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Table 1 Study assessments schedule

From: Statistical analysis plan for the control of blood pressure and risk attenuation-rural Bangladesh, Pakistan, Sri Lanka (COBRA-BPS) trial: a cluster randomized trial for a multicomponent intervention versus usual care in hypertensive patients

Assessments

Study visits

Screening

Baseline

6-monthly (until 2 years from baseline)

Informed consent

  

Demographics characteristics

  

Systolic and diastolic blood pressuresa

Current blood pressure medications

  

Socioeconomic characteristics

 

 

Medical history

 

 

Concomitant medications

 

Family medical history

 

 

Tobacco smoking status

 

International physical activity questionnaire

 

Dietary questionnaire

 

EQ-5D-5L questionnaire

 

b

MMAS-8 for antihypertensive medication adherence

 

MMAS-8 for statins adherence

 

 

Adiposity measures (BMI, waist circumference)

 

Laboratory tests

 

b

 Serum creatinine

   

 Fasting blood glucose

   

 Total cholesterol

   

 High density lipoprotein cholesterol

   

 Low density lipoprotein cholesterol

   

 Triglycerides

   

 Urine spot albumin

   

 Urine spot sodium

   

 Urine spot creatinine

   

Adverse/serious adverse events

 

Death

  

  1. aOnly measurements taken by independent assessors who will be masked to randomization will be used for the analysis
  2. bTo be assessed only at final follow-up visit