligibility assessment | ✓ | ||||
Informed consent | ✓ | ||||
Blood pressure | ✓ | ✓ | ✓ | ||
Anthropometric measures | ✓ | ✓ | ✓ | ||
Socio-demographic information | ✓ | ||||
Personal medical history | ✓ | ||||
Current medication | ✓b | ✓b | ✓b | ||
Family medical history | ✓ | ||||
Tobacco smoking | ✓ | ✓ | ✓ | ✓ | |
Physical activity | ✓ | ✓ | ✓ | ✓ | |
Dietary questionnaire | ✓ | ✓ | ✓ | ||
EQ-5D-5L health questionnaire | ✓ | ✓ | ✓ | ||
Direct and indirect healthcare cost | ✓ | ✓ | ✓ | ||
10-year CVD risk score | ✓ | ✓ | ✓ | ||
Home blood pressure monitoring | ✓ | ✓ | ✓ | ||
Traditional medicine use | ✓ | ✓ | ✓ | ✓ | |
Polyclinic visit or hospitalization since last follow-up | ✓ | ✓ | ✓ | ||
Panel lab tests - Serum sodium, potassium, chloride, creatinine, fasting blood glucose, total cholesterol. High-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglycerides, alanine aminotransferase, urine strip test (blood, protein), glycated hemoglobin (if patient has diabetes) | ✓ | ✓ | ✓ | ||
Urine spot tests - Albumin, sodium, creatinine | ✓ | ✓ | |||
Safety monitoring laboratory tests - Renal (serum sodium, potassium, chloride, creatinine) - Creatine kinase - Alanine aminotransferase | ✓ | ||||
Adverse event reports | ✓ | ✓ | ✓ |